A report by The Rt Hon the Baroness Hallett DBE
Chair of the UK Covid-19 Inquiry
Presented to Parliament pursuant to section 26 of the Inquiries Act 2005
Ordered by the House of Commons to be printed 16 April 2026
HC 1758
Introduction by The Rt Hon the Baroness Hallett DBE
When the Covid-19 pandemic hit the UK, the race was on to develop an effective vaccine and establish the most effective therapeutics (drugs used to treat disease) programme to fight this new and deadly virus.
The vaccination programme was an extraordinary feat. Effective vaccines were developed, produced and delivered to the majority of the population in record time.
Each of the four nations ran its own programme for the delivery of vaccines but all four worked to a very similar timetable – giving vaccines to the most vulnerable first, following a mainly age-based order. The system of prioritisation generally worked well, but there were groups – including some disabled people and their carers, and pregnant women – for whom the system was not as easy to navigate.
For the vast majority of the UK, the vaccines protected people against the most serious effects of Covid-19 and saved lives. They also played an important role in reducing the spread of the virus. They reduced the number of people who required hospitalisation or intensive care, thereby taking pressure off the healthcare systems of the four nations. Over time, this helped to reduce the need for lockdown restrictions and to ease some of the damaging effects of the pandemic on society.
Any vaccine carries with it a risk for a small minority of people and the Inquiry acknowledges the suffering of those for whom vaccines led to serious injury or death. There were, however, effective systems in place to assess the safety and efficacy of Covid-19 vaccines and therapeutics. These included rigorous trials and regulatory approval processes and the taking of prompt action when any problem was identified. On any objective analysis, the risks of the Covid-19 vaccines were carefully managed and were far outweighed by the benefits.
Nonetheless, in the context of a whole-population vaccination programme, when governments ask people to be vaccinated in part to protect others, there must be appropriate financial support for those rare cases of people suffering side effects. The current system of payment for those injured as a result of having a Covid-19 vaccine requires reform.
Vaccines were not the answer for everyone. Many vulnerable people cannot take vaccines and needed effective therapeutics to treat Covid-19. These too were identified at speed.
Furthermore, a small number of people in the UK declined to take up the offer of a vaccine and we explore the reasons for this vaccine hesitancy in this Report. The lack of confidence in Covid-19 vaccinations was a global issue driven by the sharing of false information online and fuelled by the fact that the vaccines were new. While this is not something the Inquiry could address conclusively, and also goes beyond Covid-19, it is clear that a lack of trust and confidence in governments and health systems in the UK underlaid susceptibility to false information about Covid-19 vaccines. Action is needed in all four nations to build trust within communities with lower vaccine uptake and to make vaccines more accessible to them, before the next pandemic hits.
Overall, the programmes were a great success. The success was due to the UK’s position as a world leader in biomedical science, with talented teams of doctors, scientists and researchers supported by the UK’s academic institutions, to the skills of those involved in managing the programmes and to the fact that the UK government took an at-risk approach to funding. It was willing to invest substantial sums of money in a wide range of potential vaccines and drugs, knowing that not all of them would be successful. All those involved deserve great credit.
However, the success in the development of vaccines and identification of drugs can only be repeated, when the next pandemic strikes, if there is a continued commitment to maintaining the UK’s research capabilities and infrastructure.
Module 4 considered 168 witness statements and more than 20,000 documents, as well as receiving five expert reports. During its public hearing in January 2025, 47 witnesses provided evidence including representatives of bereaved groups, vaccine injured and vaccine bereaved groups, groups representing the clinically vulnerable, and members of communities who faced barriers to vaccination. I thank them for their assistance and also thank those who contributed to the Inquiry’s listening exercise, Every Story Matters and to the impact film, together with the 31 Core Participants and their representatives, and the Inquiry’s secretariat and legal team.
The Rt Hon the Baroness Hallett DBE
16 April 2026
Voices
Peter was – he always kept himself fit. And he followed the rules. We all did. And it just seems to us, as parents, is that we did everything right, and yet Peter lost his life still. As did so many of similar families who are in our group, and I believe all of our families really deserve to be heard, and for those cases to be taken into account.1
My mother was 90 and had kidney disease so we were aware that Covid-19 posed a high risk. Otherwise she was fit and healthy. She was a country woman from Cookstown and nothing would get her down. She was still driving. If there had been the option to have the benefit of the vaccine at an earlier stage of the process, she would have taken it.2
Every day I’m filled with gratitude that [Jamie is] still alive, but his brain injury is the size of a credit card. His relationship with me and, mostly, his relationship with our children will never be the same again. And I have this constant conflict of that gratitude with the grief that goes with how different life is, and then the guilt for the others in our group who I know would just want five more minutes with their loved one.3
I asked if [my father] could have the vaccination as he was vulnerable and immune suppressed and likely to remain in hospital for a prolonged period. I was told that it wasn’t feasible. My father died of hospital acquired Covid-19 on the 26 January 2021. Devastatingly, my father received his vaccine invitation letter a week after his death.4
The researchers certainly had ample potential for research given the numbers of people in hospital … Sadly, neither the research re treatment nor the vaccination were of use to my mum. My husband was 6 weeks away from having his first vaccination when he died.5
When it was confirmed that the vaccine was available, the first thing I felt was, personally, it brought me hope, because I was in a hopeless situation at that time, and that’s why I wanted to be first on the list. It felt like there was light at the end of the tunnel, that was very reassuring.6
We need to look now at the total chaos surrounding clinically vulnerable people trying to access antiviral treatments when they catch Covid. There are absolute horror stories within this group of being told when catching the virus to contact their GP, who knows nothing, NHS 111, who ask them to then ring the GP, or to attend an A&E department with unmasked patients and medical staff.7
- Helena Rossiter 15 January 2025 60/17-23
- INQ000474358_0004 para 12
- Kate Scott 15 January 2025 152/1-9
- INQ000413805_0004-0005 para 15
- INQ000472173_0013 para 50
- Every Story Matters: Vaccines and Therapeutics, p11 (INQ000474465)
- Every Story Matters: Vaccines and Therapeutics, p49 (INQ000474465)
Executive summary
The UK authorised and delivered effective vaccines and therapeutics to the public within a year of the first identified case of Covid-19 in the UK in January 2020. One of the vaccines had also been developed in the UK.
The first person in the world to receive a Pfizer/BioNTech Covid-19 vaccination outside a clinical trial was 90-year-old Margaret Keenan at her local hospital in Coventry on 8 December 2020. The delivery of this vaccine kickstarted a UK-wide vaccination rollout which exceeded targets for population coverage. Therapeutics (drugs used to treat disease) were also introduced within months of the pandemic being declared. By June 2020, the drug dexamethasone was being used to save the lives of Covid-19 patients in hospital, having been made available within hours of the positive result from a clinical trial proving its effectiveness.
These achievements showcased many of the best attributes of the UK’s health and scientific research systems. The UK’s position as a world leader in biomedical science, with talented teams of scientists and researchers supported by the UK’s academic institutions, fuelled the rapid discovery and development of vaccines and therapeutics. The universal public health system in each of the four nations allowed whole-population delivery of vaccines to be coordinated and efficiently managed. The dedication of health and care staff to deliver vaccines at an unprecedented rate and the public resolve to participate in the programme to protect those around them were major factors in so many people taking up the vaccine offer.
The Inquiry has identified a number of key elements of the UK response that enabled it to develop or discover effective vaccines and therapeutics within less than a year of the pandemic threat emerging:
- the rapid and coordinated funding for research into vaccines and therapeutics;
- an expedited regulatory approval and recruitment system for clinical trials, as well as expedited authorisation of new vaccines and therapeutics, without compromising on public safety;
- the rapid establishment of specialist vaccine and therapeutic taskforces, which brought together national expertise and acted decisively to coordinate the search for effective vaccines and drugs; and
- the adoption of an at-risk approach to vaccine procurement by funding research on and development of a wide range of vaccine candidates, knowing that some would not be successful, to create as many opportunities as possible to discover an effective vaccine.
There is therefore much to be retained and built upon.
However, weaknesses in the UK’s preparedness to develop and deliver vaccines and therapeutics were also exposed during the pandemic.
The UK was in some ways fortunate that the timing of Covid-19 coincided with the coming to fruition of decades of global research about technologies that could quickly be adapted and used to create vaccines. In relation to therapeutics, preparedness was focused on the stockpiling of antivirals for an influenza pandemic.
The UK also entered the Covid-19 pandemic without sufficient drug and vaccine manufacturing capability. The UK has already taken action in a number of ways to respond to some of the issues exposed in the pandemic in relation to the discovery, development and manufacture of vaccines and therapeutics. The 100 Days Mission is a global initiative in which the UK has committed to work towards the development of diagnostics, therapeutics and vaccines so that they are available within the first 100 days of a pandemic threat being identified.
It is vital to continue investing in the UK’s research and development capabilities so that it can be at the cutting edge of vaccine and therapeutic development. Strategic thinking across government is needed, to ensure that a diverse range of vaccine and therapeutic technologies are at the UK’s disposal in the event of a future pandemic.
It is important that the UK maintains robust regulatory systems for authorisation and post-authorisation monitoring (the systems of surveillance to check for the emergence of side effects once vaccines or therapeutics are in clinical use). There must be safeguards in place to ensure that vaccines are sufficiently safe for public use, both to protect the public and to give the public confidence in government information about the safety of vaccines.
In examining vaccine safety, the Inquiry’s focus has been on the systems and processes in place. It is neither proportionate nor practicable for the Inquiry to reach a view on the safety of particular vaccines or causation in specific cases of alleged injury or death, or to attempt to quantify the precise risks of vaccination. In any event, any conclusion on the safety of specific vaccines, as opposed to the relevant systems and processes, may be of limited value in the context of preparing for a future – perhaps non-coronavirus – pandemic.
Module 4 has examined these systems and found that, despite the urgency of the task and the speed at which vaccines were developed, the steps taken by the UK government and regulatory bodies did not compromise the UK’s rigorous safety standards. To further strengthen this work, regulators should have access to up-to-date patient data from across the UK to allow for quick and comprehensive monitoring of the effects of new vaccines or therapeutics on the population.
The delivery of vaccines was, overall, a success. The vaccines were delivered in each nation according to a clear order of prioritisation via national healthcare systems, which were well equipped to coordinate distribution. However, the Inquiry has identified a number of groups for whom the vaccination programme did not work well and who were unable to, or did not want to, take up the offer of a vaccine. Most pressingly, there was lower uptake of vaccinations in communities with greater levels of deprivation and in some ethnic minority groups. These disparities were predictable, and more targeted action should be taken before the next pandemic to communicate with these communities and to build understanding about vaccines and confidence in the safety of vaccination programmes.
Vaccine hesitancy is on the rise across the world and in the UK. The use of social media and instant messaging means that false or misleading information about vaccines can spread rapidly. The UK must take action to build confidence in vaccines before the next pandemic hits. Vaccines save lives and are most effective in preventing transmission when taken by as much of the eligible population as possible. It is in the interests of everyone in the UK that communities who have been left behind in the past are included in the benefits of vaccination in the future.
The Inquiry acknowledges the suffering of those for whom vaccines led to serious injury and death. It is imperative that a sufficiently supportive government scheme is in place to help the minority of people (and their loved ones) who suffer serious injury following vaccination.
In order to ensure that the UK is in a strong position to develop and deliver vaccines and therapeutics to fight the next pandemic, the Inquiry recommends:
- establishing a pharmaceutical expert advisory panel to oversee the UK’s preparedness to develop, procure and manufacture pharmaceuticals (vaccines and therapeutics);
- producing targeted vaccination strategies and communications in order to increase vaccine uptake and reduce inequalities, including consulting with local networks about communication campaigns and delivery approaches;
- improving monitoring and evaluation of vaccine uptake and delivery in order to understand the measures proven to be effective in increasing vaccine uptake;
- facilitating regulatory bodies’ access to healthcare records for the purposes of post-authorisation safety monitoring of new vaccines and therapeutics; and
- reforming the Vaccine Damage Payment Scheme as soon as possible, with an increase in the minimum payment awarded to those injured by a vaccine and a fairer system for determining payment.
A full list of the Inquiry’s recommendations is included in Appendix 3.
Chapter 1: The landscape of vaccines and therapeutics
Introduction
| 1.1. | On 11 March 2020, the World Health Organization declared Covid-19 a global pandemic. Covid-19 was caused by a new pathogen – severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – and there were no authorised vaccines or treatments available for it at the onset of the pandemic. |
| 1.2. | By the end of 2020, the UK had access to the Pfizer/BioNTech vaccine, the Oxford/AstraZeneca vaccine and the Moderna vaccine. These were the first three vaccines approved for use in the UK and were taken by the majority of people in the UK who received a vaccine. The UK began vaccinating in December 2020, before any other European country.1 By September 2022, more than 150 million doses of Oxford/AstraZeneca, Pfizer/BioNTech and Moderna vaccines had been used in the UK.2 These vaccines offered significant protection against serious illness and death.3 Therapeutics were also used to target Covid-19, as well as to treat the inflammatory complications and boost the immune system. For example, it is estimated that the drug dexamethasone (already authorised for the treatment of other medical conditions prior to the pandemic) saved the lives of about 22,000 Covid-19 patients in the UK and a million lives globally by March 2021.4 |
| 1.3. | This chapter explains the types of vaccines and therapeutics that were widely used during the Covid-19 pandemic, and details the existing vaccination programmes and levels of vaccine uptake and confidence prior to the pandemic. This chapter also looks at the state of the UK’s capability to develop or secure vaccines at scale entering the Covid-19 pandemic. |
Understanding types of vaccines and therapeutics
Vaccines
| 1.4. | Vaccines are used to reduce the severity of a disease in an individual or prevent its transmission to others. It is not always possible to develop a vaccine to fight a disease. Where it is possible, the process of discovering, developing, testing, manufacturing and distributing vaccines takes time and, if an outbreak is widespread, people may die or become seriously ill before they can receive an effective vaccine.5 |
| 1.5. | Traditional vaccines introduce an inactivated (ie dead) or attenuated (ie weakened) form of a bacterium or virus into the body. This prompts the immune system to produce antibodies and, if the virus or bacterium is encountered again, the immune system response is considerably swifter and more effective.6 This type of ‘whole virus’ vaccine technology was well established and widely used in vaccines before 2020 – for example, in the polio and the combined measles, mumps and rubella (MMR) vaccines.7 |
| 1.6. | Vaccines that contain protein fragments of a bacterium or virus – such as that for hepatitis B – are another well-established vaccine technology. Combined with an adjuvant (a substance that helps to strengthen the body’s immune response), these protein vaccines prompt the body to fight the bacterium or virus when encountered.8 |
| 1.7. | There are two newer forms of vaccine technology which, before 2020, were the subject of research but had not yet been used to produce vaccines released to the public.9 |
| 1.8. | The first is adenoviral vector vaccine technology. Adenovirus is a type of virus that can be modified so that it cannot cause disease but can enter the cells of the body. The adenovirus vaccine contains the genetic blueprint of the spike protein from the virus being targeted. Once the adenovirus has entered the body’s cells the spike protein is produced, which stimulates the immune system to make antibodies against the targeted virus. This technology was tested in vaccines for flu, the Zika virus, the tropical disease chikungunya and Middle East respiratory syndrome (MERS) and was approved in the European Union for an Ebola virus disease vaccine. During the first year of the pandemic, this technology was developed to produce the Oxford/AstraZeneca vaccine.10 |
| 1.9. | The other newer form of vaccine technology is the messenger ribonucleic acid vaccine, known as mRNA. It carries a molecule that instructs cells in the body to produce protein that matches the spike protein of a virus. The body then produces antibodies and defensive white blood cells to attack the spike protein, offering protection in the event of infection.11 This technology had been the subject of research for several decades, including by scientists researching how mRNA might provide protection against cancer.12 In 2020, this research was adapted and ultimately used to produce the Pfizer/BioNTech vaccine – the first vaccine delivered in the UK on 8 December 2020 – and the Moderna vaccine.13 |
Therapeutics
| 1.10. | There are people for whom vaccines do not work or who cannot receive a vaccine – for example, due to an underlying medical condition or a suppressed immune system. For such groups, therapeutics and prophylactics are particularly important. In any event, they are important for the whole population pending development of a vaccine.14 |
| 1.11. | Therapeutics is a branch of medicine that deals with the treatment of disease. In this Report, the term ‘therapeutics’ is also used to refer to medicines or drugs used in the prevention of disease such as Covid-19.15 Therapeutics can be used in a number of ways, including to reduce the likelihood of death in the severely ill and the chance of becoming seriously unwell in someone with mild symptoms. When given for prevention, these medicines are known as prophylactics (although they may be the same drugs that are used to treat the infection).16 In the context of Covid-19, some categories of drugs proved to be particularly important in treatment of the disease. Three of these are the focus of this Report:
|
| 1.12. | Antivirals and neutralising monoclonal antibodies work best when they are given early in the course of an infection but some may still provide some benefit at a later stage of infection. Both antivirals and antibodies (unlike anti-inflammatory drugs) can potentially be used to prevent disease.20 |
Attitudes to vaccination
| 1.13. | It is important to examine what more can be done to instil vaccine confidence and to overcome barriers to vaccine uptake and the impact of misinformation. This requires an understanding of attitudes to vaccination prior to the pandemic (discussed further in Chapter 6: Disparities in vaccine uptake). |
| 1.14. | Entering the Covid-19 pandemic, there were a range of vaccination programmes in the UK offered to the whole population, either within particular age groups or among those with underlying health conditions or in pregnancy. These were well-established and successful vaccination programmes.21 Since the World Health Organization launched its main global childhood vaccination programme in 1974, the lives of an estimated 154 million children have been saved through routine vaccination.22 The influenza vaccine was estimated to have prevented about 100,000 hospitalisations in the 2024/25 influenza season in England alone.23 |
| 1.15. | The UK has one of the most extensive immunisation programmes in the world, and perceptions of vaccines compare relatively favourably with most European countries.24 However, closer examination of differences in the rates of vaccination in pre-Covid-19 routine vaccination programmes highlights disparities in vaccination rates across the population and changes in vaccination uptake over the decade leading up to 2020. |
| 1.16. | Influenza vaccination rates were about 70% in over-65s across all four nations of the UK in the main seasonal influenza vaccination period from the autumn of 2018 to the spring of 2019, rising to more than 75% by 2020/21 during the same seasonal vaccination period.25 There were, however, inequalities in influenza vaccination uptake in this period, most notably a lower uptake among people who lived in areas of socio-economic deprivation and among some ethnic minority groups.26 |
| 1.17. | In childhood vaccination programmes, vaccination coverage (those who received the routine recommended immunisations by their second birthday) was generally high in the UK, reaching above 90% (ie 90% of children had received their recommended vaccinations) in most nations and regions, according to data collected between 2011 and 2012.27 However, childhood vaccination rates in the UK fell in the years leading up to 2019.28 |
| 1.18. | In particular, the vaccine for measles (a highly contagious airborne virus which can cause serious complications and death, particularly in children), which is part of the routine vaccination programme in the form of the combined MMR vaccine, has seen the greatest fall in coverage. The World Health Organization advises a target of 95% coverage to maintain measles elimination – the absence of endemic measles circulation for at least 12 months. The 95% target has never been met in England, which peaked just short of this target around 2009 to 2010.29 The UK achieved measles elimination in 2016 and 2017, but by 2018 measles transmission had been re-established in the UK, at a time when Europe was experiencing large epidemics.30 The lowest rates of routine childhood vaccination were in London, which dropped to 83% for MMR vaccinations by the beginning of 2019.31 Lower rates of childhood immunisation were consistently observed among some minority ethnic communities in the UK, including migrant populations, Traveller communities and Black British groups, from the mid-1990s onwards.32 London had the lowest uptake of all routine immunisations in the decade before 2019.33 |
| 1.19. | Vaccine hesitancy, or a reduction in public confidence in vaccines, was a significant danger on the horizon at the beginning of the Covid-19 pandemic. Unfortunately, recent figures suggest that vaccination rates are continuing to fall across Europe, leading to a resurgence in preventable childhood diseases, such as measles and whooping cough (pertussis).34 Vaccine confidence generally must be encouraged and supported and this decline reversed. |
Preparedness to respond to pandemic disease
| 1.20. | The UK’s previous experience of preparing for mass vaccination and therapeutics supply in an emergency scenario before Covid-19 was the 2009 to 2010 H1N1 influenza pandemic (‘swine flu’).35 In a 2010 review into the UK’s response, Dame Deirdre Hine found that the UK government had made wide-ranging preparations in respect of vaccines and therapeutics. It had substantial stockpiles of drugs, and plans to purchase vaccines sufficient to protect the whole of the UK population with two doses via a GP-based vaccination delivery programme.36 |
| 1.21. | During H1N1, the Joint Committee on Vaccination and Immunisation advised the UK government on prioritisation of vaccination in the context of limited supply, with the primary objective of reducing death and illness from infection. The groups most vulnerable to death and serious illness from H1N1 infection included younger people, pregnant women and those with underlying medical conditions. The most vulnerable people, along with front-line health and social care workers, were prioritised for vaccination. Dame Deirdre Hine found this system also worked well.37 |
| 1.22. | The later global Ebola crisis led to the establishment of the UK Vaccine Network in 2015.38 It was created to address the perceived lack of incentive for the pharmaceutical industry to investigate the development of vaccines for intermittent infectious disease outbreaks and epidemics in low-income countries.39 Chaired since its inception by Professor Sir Christopher Whitty (Chief Medical Officer for England from October 2019), the network includes industry, academia and funding bodies and advises the Department of Health and Social Care on research and development investment relating to infectious diseases with the potential to cause an epidemic in low and middle-income countries.40 |
| 1.23. | In 2016, the UK Vaccine Network developed a list of 12 priority pathogens for UK government investment to maximise global health security.41 Influenza was excluded from this list on the grounds that there were separate funding routes.42 The work of the UK Vaccine Network led to investment in new vaccine platform technologies. It began funding research and development projects in 2016 and by the end of March 2020 had committed £77 million in funding for vaccine development. This included supporting the development of a vaccine aimed at MERS, one of the 12 prioritised pathogens, using innovative adenoviral vector vaccine technology. This technology was later adapted and ultimately became the Oxford/AstraZeneca Covid-19 vaccine.43 |
| 1.24. | In 2017 and 2018, the World Health Organization produced an annual review of diseases that posed a risk and needed to be prioritised for research and development. Pathogens that were well known and for which vaccines already existed, such as influenza, were not included. A group of closely related coronaviruses, including MERS and severe acute respiratory syndrome (SARS), were included, as was ‘Disease X’ (ie an infectious disease that is currently not known to infect humans but could cause a serious epidemic or pandemic), to acknowledge that the next pandemic might be caused by a new or as yet unknown highly pathogenic infection.44 Disease X was also included in the UK Vaccine Network’s list of priority pathogens.45 |
| 1.25. | However, when the pandemic struck, influenza was the focus of UK government pandemic preparedness and plans for a novel virus such as Covid-19 were not in the same state of readiness. |
| 1.26. | Sir Jeremy Farrar, Director of Wellcome (a global charitable foundation formerly known as the Wellcome Trust) from October 2013 to February 2023, who chaired the Scientific Advisory Group of the World Health Organization’s research and development blueprint group, told the Inquiry that there was “very little attention paid” to the concept of Disease X globally, including in the UK.46 Professor Sir Jonathan Van-Tam (Deputy Chief Medical Officer for England from October 2017 to March 2022) said that, in the period preceding the Covid-19 pandemic, the majority of UK government efforts and resources in vaccine development were focused on an influenza pandemic. He explained:
“I think I agree with what the Inquiry has already said: that there was a very substantial focus on pandemic influenza, as the threat, perhaps the only threat, and there hadn’t been that diversity of thinking to the same extent about other pathogens.” 47 |
| 1.27. | In Professor Van-Tam’s view, it was appropriate that influenza should have been the primary forecast as the most likely pathogen to spark a pandemic, both then and now. However, he agreed that attention must also be paid to Disease X.48 |
| 1.28. | Dame Kate Bingham (Chair of the Vaccine Taskforce from May to December 2020) explained that, while previous outbreaks had led to increases in new vaccine technologies, there was no apparent government plan for the vaccine response to Disease X. By 2020, the Department of Health and Social Care’s expertise and plans in the vaccine field were “narrow and constrained”.49 They were based too much on influenza models, which did not sufficiently consider the consequences of asymptomatic transmission of a virus about which very little was known.50 |
| 1.29. | According to Professor Sir Andrew Pollard (Professor of Infection and Immunity at the University of Oxford and Chief Investigator for the clinical trials of the Oxford/AstraZeneca vaccine), it was extraordinary that the University of Oxford (with AstraZeneca) was able to develop a coronavirus vaccine. He noted:
“[T]he pandemic happened at the right moment in history when a series of critical building blocks were in place that meant that the personalities, capacity, skills, know-how and infrastructure, and an enabling environment in the University were all in place at the same time.” 51 |
| 1.30. | There are limits to the extent to which vaccines (and therapeutics) can be developed to tackle novel pathogens. It was reasonable to focus significant attention on planning for the possibility of an influenza pandemic, rather than other known pathogens, because this was – and remains – the most likely scenario for a pandemic affecting the UK. Further, the UK government had supported research and development for vaccines aimed at pathogens of pandemic potential as part of the work of the UK Vaccine Network (which included research that eventually led to the Oxford/AstraZeneca vaccine).52 However, the evidence from Sir Jeremy Farrar and others suggests that vaccine preparation for a non-influenza pandemic did not receive enough attention. |
| 1.31. | As part of its influenza pandemic preparedness programme, the UK had stockpiled antivirals for treatment of pandemic influenza sufficient to treat 50% of the UK’s population. It had also stockpiled antibiotics for treatment of secondary bacterial infections. The stockpiled quantities were considered by the UK government to be sufficient to meet the reasonable worst-case scenario in an influenza pandemic.53 |
| 1.32. | In order to develop therapeutics specific to the relevant pathogen, and to treat associated conditions and infection, it is vital that, at the start of a pandemic, as wide a variety of drugs as possible are available, including repurposed drugs (ie drugs which have been authorised for the treatment of other diseases).54 |
| 1.33. | The UK had a good clinical trial infrastructure and was relatively well placed to test repurposed drugs during the pandemic. It led some of the world’s foremost clinical trials for repurposing therapeutics, with results published ahead of other countries. It was a UK trial, for example, that established the very significant benefits of dexamethasone, the repurposed anti-inflammatory drug, for severely ill hospitalised patients. This is addressed further in Chapter 2: Discovery and development. |
| 1.34. | The Inquiry was told that the development of new therapeutics and the identification of repurposed therapeutics are generally more complex than the development of vaccines. This is due to the wide range of treatment types, varying patient responses, evolving population immunity and diverse delivery methods, all of which make the clinical trials of therapeutics less straightforward.55 Professor Wendy Barclay, Action Medical Research Chair of Virology at Imperial College London and a member of the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) from 2014, observed that the preparedness to find therapeutics for Disease X or Covid-19 was “at an even lower status” in January 2020 than for vaccines.56 She noted that this was probably because vaccines are often generated using technologies that can be more easily switched between pathogens.57 |
| 1.35. | Matt Hancock MP, Secretary of State for Health and Social Care from July 2018 to June 2021, said that whether the UK was well prepared to rapidly develop therapeutics to treat Disease X in early 2020 was “a difficult question to answer”, as a therapeutic is necessarily the treatment of an existing disease and without knowledge of the disease it cannot be planned for.58 Mr Hancock accepted in large part, however, that there was little in the way of a vaccine and therapeutic plan in place for dealing with Disease X.59 |
| 1.36. | When the UK entered the Covid-19 pandemic, one weakness in its ability to produce vaccines and therapeutics was a lack of manufacturing capacity. In relation to therapeutics, the Inquiry was told that the UK’s capacity for manufacturing antibodies was particularly limited.60 When it came to vaccines, Mr Hancock noted that, while the UK was in an “excellent position with respect to research and development”, this was not the case with respect to manufacturing.61 The UK was home to some of the world’s largest pharmaceutical companies but most commercial production took place outside the UK.62 |
| 1.37. | Historically, most vaccines had been developed by academic institutions and small and medium-sized commercial producers, which lacked the capability and capacity to manufacture at speed and on a nationwide scale.63 Bulk manufacturing facilities were not extensive, although the UK had a number of smaller, flexible bioprocessing manufacturing sites and many skilled workers in the industry.64 |
| 1.38. | At the start of 2020, the UK had no dedicated manufacturing capability for mRNA vaccines, which at that time were more recent innovations yet to be authorised for use.65 In 2018, a grant of about £65 million was made to the Vaccine Manufacturing and Innovation Centre, which had been created with the aim of promoting, developing and accelerating UK leadership in new vaccine production, technology and manufacturing.66 Unfortunately, after what Professor Sir John Bell (Regius Professor of Medicine at the University of Oxford) described as a “very considerable amount of dithering”, the centre was not operational when the pandemic hit in 2020 and at that time construction was not expected to finish until at least 2022.67 While the centre’s original purpose had been to support innovation in vaccine manufacture (as opposed to manufacturing vaccines at scale), the project’s focus was changed during the pandemic to provide additional vaccine manufacturing capacity.68 (The centre is discussed further in Chapter 3: Securing supplies.) |
| 1.39. | The UK was fortunate that many of the critical building blocks required to develop vaccines quickly, such as world-leading biomedical and clinical research infrastructure and well-progressed global mRNA research, were in place. These may not be available in the next pandemic. It is vital that investment in life sciences is maintained. The UK government must also ensure that its strategy and underlying plans for future pandemics are sufficiently diverse – including in terms of vaccines and therapeutics – to meet a range of threats, including those that are unknown. This Report sets out key lessons, from discovery to delivery, that should frame that work. |
- INQ000474250_0008-0009 para 28; INQ000474337_0059 para 194; see also INQ000474590_0029 para 87. This Report focuses on the three Covid-19 vaccines that were authorised for use and deployed in the period between December 2020 and 28 June 2022: the Pfizer/BioNTech vaccine (a vaccine developed by US-headquartered company Pfizer and German-headquartered company BioNTech and based on messenger ribonucleic acid, or mRNA, vaccine technology); the Oxford/AstraZeneca vaccine (an adenoviral vector vaccine developed in the UK by the University of Oxford and UK-headquartered company AstraZeneca); and the Moderna vaccine (an mRNA vaccine developed by US-headquartered company Moderna).
- A Review of the Vaccine Taskforce, Department of Health and Social Care, 31 August 2023, p5 (https://www.gov.uk/government/publications/a-review-of-the-vaccine-taskforce/a-review-of-the-vaccine-taskforce; INQ000283321)
- INQ000474703_0068-0069 para 5.185
- INQ000474624_0020 para 97; INQ000474525_0037-0038 para 143
- INQ000474743_0006 para 1.3
- INQ000485977_0013 para 45
- INQ000474406_0014 para 10.2; ‘Types of vaccine’, University of Oxford, April 2021, p2 (https://vaccineknowledge.ox.ac.uk/types-of-vaccine#Whole-Pathogen-Vaccines; INQ000330772)
- ‘Protein subunit vaccines – What they are, and what they are not’, Coalition for Epidemic Preparedness Innovations, 13 March 2025 (https://cepi.net/protein-subunit-vaccines-what-they-are-and-what-they-are-not; INQ000662003); INQ000474250_0008 para 24(c); INQ000474703_0010 para 2.3
- INQ000474406_0014 para 10.2
- INQ000474703_0009 para 2.3; ‘Adenoviral vector vaccine platforms in the SARS-CoV-2 pandemic’, SA Mendonça, R Lorincz, P Boucher and DT Curiel, npj Vaccines (2021), 6(97), 5 August 2021 (https://doi.org/10.1038/s41541-021-00356-x; INQ000662001); ‘Immune-mediated approaches against COVID-19’, HF Florindo, R Kleiner, D Vaskovich-Koubi, RC Acúrcio, B Carreira, E Yeini et al, Nature Nanotechnology (2020), 15, p29 (https://doi.org/10.1038/s41565-020-0732-3; INQ000377505); ‘Current state of Ebola virus vaccines: A snapshot’, C Woolsey and TW Geisbert, PLoS Pathogens (2021), 17(12) (https://doi.org/10.1371/journal.ppat.1010078; INQ000508029)
- ‘What are mRNA vaccines and how do they work?’, UK Health Security Agency, 11 March 2024 (https://ukhsa.blog.gov.uk/2024/03/11/what-are-mrna-vaccines-and-how-do-they-work; INQ000662005); INQ000474703_0009 para 2.3
- INQ000474401_0025 para 6.17; Jonathan Van-Tam 20 January 2025 138/22-139/9
- INQ000474703_0009 para 2.3; INQ000485977_0014 para 48
- INQ000474743_0005-0007 paras 1.1-1.5; INQ000474401_0078-0079 para 7.17
- Drugs are active substances that create physiological effects on the body (which can be positive or negative), whereas medicines refer to drugs used in the treatment of disease with the aim of alleviating symptoms or curing the condition. However, the terms ‘drugs’, ‘medicines’ and ‘therapeutics’ are generally used interchangeably in the evidence received by the Inquiry and in this Report.
- INQ000474743_0006-0007 paras 1.4-1.5. In the case of an infectious disease, prophylactics are used to reduce the risk of a person developing the infection (pre-exposure prophylaxis), or to try to prevent illness if they have been exposed and may have already caught it (post-exposure prophylaxis).
- INQ000474743_0007 para 1.6.1
- INQ000474743_0005, 0007 paras 1.1, 1.6.2
- INQ000474743_0007-0009 paras 1.6.3, 1.10
- INQ000474743_0009-0010 paras 1.10-1.12
- INQ000474705_0010, 0018-0019, 0023 paras 17, 44.1-44.2, 49.5
- ‘Global, regional, and national trends in routine childhood vaccination coverage from 1980 to 2023 with forecasts to 2030: A systematic analysis for the Global Burden of Disease Study 2023’, The Lancet (2025), 406(10500) (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01037-2/abstract?utm_campaign=tlpr&utm_medium=email&_hsenc=p2ANqtz–Ih5kecNHBKCwhB8UCmq-g3K7w21_8lcganDUROoRQ9kv6BGR1VPjsh1UGxtzBg2kd1Cv6ccGFOD6M6_iuJEsyILIHDgvezPAojxPAGPHN_frhZAM&_hsmi=367755667&utm_content=367755667&utm_source=hs_email; INQ000652273)
- ‘Flu vaccine prevented around 100,000 hospital admissions’, HM Government, 22 May 2025 (https://www.gov.uk/government/news/flu-vaccine-prevented-around-100000-hospital-admissions; INQ000652398)
- INQ000474334_0010 para 20; INQ000474705_0018-0019 paras 42-44
- INQ000474623_0151 Table 27. The data for influenza vaccination rates in over-65s in the 2020/21 seasonal vaccination period were 80.9% in England, 79.6% in Scotland and 76% in Wales; Northern Ireland was not included.
- INQ000474623_0067-0068, 0152-0153 paras 212-213
- INQ000474705_0017. The 2011 to 2012 data available to Professor Larson did not include Scotland, and the data for Scotland in the table at page 17 reflect the position in Scotland in 2014.
- The routine vaccinations are diphtheria, tetanus and pertussis, inactivated polio and influenza (DTaP/IPV/Hib), measles, mumps and rubella (MMR), and influenza and meningitis-C (Hib/MenC) vaccines. The only exception was MMR and Hib/MenC vaccination rates in Wales, which slightly increased. The Scottish data began in September 2014. See INQ000474705_0017.
- Risk Assessment for Measles Resurgence in the UK, HM Government, 14 July 2023, p3, 12 (Appendix 1) (https://www.gov.uk/government/publications/measles-risk-assessment-for-resurgence-in-the-uk; INQ000548395)
- Risk Assessment for Measles Resurgence in the UK, HM Government, 14 July 2023, p7 (https://www.gov.uk/government/publications/measles-risk-assessment-for-resurgence-in-the-uk; INQ000548395)
- INQ000474705_0017
- INQ000474705_0012 para 22; Risk Assessment for Measles Resurgence in the UK, HM Government, 14 July 2023, p7
(https://www.gov.uk/government/publications/measles-risk-assessment-for-resurgence-in-the-uk; INQ000548395) - INQ000474705_0016 para 39
- ‘Childhood vaccination rates lag in Europe – fueling further resurgence of measles and whooping cough’, World Health Organization, 15 July 2025 (https://www.who.int/europe/news/item/15-07-2025-childhood-vaccination-rates-lag-in-europe—fueling-further-resurgence-of-measles-and-whooping-cough; INQ000659837); ‘European Region reports highest number of measles cases in more than 25 years – UNICEF, WHO/Europe’, World Health Organization, 13 March 2025 (https://www.who.int/europe/news/item/13-03-2025-european-region-reports-highest-number-of-measles-cases-in-more-than-25-years—unicef–who-europe; INQ000659838); Childhood Immunisation Statistics, Shadi Danechi, House of Commons Library, 23 May 2025, pp6-10 (https://commonslibrary.parliament.uk/research-briefings/cbp-8556; INQ000659836)
- INQ000474623_0010 para 15
- The 2009 Influenza Pandemic: An Independent Review of the UK Response to the 2009 Influenza Pandemic, Dame Deirdre Hine, July 2010, pp3, 13-14, 118-119, paras 1, 29-30, 7.23-7.25 (https://assets.publishing.service.gov.uk/media/5a7975f1ed915d0422068a10/the2009influenzapandemic-review.pdf; INQ000022705)
- The 2009 Influenza Pandemic: An Independent Review of the UK Response to the 2009 Influenza Pandemic, Dame Deirdre Hine, July 2010, pp116-117, 125-126, paras 7.17-7.20, 7.45 (https://assets.publishing.service.gov.uk/media/5a7975f1ed915d0422068a10/the2009influenzapandemic-review.pdf; INQ000022705)
- INQ000474334_0035-0036 paras 122-123
- INQ000474401_0012 para 4.11
- Module 1: The resilience and preparedness of the United Kingdom, UK Covid-19 Inquiry, July 2024, Appendix 3 (https://covid19.public-inquiry.uk/documents/module-1-full-report)
- INQ000474334_0036 paras 124-125. A priority pathogen is a disease that should be prioritised for research and development because of the risk it poses to biosecurity.
- ‘UK vaccines network: Mapping priority pathogens of epidemic potential and vaccine pipeline developments’, RJ Noad, K Simpson, AR Fooks, R Hewson, SC Gilbert, MP Stevens et al (2019), 37(43), 6241-6247, p6242 (https://www.sciencedirect.com/science/article/pii/S0264410X19311971; INQ000183378)
- INQ000474334_0036-0037 paras 125-127
- Module 1: The resilience and preparedness of the United Kingdom, UK Covid-19 Inquiry, July 2024, Chapter 5 (https://covid19.public-inquiry.uk/documents/module-1-full-report)
- ‘UK vaccines network: Mapping priority pathogens of epidemic potential and vaccine pipeline developments’, RJ Noad, K Simpson, AR Fooks, R Hewson, SC Gilbert, MP Stevens et al (2019), 37(43), 6241-6247, p6243, Figure 1 (https://www.sciencedirect.com/science/article/pii/S0264410X19311971; INQ000183378)
- INQ000496107_0001, 0003-0004 paras 1(a), 2(a)
- INQ000474404_0011 para 2.1; Jonathan Van-Tam 20 January 2025 136/18-22
- Jonathan Van-Tam 20 January 2025 136/18-137/3; INQ000474404_0011
- INQ000474406_0011 para 7.3
- INQ000474406_0011 paras 7.3-7.4
- INQ000474399_0010, 0017 paras 23, 37
- INQ000474334_0035-0038 paras 122-128; Clara Swinson 17 January 2025 82/12-83/7
- INQ000474335_0042 para 133
- Nicholas White 30 January 2025 4/2-9/5
- James Bethell 29 January 2025 36/23-37/23
- INQ000474315_0007-0008 para 28
- INQ000474315_0007-0008 para 28
- INQ000474375_0012-0013 para 41
- Matt Hancock 16 January 2025 64/13-24
- INQ000474406_0042 para 38.7; INQ000474482_0048-0049 para 126; Alok Sharma 17 January 2025 37/2-13
- Matt Hancock 16 January 2025 62/20-25
- INQ000474406_0044 para 39.1
- Alexandra Jones 20 January 2025 5/7-21
- INQ000474406_0044 paras 39.1-39.2; Alexandra Jones 20 January 2025 4/18-6/2
- INQ000474406_0011, 0014, 0027 paras 8.1, 10.2, 25.2
- INQ000474338_0032 para 107; INQ000474557_0033 para 118; INQ000474418_0033 para 4.59
- INQ000499442_0016-0017 paras 49-51; INQ000474406_0044 para 39.3
- –NQ000474338_0032 paras 104-105; INQ000474511_0063 para 177
Chapter 2: Discovery and development
Introduction
| 2.1. | At the beginning of the Covid-19 pandemic, there were no clinically proven therapeutics or vaccines available to combat the disease.1 Patient management was based on the symptoms of the patient and included the provision of respiratory and other vital organ support in hospital.2 |
| 2.2. | Nonetheless, clinical trials quickly identified existing drugs already authorised for the treatment of other medical conditions that were also effective in treating Covid-19 (known as ‘repurposed’ drugs). Most significantly, as early as June 2020, the RECOVERY trial – a large platform trial that looked at treatments for patients hospitalised with Covid-19 – identified the first effective treatment, dexamethasone. This is a cheap and readily available corticosteroid (a type of anti-inflammatory medication).3 As Professor Sir Nicholas White, expert witness on therapeutics, told the Inquiry, this was “the single most important therapeutics research result of the pandemic”.4 |
| 2.3. | There were also impressive results when it came to the development of vaccines for Covid-19. Discovering, developing and approving a new vaccine has in recent history generally taken between 10 and 20 years.5 However, the first effective Covid-19 vaccines were developed at a remarkable pace and administered in the UK within 12 months of the World Health Organization’s declaration of a public health emergency of international concern on 30 January 2020.6 This included a vaccine developed in the UK by the University of Oxford and AstraZeneca.7 |
| 2.4. | This chapter examines the discovery and development of therapeutics and vaccines, and assesses how the UK can better prepare for a future pandemic. |
Building on existing research and development strengths
| 2.5. | The acceleration of the discovery and development of vaccines and therapeutics in pandemics is crucial. The extent to which the UK was able to draw upon relevant research, knowledge and processes and direct them towards combating the pathogen threat during the pandemic is explored below. |
Scientific research
| 2.6. | The development of the Covid-19 vaccines built upon decades of global research and preparation. |
| 2.7. | In 2016, the UK Vaccine Network provided funding to develop a vaccine for Middle East respiratory syndrome (MERS).8 The research was led by Professor (later Dame) Sarah Gilbert, Professor of Vaccinology at the University of Oxford, and involved scientists and researchers developing a vaccine based on a chimpanzee virus.9 This work involved the use of a ‘platform’ technology (ie a technology that can be used as the basis for developing multiple different medicinal products). Vaccine technology platforms can accelerate the production and development of new vaccines by eliminating the need for companies to start from scratch each time they seek to develop a new product.10 They allow the design and development phase, and preparatory work for manufacturing, to be significantly shortened. This differs from traditional vaccine development, which typically begins by using a pathogen rather than an existing platform, and requires extensive work.11 When the pandemic struck, Professor Gilbert and her team pivoted their work to develop a vaccine to tackle Covid-19. The result was the Oxford/AstraZeneca vaccine. The use of the platform technology meant that the vaccine was developed for use in clinical trials in April 2020. This was only three months after receipt of the initial genetic sequencing for Covid-19 in January 2020.12 |
| 2.8. | Similarly, the Pfizer/BioNTech and Moderna Covid-19 vaccines were founded on existing messenger ribonucleic acid (mRNA) technology platforms. Decades of research went into the development of these vaccines, many of which had been conceived as cancer vaccines.13 The use of this existing technology shortened research time and allowed mRNA vaccines to enter trials very quickly; the Moderna and Pfizer/BioNTech vaccines entered Phase 1 trials in March and April 2020 respectively.14 Professor Sir Jonathan Van-Tam (Deputy Chief Medical Officer for England from October 2017 to March 2022) noted in relation to mRNA vaccines:
“[W]e shouldn’t believe that these things just appeared in a puff of smoke in early 2020, they were actually the efforts of scientists over 20 years that were just about mature enough to give us a solution at that time.”15 |
| 2.9. | The position in relation to therapeutics was different. Professor Wendy Barclay, Action Medical Research Chair of Virology at Imperial College London and a member of the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) from 2014, explained the difference between the development of vaccines and antivirals (medicines used to treat or prevent viral infections):
“[V]accines are often generated using platform technologies that can be switched between pathogens. In contrast directly acting antivirals are usually highly specific to the virus or at least the class of virus, and for coronaviruses we were in a position of starting from scratch.”16 |
| 2.10. | No antivirals specific to the treatment of Covid-19 existed because there had been no previous outbreak of the disease. As set out in Chapter 1: The landscape of vaccines and therapeutics, the UK had stockpiled antivirals for the treatment of pandemic influenza. However, these did not prove useful for the treatment of Covid-19.17 |
| 2.11. | Professor Sir Christopher Whitty (Chief Medical Officer for England from October 2019) explained that the development of antivirals was generally an area of scientific weakness, particularly when compared with vaccines, antibiotics and other antiparasitics. Even in relation to influenza, he explained that the available antivirals were “not very good” and “only moderately effective”.18 One issue in relation to the development of antivirals was a lack of investment. Professor Sir Peter Horby, Co-Chief Investigator of the RECOVERY trial and Director of the Pandemic Sciences Institute at the University of Oxford, observed that those antivirals that were shown to have some benefits during the pandemic were developed by US companies. He explained that the UK had the scientific capabilities to conduct the “foundational research” to develop such products but that there was “insufficient investment in their development”.19 |
| 2.12. | Notwithstanding the benefits of a repurposed drug like dexamethasone, Professor White explained that it was also necessary to have specific drugs to treat the infection, such as antivirals. He agreed that the aim in any future pandemic has to be to make sure that we have such therapeutics available, pending the development or in the complete absence of a vaccine.20 |
| 2.13. | The first new drugs developed by pharmaceutical companies in response to Covid-19 were engineered or ‘monoclonal’ antibodies.21 However, the rapid mutation of Covid-19 meant that the effectiveness of these drugs was reduced with the advent of new variants.22 It was then not until late 2021 that two new directly acting antivirals – Paxlovid and molnupiravir – were available, having been redirected from other antiviral development pathways.23 |
| 2.14. | The pandemic demonstrated the value of developing a range of vaccines against existing health threats that could then be pivoted to combat Covid-19. This was the result of years of work. It is crucial to continue investing in the UK’s research and development capabilities so that it can be at the cutting edge of vaccine development. The same is true of therapeutics. The development of new drugs such as antivirals may prove particularly important in the event of a future pandemic, as vaccines will not work against every pathogen and antivirals are therefore a vital component of our pandemic preparedness. |
The life sciences industry
| 2.15. | Professor Sir Patrick Vallance, Lord Vallance of Balham (Government Chief Scientific Adviser from April 2018 to March 2023), emphasised the strength of the UK’s life sciences sector prior to the pandemic. He observed that, as well as having strong academic institutions and a “world class reputation in biomedical research”, the UK was also home to major pharmaceutical companies, many contract research organisations and a flourishing biotechnology sector of small and medium-sized companies.24 |
| 2.16. | A collaborative relationship between academia and industry proved crucial in the development of one of the major Covid-19 vaccines. Professor Sir Andrew Pollard, Professor of Infection and Immunity at the University of Oxford, who led the clinical development of the Oxford/AstraZeneca vaccine, noted that the relationship between the University of Oxford and AstraZeneca was key to the success of their endeavour to develop a vaccine.25 In May 2020, the two entered into a licence agreement that saw AstraZeneca work on upscaling manufacturing, initiating clinical trials across the globe, and providing statistical analysis verifying the results of trials. AstraZeneca then coordinated global manufacturing and distribution of the vaccine.26 However, Professor Pollard noted that these relationships were not in place prior to the pandemic, and he said that it was important to consider whether developing stronger relationships between academia and industry in non-pandemic times could help with improving vaccine development in a pandemic.27 |
| 2.17. | Similarly, Professor Sir Mene Pangalos (Executive Vice-President, BioPharmaceuticals Research & Development at AstraZeneca from January 2019 to March 2024) observed that public–private partnerships and close collaboration between academia, governments, research institutes and industry were critical in the response to Covid-19 and would be critical in accelerating and strengthening any response to a future pandemic.28 |
| 2.18. | Building strong links with industry during non-pandemic times is an essential component of ensuring that the UK is prepared to face the next pandemic when it arrives. In this regard, the Inquiry welcomes the 10-year partnership between the UK government and Moderna, which will involve the opening of a new innovation and technology centre in the UK (see below). In May 2025, pharmaceutical company BioNTech committed up to £1 billion in a 10-year investment in the UK, underpinned by up to £129 million of government support. This investment will see the creation of new research and artificial intelligence centres in London and Cambridge.29 Another positive step is the Life Sciences Sector Plan, published in July 2025, which aims to position the UK as the leading life sciences economy in Europe by 2030, backed by more than £2 billion in public funding.30 The UK government has also committed up to £520 million through the Life Sciences Innovative Manufacturing Fund, aimed at incentivising manufacturing investments in the UK. |
| 2.19. | However, recent announcements paint a more negative picture. For example, in September 2025 pharmaceutical company Merck announced that it was not going ahead with a planned £1 billion expansion of its UK operations.31 In the same month, AstraZeneca paused plans to invest £200 million at a research site in Cambridge (this came eight months after the company withdrew a planned £450 million investment in a vaccine manufacturing facility in Liverpool).32 US drug maker Eli Lilly and French pharmaceutical company Sanofi have also paused substantial investments in the UK.33 |
| 2.20. | The Inquiry is concerned about these developments and, given their timing, was unable to explore the reasons for them in evidence. However, it is vital that investment in life sciences is fostered and maintained. The partnership between government, academia and the pharmaceutical industry was a crucial part of the UK’s approach to tackling Covid-19. We will not be as well prepared to face the next pandemic if industry has deserted the UK. The strength of the UK’s relationship with industry is important not only to the development of vaccines and therapeutics but also their procurement and manufacture. This is addressed further in Chapter 3: Securing supplies. |
Clinical trial infrastructure
| 2.21. | Using existing research infrastructure and processes rather than setting up new organisations and bodies is important to respond rapidly to a new global health threat.34 |
| 2.22. | The UK’s centralised health delivery systems and strong existing research infrastructure were critical to its ability to pivot and rapidly respond to Covid-19. Professor Whitty explained that relatively few countries have a “single dominant government-supported health system” like the healthcare systems in the four nations of the UK, and this can make rapid coordination of health research much easier.35 This research infrastructure included the two major government funders of clinical research: the Medical Research Council (part of UK Research and Innovation – the UK’s largest public research funder) and the National Institute for Health and Care Research (the main government funder of, specifically, applied research in health and social care).36 |
| 2.23. | The National Institute for Health and Care Research’s systems and frameworks were established by the Department of Health and Social Care over a number of years to enable a rapid research response.37 Its Clinical Research Network provides the underpinning infrastructure (including research space and staff) for clinical research in the NHS in England and also supports patients, the public, and health and care organisations across England to participate in research.38 |
| 2.24. | The Inquiry was told that this established infrastructure was critical to the successful delivery of clinical trials during the pandemic, including the Oxford/AstraZeneca vaccine trials, and to the testing in the UK of several vaccines developed in the private sector in other countries.39 |
| 2.25. | It was also important to the success of the trials looking at therapeutics. For example, Professor Christopher Butler, Co-Chief Investigator of the community-based trials PRINCIPLE (trialling repurposed drugs) and PANORAMIC (trialling new oral antivirals), explained that the NHS clinical infrastructure was able to support both trials. According to Professor Butler, the UK was unique in having such infrastructure “exclusively devoted to the efficient delivery of studies on its portfolio”.40 Similarly, Professor Anthony Gordon, Chief Investigator of REMAP-CAP (an international trial with sites in the UK looking at the treatment of largely critically ill patients), stated that having research support already embedded in hospitals through the Clinical Research Network was “key to the UK being a global leader in clinical trial activity during the pandemic”.41 |
| 2.26. | The UK research response was also able to draw upon pre-existing trial infrastructure established in relation to previous health emergencies. For example, the RECOVERY trial was informed by one of eight ‘hibernated’ studies commissioned by the National Institute for Health and Care Research following a review of the 2009 pandemic influenza outbreak. These were projects on standby in a maintenance-only state and awaiting activation in the event of a new influenza pandemic. One of these was focused on the use of early low dose steroids in patients admitted to hospital with influenza infection during a pandemic. While this trial was not activated during the Covid-19 pandemic, the study protocol was used to inform the dexamethasone arm of the RECOVERY trial (which went on to identify the effectiveness of steroids in treating Covid-19).42 |
| 2.27. | Sir Jeremy Farrar, Director of Wellcome (a global charitable foundation formerly known as the Wellcome Trust) from October 2013 to February 2023, described the National Institute for Health and Care Research as the “jewel in the crown of the NHS, and unique globally”. This research infrastructure should continue to be properly funded and maintained to ensure that it is in place to address the next pandemic threat. |
The development of new vaccines and drugs
There are a number of stages in the development of new vaccines and drugs. The first stage of discovery and development is the identification and design of potential vaccines or drugs to treat the relevant pathogen, which can then be tested in ‘preclinical studies’ (ie laboratory studies). Following the satisfactory completion of preclinical studies, clinical trials start in humans in successive phases.44 These different phases test the safety and efficacy of the medicine.45
Phase 1 trials are initial safety trials involving a small group of healthy participants (about 5 to 10 people) to assess whether the medicinal product is safe in humans and to determine the appropriate dosage.
Phase 2 trials are conducted with slightly larger numbers of people (in the range of 20 to 50) and involve the clinical response being studied in patients who have the disease the drug is aimed at treating.
Phase 3 trials study larger numbers (many hundreds or thousands of trial participants) to gain statistically robust evidence of efficacy and to collect further safety data. Phase 3 trials are used to provide the primary evidence on clinical safety and efficacy for authorisation of a medicine.46 With respect to therapeutics, during the pandemic a number of repurposed drugs were able to go straight into Phase 3 trials because they were already authorised and used to treat other diseases or infections.
Prioritising and coordinating research
| 2.28. | Early on in the pandemic, the UK government recognised the need to prioritise and coordinate research on vaccines and therapeutics. Such an approach is crucial and encompasses the rapid allocation of funding and support for research, accelerating regulatory approval of clinical trials, enabling rapid recruitment to trials and coordinating competing research. The UK’s response to these challenges is explored in detail below. |
Rapid funding
| 2.29. | In response to a global pandemic where there are no vaccines or therapeutics available, research projects need to be established or redirected at pace. This requires rapid and substantial additional funding. |
| 2.30. | From January 2020, Professor Vallance set up and convened a number of meetings of research funders. He explained that both he and Professor Whitty thought it was important to ensure the rapid funding of relevant research projects, including those aimed at vaccines and therapeutics. In respect of the former, Professor Vallance was one of the first to identify the potential of mRNA vaccine technology in tackling the disease.47 |
| 2.31. | On 4 February 2020, four days after the first official case of Covid-19 was announced in the UK, a rapid call for research, including into vaccines and therapeutics, was launched. This was jointly funded by the National Institute for Health and Care Research and UK Research and Innovation. According to Professor Lucy Chappell (Senior Investigator at the National Institute for Health and Care Research from April 2021 and Chief Scientific Adviser for the Department of Health and Social Care from August 2021), who provided evidence on behalf of the National Institute for Health and Care Research, this was “arguably the fastest, large-scale research call that ha[d] ever been commissioned in the UK”. This research call included two funding opportunities. |
| 2.32. | The first invited short-term projects for vaccines and therapeutics for rapid clinical development, while the second invited projects for diagnosing and understanding Covid-19. These funding opportunities were a notable departure from business as usual, with no predefined expectations about the scale of funding for each award (which ranged from £50,000 to £7 million) and with a focus on studies that could provide “impactful results” within 18 months (instead of 3 to 5 years).50 The initial call funded a total of just under 30 projects at a cost of approximately £26 million. These included the RECOVERY trial of treatments for adults hospitalised with Covid-19 and the development of the Oxford/AstraZeneca vaccine.51 |
| 2.33. | A subsequent rolling research call ran from April to the summer of 2020 and commissioned approximately 50 more studies at a cost of approximately £50 million.52 This supported projects that aimed to contribute to the understanding, prevention and management of the Covid-19 outbreak within 12 months. The assessment process included whether proposed studies were duplicative of already supported activity or could be aggregated into better-powered studies with more participants, as these were more likely to deliver clear-cut results.53 |
| 2.34. | The scale of work involved in both calls was significant, with almost 1,000 proposals assessed.54 Professor Whitty noted that it was important to the research response that the UK had existing clinical funders, with significant budgets.55 Coordination mechanisms between the National Institute for Health and Care Research and UK Research and Innovation existed prior to the pandemic, which allowed them to combine their budgets to make larger sums available. Professor Charlotte Deane (Executive Chair of the Engineering and Physical Sciences Research Council within UK Research and Innovation) explained that the partnership between the two funders was also critical to the success of these rapid calls, in providing a single, UK-wide point for decision-making.57 |
| 2.35. | In addition to the rolling call, in March 2020 a “fighting fund” of £30 million was approved by the UK government, to be managed by the National Institute for Health and Care Research. This fund was overseen by Professors Whitty and Vallance and enabled them to make rapid funding decisions for discrete pieces of research or related work that needed to be done so quickly that it was not possible to fund them through the normal mechanisms.58 |
| 2.36. | There must be a similar approach to government funding in the event of a future pandemic. It enabled resources to be coordinated and focused on the most important clinical trials. Professor Pollard suggested that it was necessary to have a clear government plan for funding vaccine development in a pandemic in place and ready to go before the next pandemic strikes. He recommended the creation of an “immediate vaccine fund” to initiate credible projects even more quickly in future pandemics.59 The Inquiry agrees that this would be a positive step and should also extend to therapeutic development. |
Urgent public health ‘badging’
| 2.37. | Alongside rapid funding, the need to ensure the operational prioritisation of Covid-19 studies was also recognised early on in the pandemic. |
| 2.38. | In January 2020, the Clinical Research Network activated its urgent public health processes in order to ensure the rapid set-up and delivery of research into unexpected and severe infections with the potential to cause widespread disease in the UK.60 The initial focus of research was on collecting as much information as possible about Covid-19.61 Subsequently, on 11 March 2020 and following direction from Professors Whitty and Vallance, additional studies were prioritised. These included the Oxford/AstraZeneca vaccine and the RECOVERY trial.62 The RECOVERY trial proceeded swiftly; it was designated as an urgent public health research study on the same day and within one week it had been set up at hospitals across the UK.63 |
| 2.39. | In order to further prioritise Covid-19 research, on 16 March 2020 it was announced that the National Institute for Health and Care Research, in discussion with the Chief Medical Officer, had temporarily paused the commencement of non-Covid-19 studies.64 On the same date, and in response to the growing portfolio of clinical research, the Department of Health and Social Care asked the Clinical Research Network to develop a national review and prioritisation system for Covid-19 studies across the UK.65 |
| 2.40. | This led the National Institute for Health and Care Research to establish the Urgent Public Health panel in March 2020.66 The panel aimed to ensure that, during the early phase of the pandemic, the Clinical Research Network’s resources were used to support the most important studies, prevent duplication and ensure that the health service capacity to support research was not overwhelmed.67 Under this system, the highest priority research projects were ‘badged’ by the panel with urgent public health status and were eligible for particular support and resources. This support included:
|
| 2.41. | The Clinical Research Network received about 1,600 applications for urgent public health badging in total and recommended the prioritisation of 101 studies to Professor Whitty, who ultimately signed off on each of them. Full approvals were granted within an average of eight days.69 More than 1.3 million participants were recruited across 8,773 sites.70 Professor White referred to this as a “substantial and timely national research effort”.71 The process meant that competition for recruitment between trial platforms was minimised, existing processes were sped up substantially, and access was facilitated to resources for trial recruitment and delivery across the four nations.72 |
| 2.42. | The urgent public health badging system was particularly important to the key Phase 3 trials examining repurposed drugs. In addition to RECOVERY, the REMAP-CAP and PRINCIPLE trials both received early badging.73 Early direction was provided to clinicians by way of a letter dated 1 April 2020 from the UK’s Chief Medical Officers and Professor (later Sir) Stephen Powis (National Medical Director at NHS England from 2018 to July 2025 and Interim Chief Executive Officer of NHS Improvement from August 2021 to July 2022), asking that every effort be made to enrol Covid-19 patients in these three “national priority” clinical trials and to desist from prescribing unproven off-licence drugs outside of trials (see below).74 |
| 2.43. | In the view of Professor Van-Tam, the urgent public health badging system was “the most significant innovation” introduced in respect of Covid-19 therapeutics.75 It ensured that UK research delivered meaningful results and, in the words of Professor Horby, avoided “the chaotic and wasteful research experienced in much of the rest of the world”. It is important that this system is maintained and utilised in a future pandemic. |
Expediting regulatory approval for trials
| 2.44. | A key element of urgent public health badging was expedited regulatory review. The Inquiry was told that the approval and regulatory processes outside of a pandemic can be slow and bureaucratic.77 However, the Medicines and Healthcare products Regulatory Agency (which is responsible for approving clinical trials) and the Health Research Authority (which provides ethical oversight of clinical trials) introduced measures to accelerate their usual processes.78 |
| 2.45. | The Medicines and Healthcare products Regulatory Agency’s approach to the regulation of clinical trials for vaccines and therapeutics to treat Covid-19 was broadly the same as that for any other clinical trial. However, the agency “recognised the need for flexible and rapid clinical trial management” and introduced changes to reflect the urgent public health need to develop effective vaccines and therapeutics to tackle the pandemic.79 For example, it enhanced its engagement with trial sponsors to advise on trial designs and published guidance to assist them. This included support for the commercial developers of Covid-19 vaccines and also for important non-commercial Covid-19 trials, including a number of those referred to above (RECOVERY, PRINCIPLE and PANORAMIC).80 |
| 2.46. | Clinical trial approval applications for Covid-19 medicinal products were expedited by the Medicines and Healthcare products Regulatory Agency through a process of receiving and reviewing clinical trial documents as they became available. Dame June Raine (Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency from September 2019 to March 2025) explained that this allowed the agency to provide clinical trial sponsors with feedback on their documentation prior to formal submission, which “significantly reduced” the time taken to address any grounds for refusing trial approval.81 The impact of these expedited processes is demonstrated by the approval of the RECOVERY trial within four days of the application being submitted.82 Dame June Raine said that the clinical trial assessment process, although expedited, “remained as robust as for any clinical trial authorisation application” and involved “full consideration of the same clinical trial documentation”.83 |
| 2.47. | In addition, the Health Research Authority introduced a fast-track service for Covid-19 research applications that needed a rapid research ethics review to expedite the parts of the regulatory process for approving Covid-19 studies that were within its control.84 This provided for an average approval timeline of seven days, which was a 90% reduction on normal timelines. It was achieved, in part, through members of research ethics committees reviewing applications at very short notice in virtual meetings.85 For example, the ethics application for the Phase 1 Oxford/AstraZeneca vaccine trial took only four days from submission to approval.86 |
| 2.48. | A number of witnesses commended the approach taken by the regulatory bodies during the pandemic.87 Professor Pollard praised the “very responsive” team at the Health Research Authority.88 Similarly, Professor Saye Khoo (Chief Investigator of the AGILE trial, a Phase 1 and 2 trial) said that he “did not hear of any other regulator as rapid, pragmatic or supportive” as the Medicines and Healthcare products Regulatory Agency:
“[I]t was a frequent observation from US and European colleagues that … [its] response was second to none – I emphatically concur.”89 |
| 2.49. | The flexible approach of the regulatory bodies was a positive development during the Covid-19 pandemic. |
| 2.50. | The Inquiry welcomes new legislation introduced in December 2024 to improve clinical trial regulation more generally.90 This allows for the integration of regulatory and ethics reviews of clinical trial applications, which will streamline the application process and shorten approval times. Application reviews will be processed within a maximum of 30 rather than 60 days, with a maximum of 10 days for a decision to be granted once the regulator has received any final information. These changes are aligned with the review of clinical trials led by Lord O’Shaughnessy – which identified areas for improvement with the approval processes in the UK, which will come into force from April 2026.91 The Inquiry understands that further reforms, including the use of artificial intelligence, have reduced the time taken to approve clinical trials by more than half.92 |
Trial first then treat
| 2.51. | At various points, including early in the pandemic, there were calls to use existing drugs of unproven efficacy against Covid-19, such as hydroxychloroquine. Professor White said that this drug had been recommended for use in other countries based on “inadequate” evidence.93 Professor Vallance explained that his and Professor Whitty’s view was that:
“[T]he correct way to proceed was through properly organised clinical trials, and that to act otherwise would risk detriment to health and undermine the international knowledge base required to establish what worked and what didn’t.”94 |
| 2.52. | The Office of the Chief Medical Officer played an important role in ensuring that there was emphasis on “confining treatments to proven treatments or clinical trials”.95 As explained above, on 1 April 2020 the UK’s Chief Medical Officers and Professor Powis sent a letter to clinicians to urge enrolment in clinical trials and to caution against the use of treatments off licence (ie unlicensed for the particular use) outside clinical trials.96 Although this may have been seen as controversial given that clinicians had no proven therapeutic options, Professor White characterised this as “very wise advice”.97 |
| 2.53. | In the event, it was the RECOVERY trial that established the life-saving benefit of dexamethasone in June 2020. In addition to identifying this first effective treatment, the RECOVERY trial was also instrumental in the early identification of ineffective treatments for hospitalised patients – for example, hydroxychloroquine – again in June 2020. This was contrary to prevailing views at the beginning of the pandemic and an important research outcome, particularly given the pressures to treat with existing drugs prior to definitive trial results.98 Subsequently, the RECOVERY trial went on to show that there was no clinical benefit from using convalescent plasma to treat patients with moderate to severe Covid-19. This was again contrary to views at the beginning of the pandemic and therefore another important finding.99 |
| 2.54. | Similarly, the PRINCIPLE trial, which trialled repurposed drugs for use in the community, showed that a number of antibiotics, which had been used in the early stages of the pandemic, were not generally effective treatments for Covid-19 in terms of reducing the time to recovery or the risk of hospitalisation.100 |
| 2.55. | Professor Whitty told the Inquiry:
“[W]e got off the ground in the UK extraordinarily quickly, and picked up the majority of the drugs, which, when repurposed, actually lead to a better outcome.”101 |
| 2.56. | A great strength of the UK’s response to the Covid-19 pandemic was its ability to resist the understandable urge to treat patients without first establishing the efficacy of therapeutics through clinical trials. Clinical trials ensure that meaningful data can be obtained about efficacy. Use of off-licence treatments outside a trial are a wasted opportunity to obtain information that could benefit many more patients.102 In the event of another pandemic, it will be critical to follow a similar approach. |
Rapid recruitment
| 2.57. | No clinical trial will be successful without a sufficient number of participants to obtain meaningful results. Trial recruitment at speed and scale was therefore crucial.103 |
| 2.58. | In relation to therapeutics, healthcare services played a critical role in ensuring rapid recruitment of patients to the highest priority Phase 3 trials early on in the pandemic, through the urgent public health badging system. Within three months, more than 10,000 patients were recruited to RECOVERY and it was able to report its first results. Professor White referred to this as a “remarkable achievement”. Professor Vallance said that, by contrast, the majority of other trials around the world were too small or too slow to recruit and were not able to provide the definitive answers produced by RECOVERY. RECOVERY became the largest clinical trial into treatments for Covid-19 in the world, recruiting across 177 NHS trusts as well as international sites, with more than 48,500 patients recruited. |
| 2.59. | The community-based PRINCIPLE trial recruited nearly 12,000 participants online from all over the UK, as well as from more than 1,000 GP practices in the UK.108 The later PANORAMIC trial, launched in December 2021, recruited more than 25,000 participants by the end of April 2022, making it the largest community-based trial of its kind ever in the UK.109 Central to its ability to recruit at this scale was its collaboration with the Clinical Research Network, which supported recruitment at scale and pace across multiple settings, including in care homes.110 |
| 2.60. | However, Professor Gordon noted that, although the trials badged with urgent public health status in the UK recruited very well when compared with most other countries, “we still only recruited a minority (maybe between 10-20%) of possible patients in hospital” into Covid-19 trials.111 He said:
“When hospitals are overrun with clinical cases it can be hard to find staff to carry out research specific tasks, such as long discussions about individual trial consent. In the emergency situation of a pandemic research could be embedded more in everyday clinical activity.”112 |
| 2.61. | Professor Vallance also noted the “very impressive” recruitment figures for the RECOVERY trial but queried why the percentage of eligible people in trials was not higher. He said that the aim for the future should be to give most patients with an infection during a pandemic the chance to be enrolled in a clinical trial.113 Professor White agreed that the process for encouraging recruitment to clinical trials could be further strengthened, including by the establishment of a formal system for registration of volunteers.114 Such a system – the NHS Covid-19 vaccine research registry – was introduced for Covid-19 vaccine trials during the pandemic and proved highly effective in recruiting volunteers at pace. The registry, which was launched in July 2020, was developed by the National Institute for Health and Care Research, the Vaccine Taskforce and NHS Digital, and allowed people to quickly and easily sign up to participate in clinical trials of Covid-19 vaccines.115 |
| 2.62. | Professor Chappell explained that the first 100,000 volunteers were registered by 11 August 2020, and by 1 September 2020 there were more than 200,000 registered volunteers. The registry reached its target of 500,000 volunteers in May 2021 and proved “vital” in recruiting participants to more than 14 Covid-19 vaccine clinical trials, targeting different demographic groups at different stages of the pandemic.116 |
| 2.63. | The wider value of the initiative has been recognised. Professor Chappell explained that the registry has “transitioned to form part of the ‘Be Part of Research’ Volunteer Service” and registrants have the opportunity to participate in non-Covid-19 research.117 ‘Be Part of Research’ is a UK-wide service run by the National Institute for Health and Care Research in collaboration with the devolved administrations in Scotland, Wales and Northern Ireland and acts as the main UK registry for trial volunteers across all four nations of the UK.118 In response to Lord O’Shaughnessy’s review of commercial clinical trials in the UK, the UK government has committed to further develop the Be Part of Research platform to enhance support for the public, patients and clinicians to find out about health and social care research taking place across the UK, including commercial trials.119 |
| 2.64. | Professor Cathie Sudlow (Chair of Neurology and Clinical Epidemiology at the University of Edinburgh), in her review of the UK’s health data landscape, Uniting the UK’s Health Data: A Huge Opportunity for Society, published in November 2024, stressed the importance of utilising patient data effectively for effective trial recruitment.120 She observed that volunteer registries contain only a few hundred thousand people – a tiny fraction of the population of the UK. However, recruitment via services such as NHS DigiTrials, which can issue invitations to anyone based on age, sex, geographic or health characteristics from the whole population of England, could ensure recruitment from a much larger pool of potential participants through targeted invitations.121 |
| 2.65. | Recent developments promise an improvement in the use of electronic healthcare records for research purposes. In April 2025, the UK government announced that it and Wellcome would be making a £600 million investment to create a new health data research service.122 The new service, which is due to begin at the end of 2026, aims to transform access to NHS data by providing “a secure single-access point to national-scale data sets”, with robust protections in place to protect the anonymity of patients. The health data research service was a central recommendation of Professor Sudlow’s review. The Inquiry expects that this new service will be used to ensure rapid recruitment to clinical trials. |
| 2.66. | The Inquiry welcomes the embedding of learning from the pandemic to enhance clinical trial recruitment. Establishing effective recruitment strategies not only aids medical research outside of a pandemic, but maintains systems that can be utilised at scale in the event of a future pandemic. Work in this area, including the better use of patient data to target recruitment, must continue. To ensure effective recruitment in clinical settings, trials must be incorporated into business-as-usual activity in the healthcare systems in the four nations, as addressed further below. |
| 2.67. | In the context of trial recruitment, it is important to recognise the immense contribution of the people who took part in vaccine and therapeutic clinical trials during the pandemic. Without them, no effective vaccine or treatment would have been developed at all. |
Coordinating early phase therapeutic trials
| 2.68. | Despite the overall effectiveness of coordinating Covid-19 research, there were particular challenges in the coordination of Phase 2 therapeutics trials. While a number of repurposed drugs were able to go straight into Phase 3 trials, Phase 2 trials were particularly important in relation to new or experimental drugs. The Inquiry heard that the management of these Phase 2 trials generated “some heated debate” within the scientific community, given the diversity and strength of views about the division of responsibilities among those involved.123 |
| 2.69. | In response to the large number of Phase 2 trials applying for funding and prioritisation, the Department of Health and Social Care acknowledged the need for their coordination. During March and April 2020, consideration was given to how best to do so.124 One proposal made in April 2020 was a new programme to be known as ACCORD. This was intended to coordinate early stage trials of new therapeutics for Covid-19.125 However, ACCORD experienced difficulties, including in relation to recruitment, due to the falling rate of Covid-19 hospital admissions – which meant there were fewer patients from whom to recruit – and also competition from the larger Phase 3 trials in hospitals, such as RECOVERY and REMAP-CAP.126 |
| 2.70. | A number of proposals for changes to the system were put forward, but ultimately in June 2020 UK Research and Innovation recommended that those responsible for the various Phase 2 trials should review their progress, with the trials either stopping or migrating to a newly configured RECOVERY platform. This platform would include all new Phase 2 trials funded centrally and meet the need for one UK-wide clinical trial platform for both Phase 2 and Phase 3 evaluation, which, among other things, would avoid duplication and competition. This recommendation was accepted by the Prime Minister’s senior advisers. Professor Martin Landray, Co-Chief Investigator of RECOVERY, said that the RECOVERY trial demonstrated that it was possible to conduct early trial evaluation in a way that was both practical and scalable in a pandemic.128 |
| 2.71. | Professor Whitty accepted that the UK was less strong in relation to Phase 1 and 2 trials compared with Phase 3 and 4 trials, a point also made in the December 2022 Technical Report on the Covid-19 Pandemic in the UK. Professor Whitty and Professor Van-Tam, two of its authors, told the Inquiry that this reflected the strengths of the UK’s research capabilities going into the pandemic. They stated that Phase 1 and 2 trials tend to be smaller and more industry-driven than Phase 3 trials and are conducted around the world.129 |
| 2.72. | Professor Whitty’s view was that the fundamental issue was the lack of antivirals to put into this system. He explained that there was much less pre-existing research underpinning new drugs and “the science simply wasn’t there on an international level”.130 This was illustrated by the absence of a “large portfolio of good antivirals for coronaviruses” at the end of the Covid-19 pandemic.131 |
| 2.73. | Professor Patrick Chinnery, Executive Chair of the Medical Research Council within UK Research and Innovation, explained that his primary lesson was the need for an integrated national trial platform for Phase 1 to 3 trials at the outset of the pandemic.132 This was in line with the recommendation made by Professor Deane that, in the case of a national emergency, the UK should have access to a UK-wide platform that can deliver integrated Phase 1 to 3 clinical trials.133 |
| 2.74. | The Inquiry agrees. It is clear that early phase trials are an important part of both preparing for and responding to a future pandemic – particularly in relation to the development of new therapeutics. It is therefore crucial that a proper system for coordinating both early and late phase trials should be in place, so that when promising new drugs are available they can be assessed effectively and taken forward to Phase 3 trials. |
Prioritising the right drugs
| 2.75. | Alongside effective prioritisation of trials, it is necessary to have robust systems in place to decide which drugs to trial. At the beginning of the pandemic, mechanisms for the selection of drugs varied and there were a number of different expert groups or committees that made recommendations. |
| 2.76. | Professor Van-Tam helped to establish the NERVTAG Covid-19 therapeutics sub-committee in February 2020. Its role was to advise the Chief Medical Officer and the Department of Health and Social Care on potentially viable existing drugs that could be repurposed for Covid-19. In March 2020, this sub-committee delivered the initial recommendations for drugs for inclusion in the RECOVERY trial, including dexamethasone.134 However, the NERVTAG Covid-19 therapeutics sub-committee was not established or sufficiently resourced to provide advice on candidate therapeutics on an ongoing basis.135 |
| 2.77. | Consideration was also given to the identification of drugs that could be used preventatively (ie prophylactically). In June 2020, Professor Whitty set up the Prophylaxis Oversight Group, chaired by Professor David Lalloo (Professor of Tropical Medicine at the Liverpool School of Tropical Medicine from January 2019).136 One of its sub-groups, the Prophylaxis Candidate Prioritisation Group, was responsible for assessing potential drugs for their suitability for deployment or inclusion in a clinical trial platform.137 |
| 2.78. | Following a review of the Phase 2 trials, the Therapeutics Taskforce (established to secure therapeutics for the UK) worked in collaboration with the National Institute for Health and Care Research and UK Research and Innovation to establish the UK Covid-19 Therapeutics Advisory Panel in July 2020.138 The panel’s role was to make recommendations on which therapeutics should be prioritised for platform trials.139 It was an independent body formed from an invited group of experts who had broad expertise covering key scientific and clinical issues related to Covid-19.140 It also used expert sub-groups to provide additional expertise and inform decision-making where necessary, while the Therapeutics Taskforce could highlight therapeutics of potential interest to the panel.141 |
| 2.79. | Initially the panel made recommendations on drugs for the newly reconfigured RECOVERY platform trial, but its remit was later expanded to encompass other studies. It considered both repurposed and new drugs.143 The panel reviewed available scientific evidence and made recommendations to the principal investigators of each trial and the Chief Medical Officer.144 The final decision on which treatments were included in trials lay with the Chief Medical Officer and the trial chief investigators.145 |
| 2.80. | The initial focus of the panel was on dealing with acute severe cases, as this was the “most pressing issue facing the NHS”.146 As the Covid-19 pandemic evolved, further expert sub-groups were set up to advise on what drugs to include in new platform trials: for example, a sub-group was set up in December 2020 to advise on prophylactic drugs (although final responsibility for recommendations for trials lay with the Prophylaxis Oversight Group).147 Professor Chinnery stated that, with hindsight, the expert sub-group on prophylaxis should have been created earlier but the decision to focus initially on acute treatments was a reasonable decision at the time.148 The Inquiry agrees. However, any future approach to clinical trial research in a pandemic should ensure that consideration is given to the creation of mechanisms to select drugs for prevention, as well as for treatment, from the outset. |
| 2.81. | Professor Chinnery’s overall view was that the UK Covid-19 Therapeutics Advisory Panel demonstrated the importance of “integrated, impartial and rapid drug prioritisation into national platform trials”. This allowed the investigators to focus on delivering the trials efficiently and effectively. Other witnesses agreed, stating that its establishment was a positive development. Professor Horby referred to it as “of enormous benefit” and Professor Khoo described it as “a tremendous resource and something the UK got right”. There was a clear need for the UK Covid-19 Therapeutics Advisory Panel; it (or a similar body) should be established at the outset of a future pandemic. |
Running effective clinical trials
| 2.82. | The UK’s scientific community has a strong track record of conducting clinical research, including in relation to infectious diseases.151 The extent to which the UK was able to design and deliver effective clinical trials in the emergency situation of the pandemic, both by drawing upon well-established principles and utilising innovation, is explored below. |
Trial design
| 2.83. | The success of clinical trials depends on how well they are designed.152 |
| 2.84. | This was particularly relevant to the large Phase 3 trials testing vaccines and drugs during the Covid-19 pandemic. Significantly, these trials were large randomised controlled trials, the gold standard for trial design.153 This means that the trial participants were randomly allocated to groups receiving either the drug or vaccine being tested or a placebo (ie a substance or treatment that should have no clinical effect) or other ‘control’ treatment. This prevents bias in the selection of who receives the drug or vaccine and ensures that the group receiving the real drug or vaccine and the control group will, on average, have similar people included with similar characteristics.154 |
| 2.85. | The importance of this type of trial was emphasised by Professor White, who noted that non-randomised retrospective studies based on observation can often provide a misleading picture of a beneficial effect:
“For example, sick patients are often given oxygen, and so in an observational study, receiving oxygen would be associated with an increased risk of death. But oxygen does not cause death – it is beneficial. The association is observed because the medical team diagnosed the patient as being very sick and needing oxygen.”155 |
| 2.86. | Regulators require evidence from such trials in almost all instances before authorising a new medicine, including a vaccine.156 During the pandemic, the need for such trials was also recognised in relation to existing drugs (ie drugs that had already been authorised to treat non-Covid-19 conditions and could be repurposed to treat Covid-19). Early in the pandemic, the World Health Organization and major drug regulators called for randomised trials to compare existing drugs with standard care.158 Professor Landray, whose principal academic interest has been in the design and conduct of large randomised clinical trials, said that he also first started thinking about the need for such trials for Covid-19 treatments in February 2020. These types of trials – like the RECOVERY trial – proved transformational in identifying which existing drugs were effective.159 |
| 2.87. | Despite the urgent need to develop a Covid-19 vaccine, rigorous trial standards were still applied during the pandemic. The Phase 3 trials for the Covid-19 vaccines were all ‘blind’ or ‘double blind’ randomised controlled trials.160 (A trial is blind when participants do not know whether they are receiving the medicine. In double blind trials both the participants and the trial investigators do not know which participants are receiving the medicine.) This prevents the trial outcome being influenced by participants and investigators behaving differently because they know who has received the trial medicine, thereby reducing the risk of bias and with it erroneous trial outcomes.161 |
| 2.88. | These Phase 3 vaccine trials were conducted at various locations across the world. However, Professor Stephen Evans, expert witness on vaccine safety, said that the clinical trial processes adopted were the same for all the trials, no matter where they were conducted, and complied with the principles of good clinical practice – the set of internationally agreed ethical and scientific quality standards for clinical trials.162 The European Medicines Agency has explained that compliance with these standards “provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible”.163 |
| 2.89. | A key design feature underpinning the success of the RECOVERY, REMAP-CAP, PANORAMIC and PRINCIPLE trials was that they were ‘adaptive platform trials’. This meant that drugs could enter and exit the trials on a rolling basis to allow multiple drugs to be tested simultaneously.164 Unlike traditional trials, where the question might be ‘Is this drug better than usual care?’, platform trials ask ‘What is the best drug for this disease?’.165 As Professor White explained, this is particularly important where there are several potential options and it is uncertain which is best. It also accommodates the different timing of drug availability (as new drugs are introduced), and gives “real time information as the pandemic evolves”.167 |
| 2.90. | The RECOVERY trial was one of the most successful clinical trials during the pandemic.168 It evaluated a total of 16 drugs, identifying 4 effective treatments including 1 new drug (Ronapreve).169 |
| 2.91. | In the event of a future pandemic, there must be a similar commitment to rigorous trial design, with randomised controlled trials utilised not only for vaccine and therapeutic development, but also the identification of effective repurposed drugs. Adaptive platform trials should be used to test and compare the efficacy of multiple potential drugs as they become available. |
Concurrent trial phases
| 2.92. | An important feature of the clinical trials of vaccines during the pandemic was the approach of carrying out phases concurrently rather than sequentially. This enabled rapid progression to the Phase 3 stage. As Professor Gilbert explained, under normal circumstances a Phase 1 trial would continue for a year, with blood samples being drawn after 3, 6 and 12 months to continue to assess immune responses to the vaccine. The study report would then be written, a paper would be published and, when possible, an application for further funding would be submitted, so that it would not be unusual to have an interval of three years between initiation of the Phase 1 and then the Phase 2 trial. By contrast, the Phase 1 trial of the Oxford/AstraZeneca vaccine began on 23 April 2020, overlapping with the Phase 2 and Phase 3 trials starting on 30 May 2020.170 |
| 2.93. | Vaccine manufacturers informed the Inquiry that this concurrent approach did not compromise safety assessments and that all the usual standards and approvals were required and followed.171 Dame June Raine explained that, despite the abbreviated timeframes for the Covid-19 vaccine clinical trials, the assessment process “was as robust as for any clinical trial”.172 Professor Evans also noted that “the scrutiny was intensive” in relation to the vaccine clinical trials.173 Allowing overlapping trial phases therefore did not compromise safety assessments. |
| 2.94. | The use of this concurrent structure was not new. However, it is not often used because it requires investing in late stage, large clinical trials before the totality of the data for a medicine is available, and organisations and manufacturers are rarely prepared to take such a significant financial risk.174 While it is understandable that manufacturers may not want to take such a risk generally, this is outweighed by the potential benefits during a health emergency. The Inquiry agrees with the Medicines and Healthcare products Regulatory Agency that the concurrent approach should be adopted in the event of a future pandemic.175 |
Size and diversity of clinical trials
| 2.95. | Phase 3 trials provide statistically and clinically robust evidence about efficacy and safety. The size of the trial dictates its statistical power to detect a difference between the group given the drug under investigation and the control group (ie the group given another drug or placebo). For example, it might require several hundred enrolled patients to detect a 30% advantage reliably, but several thousand to detect a 10% advantage reliably.176 It is therefore crucial that clinical trials are sufficiently large. |
| 2.96. | The Covid-19 vaccine clinical trials were sizeable. The Pfizer/BioNTech Phase 3 trial recruited almost 44,000 participants, the Oxford/AstraZeneca trials enrolled more than 25,000 participants and the Moderna Phase 3 trial enrolled more than 30,000 trial participants.177 These clinical trials were of a sufficient size to reach conclusions about the vaccines’ efficacy and safety – indeed, they were larger than some previous vaccine trials.178 Continuing a trial – or recruiting to a new one – when it is known that a vaccine or drug is effective, simply in order to gain enough data to rule out very rare adverse effects, would mean a delay in the provision of an effective vaccine or drug to both the control group (ie those given a placebo or other control drug) and the wider population.179 |
| 2.97. | The key therapeutics trials were also sufficiently large to provide meaningful useful results, identifying both effective and ineffective treatments in various settings. For example, and as set out above, the RECOVERY trial recruited more than 10,000 hospitalised patients and reported its first results within three months.180 With respect to community-based trials, the PRINCIPLE trial recruited more than 12,000 participants.181 The PANORAMIC trial recruited more than 25,000 participants within months of launching, making it the largest study worldwide into Covid-19 antiviral treatments.182 |
| 2.98. | The patient population in the trial should also be as representative as possible of the target population for the medicine or vaccine in clinical use.183 Dame June Raine said that the Covid-19 vaccine clinical trials were adequately representative in terms of age and sex.184 |
| 2.99. | Pregnant and breastfeeding women, children and immunocompromised people were generally excluded from the Covid-19 vaccine trials on safety grounds. This is discussed further in Chapter 4: Authorisation. Historically, drug development has tended to avoid testing in children and pregnancy.186 However, the RECOVERY therapeutics trial was innovative in its inclusion of pregnant women in clinical trials from early 2021. Pregnant women were invited to participate unless there was a good reason to exclude them, such as known adverse effects in pregnancy. Professor Horby described the RECOVERY trial as “deliberately inclusive” in its involvement of pregnant women (and a wide range of age groups and ethnicities).187 Professor Whitty supported the inclusion of pregnant women in the RECOVERY trial and cautioned against the systemic exclusion of people from trials more broadly.188 |
| 2.100. | In terms of ethnic diversity, the Covid-19 vaccine clinical trials were conducted across a range of countries with participants from different ethnic backgrounds. The Pfizer/BioNTech Phase 3 trial was conducted in the USA, Germany, South Africa, Turkey, Argentina and Brazil. In total, 83% of participants were ‘white’, 9% were ‘black’, 4% were ‘Asian’ and 2% were ‘multi-racial’.189 The Oxford/AstraZeneca trials enrolled participants at sites in the UK, Brazil and South Africa.190 A total of 76% of the participants were ‘white’, 10% were ‘black’, 4% were of ‘mixed ethnicity’, 3% were ‘Asian’ and 7% were of ‘other’ ethnicity. The Moderna Phase 3 trial took place in the USA. In total, 79.2% of participants were ‘White’, 10.2% were ‘Black or African American’, 4.6% were ‘Asian’, 0.8% were ‘American Indian or Alaska Native’, 0.2% were ‘Native Hawaiian or Other Pacific Islander’, 2.1% were ‘Multiracial’, 2.1% were of ‘Other’ ethnicity and 0.9% of participants were of ‘unknown’ ethnicity.193 This global trialling for vaccines provided an ethnically diverse range of participants. Dame June Raine said that the vaccine clinical trials were sufficiently diverse to “draw conclusions on safety in the indicated populations”.194 |
| 2.101. | However, the Inquiry heard that the particular vaccine clinical trials that were conducted in the UK itself were not sufficiently representative of ethnic minority populations.195 For example, Professor Daniel Prieto-Alhambra, expert witness on vaccine safety, explained that more than 90% of the participants in the UK-based Oxford/AstraZeneca trials identified as ‘white’.196 According to the England and Wales Census 2021 data published by the Office for National Statistics, 81.7% of those responding identified their ethnic group as ‘White’, 4.0% as ‘Black, Black British, Black Welsh, Caribbean or African’, 2.9% as ‘Mixed or Multiple ethnic groups’, 9.3% as ‘Asian, Asian British or Asian Welsh’ and 2.1% as ‘Other ethnic group’.197 While a lack of sufficient ethnic diversity did not affect the ability of regulators to assess safety and efficacy implications among ethnic minority groups – given the global statistics available – it impacted on confidence among ethnic minority groups.198 |
| 2.102. | The Inquiry was told that recruitment of ethnic minority groups is often a problem for clinical trials generally, and there has been a historical under-representation of ethnic minority groups in clinical trials.199 |
| 2.103. | Professor Chappell described lack of diversity as a “common issue” for clinical trials in non-pandemic settings.200 She explained that the National Institute for Health and Care Research considered diversity and inclusion in each trial and had run a number of research projects and programmes aimed at increasing diversity. For example, from 2020 the NIHR-INCLUDE programme addressed lack of representation in health research and provided an Ethnicity Framework tool for researchers with specific guidance on Covid-19 and inclusion of ethnic minority groups. A Race Equality Public Action Group was established in October 2020, aiming to give people from ethnic minority communities a stronger voice in shaping clinical research and recruitment.201 |
| 2.104. | The under-representation of ethnic minority groups in clinical trials was also raised by Dr Salman Waqar, who gave evidence on behalf of the Federation of Ethnic Minority Healthcare Organisations. He explained that it was difficult for healthcare professionals to reassure patients from ethnic minority groups about vaccine safety when trials were not sufficiently representative of their group.202 Dame June Raine said that the Medicines and Healthcare products Regulatory Agency looked “very carefully” at the issue of ethnic diversity in the Covid-19 vaccine clinical trials and found that it was “satisfactory”; however, she explained that “we could do better and would wish to do better” in relation to the ethnic diversity of trials.203 |
| 2.105. | There is no evidence that the lack of sufficient diversity of participants in clinical trials in the UK affected the ability of regulators to reach a timely decision on the safety and efficacy of the Covid-19 vaccines, including among ethnic minority groups.204 Trial diversity is a complex system-wide issue, engaging research funders, regulators and trial sponsors.205 The new clinical trials legislation and related guidance from the Health Research Authority and the Medicines and Healthcare products Regulatory Agency, which aims to provide trial investigators with greater direction and support in achieving diverse clinical trials, represents considerable progress.206 |
| 2.106. | The more ethnically diverse vaccine trials are, the more likely it is that the vaccines will command confidence and that coverage will improve.207 |
| 2.107. | With respect to therapeutics, Professor White noted that, as patients of Black or Asian ethnicity had an increased risk of severe Covid-19 and death, it was important to use the clinical trials for therapeutics to understand whether drug responses would be different in different ethnicities. Although not perfectly matched to the population at large, the representation of ethnic minority groups in the UK’s Covid-19 therapeutic trials was “generally better” than in many other trials.208 |
| 2.108. | This included the recruitment of people infected with Covid-19 in hospitals. For example, 25% of participants in the REMAP-CAP trial were “non-White”, a level greater than the general population. However, this was a consequence of the trial recruiting largely critically ill hospital patients and reflected the ethnic make-up of that group, rather than being the result of a direct drive to achieve diversity.209 While the RECOVERY trial did not report a detailed breakdown of ethnicities, the proportion of its participants who were “non-White” was similar to the UK population in the 2021 census, which reflected broad recruitment across many different hospitals.210 |
| 2.109. | The PRINCIPLE and PANORAMIC trials, which recruited participants with Covid-19 in the community, ran a community outreach programme involving faith groups, charities and community organisations to reach a wide pool of participants. This included a partnership with the largest Hindu temple in the UK to increase awareness and participation among the Hindu community.211 This helped achieve a level of ethnic diversity that reflected the population.212 However, a detailed ethnic minority breakdown showed that the proportion of Asian participants was higher than in the general population at a similar age, while the proportion of Black participants was lower.213 |
| 2.110. | Professor White said that a systematic review of Covid-19 studies in the UK found that reporting on the ethnicity of trial participants was inconsistent. Where data were available, under-representation was most marked in Black groups, but this did improve significantly over time. He stressed the challenge of achieving adequate trial representation and rapid recruitment, particularly in the urgent circumstances of a pandemic. His view was that investigator teams for the main Covid-19 therapeutic trials in the UK did well in ensuring that the trials were diverse enough, but he said that, in a rapidly unfolding pandemic, speed in identifying effective drugs is paramount.214 The Inquiry agrees. |
| 2.111. | However, the drive for greater ethnic diversity in clinical trials in the UK must continue. There were good examples of attempts to reach ethnic minority groups in the community in order to increase participation in both therapeutic and vaccine trials. These included direct appeals to the public for vaccine trial participants from ethnic minority communities and community outreach projects.215 These community outreach efforts should be built upon in order for clinical trials, particularly those for vaccinations, to have a recruitment base that is representative of the general population and instils confidence in ethnic minority groups in the next pandemic. The issue of ethnic diversity in clinical trials and its impact on vaccine confidence is further addressed in Chapter 6: Disparities in vaccine uptake. |
The future of vaccines and therapeutics
| 2.112. | Overall, the discovery and development of vaccines and therapeutics during the pandemic resulted in a number of extraordinary successes, and it is essential that lessons are learned. This is the principle that underpins the 100 Days Mission, a global initiative launched in June 2021 during the UK’s presidency of the G7. Its aim is to better prepare the world for the next pandemic by driving the development of diagnostics, therapeutics and vaccines so that they can be rapidly made available within the first 100 days of a future pandemic threat being identified.216 As the mission makes clear, “[w]e must seize the lessons from COVID-19 to improve pandemic preparedness for the future”.217 |
| 2.113. | The next pandemic may present a new set of obstacles and it would be misguided to prepare for it on the basis that it will be the same as Covid-19. This is essential for a number of reasons: it may prove impossible to develop a vaccine; it may take much longer to produce a vaccine; and, in any event, vaccines may not be suitable for everyone. The development of new drugs such as antivirals could therefore play a far greater role in a future pandemic. Set out below are key steps the UK should take to ensure resilience in respect of the discovery and development of vaccines and therapeutics. |
Stockpiling
| 2.114. | One way in which to prepare for a future pandemic is to stockpile drugs that are likely to be effective against the next likely pathogenic threat. The UK’s large stockpile of antivirals for the treatment of influenza did not prove useful for the treatment of Covid-19.218 |
| 2.115. | Clara Swinson, Director General for Global Health and Health Protection at the Department of Health and Social Care from November 2016 to September 2024, told the Inquiry that the Department of Health and Social Care was expanding its approach to clinical countermeasures to cover the five main routes of disease transmission: respiratory (eg Covid-19, influenza), touch (eg Ebola virus disease, Lassa), sexual/blood (eg HIV, mpox), oral (eg cholera, BSE/nvCJD) and vector (eg plague, Zika virus).219 |
| 2.116. | As part of this expanded approach, a review of emergency preparedness countermeasures was commissioned in 2022, to advise on materials that should be held in reserve.220 It recommended a number of licensed and unlicensed medicines for stockpiling (or consideration for stockpiling) as part of either a pandemic response or high consequence infectious disease. These included influenza antivirals, Covid-19 antivirals and monoclonal antibodies. It noted that stockpiling limited amounts of unlicensed antivirals to create a “library” of medicines and using them on an “experimental basis” could potentially develop the evidence for later stockpiling if cases were to occur.221 This was in line with the Antivirals and Therapeutics Taskforce recommendation in a report dated November 2022 for the exploration of existing broad-spectrum antivirals in order to develop a “day zero armoury” that can be used in the early stages of a pandemic.222 |
| 2.117. | Professor White accepted that there remained a high level of risk in terms of stockpiling for ‘Disease X’. However, he thought it wise to have a stockpile for both influenza and coronaviruses.223 Professor Vallance observed that stockpiling needs to be “targeted and intelligent and will always come with both cost and waste”, and in any event can only prove useful to known infectious agents.224 He referred to the advice in the 100 Days Mission that it is preferable to build up a ‘library’ of prototype drugs across different classes of likely infectious diseases (see below).225 |
| 2.118. | Stockpiling is an important part of pandemic preparedness. However, the Inquiry agrees with Professor Vallance that stockpiling must be targeted and evidence-based in order to limit unnecessary wastage, and it should not be at the expense of new drug development. |
A prototype library of vaccines and therapeutics
| 2.119. | One of the key lessons identified by the 100 Days Mission was the need to prepare prototype diagnostics, therapeutics and vaccines to treat pathogens of the greatest pandemic potential and progress them to a stage that can be adapted quickly to respond to a specific pathogen threat.226 |
| 2.120. | Dame Kate Bingham (Chair of the Vaccine Taskforce from May to December 2020) noted that, when Covid-19 emerged, scientists had a prototype design for a vaccine, given the work done in relation to previous disease outbreaks, for example MERS (as explained above). In her view, the UK needed to develop a prototype vaccine framework that could be engineered to target the specific features of future viruses across all threatening virus families.227 Professor Pollard also explained that, to be prepared for Disease X, it is important to develop an understanding of how to make vaccines against a range of viruses before the next pandemic arrives.228 |
| 2.121. | In respect of therapeutics, Eddie Gray (Chair of the Antivirals Taskforce from May 2021 to April 2022) supported a library of prototype antivirals that could then be safely expedited through Phase 2 and 3 clinical trials.229 |
| 2.122. | This was also a recommendation made in the report produced by the amalgamated Antivirals and Therapeutics Taskforce, in line with the 100 Days Mission. The taskforce noted that, although the repurposed approach used by the UK (and the rest of the world) during the Covid-19 pandemic offered some advantages, it was “resource-intensive”.230 It stated that across government, industry and academia there was consensus that understanding the broad-spectrum efficacy of existing antivirals (discussed above) and developing a library of prototype antivirals would represent a far more cost-effective model.231 Although the scope of its report was on responding to a respiratory pathogen, it assumed that the recommendations would be applicable to other pathogens of pandemic potential.232 For Professor Whitty, it was vital that there was more in the way of research and development for prototype antivirals for different groups of viruses, in particular those in animal and bird species.233 |
| 2.123. | The UK government has undertaken work on the development of vaccines and therapeutics, including in furtherance of the 100 Days Mission. This includes the following:
|
| 2.124. | These are positive developments in meeting the 100 Days Mission, and the Inquiry welcomes the fact that some of the preclinical and early clinical vaccine trials quoted in the 100 Days Mission 2024 Implementation Report are being carried out in the UK.242 However, it is not clear the extent to which the work that has been done will provide a range of prototype vaccines and therapeutics that can be utilised in the event of a future pandemic. |
| 2.125. | In terms of further work, the Vaccine Development and Evaluation Centre’s objectives should be aligned with the 100 Days Mission goal of creating a library of prototype vaccines for those pathogens identified as having the highest pandemic potential by the World Health Organization. Further to this, the UK Health Security Agency’s priority pathogen families research and development tool should guide the UK government’s investment in the domestic life sciences industry, beyond the 10 pathogens identified by the World Health Organization. |
| 2.126. | While there is an understandable focus on vaccines, given their role in bringing the Covid-19 pandemic to an end, it is essential that there is also investment in platform therapeutics, in particular antivirals. The extent to which work on antiviral development specifically has been taken forward is unclear, and Professor Sir John Bell, Regius Professor of Medicine at the University of Oxford, stated that it needed “a significant push”.243 It is critical that work on the development of therapeutics continues. The aim for the future should be to ensure that therapeutics are available as early as possible in a pandemic, pending the development or even the complete absence of a vaccine. |
Maintaining clinical trial capability
| 2.127. | Overall, the UK’s research and development response to the pandemic was timely, effective and, in many respects, world-leading. Professor Whitty told the Inquiry that the UK’s achievements depended on “steady investment and an integrated system of science and medicine” in advance of the pandemic.244 He emphasised that central to this was the UK’s ability to conduct clinical trials, and especially Phase 3 clinical trials.245 It is therefore vital to maintain such clinical trial capability to respond to a future pandemic. |
| 2.128. | A number of witnesses emphasised the importance of putting in place trial-ready infrastructure and processes prior to a future pandemic.246 This included having finalised protocols and ethical approval in place, as well as predesignated sites and investigators. Professor Van-Tam explained that this speeds up the time to recruitment of the first patients and ultimately delivers a quicker study result. In his view, the UK needed to ensure that in the event of a future pandemic something similar to the RECOVERY trial “can be activated in 1-2 weeks not 1-2 months”.247 Similarly, Professor Pollard said that trial sites have to be doing something “to be kept warm” in non-pandemic times, in order to build expertise and experience for when a pandemic strikes.248 |
| 2.129. | As set out above, the Antivirals and Therapeutics Taskforce recommended the development of a day zero armoury of broad-spectrum antivirals, as well as building a library of prototype antivirals. However, it made clear that for both recommendations to work in practice the UK’s clinical trial capabilities, “already recognised as world-leading, need to be embedded” through retaining its solid clinical trials and regulatory infrastructure. It pointed to the NHS as a significant asset for clinical trials as it provides a model to develop, test and adopt innovations at a population scale.249 |
| 2.130. | Despite this general recognition of the importance of clinical trial infrastructure for pandemic preparedness, the Inquiry heard evidence that the UK’s current trial capability was not what it should be. Matt Hancock MP (Secretary of State for Health and Social Care from July 2018 to June 2021) told the Inquiry that capability had “degraded very significantly since the pandemic”, particularly in relation to therapeutics.250 Possible reasons for this included the day-to-day pressures on the NHS, as well as a funding issue that “needs to be sorted”.251 In his view, “critical for pandemic response is to ensure that our clinical trial capability is stronger”.252 |
| 2.131. | This reflected evidence from a number of the investigators from the therapeutics trials, who told the Inquiry that clinical trial platforms established in the UK during the pandemic had effectively been stood down. Professor Butler told the Inquiry that an application for funding to maintain and broaden the PANORAMIC platform trial infrastructure – to enable it to evaluate therapeutics for a wider range of epidemic and pandemic infections – was not taken forward. He stated:
“To my current knowledge, once the PANORAMIC Trial ends, there will [be] no standing infrastructure that could be stood up within days or weeks of an outbreak of an infection of concern in the community. Expertise will be lost on a wide range of mission-critical functions for such capability.”254 |
| 2.132. | Professor Landray told the Inquiry that, since the Covid-19 pandemic, the RECOVERY trial had diversified to allow the study of treatments for patients admitted to hospital with influenza or community-acquired pneumonia. However, he said it was only able to continue evaluating treatments for influenza due to a grant from an organisation abroad; there was currently no government funding to maintain the trial infrastructure. In his view, this “is not in the best interests of preparedness for future pandemics”.255 |
| 2.133. | While Professor Horby accepted that it is impractical to maintain “a whole suite of clinical trial platforms”, he stated that there was a good case for strategic investment in the most innovative and cost-effective platforms, which could be redirected to everyday health problems. The Inquiry agrees; central to the preservation of clinical trial infrastructure is the need to embed clinical research within healthcare services. |
| 2.134. | Professor Vallance explained that high-quality clinical trials should be run within everyday practice in the NHS. This would be good for patient care generally, but also ensure that the infrastructure, data systems, skills and people are in place before the next pandemic arrives.257 The need to embed clinical research within the NHS was also identified by Lord O’Shaughnessy in his 2023 review on commercial clinical trials.258 Among the issues he identified was that research was not systematically prioritised within the NHS and was especially underutilised in primary care. The UK government’s response to the review, published in December 2023, addressed the issue of embedding research in the NHS and stated that it aimed to create a “step change” in the delivery of clinical research, so that “research is increasingly seen as an essential part of healthcare”.259 |
| 2.135. | Alongside this commitment to embedding clinical trial research within the NHS, the UK government has taken further relevant steps. These include:
|
| 2.136. | The Inquiry recognises and welcomes the steps the UK government has taken to strengthen clinical trial capabilities generally, as well as to commission research aimed at improving pandemic preparedness, including the work on hibernated protocols. It is essential that the UK’s research infrastructure is maintained and used to address everyday health problems – this must ensure that it is in a strong position when the next pandemic strikes and can pivot to focus on the research response to combat the new pathogen threat. It remains to be seen whether the steps taken will be sufficient. |
| 2.137. | There are obviously cost implications in maintaining the clinical trial platforms that were established during an emergency pandemic, but the benefits are not limited to pandemic response. Such platforms can be utilised in non-pandemic times to address perennial health problems. If the key components of clinical trials – such as expertise, databases, systems and regulatory and associated approvals – are in place, the cost of investment should be outweighed by the benefits, and when the next pandemic strikes the UK could move even more swiftly to developing vaccines and therapeutics. |
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p313
(https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642) - INQ000474743_0029-0030 para 5.2
- INQ000474525_0037 para 142; INQ000474511_0065-0066 para 190. The life-saving benefits of corticosteroids were also supported in part by the REMAP-CAP trial of hydrocortisone (a very similar drug to dexamethasone) (INQ000474743_0037 para 5.15).
- INQ000474743_0036-0037 para 5.14
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p323
(https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642) - 100 Days Mission to Respond to Future Pandemic Threats, Cabinet Office, 12 June 2021, p11 (https://www.gov.uk/government/publications/100-days-mission-to-respond-to-future-pandemic-threats; INQ000101061); INQ000474684_0003; INQ000474278_0009 para 36
- INQ000474334_0079 para 294
- INQ000474334_0037 para 126e; INQ000474401_0025 para 6.18; INQ000474537_0009 para 22; Clara Swinson 17 January 2025 82/12-83/7
- INQ000474278_0002 para 7
- INQ000474537_0009 para 22; INQ000474483_0010 para 29, footnote 17
- INQ000474278_0008 para 30
- INQ000474537_0009 para 22; INQ000474684_0001; INQ000474278_0009 para 36. Genetic sequencing is the process of ‘reading’ and spelling out an organism’s genetic code.
- INQ000474401_0025 para 6.17; Clara Swinson 17 January 2025 82/3-11
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p324 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642); INQ000474684_0003
- Jonathan Van-Tam 20 January 2025 138/22-139/9
- INQ000474315_0007-0008 para 28
- INQ000474335_0044 para 142
- Christopher Whitty 20 January 2025 65/25-67/14, 68/9-70/22
- INQ000474624_0028 para 127. Professor Horby specifically referred to the following small molecule antiviral drugs: remdesivir (Veklury), molnupiravir (Lagevrio) and nirmatrelvir plus ritonavir (Paxlovid). See also 100 Days Mission to Respond to Future Pandemic Threats, Cabinet Office, 12 June 2021, p12, para 11 (https://www.gov.uk/government/publications/100-days-mission-to-respond-to-future-pandemic-threats; INQ000101061).
- Nicholas White 30 January 2025 5/12-9/5
- INQ000474335_0019 para 62. An antibody is a protein module produced by the immune system that recognises and binds to an antigen (ie a foreign substance that can include bacteria or viruses). Monoclonal antibodies are identical in structure and are specific to one antigen only. These antibodies can be mass produced in a laboratory through a cell line of immune cells (B cells) and then harvested for use against the target antigen.
- INQ000474335_0058 para 182; INQ000474743_0046-0047 para 5.37
- INQ000474743_0045, 0048-0049 paras 5.30, 5.39; INQ000474335_0058 para 182
- INQ000474482_0010 para 20
- INQ000474399_0044 para 100
- INQ000474399_0039-0040 para 83
- INQ000474399_0044 paras 100-101
- INQ000474431_0031-0032 para 114a
- ‘£1 billion BioNTech investment sets way for jobs, growth, breakthroughs’, Department for Science, Innovation and Technology, 20 May 2025 (https://www.gov.uk/government/news/1-billion-biontech-investment-sets-way-for-jobs-growth-breakthroughs; INQ000659866)
- Life Sciences Sector Plan, Office of Life Sciences, 16 July 2025 (https://www.gov.uk/government/publications/life-sciences-sector-plan/life-sciences-sector-plan; INQ000654126)
- ‘Blow for UK drugs sector as Merck scraps £1bn expansion’, BBC News, 11 September 2025 (https://www.bbc.co.uk/news/articles/ckgzyxjr0lzo; INQ000654125)
- ‘AstraZeneca pauses £200m Cambridge investment’, BBC News, 12 September 2025 (https://www.bbc.co.uk/news/articles/cderlg227j4o; INQ000654122)
- ‘Big pharma firms have paused nearly £2bn in UK investments this year’, The Guardian, 16 September 2025 (https://www.theguardian.com/business/2025/sep/16/big-pharma-firms-uk-investment-trump-msd-eli-lilly-astrazeneca; INQ000659902)
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p115
(https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642) - INQ000474401_0011-0012 para 4.9
- INQ000474401_0007-0008, 0011 para 4.8; INQ000474511_0026 para 65
- INQ000474525_0011 para 38
- INQ000474525_0015 para 51; INQ000474401_0011-0012 para 4.9. The Clinical Research Network was relaunched in October 2024 as the Research Delivery Network (INQ000474525_0015 para 51).
- INQ000474525_0024-0025 para 94; Kate Bingham 21 January 2025 34/7-8; Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p324 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642)
- INQ000474479_0015 para 7.11
- INQ000474416_0002-0004, 0016 paras 3-7, 47. The REMAP-CAP trial was established after the 2009 influenza pandemic and pivoted to Covid-19 research during the pandemic.
- INQ000474401_0014 para 4.15v
- INQ000496107_0004 para 2
- INQ000474707_0007 para 2.2
- INQ000474337_0033 para 100; INQ000474707_0007-0009 paras 2.2-2.6; INQ000474743_0013-0021 paras 3.1-3.28. ‘Efficacy’ refers to a drug’s effect in a controlled research setting where its correct dosing and administration can be assured. It is often used interchangeably with ‘effectiveness’; however, the latter refers to how a prescribed medicine or vaccine performs in routine use (INQ000474743_0010 footnote 3).
- Phase 4 trials support post-authorisation surveillance and collect data across a wider population that is using the product, to detect rare adverse effects and assess long-term effectiveness (INQ000474337_0033 para 100).
- INQ000474406_0027-0028 para 25.2; INQ000474482_0013-0014 para 29
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p313
(https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642) - INQ000474525_0023 para 90; see also INQ000474401_0012-0013, 0016 para 4.12
- INQ000474511_0039 para 106
- INQ000474401_0012-0013 paras 4.12-4.13; INQ000474525_0023 para 91; INQ000474511_0039-0040 para 107
- INQ000474525_0023-0024 para 92
- INQ000474511_0040 paras 108-109
- INQ000474525_0023-0024 para 92
- INQ000474401_0011 para 4.8
- Christopher Whitty 20 January 2025 56/20-57/12
- INQ000474511_0041 para 112
- INQ000474401_0014-0015 para 4.17
- INQ000474399_0037 para 76
- INQ000474525_0020-0021 para 77
- INQ000474743_0033 para 5.9
- INQ000474525_0021 para 81; INQ000475521
- INQ000474525_0021 para 81; INQ000048103
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p313 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642); INQ000474401_0013-0014 para 4.14; INQ000474525_0022 para 82
- INQ000474624_0012 para 52; INQ000474525_0022 para 83
- INQ000474525_0015, 0022 paras 53, 83; INQ000474624_0012 para 52
- INQ000474525_0022 para 83; INQ000474401_0013-0014 para 4.14
- INQ000474525_0022-0023 paras 86-87; Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p318 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642); INQ000474743_0033 para 75.9
- INQ000474525_0023 para 87; Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p318 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642); Christopher Whitty 20 January 2025 72/11-16
- INQ000474743_0033 para 5.9
- INQ000474743_0033 para 5.9
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p318 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642)
- INQ000474416_0003 para 6; INQ000474479_0003, 0018 paras 2.3, 11.1
- INQ000068589; INQ000474401_0016
- INQ000474404_0065-0066 para 3.23
- INQ000474624_0030-0031 para 135; see also INQ000474660_0068-0069 para 271; INQ000474479_0051-0053 para 53.1; INQ000474416_0016-0017 para 48
- INQ000474743_0028-0029, 0033 paras 4.3, 5.8; Commercial Clinical Trials in the UK: The Lord O’Shaughnessy Review – Final Report, Department of Health and Social Care and Department for Science, Innovation and Technology, 26 May 2023, p18 (https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report; INQ000409267)
- INQ000474337_0032 para 96; INQ000474401_0024 para 6.13
- INQ000474337_0043 para 139
- INQ000474337_0044 para 140
- INQ000474337_0044 para 141
- INQ000474337_0075 para 26
- INQ000474337_0044 para 141
- INQ000474335_0053 para 163
- ‘Fast-track review service helps COVID-19 research deliver results quickly’, NHS Health Research Authority, 25 June 2020 (https://www.hra.nhs.uk/about-us/news-updates/fast-track-review-service-helps-covid-19-research-deliver-results-quickly; INQ000651975)
- INQ000474399_0008 para 17
- INQ000499442_0067-0068 para 192; INQ000474416_0018 para 54; INQ000474399_0008 para 17
- INQ000474399_0008 para 17
- INQ000474449_0007 para 26
- The Medicines for Human Use (Clinical Trials) Regulations 2004 (https://www.legislation.gov.uk/uksi/2004/1031/contents); INQ000651973; see also The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (https://www.legislation.gov.uk/uksi/2025/538/contents)
- ‘MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years’, Medicines and Healthcare products Regulatory Agency, 21 March 2023 (https://www.gov.uk/government/news/mhra-to-streamline-clinical-trial-approvals-in-biggest-overhaul-of-trial-regulation-in-20-years; INQ000651979); ‘MHRA highlights “remarkable” progress and launches real-world data consultation on International Clinical Trials Day’, Medicines and Healthcare products Regulatory Agency, 20 May 2025(https://www.gov.uk/government/news/mhra-highlights-remarkable-progress-and-launches-real-world-data-consultation-on-international-clinical-trials-day; INQ000652094); Commercial Clinical Trials in the UK: The Lord O’Shaughnessy Review – Final Report, Department of Health and Social Care and Department for Science, Innovation and Technology, 26 May 2023 (https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report; INQ000409267)
- ‘UK clinical trial approval times twice as fast with AI and reforms’, Medicines and Healthcare products Regulatory Agency, 7 October 2025 (https://www.gov.uk/government/news/uk-clinical-trial-approval-times-twice-as-fast-with-ai-and-reforms; INQ000658644)
- INQ000474743_0035 para 5.13
- INQ000474482_0047-0048 para 123; see also INQ000474401_0073 paras 7.1-7.2
- INQ000474401_0074 para 7.3
- INQ000474401_0016, 0074 paras 5.1, 7.3
- INQ000474743_0068-0069 para 6.5; see also Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p314 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642)
- INQ000474525_0038 para 147; INQ000474743_0035 para 5.13; INQ000474482_0047-0048 para 123
- INQ000474401_0018; INQ000474624_0023 para 113a; INQ000474743_0041 para 5.19
- INQ000474525_0042 para 158
- Christopher Whitty 20 January 2025 60/24-61/4
- INQ000474401_0074 para 7.3
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p317
(https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642 - Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p314 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642); INQ000474401_0016-0017 para 5.1
- INQ000474743_0034 para 5.10; INQ000474525_0037 para 140
- INQ000474482_0011 para 21
- INQ000474624_0018 paras 84-85
- INQ000474525_0041 para 156
- INQ000474479_0006-0007 para 2.11; INQ000474525_0043 para 161
- INQ000474479_0015-0016, 0044 paras 7.11, 7.13, 49.2
- INQ000474416_0018 para 55
- INQ000474416_0018 para 55
- INQ000474482_0047 para 122
- Nicholas White 30 January 2025 31/18-32/18
- INQ000474525_0026-0027 paras 98-99
- INQ000474525_0027 para 100
- INQ000474525_0027 para 102
- INQ000474525_0032-0033 para 123
- Full Government Response to the Lord O’Shaughnessy Review into Commercial Clinical Trials, Department of Health and Social Care, 8 December 2023, p19 (https://www.gov.uk/government/publications/government-response-to-the-review-into-commercial-clinical-trials/full-government-response-to-the-lord-oshaughnessy-review-into-commercial-clinical-trials; INQ000625745)
- Uniting the UK’s Health Data: A Huge Opportunity for Society, Professor Cathie Sudlow, November 2024 (https://zenodo.org/records/13353747; INQ000474861)
- Uniting the UK’s Health Data: A Huge Opportunity for Society, Professor Cathie Sudlow, November 2024, p97 (https://zenodo.org/records/13353747; INQ000474861)
- ‘Prime Minister turbocharges medical research’, Department of Health and Social Care, Prime Minister’s Office, Department for Science, Innovation and Technology, Office for Life Sciences and Office for Investment, 7 April 2025 (https://www.gov.uk/government/news/prime-minister-turbocharges-medical-research; INQ000651980)
- INQ000474511_0069 para 202; INQ000474404_0055-0056 para 3.3; INQ000496107_0005
- INQ000474525_0051 paras 189-190
- INQ000474525_0051 paras 189-190
- Alok Sharma 17 January 2025 45/23-46/18; INQ000474525_0053 para 198; INQ000474619_0007, 0014 paras 20, 49; INQ000474511_0071-0072 paras 215, 219; INQ000474534_0034 para 118
- INQ000478983_0001, 0005; INQ000474590_0021-0025 paras 63-72; Alok Sharma 17 January 2025 47/3-21; INQ000478978
- INQ000474660_0068-0069 para 271
- INQ000474404_0055-0056 para 3.3; INQ000474401_0084-0085 paras 7.43-7.44; see also Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p314 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642)
- Christopher Whitty 20 January 2025 77/17-18
- Christopher Whitty 20 January 2025 63/15-65/20, 77/6-18
- INQ000474534_0035 paras 122-123
- INQ000474511_0073 para 228
- INQ000474404_0060-0061 paras 3.9-3.11; INQ000474401_0075-0076 paras 7.6-7.7
- INQ000474624_0010 para 42
- INQ000474625_0006, 0008 paras 14-15, 21. This was formally established by the Department of Health and Social Care in January 2021.
- INQ000474625_0007 para 20
- INQ000474335_0027 para 92
- INQ000474534_0015 para 46
- INQ000474534_0007, 0014 paras 18, 42
- INQ000474534_0014, 0023 paras 44.1, 68
- INQ000474534_0016-0017 para 51
- INQ000474534_0026 para 81
- INQ000474624_0011 para 45
- INQ000474534_0007 para 18
- INQ000474534_0024 para 71
- INQ000474625_0007 para 20; INQ000474534_0023-0024 paras 70-71
- INQ000474534_0024 para 71
- INQ000474534_0036 para 126
- INQ000474624_0011 para 49; INQ000474449_0016 para 58ii
- INQ000474743_0029 para 4.3; INQ000474482_0010 para 20
- 100 Days Mission to Respond to Future Pandemic Threats, Cabinet Office, 12 June 2021, p38, para 57 (https://www.gov.uk/government/publications/100-days-mission-to-respond-to-future-pandemic-threats; INQ000101061)
- Stephen Evans 22 January 2025 12/23-13/8; INQ000474624_0016 para 72; INQ000474416_0014-0015 para 41; INQ000474479_0011 para 7.1; INQ000474703_0008 para 2.1
- INQ000474743_0019 para 3.21; INQ000474707_0008 para 2.5
- INQ000474743_0019-0020 para 3.22
- INQ000474707_0008 para 2.5
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p313 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642)
- INQ000474660_0007-0008 para 30
- 100 Days Mission to Respond to Future Pandemic Threats, Cabinet Office, 12 June 2021, p38, para 58 (https://www.gov.uk/government/publications/100-days-mission-to-respond-to-future-pandemic-threats; INQ000101061)
- Stephen Evans 22 January 2025 12/23-13/8. As explained in Chapter 1: The landscape of vaccines and therapeutics, the Inquiry has focused on the first three Covid-19 vaccines authorised for use in the UK and rolled out among the UK population: the Pfizer/BioNTech vaccine, the Oxford/AstraZeneca vaccine and the Moderna vaccine.
- Stephen Evans 22 January 2025 11/21-12/10; INQ000474743_020 para 3.24
- Stephen Evans 22 January 2025 17/6-18/6; INQ000474707_0052-0053 para 6.2
- ‘Good clinical practice’, European Medicines Agency, p1 (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-clinical-practice; INQ000506088)
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p320 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642); INQ000474479_0011 para 7.1; INQ000474416_0002 para 3
- INQ000474525_0036 para 137
- INQ000474743_0023 para 3.32
- INQ000474743_0023 para 3.32
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p319
(https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642) - INQ000474624_0018-0019 paras 86-88. The four treatments were: dexamethasone, tocilizumab, baricitinib and casirivimab-imdevimab (Ronapreve).
- INQ000474278_0016 para 72
- Ben Osborn 23 January 2025 127/5-24; INQ000474453_0008-0009 para 35
- INQ000474337_0032-0033 para 98
- INQ000474707_0028 para 3.5
- INQ000474537_0010 para 25
- INQ000474337_0052 para 167
- INQ000474743_0018 para 3.17
- Ben Osborn 23 January 2025 128/1-10; Justin Green 23 January 2025 161/16-162/12; Darius Hughes 27 January 2025 4/3-21
- June Raine 22 January 2025 143/16-23
- INQ000474707_0015 para 2.23; Stephen Evans 22 January 2025 13/9-14/7
- INQ000474743_0034 para 5.10; INQ000474525_0037 para 140
- INQ000474525_0041 para 156
- INQ000474479_0006-0007 para 2.11; INQ000474525_0043 para 161. The Inquiry notes Professor White’s observation that even very large trials such as PANORAMIC were insufficiently powered to show moderate benefits, given that by 2022 Covid-19 had become much milder (INQ000474743_0046, 0049-0050 paras 5.33, 5.41).
- INQ000474743_0017 para 3.15
- INQ000474337_0045-0046 para 146. Professor Prieto-Alhambra noted that the Oxford/AstraZeneca trials included low numbers of elderly people (INQ000474703_0020 paras 4.23-4.24).
- INQ000474703_0020 para 4.26; INQ000474707_0054, 0056-0058 paras 6.7, 6.11-6.14; INQ000485977_0037 para 107; INQ000474337_0046 para 147. Later trials were conducted specifically for children (Daniel Prieto-Alhambra 22 January 2025 86/19-25).
- INQ000474743_0026 para 3.39
- INQ000474624_0018, 0021 paras 81, 98; INQ000474337_0077 para 270
- Christopher Whitty 20 January 2025 80/10-15
- Ben Osborn 23 January 2025 128/1-10, 129/3-9
- Justin Green 23 January 2025 161/16-162/12
- Justin Green 23 January 2025 169/5-13
- Darius Hughes 27 January 2025 4/3-21
- ‘Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine’, LR Baden, HM El Sahly, B Essink, K Kotloff, S Frey, R Novak et al, The New England Journal of Medicine (2020), 384(5), 403-416 (https://www.nejm.org/doi/full/10.1056/NEJMoa2035389; INQ000408427)
- INQ000474337_0045-0046 para 146
- Clara Swinson 17 January 2025 68/20-69/18; Daniel Prieto-Alhambra 22 January 2025 50/19-25
- INQ000474703_0020 para 4.25
- INQ000474537_0015 footnote 23; ‘Ethnic group, England and Wales: Census 2021’, Office for National Statistics, 29 November 2022 (https://www.ons.gov.uk/peoplepopulationandcommunity/culturalidentity/ethnicity/bulletins/ethnicgroupenglandandwales/census2021; INQ000659831)
- INQ000474623_0079 para 261; INQ000474705_0041 paras 90-91; INQ000492283_0014 para 48
- INQ000474707_0054-0055 para 6.8; Salman Waqar 16 January 2025 7/2-8/12; INQ000485278_0005 para 15
- INQ000474525_0032 para 120
- INQ000474525_0029-0031 paras 113-117
- Salman Waqar 16 January 2025 7/2-8/20; INQ000485278_0010 para 31
- June Raine 22 January 2025 144/4-14
- INQ000474336_0079 para 192; INQ000474337_0045-0046 para 146; Daniel Prieto-Alhambra 22 January 2025 50/19-51/13
- INQ000474337_0045-0046, 0231-0232 paras 146, 825, 827-828
- ‘Guidance for developing and submitting an inclusion and diversity plan second draft’, NHS Health Research Authority, 13 May 2025 (https://www.hra.nhs.uk/about-us/news-updates/guidance-developing-and-submitting-inclusion-and-diversity-plan-second-draft; INQ000659854); ‘Clinical trials regulations reform’, NHS Health Research Authority, 6 November 2025 (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/clinical-trial-regulations-reform; INQ000662000)
- Daniel Prieto-Alhambra 22 January 2025 51/8-21; June Raine 22 January 2025 182/18-25
- INQ000474743_0062 paras 5.68-5.69
- INQ000474416_0004, 0006 paras 7, 15
- INQ000474743_0062 para 5.69; see also INQ000474624_0021 para 99
- INQ000474479_0014 para 7.9
- INQ000474479_0014 para 7.9
- INQ000474743_0062 para 5.69
- INQ000474743_0062-0063 paras 5.69-5.70
- Alok Sharma 17 January 2025 49/5-50/1; INQ000474479_0014 para 7.9
- INQ000496177_0069 para 13.19; INQ000474482_0053 paras 141-142
- 100 Days Mission to Respond to Future Pandemic Threats, Cabinet Office, 12 June 2021, p15, para 14 (https://www.gov.uk/government/publications/100-days-mission-to-respond-to-future-pandemic-threats; INQ000101061)
- INQ000474335_0042, 0044 paras 133-134, 142
- INQ000474335_0073-0074 para 240
- INQ000474335_0073-0074 para 240; INQ000184088
- INQ000184088_0009 para 30
- INQ000497096_0001, 0006
- Nicholas White 30 January 2025 33/11-34/23; INQ000474743_0085-0086 paras 7.3, 7.5
- INQ000474482_0049 para 127
- INQ000474482_0049 para 127
- INQ000474482_0053 para 142
- INQ000474406_0068 para 49.2
- INQ000474399_0010-0012 paras 23, 25
- Eddie Gray 29 January 2025 114/22-115/14
- INQ000497096_0006 para 14
- INQ000497096_0001, 0006 para 14
- INQ000497096_0003 para 6
- Christopher Whitty 20 January 2025 68/9-70/22
- UK Biological Security Strategy, Cabinet Office, June 2023, p10 (https://www.gov.uk/government/publications/uk-biological-security-strategy; INQ000208910); INQ000474418_0085 para 6.17
- INQ000474418_0085 para 6.17; INQ000496177_0069 para 13.19
- INQ000496177_0068-0069 para 13.17
- Alexandra Jones 20 January 2025 21/1-13
- INQ000496177_0068 para 13.16; ‘UKHSA unveils VDEC in “step change” for UK’s growing vaccine capabilities’, UK Health Security Agency, 7 August 2023 (https://www.gov.uk/government/news/ukhsa-unveils-vdec-in-step-change-for-uks-growing-vaccine-capabilities; INQ000661262); ‘UKHSA’s Vaccine Development and Evaluation Centre (VDEC)’, UK Health Security Agency, 10 January 2025 (https://www.gov.uk/guidance/ukhsas-vaccine-development-and-evaluation-centre-vdec; INQ000651919)
- UKHSA Science: Securing Health and Prosperity 2024 Review, UK Health and Security Agency, January 2025, p45 (https://assets.publishing.service.gov.uk/media/677b8e0396026fd694d92c60/Science_review_2024.pdf; INQ000563069)
- INQ000496177_0069 para 13.19
- ‘Priority pathogens: The disease families which require urgent scientific research’, UK Health Security Agency, 25 March 2025 (https://ukhsa.blog.gov.uk/2025/03/25/priority-pathogens-the-disease-families-which-require-urgent-scientific-research; INQ000651918); Priority Pathogen Families Research and Development (R&D) Tool, UK Health Security Agency, March 2025 (https://assets.publishing.service.gov.uk/media/67f5259ae3c60873d6c90d08/UKHSA-priority-pathogen-families-research-and-development-tool.pdf; INQ000587354)
- 100 Days Mission Implementation Report, International Pandemic Preparedness Secretariat, 31 January 2025, p44
(https://ippsecretariat.org/publication/fourth-implementation-report; INQ000651978) - INQ000499442_0064 para 182
- INQ000474401_0086 para 8.3
- INQ000474401_0086 para 8.4
- INQ000499442_0059-60 para 171; INQ000474479_0045, 0051-0053 paras 50.1, 53.1; INQ000474537_0048-0049 para 92
- INQ000474404_0066 para 3.24
- INQ000474399_0019 para 41
- INQ000497096_0007 para 16
- Matt Hancock 16 January 2025 68/14-16
- Matt Hancock 16 January 2025 68/20-24
- Matt Hancock 16 January 2025 69/5-6
- INQ000474660_0015 para 49; INQ000474479_0051-0054 paras 53.1-53.3
- INQ000474479_0051-0053 para 53.1
- INQ000474660_0015, 0086 paras 49-50, 333
- INQ000474624_0027 para 124
- INQ000474482_0011 para 22; see also INQ000474624_0031 paras 136-138
- Commercial Clinical Trials in the UK: The Lord O’Shaughnessy Review – Final Report, Department of Health and Social Care and Department for Science, Innovation and Technology, 26 May 2023, pp43-45 (https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report; INQ000409267)
- Full Government Response to the Lord O’Shaughnessy Review into Commercial Clinical Trials, Department of Health and Social Care, 8 December 2023 (https://www.gov.uk/government/publications/government-response-to-the-review-into-commercial-clinical-trials/full-government-response-to-the-lord-oshaughnessy-review-into-commercial-clinical-trials; INQ000625745_0032)
- ‘UK secures £400 million investment to boost clinical trials’, Department of Health and Social Care and Office for Life Sciences, 28 August 2024 (https://www.gov.uk/government/news/uk-secures-400-million-investment-to-boost-clinical-trials; INQ000506082)
- ‘£100 million public-private health research boost’, Department of Health and Social Care and Department for Science, Innovation and Technology, 12 December 2024 (https://www.gov.uk/government/news/100-million-public-private-health-research-boost; INQ000652275)
- INQ000474525_0068 para 253
- Module 1: The resilience and preparedness of the United Kingdom, UK Covid-19 Inquiry, July 2024, Chapter 4 (https://covid19.public-inquiry.uk/documents/module-1-full-report)
- UK Government Response to the Covid-19 Inquiry Module 1 Report, Cabinet Office, 16 January 2025 (https://assets.publishing.service.gov.uk/media/67879a232cca34bdaf58a239/UK_Government_Response_to_the_Covid-19_Inquiry_Module_1_Report.pdf; INQ000625630)
- ‘Pandemic preparedness – platform clinical trials in hospital and community settings’, National Institute for Health and Care Research (https://www.nihr.ac.uk/funding/pandemic-preparedness-platform-clinical-trials-hospital-and-community-settings/2025311; INQ000652274)
- UK Government Response to the Covid-19 Inquiry Module 1 Report, Cabinet Office, 16 January 2025 (https://assets.publishing.service.gov.uk/media/67879a232cca34bdaf58a239/UK_Government_Response_to_the_Covid-19_Inquiry_Module_1_Report.pdf; INQ000625630); Health and Care Research and Development Framework for Pandemic Preparedness, Prevention and Response, Cabinet Office and Department of Health and Social Care, 8 July 2025 (https://www.gov.uk/government/publications/pandemic-preparedness-prevention-and-response-health-and-care-research-and-development-framework/health-and-care-research-and-development-framework-for-pandemic-preparedness-prevention-and-response; INQ000653645)
Chapter 3: Securing supplies
Introduction
| 3.1. | During the Covid-19 pandemic, three specialist taskforces were established to secure vaccines, therapeutics and antivirals. By the end of 2020, the Vaccine Taskforce had struck agreements to secure access to seven Covid-19 vaccines.1 The Therapeutics Taskforce also played a significant role, including by ensuring that dexamethasone was made available to the patient within hours of the positive result from the RECOVERY trial.2 By the winter of 2021/22, the Antivirals Taskforce had met its objective of securing two effective antivirals – which could treat Covid-19 early – for the UK.3 |
| 3.2. | This chapter examines the effectiveness of the taskforces and the key factors underpinning their success, in order to identify the lessons that can be learned in relation to planning and responding to future pandemics. |
The taskforces
Identifying the need for taskforces
| 3.3. | A key part of the UK’s early response to the Covid-19 pandemic was identifying the need for, and then establishing, a number of specialist taskforces focused on vaccines and therapeutics. Professor Sir Patrick Vallance (later Lord Vallance of Balham), Government Chief Scientific Adviser from April 2018 to March 2023, was instrumental in this process.4 Drawing upon his experience as a clinician and of working in the pharmaceutical industry, Professor Vallance identified at an early stage the need to create a dedicated team focused on the development, procurement and manufacture of Covid-19 vaccines.5 As a result – and with the assistance of Alexandra Jones, Director of Science, Research and Innovation at the Department for Business, Energy and Industrial Strategy from April 2019 to May 2023 – the Vaccine Taskforce was established in March 2020.6 |
| 3.4. | The Vaccine Taskforce began life as an expert advisory board, consisting of experts from industry and academia, chaired by Professor Vallance.7 However, in light of the scale of the challenge, it became clear that it was necessary to have a formal operational structure with decision-making authority, supported by a team within the UK government and with ministerial oversight.8 At the time, the Department of Health and Social Care was the lead department for vaccine development. However, it was under considerable pressure responding to the pandemic. It was therefore decided that the taskforce should be part of the Department for Business, Energy and Industrial Strategy, drawing on its existing links to industry through the Office for Life Sciences.9 |
| 3.5. | Professor Vallance also identified the need for a separate Therapeutics Taskforce to coordinate the UK government’s efforts to deliver safe and effective treatments for Covid-19 for the whole of the UK. The Therapeutics Taskforce was therefore established.10 After some debate as to which government department should oversee the taskforce, Boris Johnson MP (Prime Minister from July 2019 to September 2022) decided that it should sit under the Department of Health and Social Care.11 Professor Vallance agreed this was appropriate given that the department’s work was more closely associated with treatment, clinical trials and outcomes.12 |
| 3.6. | By early 2021 there were several new antiviral drugs for Covid-19 in development. In January 2021, Professor Vallance wrote to Charlotte Taylor (Deputy Director then Director of the Therapeutics Taskforce from April 2020 to April 2022) to advise that it was critical that the Therapeutics Taskforce had a good overview of any antivirals being developed and to ensure that it had industry experts on board. He believed that there needed to be a focus on how the UK might accelerate the development of antivirals and he suggested a new taskforce, which would require similar support from senior decision-makers in the UK government as had been given to the Vaccine Taskforce.13 The establishment of the Antivirals Taskforce was subsequently agreed on 1 April 2021 and publicly announced shortly thereafter.14 |
| 3.7. | The identification and timely establishment of these taskforces were a critical part of the UK’s response to the Covid-19 pandemic and will need to be repeated in the event of a future pandemic. However, Ms Jones explained that establishing organisational structures was not a normal part of the Government Chief Scientific Adviser’s role and cautioned against assuming that, in a future emergency, they would have the “directly relevant scientific background and professional experience that Sir Patrick had”.15 Future planning must take this into account. |
Remit
| 3.8. | In May 2020, there was considerable debate as to the remit of the Vaccine Taskforce and what, if anything, it should include beyond vaccines. The main issue was whether to combine work on vaccines with therapeutics, given the degree of overlap between the two areas. For example, neutralising antibodies – antibodies which can neutralise antigens by stopping them from further harming the host and by directly limiting infection – can both act as a medicine to treat disease and also be given prophylactically (ie to prevent infection).16 |
| 3.9. | However, each area of work involved different challenges. The focus in relation to vaccines was on discovery, development and manufacture. Therapeutics were more closely associated with the work of the NHS.17 There was a concern that the inclusion of therapeutics generally within the Vaccine Taskforce’s remit risked splitting its focus and the objectives for both workstreams might become more diffuse.18 It was therefore agreed by Mr Johnson that there should be two separate bodies.19 |
| 3.10. | Professor Vallance’s view was that, despite there being “a degree of tension” between the Department of Health and Social Care and the Department for Business, Energy and Industrial Strategy about the remit of the Vaccine Taskforce, the establishment of the two separate taskforces in this way was appropriate.20 Ms Jones emphasised that the exclusion of therapeutics from the Vaccine Taskforce’s remit was not reflective of a lower priority being given to them but of the need to ensure the most effective use of resources.21 |
| 3.11. | There was one exception to the general exclusion of therapeutics from the scope of the Vaccine Taskforce’s work. Initially, antibodies remained within its scope, in relation to both treatment and prevention (ie prophylaxis).22 Professor Vallance explained that some of the approaches to discovering and making antibodies were related to the science needed for vaccines.23 In respect of prophylaxis, the antibodies were particularly important because of their potential to protect people with compromised immune systems, for whom vaccines might have been ineffective. It was for this reason that Dame Kate Bingham (Chair of the Vaccine Taskforce from May to December 2020) “felt strongly” that they should be included within the remit of the Vaccine Taskforce.24 |
| 3.12. | By August 2020, a collaborative approach had been adopted between the Vaccine Taskforce and the Therapeutics Taskforce on an antibodies workstream.25 However, responsibility for these antibodies was transferred to the Therapeutics Taskforce between October and December 2020, at the request of the Department of Health and Social Care. Ms Taylor noted that antibodies needed “bringing into the normal channels of medicine regulation, and procurement”.26 |
| 3.13. | In the event of a future pandemic, early consideration should be given to the remit of any taskforce, with clear lines of responsibility established from the outset. However, there should be a degree of flexibility in the remits of such bodies, to enable an appropriate response as the pandemic threat develops and technologies adapt. |
Prioritisation of resources
| 3.14. | During a pandemic, decisions about the prioritisation of resources are inevitable. Mr Johnson said that in early 2020 he sought to invest all “possible effort and resources into finding an effective treatment or vaccine” to combat Covid-19. He explained that this was “central to the UK Government’s overarching strategy” for responding to the pandemic.27 This accorded with the evidence of other witnesses, who explained that vaccines and therapeutics were both considered important at the start of the pandemic when it was not clear whether it would be possible to develop an effective vaccine.28 |
| 3.15. | As the pandemic progressed and the significance of the vaccines became clear, therapeutics became less important at a population level, although they remained vital for those who were in hospital or otherwise still required treatment.29 Matt Hancock MP (Secretary of State for Health and Social Care from July 2018 to June 2021) told the Inquiry that both vaccines and therapeutics were “incredibly important”. However, in his view, vaccines were “obviously the way out for all of us”.30 This accorded with the evidence of Ms Taylor, who said that vaccines were ultimately given more resources and ministerial attention.31 |
| 3.16. | James Bethell, Lord Bethell (Parliamentary Under Secretary for Technology, Innovation and Life Sciences from March 2020 to September 2021), had ministerial oversight of the Therapeutics Taskforce. He characterised any debate as to whether vaccines were prioritised over therapeutics as a “false dichotomy”. His view was that the therapeutics programme was “an unsung success for the UK in many ways”, and the fact that it was not “on the front pages of newspapers” did not mean that it was not focused on by the government.32 Lord Bethell explained that, compared with the process for developing and deploying vaccines – which was “relatively linear” – the area of therapeutics was “extremely complex” given the number of variables:
“There are lots of different types of therapeutics and antivirals. The population itself changes as vaccination is rolled out. There are lots of different types of … responses from individuals … The delivery of different medicines is completely different.”33 He described this as a “five-sided Rubik’s cube” which required a completely different approach from the one taken to vaccines.34 |
| 3.17. | By the time there were new antiviral drugs in development, the UK’s vaccination programme was well under way. The purpose of the antivirals programme was to combine vaccination with “effective post infection treatments” and minimise the hospitalisation of Covid-19 patients during the following autumn/winter of 2021/22.35 According to Lord Bethell, although it did not get the “profile of the vaccination programme”, some “very ambitious and high energy work” was done.36 Professor Vallance noted that the precise role for antivirals was “less clear” compared with vaccines, which from an early stage had been prioritised by the UK government as the principal means of providing protection for the population. He believed that the prioritisation of vaccines over antivirals was the correct approach at that time.37 |
| 3.18. | While vaccines were seen as the primary route out of the Covid-19 pandemic, and the Inquiry does not criticise that approach, it may not be possible to develop a vaccine for the disease which causes the next pandemic. Equally, antivirals may play a more significant role depending on the nature of the threat, including in relation to preventing or limiting transmission when used prophylactically. In preparing to respond to the next pandemic, future governments must have an open mind about the relative prioritisation of vaccines and therapeutics, including antivirals, and develop flexible plans. |
Effective leadership
| 3.19. | Effective decision-making during an emergency requires excellent leadership. The first Chair of the Vaccine Taskforce was Dame Kate Bingham, who had experience of both venture capital and private equity (both forms of private market investing) and had specialised in building and investing in biotechnology companies.38 Witnesses praised Dame Kate Bingham’s work as Chair of the Vaccine Taskforce and pointed to her appointment as a key reason for its success. Alok Sharma, Lord Sharma (Secretary of State for Business, Energy and Industrial Strategy from February 2020 to January 2021), observed that she had “the right skills” in terms of scientific understanding and “bringing her private sector knowledge into play”.39 Mr Johnson explained that appointing Dame Kate Bingham was one of his “key policy decisions” in relation to vaccines.40 He said: “I knew from personal experience that she had mastery in driving things forward and, that she was superabundantly qualified for the task. Indeed, her paper qualifications were perfect. She had built a career and reputation by investing in new medicines and she had the right leadership qualities to do the job. I maintain that I was right.”41 |
| 3.20. | Professor Sir Jonathan Van-Tam (Deputy Chief Medical Officer for England from October 2017 to March 2022) told the Inquiry that it was “a stroke of genius to have a venture capitalist who understood biotechnology” at the heart of the vaccine project, which involved bringing “science to the marketplace”.42 The Inquiry agrees. |
| 3.21. | Unlike the Vaccine Taskforce, the Therapeutics Taskforce did not have a Chair with industry experience. Professor Vallance, who thought that it should follow a similar structure to the Vaccine Taskforce, recalled that there were early discussions about an external Chair but it appeared that the Department of Health and Social Care preferred to appoint from within the Civil Service.43 Ms Taylor was appointed Deputy Director and then Director of the Therapeutics Taskforce (and then also Director of the Antivirals Taskforce and the subsequently amalgamated Antivirals and Therapeutics Taskforce).44 |
| 3.22. | In relation to the establishment of the Antivirals Taskforce, the Department of Health and Social Care followed the approach of the Vaccine Taskforce and recruited an external Chair, Mr Eddie Gray (May 2021 to April 2022).45 He had spent decades in the pharmaceutical and biotechnology sector, including as President of European Pharmaceutical Business at GlaxoSmithKline and Chief Executive Officer of Dynavax Technologies (a biopharmaceutical company).46 A later report on lessons learned produced by the Antivirals and Therapeutics Taskforce noted that Mr Gray benefited the Antivirals Taskforce “by bringing an industry mindset” and “through his reputation and experience in the field”.47 |
| 3.23. | As a condition of her appointment, Dame Kate Bingham insisted on a direct reporting line to the Prime Minister. This was to avoid “interference at a ministerial level” and she described it as “worth its weight in gold”.48 However, there was no direct reporting line to the Prime Minister for Mr Gray – he reported to Mr Hancock and Lord Bethell.49 Mr Gray’s view was that by this time there was a greater sense of a return to business as usual, and that is why he had no direct reporting line to the Prime Minister. However, he also pointed out that there was nothing to prevent him from writing to “whoever [he] chose”. In fact, he wrote repeatedly to the Prime Minister about antiviral procurement.50 |
| 3.24. | There is great merit in the Chair of a taskforce having a direct reporting line to the Prime Minister at a time of national crisis. Clara Swinson, Director General for Global Health and Health Protection at the Department of Health and Social Care from November 2016 to September 2024, acknowledged as much.51 It enables faster decision-making and more rapid problem-solving. This must be borne in mind when taskforces are created or given an elevated role in any future pandemic. |
Expertise and skill sets
| 3.25. | When establishing any form of specialist emergency body, it is important to ensure the right mix of expertise and skills. |
| 3.26. | Dame Kate Bingham explained that, to deliver the Vaccine Taskforce’s objectives, its team needed both industrial expertise and skills in science, manufacturing and clinical development, together with the more usual areas of Civil Service expertise in government processes for contracting, project management and diplomacy. In particular, the Vaccine Taskforce needed to “bring to the table and leverage” trusted, current relationships in the biotech, pharmaceutical and bioprocessing industries.52 The Vaccine Taskforce mobilised and recruited staff from across the Civil Service, private sector and academia, which provided a breadth of expertise, ranging from clinical and scientific knowledge through to supply, programme management, delivery and commercial.53 |
| 3.27. | As explained above, external industrial experience was brought to the team by Dame Kate Bingham. In addition, the Deputy Chair (and later Chair) was Dr Clive Dix, who had extensive experience in the fields of biotechnology and pharmaceuticals.54 Dame Kate Bingham described him as “phenomenal”.55 The subsequent Chair of the Vaccine Taskforce, Sir Richard Sykes, also had industry credentials as the former Chair and Chief Executive of GlaxoSmithKline.56 Other key external appointments included Ian McCubbin, Head of the BioIndustry Association Bioprocessing Group, and Steve Bates, Chief Executive Officer of the BioIndustry Association.57 Working alongside these external experts was a team of civil servants, many of whom had private sector experience.58 It included Nick Elliott (the Vaccine Taskforce’s first Director General), Madelaine McTernan (the chief commercial and legal negotiator, who later took over the Director General role) and Ruth Todd, who led on delivery and project management.59 The collaborative approach between external professionals and civil servants was an important driver of the taskforce’s success.60 |
| 3.28. | The Therapeutics Taskforce also comprised external professionals, scientists, industrialists, venture capitalists and civil servants.61 |
| 3.29. | The Antivirals Taskforce had a similar make-up. Following Mr Gray’s appointment, a steering committee was established including Mr Gray, Ms Taylor and other civil servants, plus external clinical, scientific and industry advisers. Mr Gray explained that this membership ensured the right balance of scientific and Civil Service skills to address strategic questions relating to the procurement of antivirals.62 Bringing together the experts provided clear steers for the Antivirals Taskforce, and Mr Gray’s view was that the formulation and operation of this committee worked well.63 |
| 3.30. | Despite the overall success of the Vaccine Taskforce and Antivirals Taskforce, Dame Kate Bingham and Mr Gray were critical of a number of aspects of the UK government and Civil Service approach. In Mr Gray’s view, these included:
Dame Kate Bingham considered that there was an overly bureaucratic focus on process rather than outcome, a deep suspicion of industry, and a lack of scientific, commercial and manufacturing skills within government.65 |
| 3.31. | The Inquiry is not in a position to conclude whether all of those criticisms of the UK government and Civil Service approach were justified. What one person perceives as overly bureaucratic may be another person’s attempt to ensure proper governance and value for taxpayers’ money. However, the point about expertise was also made by Professor Vallance and Dr Dix, who called for more scientific and commercial experience within government.66 Catherine Little (Director General of Public Spending at the Treasury from March 2020 to October 2022) agreed with Dame Kate Bingham about a lack of science, technology, engineering and mathematics (STEM) backgrounds and commercial skills within government.67 |
| 3.32. | The UK government and devolved administrations should better embed scientific thinking and science in policy-making. In this regard, the Inquiry welcomes the UK government’s target of increasing the recruitment of STEM graduates to the Civil Service Fast Stream from 10% to 50%.68 |
Procurement
| 3.33. | Effective identification of which vaccines and drugs to pursue is key to facilitating rapid procurement and subsequent deployment. However, this presents a challenge where the likelihood of any vaccine or therapeutic being effective is low or unknown. |
Identification of vaccine and drug candidates
| 3.34. | At the outset of its establishment, the prospects of the Vaccine Taskforce meeting its primary objective to secure vaccines for the UK population were not promising. In early 2020, the scientific consensus was that the chances of successfully developing a Covid-19 vaccine were very low, and that even if a vaccine could be developed it might take years. No vaccine had ever been developed successfully to combat a human coronavirus.69 HIV offered a salutary lesson – after 40 years and despite a massive scientific effort, there was still no vaccine.70 The prevailing view was that any Covid-19 vaccine candidate that was already in clinical trials had a 15% chance of success and any vaccine that had not yet entered clinical trials had a less than 10% chance of success.71 In a briefing in May 2020, Dame Kate Bingham described finding a vaccine as a “harder challenge than Everest”.72 |
| 3.35. | Recognising that many of the vaccines in development would fail, the Vaccine Taskforce decided to build a diverse portfolio of Covid-19 vaccines across the four different vaccine technology formats (ie the technology underpinning the vaccine): adenoviral vector, messenger ribonucleic acid (mRNA), adjuvanted protein and whole inactivated (ie dead) virus.73 This increased the chances of backing at least one vaccine that would prove successful. This approach was the one Dame Kate Bingham had used in biotechnology venture capital investing and which she described as having “multiple different shots on goal”.74 |
| 3.36. | A range of vaccine formats also improved the Vaccine Taskforce’s chances of finding a vaccine that was suitable for the elderly, whose immune systems respond less well to vaccines. It was also hoped that including more traditional vaccine technology formats would prove more attractive to those who had less confidence in newer vaccine technologies.75 |
| 3.37. | There were more than 200 vaccines for Covid-19 in development globally at the time the Vaccine Taskforce was established, so prioritisation was essential. After filtering out vaccines that would not be ready to be tested in humans by the end of December 2020, the list was reduced to about 15. A rigorous due diligence process followed – overseen by Dr Dix – with the Vaccine Taskforce meeting with representatives from the relevant pharmaceutical companies and conducting a detailed analysis of the science underpinning each vaccine.76 The result was a final portfolio of seven vaccines.77 |
| 3.38. | Prior to the transfer of responsibility for antibodies to the Therapeutics Taskforce, Dr Dix also led the due diligence on which antibodies should be included in the Vaccine Taskforce’s portfolio for prophylaxis and which would be included in the trials to be assessed as therapeutics.78 He and his diligence team worked with Jane Osbourn, BioIndustry Association Chair and “world-renowned antibody developer”, to review all the potential antibody opportunities.79 |
| 3.39. | Dr Dix concluded that a drug called Ronapreve was the most advanced and effective antibody ‘cocktail’ (a combination of two neutralising monoclonal antibodies) for treatment.80 In response to his recommendation, it was successfully evaluated in the RECOVERY trial and ultimately procured.81 In respect of prophylactic candidates, Dr Dix determined that the most promising was the antibody cocktail Evusheld.82 The decision not to procure this is addressed below. |
| 3.40. | For therapeutics more broadly, the Therapeutics Taskforce adopted a similar “portfolio approach strategy to secure a range of treatments with different mechanisms of action”, which was achieved through “horizon scanning”.83 As with vaccines, decisions to procure drugs were generally taken on behalf of all four nations of the UK.84 |
| 3.41. | The Therapeutics Taskforce was helped in its task of identifying credible or plausible therapeutic candidates by a multi-agency initiative called the ‘research to access pathway for investigational drugs for COVID-19’ (RAPID C-19).85 Established in April 2020, RAPID C-19 was a multi-agency initiative involving a number of bodies including NHS England, the Medicines and Healthcare products Regulatory Agency, the National Institute for Health and Care Research and the National Institute for Health and Care Excellence. Although its focus was on access to therapeutics in England, representatives from the devolved nations also participated in the initiative.86 |
| 3.42. | RAPID C-19’s role was to identify and monitor the development of potential therapeutics and then assess their clinical effectiveness in order to facilitate rapid access to patients. Unlike the usual process followed by the National Institute for Health and Care Excellence, there was no consideration of cost-effectiveness, which helped expedite the process.87 RAPID C-19 made recommendations to the Chief Medical Officer for England and the UK government’s Department of Health and Social Care, but ultimately it was the department’s decision to decide whether to provide access to a particular drug.88 |
| 3.43. | Ms Swinson told the Inquiry that RAPID C-19 became an important partner for the Antivirals and Therapeutics Taskforce.89 Ms Taylor’s view was that the initiative’s work was “innovative and agile” and expedited patient access while ensuring that the decisions made by the four Chief Medical Officers on whether to make a drug available “were rooted in robust evidence and analysis”.90 Professor Sir Nicholas White, expert witness on therapeutics, expressed the view that overall its process seems to have been “comprehensive and well-informed”.91 |
| 3.44. | In respect of antivirals, Mr Gray stated that the Antivirals Taskforce relied on assessment by bodies such as RAPID C-19 and utilised industry personnel and external experts. This was a “similar process” to that adopted by the Vaccine Taskforce and will “definitely be necessary in a future pandemic”.92 |
| 3.45. | These approaches (aiming to build a diverse portfolio, adopting a rigorous due diligence process and utilising accelerated external assessment) to identifying vaccine and therapeutic candidates at speed contributed to the successes of the taskforces. A similar approach should be taken in a future pandemic. |
An ‘at-risk’ approach
| 3.46. | At the start of the pandemic, the procurement of potential treatments was challenging due to the changing and competitive global markets.93 |
| 3.47. | The Vaccine Taskforce decided that it would need to purchase its shortlisted vaccine candidates ‘at risk’ – ie before it was known which, if any, was ‘acceptably safe’ and effective and would therefore be authorised for use. This “up-front” investment allowed the vaccine companies to fund clinical development of their vaccines and, in parallel, to prepare for bulk manufacturing so that, if their vaccine gained regulatory approval, they could move quickly to the manufacturing stage.94 |
| 3.48. | Early decisions were also taken to stockpile potentially useful repurposed therapeutic drugs such as dexamethasone and hydroxychloroquine.95 Professor Van-Tam, who advised on the procurement of these drugs, felt there was no choice but to adopt an ‘at-risk’ approach to procurement because of the “fiercely competitive market”.96 He explained that, if the UK had only bought enough dexamethasone to cover the clinical trials, then by the time of any positive trial result there would “very likely have not been enough product on the market to meet our clinical needs”. In his view:
“The negative consequence of this approach is of course purchasing large quantities of drugs that do not prove to be effective. However, the alternative, of being unable to acquire a treatment that ultimately proves to be lifesaving, is in my opinion, significantly worse.”97 This approach was central to the Therapeutics Taskforce’s work on the procurement of repurposed drugs and was effective in ensuring an adequate supply of them during the pandemic.98 Some new drugs were also procured prior to trial results or regulatory authorisation, for example Ronapreve – on which the Vaccine Taskforce had advised – although this did not extend to the prophylactic drug Evusheld (addressed in detail below).99 |
| 3.49. | In relation to new antivirals, the Antivirals Taskforce adopted an at-risk approach in terms of procuring antivirals still in development. It aimed to mitigate that risk by making every contract subject to the completion of the clinical trials and approval of the medicines by the Medicines and Healthcare products Regulatory Agency.100 |
| 3.50. | The importance of an at-risk mindset was emphasised by Professor Vallance, who said that one lesson that arose repeatedly from reflecting on the Covid-19 pandemic was to:
“be prepared to fail. Processes in government pull against risk taking, but many of the efforts during a pandemic, including developing vaccines and therapeutics, require it … We should expect that not all risks will pay off in the future.”101 The Inquiry agrees. |
Financial oversight
| 3.51. | Taskforces intending to spend large sums of public money must naturally be subject to financial oversight. However, those involved in such oversight must be mindful of the need to ensure that their processes do not impede rapid decision-making. During the Covid-19 pandemic, this was particularly relevant to both the Vaccine Taskforce and the Antivirals Taskforce. |
| 3.52. | The Vaccine Taskforce was required to produce a business case in an attempt to quantify what it was likely to spend and the prospective benefit of its work. There was tension between Dame Kate Bingham and the Treasury over the creation of these business cases. Dame Kate Bingham felt that the process was too slow, was overly rigid and failed to address important things: for example, the process lacked a “science case” (compared with a strategic, economic, commercial, financial and management case) for the procurement of vaccines.102 |
| 3.53. | Nevertheless, in September 2020, the Treasury approved a business case for up to £5.2 billion in funding to be allocated to the work being carried out by the Vaccine Taskforce.103 While Dame Kate Bingham felt that the approval had been slow, she explained that this did not impede the taskforce’s work as government consent was only needed to approve the binding legal commitments which “fell later in the process”.104 |
| 3.54. | This was a vast spending envelope, unheard of outside a spending review. Ms Little explained that the vaccines programme was “extremely unusual” in the context of public spending control:
“It was very difficult to accurately forecast spend, and impossible to set a precise budget for the programme in the early stages of the pandemic. There was a need to apply the public spending framework in a more flexible way.”105 |
| 3.55. | The approved budget marked a significant change in the Treasury’s appetite for risk and was intended to allow the taskforce to operate with a significant degree of freedom and pragmatism.106 The Treasury is to be commended for this approach, which was essential in the context of a UK-wide emergency in which thousands of lives were at risk. |
| 3.56. | The Vaccine Taskforce was given a delegated spending limit of £150 million, significantly higher than the Department for Business, Energy and Industrial Strategy’s existing threshold of £70 million.107 Investments of more than £150 million, or novel or contentious investments below that threshold, required the approval of a ministerial panel.108 The panel consisted of four decision-makers: the Secretary of State for Business, Energy and Industrial Strategy, the Secretary of State for Health and Social Care, the Chief Secretary to the Treasury and the Minister of State at the Cabinet Office.109 Rather than the departments giving approval sequentially, the ministerial panel enabled the relevant ministers to approve investments together.110 This expedited the decision-making process, which was vital in the emergency conditions of a pandemic. |
| 3.57. | In relation to antivirals, in June 2021 the Treasury approved the Antivirals Taskforce’s business case for initial funding of £621.5 million.111 The budget was modelled on the purchase of antivirals in response to the H1N1 influenza pandemic (‘swine flu’). Mr Gray said that it became clear early on that the budget was going to be “challenging to meet”. However, he acknowledged that the taskforce’s first assessment and recommendation – based on widespread population use – was an “eye-watering” figure in the region of £11 billion.112 This was more than the overall investment in vaccines.113 This led to a change in the taskforce’s proposed approach to focus on the use of antivirals for high-risk individuals only.114 |
| 3.58. | The Treasury requested that the Antivirals Taskforce produce updated business cases before submitting individual deals to the ministerial panel, which had by this point assumed responsibility for approving business cases for therapeutics costing more than £100 million.115 However, decisions on antivirals in September 2021 and December 2021 were escalated to Rishi Sunak MP (Chancellor of the Exchequer from February 2020 to July 2022) and Mr Johnson.116 |
| 3.59. | In relation to the first key phase of decision-making in September 2021, disagreements arose between the Treasury and the Department of Health and Social Care about the number of courses of antivirals that should be purchased where the spending would have been over budget. The two departments were asked by 10 Downing Street to try to reach a common position; however, no such position could be reached and Mr Johnson had to intervene, ultimately deciding that any purchase needed to stay within the original budget.117 |
| 3.60. | The tensions between the departments were particularly acute in the face of the Omicron variant. In December 2021, disagreements arose about the Department of Health and Social Care’s proposal to procure more than 4 million courses of antivirals (in addition to those already purchased). The Treasury’s view was that vaccines should be the UK government’s priority for combating the new variant and noted that any additional doses of antivirals would not be ready for deployment until the second half of 2022/23, making it unlikely that they would support the response to the Omicron variant.118 Sir Sajid Javid MP (Secretary of State for Health and Social Care from June 2021 to July 2022) told the Inquiry that the Treasury’s willingness to take risks, as had been shown with the approach to vaccines, “did not even last the length of the pandemic”. His view was that it was not helpful to adopt “an overly risk adverse approach”, particularly in the face of clinical advice.119 |
| 3.61. | Ms Little, however, rejected any characterisation of the Treasury “doing its own clinical assessments”, stating that it looked at the balance and proportion of public spending and whether it was good value for money.120 On this occasion, in light of the particular challenges posed by the Omicron variant, Mr Johnson decided that the proposed purchase should proceed urgently and that the Treasury should provide additional funding.121 |
| 3.62. | It is perhaps inevitable that disagreements about budgets will arise between decision-makers and the Treasury, particularly in the emergency circumstances of a pandemic. In relation to vaccines in an emergency, the streamlined, innovative approach of the ministerial panel significantly expedited decision-making while ensuring robust oversight.122 Although it was not utilised in the same way in respect of antivirals, this approach should be adopted in the event of a future pandemic. |
Relations with industry
Being the ‘best’ customer
| 3.63. | The initial planning assumption was that 30 million people in the UK would be vaccinated. The UK was not, therefore, going to be the largest purchaser of vaccines in the world. In response, the Vaccine Taskforce adopted a strategy of being the ‘best’ customer.123 |
| 3.64. | This involved emphasising features about the UK that made it an attractive country with which to do business. This included the ability to run clinical trials at a population scale and the ability to recruit trial participants rapidly through the NHS Covid-19 vaccine research registry (as explained in Chapter 2: Discovery and development). In order to further attract companies to the UK, the Vaccine Taskforce highlighted the collaborative approach of the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency, which adopted a “rolling review” process so as to expedite authorisation (addressed in Chapter 4: Authorisation).124 |
| 3.65. | This ‘best customer’ strategy was appropriate and effective. Pharmaceutical companies were overwhelmingly positive about the approach of the Medicines and Healthcare products Regulatory Agency – in relation to both vaccines and therapeutics.125 Similarly, witnesses from industry generally praised the approach of the taskforces, in particular the way in which they enabled a collaborative approach between government and industry.126 For example, Ben Osborn (President of the International Commercial Office at Pfizer) described the Vaccine Taskforce as a “single front door” for industry:127
“It was a very significant shift for us in terms of our relationship and working with government. It provided single points of accountability, it provided a very rapid and agile decision-making approach. It ensured that when there were issues, when there were challenges that needed to be navigated, there was a rapid access to the right expertise to essentially resolve those, in a very collaborative partnership way.”128 |
| 3.66. | Another way in which the UK ensured that it was competitive in the global vaccine marketplace was its approach to indemnities. All the Covid-19 vaccine companies that entered into negotiations with the Vaccine Taskforce requested broad and unlimited indemnity from the UK government for losses arising from their products, including death and personal injury. Some companies wanted the UK to pass legislation that would give them statutory immunity from any liability whatsoever, but this was described as a “non-starter” for the UK government.129 Lord Sharma explained why:
“[F]rom a taxpayer perspective, it made much more sense for … individual companies to come to us with their asks rather than us giving statutory immunity. And, anyway, I think giving statutory immunity would have required effectively an Act of Parliament and so that was resisted.”130 |
| 3.67. | The UK government instead negotiated indemnities with vaccine companies on a case-by-case basis.131 These indemnities did not prevent an individual from bringing a court claim against a particular company, for example under the Consumer Protection Act 1987. They operated so that, in the event of a successful claim, the government could, in certain circumstances, cover any damages awarded by the court, as well as any legal costs.132 |
| 3.68. | Lord Sharma explained that, when considering the issue of indemnities, careful consideration was given to the risks and benefits, and it was clear that the benefit of the UK successfully deploying vaccines greatly outweighed any potential contingent liabilities.133 Dame Kate Bingham’s evidence was starker: if indemnities had not been offered, then the UK would not have procured any vaccines.134 In this context, the Inquiry concludes that the indemnities negotiated by the UK government were reasonable and not unduly onerous or generous – they were essential. |
Maintaining positive relations
| 3.69. | Positive relations with industry must be maintained both during and in between pandemics. This ensures that the necessary foundations for a rapid and ‘joined-up’ response are in place when the next pandemic strikes. |
| 3.70. | The Vaccine Taskforce, in particular, built excellent relations with industry.135 However, Dame Kate Bingham and Dr Dix were critical of the UK government’s treatment of the French company Valneva during the latter part of the pandemic. Valneva was developing the only whole virus-based vaccine (a more traditional vaccine technology which uses an inactivated virus) in the Vaccine Taskforce’s portfolio and had a manufacturing site in Livingston in Scotland.136 In September 2021, the UK government terminated the agreement with Valneva based on advice from the Vaccine Taskforce (Dame Kate Bingham and Dr Dix had left the taskforce by this point).137 Dame Kate Bingham characterised the decision as inexplicable and indicative of a wider shift on the part of the government from viewing vaccine companies as partners to viewing them as adversaries. She said the cancellation sent the “worst possible message to any future UK industrial investor or life sciences partner”.138 Dr Dix said the decision was based on a flawed study and, in his view, the termination had been “devastating” for relations with industry.139 |
| 3.71. | The decision to terminate the contract was taken by Mr Javid. Sir Sajid Javid told the Inquiry that the decision was based on very clear advice from the Vaccine Taskforce that the Valneva vaccine was ineffective as a booster dose and it would not have been good value for money to purchase a vaccine that the UK was not going to use.140 Similarly, Nadhim Zahawi MP (Minister for Covid-19 Vaccine Deployment from November 2020 to September 2021) said that the decision was evidence-based; trial data did not support using the Valneva vaccine either as a primary vaccine or as a booster. Mr Zahawi also said that relations with industry were taken into account when the termination decision was made.141 Professor Dame Jenny Harries (Deputy Chief Medical Officer for England from July 2019 to March 2021 and Chief Executive of the UK Health Security Agency from April 2021 to May 2025) said that the termination had not damaged relations with industry in general or with Valneva in particular and that valuable work continued at the company’s facility in Livingston, Scotland.142 |
| 3.72. | In light of the Vaccine Taskforce advice, there were sufficient reasons for terminating the Valneva agreement. While the vaccine did go on to receive regulatory approval, the company itself accepted that its practical utility as a booster vaccine in the UK was limited.143 Whatever the rights and wrongs of the Valneva decision, and whether it had any impact on relationships, ministers cannot be criticised for acting on the technical advice that they were given. At the same time, they must strive to maintain positive relationships with industry. |
| 3.73. | This is even more important in the current commercial climate. As explained in Chapter 2: Discovery and development, a number of pharmaceutical companies have recently paused or withdrawn investment in the UK. |
The immunocompromised and Evusheld
| 3.74. | Despite the overall successes of the taskforces in procuring a number of vaccines and treatments, there were some clinically vulnerable groups, particularly the immunocompromised, who were unable to benefit from them or for whom they were less effective. For such people, non-vaccine prophylactics can offer protection. |
| 3.75. | During the pandemic, Evusheld (a combination of two neutralising monoclonal antibodies) was considered as a preventative drug for people who were unlikely to mount an immune response from Covid-19 vaccination or for whom vaccination was not recommended.144 A number of witnesses questioned the decision not to procure Evusheld and whether the decision was based on clinical effectiveness or purely on cost.145 |
The ministerial decision in February 2021
| 3.76. | As described above, the procurement of antibodies was originally within the remit of the Vaccine Taskforce. |
| 3.77. | In June 2020, the taskforce provisionally agreed with AstraZeneca to buy 1 million doses of Evusheld for delivery between December 2020 and May 2021. The aim was to provide prophylactic protection for 500,000 immunocompromised people in the UK for whom vaccines might be ineffective.146 Subsequently, AstraZeneca reduced its offer to 300,000 doses and therefore the Vaccine Taskforce wrote to Professor (later Sir) Christopher Whitty (Chief Medical Officer for England from October 2019) and Ms Swinson in October 2020, seeking confirmation of the exact number of immunocompromised patients to whom Evusheld was likely to be deployed.147 In response, in December 2020, Professor Whitty stated that the earliest Evusheld would become available for use was after the spring of 2021. He explained that this represented “a changed landscape”, particularly given the vaccines in use or under review. On this basis, he could not recommend a large advance purchase but stated that, if there remained “political appetite to buy on an at risk, precautionary basis”, the amounts should remain “low”. He suggested under 50,000 doses for particularly high-risk individuals.148 |
| 3.78. | On 10 February 2021, Professor Van-Tam responded to the Vaccine Taskforce’s request to press ahead with securing 50,000 doses. He noted that it was challenging to put a definitive figure on the total number of people in the UK who might benefit from prophylactic antibody administration, but there was a cohort of about 500,000 immunocompromised patients who could remain vulnerable.149 |
| 3.79. | However, Professor Van-Tam stated that, having discussed the issue with the Therapeutics Taskforce, he and the Chief Medical Officer did not recommend proceeding with any advance at-risk purchase, prior to evidence from trial results on efficacy. Underpinning the recommendation were the following factors:
Professor Van-Tam did, however, make clear that Evusheld should be kept under consideration, and concluded that purchase at a later point might be desirable once there was clearer evidence of efficacy and there was better understanding of demand.151 He reiterated to the Inquiry that it was not a “permanent no”; it was a “no, not now, and not in these quantities”.152 |
| 3.80. | Both Dame Kate Bingham and Dr Dix strongly disagreed with this reasoning.153 They told the Inquiry that the approach to the at-risk purchase of Evusheld was at odds with that taken to vaccines and there was simply less appetite or enthusiasm in relation to these antibodies and prophylactics.154 Dame Kate Bingham was clear in her view that cost “played a role”.155 Dr Dix went even further, stating that most of the reasons provided were “excuses” and “the actual reason that it wasn’t purchased was cost”.156 |
| 3.81. | Professor Whitty, however, set out a number of reasons why the difference in approach was justified. First, the clinical position for Evusheld was “fundamentally different” from vaccines, which provided broader protection and could better deal with the evolution of the virus. Second, the time between making the purchase and the vaccine being available was much shorter and so there was less risk associated with it. Third, Evusheld was a much more expensive product in terms of “per person protected”, although Professor Whitty stressed that the matter of cost was only a “third order question”.157
Professor Van-Tam did, however, make clear that Evusheld should be kept under consideration, and concluded that purchase at a later point might be desirable once there was clearer evidence of efficacy and there was better understanding of demand.151 He reiterated to the Inquiry that it was not a “permanent no”; it was a “no, not now, and not in these quantities”.152 |
| 3.82. | Ultimately, ministers decided not to proceed with the advance purchase of Evusheld.158 Lord Bethell’s view was that, although resources in a broad sense were a consideration, the recommendations relating to Evusheld were based on clinical evidence and not cost.159 Mr Hancock told the Inquiry that the advice was “clear and unambiguous on the clinical grounds” but echoed Professor Van-Tam’s evidence that this was a “decision ‘not now’ rather than a decision ‘not ever’”.160 |
| 3.83. | The Inquiry understands the concerns raised by the immunocompromised, Dame Kate Bingham and Dr Dix, and acknowledges the need to protect vulnerable groups, if at all possible. However, based on the advice provided to ministers, the decision not to proceed with the advance purchase of Evusheld in February 2021 was a reasonable one. |
Subsequent consideration of Evusheld
| 3.84. | In February 2021 (the same month as the decision not to proceed with the advance purchase), the Antivirals and Therapeutics Taskforce asked RAPID C-19 to monitor the effectiveness of Evusheld.161 As explained above, RAPID C-19 was a multi-agency initiative established during the pandemic to assess the clinical effectiveness of therapeutics – but not the cost-effectiveness – in order to facilitate rapid access.162 |
| 3.85. | According to Ms Taylor, by August 2021 there was “limited enthusiasm for prophylactic use across the system”. Professor Vallance’s view was that this was “misguided”, which prompted Ms Taylor to request that the issue of prophylaxis was looked at again.163 Shortly thereafter, the issue as to whether to procure Evusheld was revisited in light of new trial evidence, which suggested it might be effective. |
| 3.86. | RAPID C-19 considered the new trial evidence in a report dated 23 December 2021 to the Chief Medical Officer. Despite the promising trial results, there was a concern on the part of the Prophylaxis Oversight Group (which had been asked to provide expert advice) as to Evusheld’s efficacy against the Omicron variant. RAPID C-19’s recommendation was that the trial results warranted action to prepare for patient access; however, this was subject to confirmation of the drug’s continued effectiveness against the Omicron variant, as well as it gaining marketing authorisation.164 The UK Health Security Agency was asked to conduct laboratory-based studies to assess ongoing effectiveness. RAPID C-19 also proposed that the Therapeutics Taskforce should consider taking forward procurement of sufficient volumes of the drug.165 |
| 3.87. | On 17 March 2022, the Medicines and Healthcare products Regulatory Agency issued a conditional marketing authorisation for Evusheld.166 This authorisation noted that Evusheld’s effectiveness against Covid-19 variants was unknown. A further RAPID C-19 meeting then took place on 18 May 2022, by which time the data from the UK Health Security Agency were available. Expert advice was provided again by the Prophylaxis Oversight Group. RAPID C-19 considered that, due to the difficulties in interpreting the available data, it was not possible to conclude that Evusheld was effective against the Omicron variant and therefore recommended that it should not be progressed.167 Professor White suggested in his expert evidence that pharmacometric studies (which use data to model the interaction between the drug and the body) could have answered any unresolved questions about Evusheld’s efficacy.168 In response, Helen Knight (Director of Medicines Evaluation at the National Institute for Health and Care Excellence from March 2022) stated that she was unsure whether this would have resolved the issue. In any event, she explained that RAPID C-19 was not in control of accessing the drug.169 |
| 3.88. | In June 2022, the Antivirals and Therapeutics Taskforce provided a submission to ministers and recommended against deployment of Evusheld due to the “continued uncertainty” regarding its effectiveness against the Omicron variant and the unaffordability of any deployment. Instead, it recommended that it should be considered through the National Institute for Health and Care Excellence’s technology appraisal (the usual pre-pandemic process). Ministers agreed.170 |
| 3.89. | RAPID C-19 was subsequently asked to consider real-world data from countries that had deployed Evusheld. In its report dated 24 August 2022, it concluded that the quality of the data was insufficient to progress beyond the National Institute for Health and Care Excellence’s technology appraisal, which by that point had commenced. Further research was recommended.171 In June 2023, the National Institute for Health and Care Excellence concluded its appraisal and did not recommend Evusheld for treatment on the basis that it was unlikely to be effective against most of the relevant variants. However, in doing so it acknowledged that there is “an urgent unmet need for an effective prophylactic treatment” for those for whom vaccination does not provide sufficient protection.172 |
| 3.90. | It is clear that the issue of whether to procure Evusheld at this time was carefully considered. RAPID C-19 was mindful of the unmet need faced by vulnerable groups and gave careful consideration to recommending the use of Evusheld. In this context, Ms Knight explained that there was a particular need for a high level of confidence in Evusheld’s effectiveness given the clinical vulnerabilities of the intended patients.173 |
| 3.91. | While cost was a factor in UK government decision-making (as opposed to RAPID C-19’s assessment), it was one of several considerations. Central to the decision-making were concerns about Evusheld’s effectiveness in the face of the Omicron variant. There was a proper basis not to proceed, and the Inquiry also notes that Evusheld was later withdrawn in a number of countries due to similar concerns.174 |
| 3.92. | However, the Inquiry acknowledges that many of those who were not protected by the vaccine during the pandemic felt left behind. Lara Wong (founder and leader of Clinically Vulnerable Families) told the Inquiry that Evusheld would have given these people:
“the freedoms that other people received through their own vaccination, and the consequence of not protecting this group was phenomenal in terms of their mental health, in terms of their social connections, in terms of their general ability to re-engage with the rest of the world”.175 |
| 3.93. | Evusheld may or may not have been the answer, but the Inquiry accepts without reservation that the need to provide protection to the immunocompromised, including through prophylactic drugs, must be a priority when preparing for the next pandemic. |
Manufacturing
| 3.94. | The manufacture of vaccines involves complex processes, requiring the ‘on-time’ delivery of hundreds of elements across international supply chains. Alongside the active ingredient, vaccines also contain other elements such as adjuvants (which create a stronger immune response to the vaccine), stabilisers and preservatives. As well as the biological and chemical processes to produce the bulk vaccine, there are ‘fill and finish’ processes to transfer the vaccine into vials ready for use, alongside extensive quality control and quality assurance processes.176 |
Manufacturing capacity during the pandemic
| 3.95. | The Vaccine Taskforce recognised that, while some of the vaccines in its portfolio would need to be imported into the UK, the UK government could not rely entirely on imports given the risk of ‘vaccine nationalism’ (ie other countries preventing the export of vaccines, or key vaccine ingredients, in order to retain them for their own populations).177 Vital work surveying the UK’s vaccine manufacturing capabilities, including fill and finish capacity (which is often a bottleneck in the manufacturing process), revealed that the UK’s manufacturing capabilities were inadequate to meet the demands of vaccine manufacturing in a pandemic.178 This was particularly the case in relation to mRNA manufacturing capacity.179 |
| 3.96. | In response, the Vaccine Taskforce identified a number of targeted investments to boost the UK’s vaccine manufacturing and fill and finish capabilities. These included sites such as Oxford Biomedica, Cell and Gene Therapy Catapult in Braintree in Essex, the Centre for Process Innovation in Darlington in County Durham and the Vaccine Manufacturing and Innovation Centre in Harwell in Oxfordshire.180 As a result of this work, the UK went from having a minor vaccine manufacturing base to having one capable of providing flexible manufacturing capability for all the main vaccine formats at a population scale.181 This was also an important part of making the UK an attractive customer for vaccine companies.182 |
Current manufacturing capability
| 3.97. | The work on strengthening the UK’s manufacturing capability was a key part of the Vaccine Taskforce meeting its third objective: to make the UK more resilient in the face of a future pandemic. Dame Kate Bingham’s view was that the taskforce had fallen short in relation to this objective. She said that the taskforce had created considerable scope for future long-term pandemic resilience, but did not succeed in building permanent capabilities in the UK.183 |
| 3.98. | As described above, the Vaccine Taskforce had identified gaps in the UK’s manufacturing capabilities and made targeted investments in particular sites. Among these was the Vaccine Manufacturing and Innovation Centre in Harwell in Oxfordshire. As set out in Chapter 1: The landscape of vaccines and therapeutics, this had still been under construction when the pandemic hit. As the pandemic progressed, further funding was allocated on the advice of the Vaccine Taskforce.184 This brought the total funding to about £205 million.185 In early 2021, Treasury officials described the Vaccine Manufacturing and Innovation Centre as a “critical piece of vaccine sovereign capability”.186 Despite the further investment, there were more delays to the project and the Vaccine Manufacturing and Innovation Centre was never completed and did not manufacture any Covid-19 vaccines.187 Amid continued delays and cost overruns, the site’s board made the decision to sell it to a private company in April 2022, and it subsequently closed.188 |
| 3.99. | The Inquiry received evidence about the impact that the sale and closure of the Vaccine Manufacturing and Innovation Centre have had on the UK’s vaccine manufacturing capabilities.189 For example, Professor Dame Sarah Gilbert, Professor of Vaccinology at the University of Oxford, who was pivotal in developing the Oxford/AstraZeneca vaccine, said:
“The UK has no national capability in vaccine manufacturing, which [the Vaccine Manufacturing and Innovation Centre] would have provided.”190 |
| 3.100. | Responsibility for strengthening the UK’s onshore vaccine development, manufacturing and supply capacity and capability now rests with the Office for Life Sciences – a joint unit of the Department of Health and Social Care and the Department for Science, Innovation and Technology.191 Ms Jones explained that the role of the Department for Science, Innovation and Technology includes providing support to “stimulate domestic manufacturing” of vaccines and therapeutics, including through the Life Sciences Innovative Manufacturing Fund. The Office for Life Sciences works closely with the Department of Health and Social Care – the lead department for pandemic preparedness – to maximise the fund’s health resilience benefits and has convened a group of independent manufacturing experts who assist with the grant application process for the fund.192 The Life Sciences Innovative Manufacturing Fund follows on from the £38 million Biomanufacturing Fund launched in 2023 to contribute to strengthening UK health resilience.193 |
| 3.101. | Ms Jones set out the current state of the UK’s manufacturing capability, placing particular emphasis on a 10-year strategic partnership with Moderna that involves the establishment of an innovation and technology centre in the UK. The centre opened in September 2025 and is predicted to have the capacity to create up to 250 million mRNA vaccines a year in the event of a pandemic.194 However, when asked if there was sufficient domestic vaccine manufacturing capacity to ensure resilience if there was a pandemic in the near future, Ms Jones said that, while the UK was now in a “better position” and had a number of sites to call on, “we’re not exactly where we need to be as yet”.195 |
| 3.102. | This sentiment was echoed by Professor Harries, who told the Inquiry that when it came to vaccine manufacturing:
“[W]e do not have, in this country, complete coverage, if you like, of all different technologies that we might require. And we certainly don’t have a logic, I think, sitting behind it.”196 |
| 3.103. | On 31 January 2025, it was announced that AstraZeneca’s planned multi-million-pound investment in the manufacture of vaccines in the UK would no longer be going ahead.197 Ms Jones had told the Inquiry that this planned investment would assist the UK in achieving diversity of vaccine manufacturing capability.198 She explained that the new AstraZeneca facility would have deployed more sustainable manufacturing processes and would have offered health resilience benefits as it could have pivoted to produce different vaccines in a pandemic scenario. |
| 3.104. | Ms Jones noted that, with the deal falling through, the UK has “lost out on the potential health resilience benefits” that the investment was intended to bring.199 In terms of mitigating this loss, Ms Jones highlighted a “range of capabilities” relevant to manufacturing vaccines and other pharmaceutical countermeasures, including CSL Seqirus’s site in Speke, Liverpool, which provides end-to-end manufacture of adult flu vaccines for seasonal flu and has the capacity to produce more than 100 million influenza vaccines if required. Further, Ms Jones noted that the UK government is “actively engaging companies” that could invest in manufacturing capability critical to building domestic health resilience, such as diverse vaccine manufacturing capability.200 |
| 3.105. | There have been further positive developments in this area. As described in Chapter 2: Discovery and development, in May 2025 pharmaceutical company BioNTech – which played a significant role in developing mRNA vaccines during the pandemic – committed up to £1 billion in a 10-year investment in the UK.201 In addition, in August 2025, the government announced a £29.6 million investment to establish the UK RNA Biofoundry; this is a new facility based in Darlington which will develop new RNA therapies and be able to switch to vaccine production if necessary, thus strengthening pandemic resilience.202 |
| 3.106. | Further, the Inquiry was informed that the Department of Health and Social Care, together with the UK Health Security Agency and the Office for Life Sciences, had developed a decision-making framework to inform strategic decisions on investment in onshore manufacturing capabilities for vaccines, therapeutics and diagnostics. This framework takes a deliberate pathogen-agnostic approach, recognising the need to be prepared for a pandemic caused by any pathogen, including a novel ‘Disease X’, and spread through any route of transmission.203 |
| 3.107. | However, the Inquiry remains concerned about the AstraZeneca deal not going ahead and, more broadly, about the recent announcements of pharmaceutical companies withdrawing investment in the UK (as set out in Chapter 2: Discovery and development). More needs to be done to strengthen the UK’s onshore vaccine manufacturing capability. This does not necessarily mean the creation of expensive, state-owned facilities like the Vaccine Manufacturing and Innovation Centre. Rather, vaccine companies should be incentivised to invest in sites in the UK and provide the government with the right to use the facility in the event of a future pandemic.204 |
| 3.108. | Such investment should be utilised outside a pandemic and ensure manufacturing resilience across a range of vaccine formats. Initiatives such as the Moderna partnership and the UK RNA Biofoundry are to be welcomed; however, the Inquiry agrees with Dr Dix, who warned of the dangers of viewing mRNA vaccines with “rose-tinted glasses”.205 The UK must not be overly reliant on mRNA vaccine technology, which cannot be guaranteed to be as effective in tackling the next pandemic as it was in relation to Covid-19.206 |
| 3.109. | It is also important to ensure that there is sufficient focus on building adequate manufacturing capacity for antibodies. Lord Sharma, who approved a number of vaccine manufacturing investments during the pandemic, reflected on the UK’s antibody manufacturing capacity. He said that, during the pandemic, he had approved funding to acquire a manufacturing capacity abroad for antibody therapies and wondered why the UK did not have this capability. Lord Sharma posed the question: “If we needed this tomorrow, could we actually do this in our own country?” 207 |
| 3.110. | Professor Vallance told the Inquiry that the experience of developing monoclonal antibodies during the Covid-19 pandemic “exposed the UK’s poor infrastructure for manufacturing biological medicines”. His view was:
“The relative weakness of capacity for monoclonal antibody production, which is well recognised and remains the case today, may leave the UK vulnerable in future pandemics if monoclonal antibodies (rather than vaccines) happened to be the preferred or more rapid means of response.”208 |
| 3.111. | A number of witnesses stated that monoclonal antibodies are important in responding to a pandemic, with Professor Vallance calling for them to be given “special consideration”.209 They have the potential to be developed relatively quickly compared with small molecule antivirals and, due to their long-lasting effects, they can be useful for prevention as well as treatment.210 |
| 3.112. | The potential of antibodies for prevention was one of the reasons why Dame Kate Bingham wanted them included within the remit of the Vaccine Taskforce.211 She highlighted the inability of the Vaccine Taskforce to secure government backing for an industry partnership to build a bulk antibody UK manufacturing capability as an example of why the taskforce had not met its third objective. This is a “serious matter” as it means that the UK does not have a large onshore supply of antibodies, which are an increasingly important part of the therapeutic armoury for controlling severe diseases such as cancer and autoimmune disorders.212 Dame Kate Bingham said that the “lack of biomanufacturing capacity in the UK is a major vulnerability”.213 |
| 3.113. | The Inquiry was informed that the UK government, including the Department for Science, Innovation and Technology and the Department of Health and Social Care, is working to improve the UK’s capabilities in this respect. Ms Jones acknowledged that antibody – and antiviral – capacity was rightly considered to be a “critical capability for UK resilience”. However, she also explained that the manufacturing landscape is constantly evolving and comprises predominantly commercial manufacturing sites which make market-led decisions. She set out a number of sites in the UK which have this capacity, including FUJIFILM Diosynth Biotechnologies and Oxford Biomedica, but noted that these sites are commercial operations responding to market opportunities as they arise. She told the Inquiry that she was unable to provide full details due to commercial sensitivities.214 |
| 3.114. | It therefore remains unclear whether the work being conducted in this area is sufficient to address the serious concerns raised in the evidence before the Inquiry. Any deficiencies in the UK’s antibody manufacturing capacity must be prioritised as part of the UK’s strategy for pandemic preparedness, including through the work of the Life Sciences Innovative Manufacturing Fund. |
Strategic oversight for the future
Building on the legacy of the taskforces
| 3.115. | The taskforces were, by their very nature, temporary bodies created to deal with an emergency situation. |
| 3.116. | Post-pandemic, their functions and responsibilities were transferred to other parts of the health system. Two new boards were established in April 2022 that oversaw the closure of the Antivirals and Therapeutics Taskforce, when the elements of its work were either completed, transferred to business-as-usual functions or moved to contingency arrangements.215 In October 2022, the functions of the Vaccine Taskforce were split between different government departments. The Department of Health and Social Care took on the Vaccine Taskforce’s international function.216 The UK Health Security Agency’s responsibilities included supply management and readiness, while, as set out above, the Office for Life Sciences became responsible for strengthening the UK’s onshore vaccine development, manufacturing and supply capacity and capability.217 |
| 3.117. | The Department of Health and Social Care, which has overall responsibility for pandemic preparedness, co-chaired the Pandemic Diseases Capabilities Board with the Cabinet Office. This was first established in June 2021 to enhance the cross-government and cross-UK approach to preparing for a broader range of pandemics.218 The Department of Health and Social Care, the UK Health Security Agency and the Office for Life Sciences have also been working together to develop capabilities to scale up the discovery and development of therapeutics and vaccines within the first 100 days of a pandemic – an aim set out in the Biological Security Strategy (see Chapter 2: Discovery and development).219 The Inquiry was also told that this work on preparedness is overseen by various boards of the Department of Health and Social Care and is also subject to the Cabinet Office-led governance of the Biological Security Strategy. |
| 3.118. | The current strategic priorities of the UK Health Security Agency include a readiness to respond to health hazards, including pandemics, and improving health outcomes through vaccines.220 The agency is leading on work in relation to the development of both vaccines and therapeutics.221 As set out in Chapter 2: Discovery and development, it has established a Vaccine Development and Evaluation Centre, published a priority pathogen families reference tool and been involved in work to develop a vaccine for the mpox virus (which causes a rash and flu-like symptoms).222 |
| 3.119. | The UK Health Security Agency’s commercial priorities include strengthening partnerships with industry.223 The agency told the Inquiry that its Centre for Pandemic Preparedness works with its commercial, vaccines and countermeasures delivery function, the Office for Life Sciences and the Department of Health and Social Care to support market engagement and industry partnerships.224 In addition to being responsible for delivering the 10-year Moderna partnership, the agency has entered into advance purchase agreements with vaccine companies – for example, it has one contract for the production of more than 100 million influenza pandemic vaccines.225 The Inquiry understands that the UK was the first European country to secure vaccines against mpox, benefiting from the agency’s established relationship with the manufacturer.226 |
Strategic planning and coordination
| 3.120. | Nevertheless, despite the positive steps currently being undertaken, the Inquiry received concerning evidence about the extent of strategic planning and coordination in relation to vaccine pandemic preparedness. |
| 3.121. | Referring to initiatives such as the Moderna partnership, Professor Sir John Bell, Regius Professor of Medicine at the University of Oxford, stated that they had “emerged in an ad hoc way” and not as part of an “overall framework”.227 In relation to therapeutics, he said that work on antiviral development needed “a significant push” and that, in terms of preparing for a future pandemic generally, “[s]omeone needs to get a grip”.228 |
| 3.122. | Dame Kate Bingham echoed these concerns. She acknowledged that there were “lots of good well-meaning … strategies” and investment being made. However, in her view, there was nothing that brought together the end-to-end process for the production of vaccines.229 She said that “all these shiny new buildings” had to be accompanied by a plan.230 In her view, the failure to build permanent capabilities in the UK was in part due to a lack of “coherent” and “overarching leadership”.231 Dame Kate Bingham told the Inquiry:
“[I]t’s about a plan and a coordinated plan to bring together the public sector, the private sector, government, all of which — we’ve got all the bits in place, and we’ve shown we can do it in 2020, but that is not being nurtured, and it is not being coordinated effectively and we don’t have the people to do it. And that is what’s missing and that is what needs to get put in place.”232 |
| 3.123. | Similarly, Professor Gilbert expressed her view that the UK is not well prepared to produce vaccines for the next pandemic: “There is no co-ordination and no plan. There is no national capability.”233 Dr Dix told the Inquiry that lessons had not been learned from the Covid-19 pandemic and that strategic leadership was needed.234 He said:
“[W]e have rolled the dice on Moderna being our solution. This is totally at odds to any strategy to build resilience and preparedness for the future.”235 |
| 3.124. | A number of witnesses said that the solution was some form of new body to oversee the UK’s preparedness to tackle a future pandemic.236 One such body was a National Vaccines Agency. This was first proposed by Dame Kate Bingham and Dr Dix in December 2020 as a successor to the Vaccine Taskforce.237 Dr Dix agreed that the UK needed a “central body that understands vaccines” and could foster relationships with industry.238 |
| 3.125. | Dame Kate Bingham’s central recommendation to the Inquiry was for a “senior and permanent pandemic security capability”.239 The Inquiry recommended a UK-wide independent statutory body for whole-system civil emergency preparedness and resilience in its Module 1 Report.240 |
| 3.126. | When asked what arguments they might put forward to persuade the UK government of the need for a National Vaccines Agency, both Dr Dix and Dame Kate Bingham used the analogy of military defence planning and investment.241 Dr Dix’s view was that, unless the UK had a similar level of investment and expertise in relation to vaccines, “then when the next pandemic comes, we’ll be back where we started”.242 He also noted that setting up such an agency would attract investment into the UK.243 |
| 3.127. | Continuing the defence analogy, Dame Kate Bingham observed that the UK does not wait for a major military threat to appear and then set up a taskforce to deal with it; rather, the approach is long term and strategic. The same approach was needed in relation to vaccines, as the UK was “much more likely to have another pandemic than we are to be invaded”. Further, Dame Kate Bingham observed that the task of ensuring the nation’s defence was not “split between different departments” with “lots of people putting their oars in”. Instead, there was centralised decision-making and a “very clear goal”.244 In her view, a separate vaccines agency would be empowered to “make recommendations that deliver an outcome”, just as the Vaccine Taskforce had done during the pandemic, and would build on the taskforce’s good work.245 |
| 3.128. | Lord Sharma agreed that the suggestion of a national agency merited consideration but expressed concern about whether it would become “business as usual”.246 His own suggestion was for the creation of an external advisory panel that comprised external experts (including those who had worked on the Vaccine Taskforce), ministers and civil servants, and that met on a regular basis throughout the year to “take stock of potential international health trends and risks” and assess the UK’s ability to respond to them.247 Lord Sharma explained that the panel could have a role both in relation to preparedness and in responding to a future pandemic.248 |
| 3.129. | Other witnesses were more sceptical about the need for any form of new body. Professor Van-Tam’s view was that the UK Health Security Agency undertakes surveillance “very well” and, in respect of other aspects of preparedness, the issue was more about the “cadre of people that you are going to bring in” if there is a need to “move at real speed”.249 |
| 3.130. | Mr Hancock accepted the need for a non-pandemic body that, like the Vaccine Taskforce during the pandemic, had end-to-end oversight of the vaccine development and procurement process. However, his view was that this was the responsibility of the UK Health Security Agency and if any elements of the process were not within the remit of the agency then this should be rectified.250 While Ms Jones understood the arguments being made for an agency or panel, she was also mindful of both creating an additional structure alongside the UK Health Security Agency and the potential duplication of “some excellent external advisory groups for life sciences investments” already in existence.251 |
| 3.131. | The Inquiry is aware that, since 2022, the UK Health Security Agency has operated an advisory board, comprising experience across sectors including health, technology, local government, the military and third sector organisations. However, the remit of this board is wide and is not focused solely on pandemic preparedness or vaccines.252 In addition, the UK Health Security Agency does not have responsibility for a key part of the vaccine process: manufacturing.253 The existence of this board does not, therefore, solve the key problem of a lack of strategic oversight of vaccine pandemic preparedness. |
| 3.132. | As explained above, responsibility for vaccine manufacturing capability rests with the Office for Life Sciences. Professor Harries was of the view that this should be within the remit of the UK Health Security Agency.254 She said that connectivity between the Department of Health and Social Care and the Department for Science, Innovation and Technology was missing. She noted, by way of example, that the UK Health Security Agency had not been consulted “in any way at all” about the sale of the Vaccine Manufacturing and Innovation Centre.255 This highlighted:
“a wider issue about government internally knowing what skills, capabilities it has at its disposal in order to link them effectively in peacetime and be ready to go in a pandemic”.256 |
| 3.133. | The Inquiry is not convinced that moving responsibility is the solution. There are clear benefits to the Department for Science, Innovation and Technology having responsibility, through the Office for Life Sciences, for vaccine manufacturing capacity, given its links to industry. This was demonstrated during the pandemic, when the Vaccine Taskforce was successfully situated within the department’s predecessor, the Department for Business, Energy and Industrial Strategy. Dame Kate Bingham stressed the importance of these links to the private sector and expressed scepticism about whether they existed between the UK Health Security Agency and industry.257 |
| 3.134. | What is required is greater connectivity across government. One of the great strengths of the Vaccine Taskforce was its responsibility and oversight of every stage of the vaccine journey – from development and clinical trials through to procurement and manufacture. That strategic oversight by any one body or department is currently missing. It is clear to the Inquiry that the UK lacks appropriate joined-up thinking when it comes to preparedness to develop, procure and manufacture vaccines in the event of a future pandemic. This must be rectified through the creation of a new strategic expert body, which sits above the existing government agencies and bodies. Again, drawing on the strengths of the Vaccine Taskforce, such a body should include ministers, civil servants and representatives from industry and academia, and be led by an independent Chair with experience of working in a relevant industry. |
| 3.135. | There is much merit in the suggestion of a National Vaccines Agency and the Inquiry has given it careful consideration. However, the Inquiry is concerned that the creation of a body like the Vaccine Taskforce in the form of a national agency would create a further layer of bureaucracy. It is also preferable for a body like the Vaccine Taskforce to be created when a pandemic occurs – its drive comes, in part, from the fact that it is different from the business-as-usual government systems.258 While a replica of the Vaccine Taskforce outside a pandemic is unnecessary, strategic oversight of vaccine preparedness is nevertheless still required. |
| 3.136. | The Inquiry is therefore recommending the creation of an external advisory panel to oversee the UK’s preparedness to develop, procure and manufacture pharmaceuticals, including vaccines and therapeutics, either or both of which may be vital in the next pandemic. It should meet regularly and facilitate strong links between the UK government and the pharmaceutical industry, as well as advise the UK government on how to incentivise industry investment in manufacturing facilities and research in the UK. The panel should also advise the UK government on research investments, with the aim of ensuring a diverse portfolio of pharmaceutical research in the UK, which can then be utilised in the event of a pandemic. |
| 3.137. | During a pandemic, the panel should form the basis of specialist taskforces, incorporating the ingredients that made the Vaccine Taskforce so effective. This includes a direct reporting line to the Prime Minister, an at-risk mindset and a streamlined process (such as a ministerial panel) to expedite spending decisions. |
Recommendation 1: Establish a pharmaceutical expert advisory panel
The UK government should establish a standing pharmaceutical expert advisory panel, in consultation with the Department of Health and Social Care and the Department for Science, Innovation and Technology.
The panel should include ministers, civil servants and representatives from industry and academia, and be led by an independent Chair with experience of working in a relevant industry.
The panel’s role should be to:
- oversee the UK’s preparedness to develop, procure and manufacture pharmaceuticals (vaccines and therapeutics) in the event of a pandemic or health emergency, assisting with cross-government strategy development;
- ensure that the UK government and devolved administrations, their agencies, industry and academia are aligned around shared goals in developing vaccines and therapeutics for pandemic diseases;
- oversee strong links between government and the pharmaceutical industry;
- advise the UK government on how to incentivise pharmaceutical companies to invest in manufacturing facilities and research in the UK; and
- advise the UK government on its research investments, with a view to ensuring a diverse portfolio of pharmaceutical research in the UK.
During a pandemic, the panel should form the basis of specialist taskforces, which would be responsible for securing and developing medical interventions and leading on their procurement on behalf of the four nations of the UK. They should have sufficient autonomy, delegation and direct access to senior ministers, similar to that which worked well in the Covid-19 pandemic.
- UK Vaccine Taskforce 2020 Achievements and Future Strategy: End of Year Report, Department for Business, Energy and Industrial Strategy, December 2020, p12 (https://assets.publishing.service.gov.uk/media/63f640d0d3bf7f62e6db48ce/vtf-interim-report-withdrawn.pdf; INQ000128474)
- INQ000474273_0020 para 92; INQ000474404_0078 para 5.7
- INQ000474273_0005 paras 17-18
- Alexandra Jones 20 January 2025 28/7-12; INQ000474338_0005 para 7
- INQ000474338_0005 para 7; INQ000474406_0002 para 3.1; INQ000474482_0017 para 40
- INQ000474482_0018-0019 paras 43-44; INQ000474338_0012 para 42
- INQ000474482_0016-0017, 0042 paras 38, 107c
- INQ000474482_0017 para 40
- INQ000474338_0012 paras 40-41
- INQ000474482_0044 para 111; INQ000474338_0006 para 14; INQ000474273_0004-0005 paras 14-16
- Clara Swinson 17 January 2025 61/19-62/20
- INQ000474482_0021, 0044 paras 52, 111
- INQ000474338_0042 paras 167-168; INQ000474482_0044 para 111
- INQ000474338_0043 para 172
- INQ000474338_0008 paras 24-25; Alexandra Jones 20 January 2025 28/13-29/10
- INQ000474482_0020 para 48; INQ000330574
- INQ000474482_0021 para 52
- Kate Bingham 21 January 2025 17/2-19/5; INQ000474482_0020 para 49
- INQ000474338_0041 paras 158-159
- INQ000474482_0021, 0044 paras 51-52, 111
- Alexandra Jones 20 January 2025 35/3-36/10
- INQ000474423_0018 para 9.1; INQ000474406_0041 para 38.3
- INQ000474482_0020 para 48
- Kate Bingham 21 January 2025 19/13-25; INQ000474406_0041 para 38.3
- INQ000474335_0031 para 107
- INQ000152774_0002
- INQ000474739_0004 para 7
- Clara Swinson 17 January 2025 66/10-67/5; Jonathan Van-Tam 20 January 2025 175/23-177/1
- Clara Swinson 17 January 2025 66/10-67/16; Jonathan Van-Tam 20 January 2025 175/23-177/1
- Matt Hancock 16 January 2025 83/1-3; INQ000474375_0016 para 56
- INQ000474273_0004 para 14
- James Bethell 29 January 2025 37/1-38/17
- James Bethell 29 January 2025 37/7-18
- James Bethell 29 January 2025 37/22-23
- INQ000474434_0020 paras 59-60; INQ000410503_0001-0002
- James Bethell 29 January 2025 47/10-48/20
- INQ000474482_0045-0046 para 115
- Kate Bingham 21 January 2025 1/17-2/4
- Alok Sharma 17 January 2025 9/10-12
- INQ000474739_0004 para 8
- INQ000474739_0006 para 20
- Jonathan Van-Tam 20 January 2025 148/1-6
- INQ000474482_0044-0045 paras 111, 113
- INQ000474273_0002 paras 5-6; see also Clara Swinson 17 January 2025 63/19-65/11
- INQ000474335_0023 para 81
- INQ000474342_0002 para 3; INQ000474338_0043 para 173
- INQ000502142_0002 para 4
- Kate Bingham 21 January 2025 5/6-17
- INQ000410503_0002
- Eddie Gray 29 January 2025 80/19-81/5, 83/16-85/19
- Clara Swinson 17 January 2025 63/19-65/11
- INQ000474406_0007 para 5.1
- A Review of the Vaccine Taskforce, Department of Health and Social Care, 31 August 2023, pp3, 25 (https://www.gov.uk/government/publications/a-review-of-the-vaccine-taskforce/a-review-of-the-vaccine-taskforce; INQ000283321)
- INQ000474406_0007 para 5.4
- Kate Bingham 21 January 2025 10/8-9
- INQ000474406_0022 para 19.2; INQ000474334_0015 para 37
- Kate Bingham 21 January 2025 9/18-23; INQ000474406_0007-0008 paras 5.6, 5.8
- Kate Bingham 21 January 2025 10/19-11/9
- Kate Bingham 21 January 2025 9/23-10/14; INQ000474406_0007-0009 paras 5.2, 5.3, 5.10-5.11
- Alok Sharma 17 January 2025 10/5-15; Kate Bingham 21 January 2025 10/19-11/9
- Clara Swinson 17 January 2025 65/25-66/9
- INQ000502142_0003 para 5; INQ000474342_0004-0005 para 13
- INQ000474342_0022 para 49
- INQ000474342_0022-0023, 0025-0027 paras 51, 62, 65-66, 68-69
- Kate Bingham 21 January 2025 55/6-57/1, 57/14-59/19; INQ000474406_0062-0066 paras 48.1-48.20
- INQ000474482_0056 para 149e; INQ000474423_0021 para 10.3
- Catherine Little 17 January 2025 167/18-25
- INQ000474482_0056 para 149e
- INQ000474406_0011 para 8.1
- INQ000474401_0010 para 4.5
- Kate Bingham 21 January 2025 24/15-21
- Kate Bingham 21 January 2025 25/19-25; INQ000506824_0003
- INQ000474250_0007-0008 para 24. The four vaccine technology formats are explained in Chapter 1: The landscape of vaccines and therapeutics.
- Kate Bingham 21 January 2025 26/23-28/2; INQ000506824_0003; INQ000474406_0014 para 10.3
- INQ000474406_0014 para 10.3
- Clive Dix 30 January 2025 71/3-73/7
- INQ000474406_0024 para 20.7
- INQ000474406_0042 para 38.5
- INQ000474406_0042 para 38.8
- Neutralising monoclonal antibodies are synthetic, lab-produced antibodies that bind to the spike protein of the virus, preventing the host cell from becoming infected and stimulating an immune response.
- INQ000474406_0042 para 38.9; INQ000474335_0031-0032 para 108
- INQ000474406_0042 para 38.10
- INQ000502142_0004
- INQ000474273_0003 paras 11-12
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, pp321-322 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642); Helen Knight 30 January 2025 43/6-10
- Helen Knight 30 January 2025 43/16-44/2
- Helen Knight 30 January 2025 44/3-25; INQ000474611_011 para 35
- Helen Knight 30 January 2025 45/1-46/13; INQ000474611_0004, 0013 paras 14, 41. Where interim access was approved, NHS England’s specialised commissioning prepared clinical policy and secured clinical consensus on the use of the therapeutic to support deployment across the four nations (see INQ000474611_013 para 41; INQ000474312_0009 para 19b; INQ000474328_0027-0028 para 106).
- INQ000474335_0055 para 171
- INQ000474273_0013 para 59
- INQ000474743_0070 para 6.7
- INQ000474342_0031 para 86
- Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p313 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642); INQ000474335_0045 para 149
- Kate Bingham 21 January 2025 28/3-22; see INQ000474337_0007-0008 para 13
- INQ000474273_0004, 0012-0013 paras 15, 54; INQ000474335_0045-0046 para 149
- INQ000474404_0078 para 5.8
- INQ000474404_0078 para 5.8
- INQ000474273_0020 para 92; Christopher Whitty 20 January 2025 63/6-14; Technical Report on the COVID-19 Pandemic in the UK, Department of Health and Social Care, 1 December 2022, p322 (https://www.gov.uk/government/publications/technical-report-on-the-covid-19-pandemic-in-the-uk; INQ000101642)
- INQ000474335_0049; INQ000474557_0053-0054 paras 200-202; Clara Swinson 17 January 2025 131/23-132/11, 134/1-7
- INQ000474342_0017 para 31; Eddie Gray 29 January 2025 87/5-22; INQ000064095; INQ000474273_0009 para 39
- INQ000474482_0054-0055 para 148
- Kate Bingham 21 January 2025 36/5-40/8
- INQ000474406_0039 para 34.1. This commitment envelope was over a three-year period, enabling the Vaccine Taskforce to make multi-year commitments as needed, and was increased several times – in the final instance to a total of £9.35 billion (INQ000474557_0013 para 38i).
- INQ000474406_0018 para 14.4
- INQ000474557_0013 para 38
- Catherine Little 17 January 2025 144/10-145/7
- INQ000474557_0018 para 48
- INQ000474250_0013 para 46
- INQ000474250_0013 para 47
- INQ000474250_0014 para 50; INQ000474406_0016 para 12.5
- INQ000474557_0047 para 176
- INQ000474342_0023-0024 paras 55, 58; Eddie Gray 29 January 2025 86/3-87/4
- Catherine Little 17 January 2025 162/15-18
- INQ000474342_0024 para 59
- INQ000474557_0047-0048 para 177; INQ000474335_0047 para 156; INQ000420973_0001
- INQ000502142_0003 para 6; Eddie Gray 29 January 2025 87/23-88/13; INQ000474418_0077-0078 para 5.40
- INQ000489914_0001; INQ000474418_0078 paras 5.41-5.43; INQ000474739_0042 para 176; INQ000474557_0048-0050 paras 178-186; INQ000474342_0010-0011 paras 27.14-27.26
- INQ000474418_0079-0080 paras 5.45-5.47; Sajid Javid 23 January 2025 43/14-44/5; INQ000474557_0050-0051 paras 187-189
- INQ000474381_0009 paras 23-24
- Catherine Little 17 January 2025 164/13-165/21
- INQ000474418_0079-0080 para 5.47; INQ000474739_0042-0043 para 177
- Alok Sharma 17 January 2025 23/3-25/7; Catherine Little 17 January 2025 147/14-148/8; Kate Bingham 21 January 2025 41/2-14
- INQ000474406_0015 paras 11.3-11.4
- Kate Bingham 21 January 2025 29/20-31/13; INQ000474406_0047-0048, 0055 paras 40.1, 40.4, 45.1
- Justin Green 23 January 2025 156/10-157/6; INQ000474706_0030 paras 117-118; INQ000485978_0005, 0008 paras 20, 31
- Ben Osborn 23 January 2025 147/21-149/6; Darius Hughes 27 January 2025 29/9-19; INQ000474706_0031 para 123. However, witnesses for AstraZeneca were less effusive about the later approach of the taskforces in relation to Evusheld, variant vaccines and booster doses (INQ000474706_0031 paras 124-125); INQ000474431_0030-0031 para 111.
- INQ000485977_0055 para 165.1
- Ben Osborn 23 January 2025 148/12-19
- INQ000474406_0039 paras 35.1-35.2
- Alok Sharma 17 January 2025 25/11-26/6
- Kate Bingham 21 January 2025 35/4-5
- Alok Sharma 17 January 2025 26/13-27/14
- Alok Sharma 17 January 2025 27/17-29/11
- Kate Bingham 21 January 2025 35/6-10
- INQ000485977_0055-0056 para 165.1; INQ000474453_0045 para 202; INQ000474431_0031 para 112
- INQ000474406_0037-0038 paras 33.1-33.6
- INQ000514013; INQ000492334_0042 para 5.81
- INQ000474406_0060-0061 paras 47.12-47.15
- Clive Dix 30 January 2025 78/15-80/22
- Sajid Javid 23 January 2025 57/25-59/4
- Nadhim Zahawi 27 January 2025 121/6-122/19
- Jenny Harries 20 January 2025 212/4-213/1
- INQ000474561_0036 para 104
- INQ000474337_0078 para 273; INQ000474743_0061-0062 para 5.66
- Kamran Mallick 15 January 2025 186/14-187/18; INQ000474526_0035-0037 paras 72-79; Lara Wong 16 January 2025 52/3-53/15; Clive Dix 30 January 2025 88/20-21
- INQ000474406_0042 para 38.11; INQ000412418_0003; Kate Bingham 21 January 2025 46/15-48/7
- INQ000071342; INQ000474406_0042-0043 para 38.12; Kate Bingham 21 January 2025 48/8-24
- INQ000507423; INQ000474401_0080-0081 para 7.25
- INQ000072735; INQ000474404_0070-0072 paras 3.37-3.38
- INQ000072735; INQ000474404_071 para 3.38
- INQ000072735
- Jonathan Van-Tam 20 January 2025 180/11-16
- Kate Bingham 21 January 2025 50/1-52/21; Clive Dix 30 January 2025 87/14-89/22
- Kate Bingham 21 January 2025 21/7-24; Clive Dix 30 January 2025 90/1-91/7
- Kate Bingham 21 January 2025 52/1-9
- Clive Dix 30 January 2025 88/20-21
- Christopher Whitty 20 January 2025 113/5-115/2
- INQ000497987
- James Bethell 29 January 2025 63/13-64/9
- Matt Hancock 16 January 2025 87/12-89/21
- Helen Knight 30 January 2025 49/1-50/6
- Helen Knight 30 January 2025 43/16-44/25
- INQ000066712_0002
- Helen Knight 30 January 2025 50/7-52/17; INQ000479901_0012, 0016
- INQ000479901_0010-0017; Helen Knight 30 January 2025 52/18-54/13
- A conditional marketing authorisation is granted on less comprehensive clinical data than are normally required for a marketing authorisation when there is a public health need. It is valid for a year (INQ000474337_0036 paras 111-112).
- INQ000479901_0008-0011; Helen Knight 30 January 2025 54/2-56/14
- INQ000474743_0071-0073 paras 6.11, 6.15
- Helen Knight 30 January 2025 56/14-61/5
- INQ000497090_0001-0005, 0007-0008; INQ000497091
- Helen Knight 30 January 2025 59/5-60/19; INQ000479901_00001, 0006-0007
- Tixagevimab Plus Cilgavimab for Preventing COVID-19: Technology Appraisal Guidance, National Institute for Health and Care Excellence, 14 June 2023, pp8-9, 30, paras 3.3, 3.27 (https://www.nice.org.uk/guidance/ta900; INQ000339319)
- Helen Knight 30 January 2025 55/5-21
- See Christopher Whitty 20 January 2025 115/23-116/2; INQ000474273_0017-0018 para 78; INQ000474336_0039-0040 para 73; INQ000474335_0062 para 201
- Lara Wong 16 January 2025 52/18-53/15
- INQ000474338_0029-0030 paras 94, 97
- INQ000474406_0044 para 39.1
- Alexandra Jones 20 January 2025 4/18-6/2; Jonathan Van-Tam 20 January 2025 152/20-153/2; INQ000474406_0045-0046 paras 39.4, 39.7
- Alexandra Jones 20 January 2025 21/12-13; INQ000474338_0009-0010 para 31
- INQ000474338_0032, 0034-0035 paras 108, 115-122; INQ000474406_0045-0046 paras 39.4-39.9; INQ000474250_0024-0025 paras 92-96
- INQ000474406_0046-0047 para 39.12
- Kate Bingham 21 January 2025 29/24-30/13
- INQ000474406_0059 para 47.10; Kate Bingham 21 January 2025 14/16-17/1
- INQ000474406_0045 para 39.6
- INQ000474338_0032 para 107
- INQ000421276_0002
- Alexandra Jones 20 January 2025 10/4-8
- Alexandra Jones 20 January 2025 12/3-14/11; INQ000474338_0032 para 110
- INQ000474406_0060 para 47.11
- INQ000474278_0013 para 57
- INQ000474334_0017 para 45; Alexandra Jones 20 January 2025 3/22-4/9; INQ000492334_0060 para 9.1(2)
- INQ000474334_0017 para 45; Alexandra Jones 20 January 2025 3/22-4/9; INQ000492334_0060 para 9.1(2)
- INQ000474338_0034 para 114b; INQ000588171_0005 para 10
- Alexandra Jones 20 January 2025 14/23-21/21; ‘Millions of vaccines to be made in Oxfordshire, and government unveils £50 million fund, in double boost for life sciences’, Department for Science, Innovation and Technology, Department of Health and Social Care, Medicines and Healthcare products Regulatory Agency and UK Health Security Agency, 25 September 2025 (https://www.gov.uk/government/news/millions-of-vaccines-to-be-made-in-oxfordshire-and-government-unveils-50-million-fund-in-double-boost-for-life-sciences; INQ000658641)
- Alexandra Jones 20 January 2025 25/5-20
- Jenny Harries 20 January 2025_208/13-17
- ‘Blow for Reeves as AstraZeneca ditches £450m investment’, BBC News, 31 January 2025 (https://www.bbc.co.uk/news/articles/c1we943zez9o; INQ000651917)
- Alexandra Jones 20 January 2025 24/9-25/2
- INQ000588171_0004-0005 para 8
- INQ000588171_0005-0006 paras 9-12
- ‘£1 billion BioNTech investment sets way for jobs, growth, breakthroughs’, Department for Science, Innovation and Technology, 20 May 2025 (https://www.gov.uk/government/news/1-billion-biontech-investment-sets-way-for-jobs-growth-breakthroughs; INQ000659866)
- ‘Next-gen therapies for cancer, dementia and more fast-tracked with new facility’, Department for Science, Innovation and Technology, 28 August 2025 (https://www.gov.uk/government/news/next-gen-therapies-for-cancer-dementia-and-more-fast-tracked-with-new-facility; INQ000659867)
- INQ000658678; INQ000658679
- Jonathan Van-Tam 20 January 2025 150/3-151/5; Clive Dix 30 January 2025 82/12-19, 83/16-84/1
- Clive Dix 30 January 2025 85/19-87/13
- Alexandra Jones 20 January 2025 21/22-23/7; Jonathan Van-Tam 20 January 2025 151/13-24
- Alok Sharma 17 January 2025 32/9-37/20; INQ000474590_0008-0012 paras 26, 32-35
- INQ000474482_0048-0049 para 126
- INQ000474482_0048-0049 para 126; INQ000474743_0091 para 8.1; INQ000474624_0028 para 128
- INQ000474482_0048-0049 para 126; INQ000474743_0045 para 5.32
- INQ000474406_0041 para 38.3
- INQ000474406_0059-0060 para 47.10
- INQ000474406_0047 paras 39.13-39.14
- INQ000588171_0003-0004 paras 2, 4
- INQ000474335_0024 para 84
- INQ000492334_0060 para 9.1. The Vaccine Taskforce’s second objective was to ensure that vaccines were distributed equitably around the world.
- INQ000492334_0060 para 9.1
- INQ000474418_0084 para 6.13
- UK Biological Security Strategy, Cabinet Office, June 2023, p10 (https://www.gov.uk/government/publications/uk-biological-security-strategy; INQ000208910)
- UKHSA Strategic Plan 2023 to 2026, UK Health Security Agency, July 2023 (https://assets.publishing.service.gov.uk/media/650d530e52e73c00139426c1/UKHSA_3_year_strategy.pdf; INQ000235221); ‘Letter from Ashley Dalton MP to Professor Susan Hopkins, UKHSA Chief Executive’, Department of Health and Social Care and UK Health Security Agency, 11 December 2025 (https://www.gov.uk/government/publications/ukhsa-priorities-in-2025-to-2026; INQ000660109). This supports the overarching goals of the UK Health Security Agency’s 10-year Science Strategy: UKHSA Science Strategy 2023 to 2033: Securing Health and Prosperity, UK Health Security Agency, May 2023 (https://assets.publishing.service.gov.uk/media/646c93e6a726f6000ccebc20/UKHSA_Science_strategy.pdf; INQ000235220). See also INQ000521972_0079-0080 paras 8.1-8.2.
- This work is being led alongside the Department of Health and Social Care (INQ000474418_0085 para 6.17).
- ‘UKHSA’s Vaccine Development and Evaluation Centre (VDEC)’, UK Health Security Agency, 10 January 2025 (https://www.gov.uk/guidance/ukhsas-vaccine-development-and-evaluation-centre-vdec; INQ000651919); ‘Priority pathogens: The disease families which require urgent scientific research’, UK Health Security Agency, 25 March 2025 (https://ukhsa.blog.gov.uk/2025/03/25/priority-pathogens-the-disease-families-which-require-urgent-scientific-research; INQ000651918); Priority Pathogen Families Research and Development (R&D) Tool, UK Health Security Agency, March 2025 (https://assets.publishing.service.gov.uk/media/67f5259ae3c60873d6c90d08/UKHSA-priority-pathogen-families-research-and-development-tool.pdf; INQ000587354); UKHSA Science: Securing Health and Prosperity 2024 Review, UK Health Security Agency, January 2025, p45 (https://assets.publishing.service.gov.uk/media/677b8e0396026fd694d92c60/Science_review_2024.pdf; INQ000563069)
- A Commercial Strategy for UK Health Security: Commercial Practice in a Changing World, UK Health Security Agency, April 2024 (https://assets.publishing.service.gov.uk/media/662f5a9d7278ec7b2c869692/UKHSA_Commercial_Strategy_2024.pdf; INQ000421934); INQ000521972_0080-0081, 0083-0084 paras 8.5-8.9, 8.16-8.19
- INQ000521972_0009 para 2.27
- INQ000496177_0068-0069 paras 13.17, 13.20
- A Commercial Strategy for UK Health Security: Commercial Practice in a Changing World, UK Health Security Agency, April 2024, p18 (https://assets.publishing.service.gov.uk/media/662f5a9d7278ec7b2c869692/UKHSA_Commercial_Strategy_2024.pdf; INQ000421934)
- INQ000499442_0034-0035 paras 99-100
- INQ000499442_0064, 0069-0070 paras 182, 198
- Kate Bingham 21 January 2025 16/19-17/1
- Kate Bingham 21 January 2025 61/16-17
- Kate Bingham 21 January 2025 14/16-17/1; INQ000474406_0059-0060 para 47.10
- Kate Bingham 21 January 2025 69/6-14
- INQ000474278_0018 para 82
- INQ000474423_0015 para 6.4
- INQ000474423_0015 para 6.2
- INQ000474423_0019 para 10.1.1; INQ000496107_0002 paras 1-2; INQ000474590_0030 para 90
- Kate Bingham 21 January 2025 61/25-63/12; Clive Dix 30 January 2025 92/16-95/20; INQ000330659_0001-0002
- Clive Dix 30 January 2025 95/12-13, 97/10-11
- INQ000474406_0066 para 48.22
- Module 1: The resilience and preparedness of the United Kingdom, UK Covid-19 Inquiry, July 2024, Executive Summary
(https://covid19.public-inquiry.uk/documents/module-1-full-report) - Clive Dix 30 January 2025 98/3-19; Kate Bingham 21 January 2025 16/9-17/1, 65/2-9
- Clive Dix 30 January 2025 98/3-8
- Clive Dix 30 January 2025 98/20-25
- Kate Bingham 21 January 2025 65/2-8
- Kate Bingham 21 January 2025 61/25-64/5
- Alok Sharma 17 January 2025 16/21-25
- INQ000474590_0030 para 90; Alok Sharma 17 January 2025 17/6-17
- INQ000474590_0030 para 91
- Jonathan Van-Tam 20 January 2025 153/7-24
- Matt Hancock 16 January 2025 103/12-104/7
- Alexandra Jones 20 January 2025 32/16-35/2
- INQ000410867_0015-0016 paras 46-50; ‘UKHSA appoints non-executive members to its board’, UK Health Security Agency, 28 April 2022 (https://www.gov.uk/government/news/ukhsa-appoints-non-executive-members-to-its-board; INQ000090314)
- INQ000492334_0060 para 9.1; Jenny Harries 20 January 2025 207/5-12
- Jenny Harries 20 January 2025 207/5-12
- Jenny Harries 20 January 2025 208/24-209/3
- Jenny Harries 20 January 2025 206/23-209/7
- Kate Bingham 21 January 2025 68/11-69/5
- Alok Sharma 17 January 2025 16/19-19/7
Chapter 4: Authorisation
Introduction
| 4.1. | The Medicines and Healthcare products Regulatory Agency is responsible for regulating the marketing of medicines, including vaccines, in the UK.1 If data from clinical trials show that the medicine is effective and ‘acceptably safe’, the manufacturer may apply to the agency for a marketing authorisation (sometimes called a product licence).2 This confirms that the medicine’s safety, efficacy and quality has been assessed and that its benefits outweigh its risks for a specified use.3 |
| 4.2. | During a pandemic, medicine regulators like the Medicines and Healthcare products Regulatory Agency must ensure adherence to exacting safety standards while making decisions on authorising vaccines and therapeutics for use among the population as quickly as possible. Any delay could slow the rollout of effective drugs and vaccines and cost lives; innovation and flexibility may therefore be required. At the same time, the regulator must ensure that it commands public confidence, that its decision-making processes are independent and free from real or perceived conflicts of interest, and that the standards it applies are sufficiently rigorous and exacting. |
| 4.3. | This chapter examines the UK’s regulatory systems and processes for authorising the use of vaccines and therapeutics during the Covid-19 pandemic, including the measures in place to ensure the independence of the relevant regulatory bodies. |
The independence of regulatory decision-making
| 4.4. | Medicines regulation in the UK is funded from fees charged by the Medicines and Healthcare products Regulatory Agency to the pharmaceutical industry.4 This is in line with other regulators, such as the European Medicines Agency and the Food and Drug Administration in the USA.5 |
| 4.5. | Dame June Raine, Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency from September 2019 to March 2025, explained that its regulatory decisions were based on the safety, quality and effectiveness of the medicine under review and were “in no way influenced” by the set fees it charged industry.6 She said that this funding allowed the Medicines and Healthcare products Regulatory Agency “to match resource with demand” and, without it, it would be “less able to run its operations independently from central government”.7 She placed great emphasis on the importance of independence from government.8 While the Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health and Social Care, it is “operationally independent”.9 This ensures that it is free from political interference and pressure. |
| 4.6. | The value of this independence was recognised during the pandemic by Professor (later Sir) Christopher Whitty (Chief Medical Officer for England from October 2019) and Professor Sir Patrick Vallance, later Lord Vallance of Balham (Government Chief Scientific Adviser from April 2018 to March 2023). They wrote to Dame June Raine in November 2020 praising the agency’s role as a “strong independent regulator” and reassuring her that, in the “very unlikely” event she felt under any pressure that impinged on her total independence, she could rely on them for support.10 She did not complain of such pressure and Professor Whitty’s ultimate view was that the agency had performed its role with “rigour and independence” during the pandemic.11 |
| 4.7. | Under normal circumstances, the power to decide whether a medicine should be authorised for use in the UK is delegated by the relevant health ministers to the Medicines and Healthcare products Regulatory Agency, which acts as the ‘licensing authority’.12 However, due to the exceptional circumstances of the Covid-19 pandemic, it was agreed between the agency and Matt Hancock MP (Secretary of State for Health and Social Care from July 2018 to June 2021) that authorisation decisions on Covid-19 medical products should no longer be delegated and would instead be taken by a designated ‘licensing minister’ within the Department of Health and Social Care.13 Dame June Raine explained:
“[T]his clearly was a very special set of circumstances and it seemed very appropriate that the licensing authority, the Health Minister, the Secretary of State, should be in a position to exercise that full power.” 14 |
| 4.8. | It was recognised that, as the Secretary of State was also making decisions on the supply and rollout of the vaccines, this could create a possible conflict of interest, hence the creation of the role of licensing minister.15 This minister could not be involved in the purchase and deployment of vaccines or medicines, and could not liaise directly with interested pharmaceutical companies.16 The licensing minister took authorisation decisions following advice from the Commission on Human Medicines – the UK government’s independent expert scientific advisory body on medicines – and recommendations of the Medicines and Healthcare products Regulatory Agency. It was open to the licensing minister to reject the agency’s recommendations, although in fact this never happened.17 |
| 4.9. | The Inquiry was informed that during the pandemic the Medicines and Healthcare products Regulatory Agency ensured its independence from commercial or financial interests. This included through its conflict of interest policy, which Dame June Raine described as “extensive” and “rigorous”, with staff attesting annually that they have no interest in the pharmaceutical medical device industries.18 The agency also had a Corporate Conflicts of Interest Policy and Procedure, which required it to “continually assess” whether any activity that it undertook would cause an actual or a perceived conflict of interest.19 One example of this approach was the decision, taken in September 2020, to withdraw the agency’s representation on the Vaccine Taskforce (established in April 2020, to gather together the collective efforts of government, academia and industry to help find a Covid-19 vaccine: see Chapter 3: Securing supplies). This happened when the taskforce’s focus shifted from supporting vaccine development generally – in respect of which the agency could play a role in advising on likely regulatory requirements – to considering purchasing decisions for the UK government.20 |
| 4.10. | As well as providing advice to ministers, the Commission on Human Medicines also advises the Medicines and Healthcare products Regulatory Agency.21 During the pandemic, the commission established expert working groups made up of doctors, academics and other experts to assist it in giving advice. These groups included the Covid-19 Therapeutics Expert Working Group and the Covid-19 Vaccine Benefit Risk Expert Working Group, which advised on, among other things, the safety and efficacy of Covid-19 treatments and vaccines.22 |
| 4.11. | Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines from February 2021, explained that its members were subject to a “strict Code of Practice”, which set out the rules and processes to be followed for identifying and declaring interests that were relevant to the commission’s work.23 No member of the commission was allowed to hold personal interests (ie financial interests that involve a payment) in the pharmaceutical industry.24 Members of its expert working groups were allowed to hold such personal interests; however, they were asked to leave the room while any item relevant to their interest was discussed. For the Covid-19 vaccines and therapeutics considered by the commission during the pandemic, all interests were declared for every meeting and published in the annual report.25 Professor Pirmohamed observed that, if it were required that members had no links to industry at all, it is unlikely that the commission would have access to the best expertise:
“If membership of the [Commission on Human Medicines] was restricted to individuals who did not have any interests or connections with Industry, we would have difficulty in recruiting to the Commission, and it is unlikely that it would be constituted by the best experts in the field.”26 |
| 4.12. | It is clear that careful regard was had to the safeguarding of the independence of the Medicines and Healthcare products Regulatory Agency during the pandemic, and to ensuring that independent advice was provided on the authorisation of Covid-19 vaccines and therapeutics. Both the Medicines and Healthcare products Regulatory Agency and the Commission on Human Medicines had appropriate and robust systems in place for managing conflicts of interest. |
Balancing risks and benefits
| 4.13. | The Medicines and Healthcare products Regulatory Agency is responsible for regulating medical products, including vaccines, medicines and devices, in the UK by ensuring that they work and are ‘acceptably safe’.27 This obligation is central to the agency’s functions.28 This responsibility begins at the authorisation stage and continues throughout the period for which a medical product remains licensed in the UK.29 |
| 4.14. | Dame June Raine explained that the Medicines and Healthcare products Regulatory Agency has many decades of experience in this work and its approach is guided by, and helps shape, internationally agreed standards.30 For example, in relation to Covid-19 vaccines, prior to the start of data submissions from pharmaceutical companies, the agency participated in World Health Organization and International Coalition of Medicines Regulatory Authorities workshops, where medicines regulators discussed the regulatory aspects of Covid-19 vaccine development. The regulators agreed on several aspects of vaccine development, including the need for randomised, double blind, controlled trials.31 Agreement was also reached on statistical evaluation of the trial results – for example, the minimum vaccine efficacy that would be considered acceptable. This was agreed at 50% vaccine efficacy.32 These standards were adopted by the Medicines and Healthcare products Regulatory Agency alongside its normal regulatory requirements.33 |
| 4.15. | No medical product is completely risk free because all have the potential to cause side effects.34 ‘Acceptably safe’ means that, based on the assessment of the Medicines and Healthcare products Regulatory Agency, the benefits or expected benefits associated with a particular product are considered to outweigh any risks associated with that product, at population level.35 Dame June Raine explained the importance of “context” when assessing risk; in relation to vaccines, there must be particularly strong evidence that the benefit outweighs the risk. This is because vaccines are given to healthy people in order to prevent sickness, as opposed to other medicines which are given to those who are already unwell.36 |
| 4.16. | This was recognised in the context of therapeutics by Professor Sir Nicholas White, expert witness on therapeutics, who said:
“People who are ill with Covid-19, their loved ones, and the clinical team are all willing to accept a higher risk of side effects given the clear and present danger of their current infection.”37 |
| 4.17. | An applicant for marketing authorisation is asked and expected to provide assurance to the Medicines and Healthcare products Regulatory Agency that it has provided all information and evidence available both for and against its product. A scientific review is then undertaken by a team of scientific and clinical assessors within the Medicines and Healthcare products Regulatory Agency with reference to internationally agreed standards.38 This involves evaluation of the robustness of the evidence presented on the safety, quality and effectiveness of the product.39 |
| 4.18. | Regulatory authorities have attempted to quantify the risk–benefit analysis, but there is no one consensus method. The Medicines and Healthcare products Regulatory Agency takes a qualitative approach to this analysis (ie a “critical appraisal”).40 This weighs the strength of the evidence on efficacy and safety in the context of what would be expected for a particular product with its mode of action, used in a particular indication, current treatment options and taking into account the disease and the patient population in question.41 In practice, this involves expert assessors considering all evidence from the preclinical studies and clinical trials on how well a given medical product works and its safety profile. The Inquiry heard that this process involves “leaving no stone unturned”.42 |
| 4.19. | Dame June Raine explained that the results of the clinical trials and other data on safety, quality and effectiveness received from vaccine developers were summarised in a scientific assessment report, together with a critical appraisal of benefit and risk prepared by the Medicines and Healthcare products Regulatory Agency’s assessors. This report was provided to the Commission on Human Medicines, and its expert working groups, which were formally consulted at meetings for their independent advice on matters such as risk and benefit.43 |
Risks: Obtaining safety data from clinical trials
| 4.20. | As explained by Professor Stephen Evans, expert witness on vaccine safety, safety itself cannot be measured. It is the “relative absence of harm that demonstrates safety”.44 Data from clinical trials are crucial in assessing this. |
| 4.21. | In relation to all clinical trials conducted in the UK, the Medicines and Healthcare products Regulatory Agency requires the reporting of all suspected unexpected serious adverse reactions.45 This is an adverse event that occurs in a clinical trial participant, which is assessed by the trial sponsor or investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the medicine being tested.46 The agency also monitors the accurate reporting of adverse reactions through its data management processes, its statistical review of trial data and regular review meetings. Dame June Raine explained that audits and visits to the investigator site by a trial monitor were conducted for all UK clinical trials for Covid-19 vaccines.47 |
| 4.22. | The monitoring of clinical trials conducted outside the UK is the responsibility of the regulatory body for the country in which the trial is being conducted. However, where a multi-site global trial has at least one trial site in the UK, the Medicines and Healthcare products Regulatory Agency requires that all suspected unexpected serious adverse reactions that occur at non-UK sites are reported to it, as they are relevant to UK trial participants. It is also provided, for any medicine, with all safety data for all trials conducted up until the point of the authorisation application.48 |
| 4.23. | In addition, clinical trials have layers of oversight, which are independent of the Medicines and Healthcare products Regulatory Agency.49 Each trial has a data and safety monitoring board (also known as a data monitoring committee), which meets regularly. Its role is to continually oversee the safety data as these accrue from the trial. It advises an investigators’ trial steering committee whether to continue the trial as it is, amend it in some way, or pause or stop the trial. The board must be independent of the organisation running the trial and the trial investigators; its members must not have a vested interest in the success or otherwise of the product under trial.50 |
| 4.24. | Professor Evans explained that these rigorous standards of oversight were observed during the pandemic:
“The oversight mechanisms for the Covid-19 vaccine clinical trials were robust and on a par with non-pandemic standards.”51 |
| 4.25. | In July and September 2020, the Oxford/AstraZeneca clinical trials were temporarily halted due to reported cases of suspected transverse myelitis, a condition that involves inflammation of the spinal cord.52 These reports were considered by the trial’s data monitoring and safety board and both the Medicines and Healthcare products Regulatory Agency and the Commission on Human Medicines.53 |
| 4.26. | At a meeting in September 2020, the commission noted that the first case, from July 2020, was most likely a first clinical presentation of existing multiple sclerosis but there was still uncertainty as to the underlying diagnosis for the September 2020 case. However, both were considered in the ensuing discussion and the commission concluded that there was insufficient evidence to indicate a causal association with the vaccine but this should remain under close review.54 In relation to this response, Professor Evans said:
“The system of trial monitoring worked extremely well, with rapid reporting of the adverse event to the trial investigators and regulators. The pausing of recruitment showed a cautious approach, illustrating that the safety of trial participants is paramount … The further monitoring did not show any increase in risk during the trial.”55 |
| 4.27. | Dame June Raine informed the Inquiry that, aside from a reported case of migraine in the Oxford/AstraZeneca trials, no other suspected unexpected serious adverse reactions were reported during the clinical trials for the Covid-19 vaccines.56 |
| 4.28. | In the context of therapeutics trials, one specific safety concern arose early in the pandemic relating to hydroxychloroquine (a drug used in rheumatic disease treatment).57 This was being considered for prophylaxis (ie a drug taken to prevent, rather than treat, a disease) as well as treatment. However, in May 2020, the Commission on Human Medicines advised that there should be a reassessment of the risk–benefit balance of the relevant trials in the UK, in light of concerns about the risk of potential harm (especially with regard to heart rhythm abnormalities), combined with the lack of any convincing data on effectiveness. This was in part due to a study published in the medical journal The Lancet, in addition to a number of other studies. Following communication with the Medicines and Healthcare products Regulatory Agency, seven trials confirmed that recruitment would be paused. The RECOVERY trial, which was trialling hydroxychloroquine as a treatment, was permitted to continue on the basis of the information it provided on safety.58 |
| 4.29. | On 5 June 2020, The Lancet retracted the paper due to concerns about the reliability of the underlying data and the Commission on Human Medicines agreed that the data and findings of the study should no longer be used. However, on the same day, the RECOVERY trial reported that there was no clinical benefit from use of hydroxychloroquine in hospitalised patients with Covid-19. None of the other trials on hydroxychloroquine were restarted save for the COPCOV study on prophylaxis, which was allowed to resume on 26 June 2020.59 |
| 4.30. | Despite the measures outlined above, there are limits on what safety information can be obtained from clinical trials. Intensive follow-up with vaccine trial participants is normally limited to about three months and therefore clinical trials are not expected to detect adverse effects with delayed onset.60 Such effects are very rare, which also means they are unlikely to be detected.61 It can also be very difficult for trials to detect adverse effects that arise from a ‘multi-hit’ process (ie resulting from a medicine having an effect on an individual’s existing health conditions or environmental factors).62 |
| 4.31. | Clinical trials can only study a finite number of patients over a defined period, so very rare adverse reactions are unlikely ever to be identified by them. A reaction or condition that only occurs in 1 in 200,000 people may not be apparent in a clinical trial involving 30,000 people.63 |
| 4.32. | As set out in Chapter 2: Discovery and development, the Covid-19 vaccine clinical trials were sizeable. The Pfizer/BioNTech Phase 3 trial recruited almost 44,000 participants, the Oxford/AstraZeneca trials enrolled more than 25,000 participants and the Moderna Phase 3 trial enrolled more than 30,000 trial participants.64 These clinical trials were larger than some previous vaccine trials and were of sufficient size to enable regulators to assess safety properly.65 |
| 4.33. | There are ethical constraints on running ever larger trials in a bid to identify very rare adverse effects. Professor Evans explained that, once convincing evidence of efficacy emerges, it is not possible to continue running large Phase 3 trials or recruit to new Phase 3 trials. This would be unethical as it would involve subjecting the control group to a placebo (or control drug) when an effective treatment had been identified.66 It is only once a vaccine or drug is rolled out at a population level that very rare adverse effects will be detectable.67 This makes it vital to ensure that there are effective systems of post-authorisation safety monitoring in place.68 These systems are the subject of Chapter 7: Post-authorisation safety and surveillance systems. |
Benefits: Efficacy and effectiveness
| 4.34. | During the authorisation process the risks of a medicine or vaccine are weighed against its benefits, or efficacy.69 For example, in relation to therapeutics, towards the latter part of the pandemic the Covid-19 Therapeutics Expert Working Group and the Commission on Human Medicines considered data from clinical trials on the new antivirals, molnupiravir and Paxlovid. In respect of both, the expert working group and the commission concluded that the balance of benefits and risks was positive. This led to recommendations for authorisation from the Medicines and Healthcare products Regulatory Agency, which were accepted by the licensing minister.70 |
| 4.35. | Initial estimates on how well vaccines protect against severe Covid-19 came from large, randomised Phase 3 clinical trials. These first studies reported on the Oxford/AstraZeneca, Pfizer/BioNTech and Moderna vaccines in December 2020. Despite differences in study populations, the geographical location from which participants were recruited and the choice of comparator (placebo in most trials, non-Covid-19 active vaccines in others), they all showed high protection against symptomatic Covid-19.71 |
| 4.36. | The first interim results from a large clinical trial on the efficacy of the Pfizer/BioNTech vaccine showed an efficacy of 95% to prevent laboratory-confirmed Covid-19 at least 7 days after the second dose when administered 21 days after the first dose.72 In an interim analysis, the efficacy of two doses of the Oxford/AstraZeneca vaccine against symptomatic Covid-19 (positive test and at least one symptom) was reported to be 70.4% after more than 14 days following the second dose. Notably, efficacy was higher – about 90% – in a sub-group of people who received a lower vaccine dose as their first dose, followed by a normal dose for the second.73 The Phase 3 trial results for the Moderna vaccine showed 94.1% protection against symptomatic Covid-19 at least 14 days after the second dose when given 28 days after the first dose.74 |
| 4.37. | The efficacy results were all well above the required threshold of 50%, agreed by the Covid-19 Vaccine Benefit Risk Expert Working Group and the Commission on Human Medicines. As described above, this was in keeping with criteria set by the World Health Organization, as well as the Food and Drug Administration in the USA.75 |
| 4.38. | These data on the efficacy of vaccines – along with the information on safety obtained from the clinical trials (set out above) – were considered by the Covid-19 Vaccine Benefit Risk Expert Working Group, the Commission on Human Medicines and the Medicines and Healthcare products Regulatory Agency as part of the authorisation process. In respect of each vaccine, the requirements for safety, quality and effectiveness were found to have been met and the bodies recommended to the licensing minister that the vaccines should be authorised. This advice was accepted on each occasion and, as a result, the Pfizer/BioNTech and Oxford/AstraZeneca vaccines were authorised for use in December 2020, and the Moderna vaccine was authorised in January 2021.76 |
| 4.39. | The efficacy results from clinical trials were replicated in real-world, post-authorisation studies. Evidence published on 23 April 2021 from Scotland showed that the first dose of the Oxford/AstraZeneca vaccine reduced the likelihood of hospitalisation by 88% (most of the vaccine recipients being over the age of 65 years).77 An effectiveness study of the Pfizer/BioNTech vaccine, published by Public Health England on 13 May 2021, showed that a single dose of the vaccine was about 80% effective at preventing admission to hospital and 85% effective at preventing death with Covid-19.78 A 2021 meta-analysis of real-world data showed that the Moderna vaccine was 98.1% effective after deployment in different parts of the world.79 |
| 4.40. | Professor Daniel Prieto-Alhambra, expert witness on vaccine safety, stated that Covid-19 vaccines were effective.80 He explained that:
|
The make-up of clinical trials
| 4.41. | In order to assess the information on risks and benefits obtained from clinical trials, it is important that those trials adequately reflect the population among whom the medicine is to be used.87 |
| 4.42. | Dame June Raine said that the Covid-19 vaccine clinical trials were adequately representative in terms of age and sex.88 Pregnant and breastfeeding women, children and immunocompromised people were, however, generally excluded from trials of vaccines on safety grounds.89 Dame June Raine stressed the importance of post-authorisation surveillance for groups excluded from clinical trials.90 |
| 4.43. | Professor Prieto-Alhambra explained that post-authorisation studies showed that the messenger ribonucleic acid (mRNA) vaccines were similarly safe and beneficial in pregnant women as in the general population.91 Professor Prieto-Alhambra further noted that there was no evidence of an association between the vaccines and adverse pregnancy outcomes.92 The impact of the exclusion of pregnant women on vaccine hesitancy among this group – and the need to encourage the inclusion of pregnant women in future clinical trials of both vaccines and therapeutics – is considered in Chapter 5: Delivery. |
| 4.44. | In respect of immunosuppressed people, Professor Prieto-Alhambra noted that post-authorisation studies had shown that there was substantially reduced vaccine effectiveness against infection among this group.93 This is unsurprising given that vaccination is reliant on the immune system of the recipient reacting to the vaccine to mount a response against a virus.94 However, there was nevertheless a substantial reduction in hospitalisation.95 |
| 4.45. | Similarly, post-authorisation evidence was utilised when assessing the risks of the vaccines for children. The Pfizer/BioNTech and Moderna vaccines were authorised for use in children in May and August 2021, respectively – more than a year into the pandemic. Dame June Raine explained that these authorisation decisions were based on clinical trials which found that the majority of side effects were “mild and comparable to that seen in adults”.96 Importantly, these findings were supported by real-world evidence where vaccines had been deployed in children in the UK and internationally.97 |
| 4.46. | The issue of ethnic diversity in clinical trials – including UK clinical trials – is addressed in detail in Chapter 2: Discovery and development, which sets out the ethnic diversity figures for the vaccine Phase 3 clinical trials. Dame June Raine said that these trials were sufficiently diverse to “draw conclusions on safety in the indicated populations”.98 This diversity was achieved, in part, because many trials were conducted in countries with a greater proportion of non-White trial participants than in the UK.99 There is no evidence that a person’s ethnicity has any impact on the efficacy of Covid-19 vaccinations.100 |
‘Novel’ technologies and scale-up
| 4.47. | There were concerns that the mRNA technology (underpinning the Pfizer/BioNTech and Moderna vaccines) and the adenoviral vector technology (underpinning the Oxford/AstraZeneca vaccine) had not been used at such scale in healthy populations before, and their long-term safety had not been established.101 However, while sometimes characterised as a ‘novel’ technology, it is important to note that research on mRNA had been ongoing for decades at the time of the pandemic and the adenovirus-vectored vaccine platform had been investigated for years by scientists at the University of Oxford (as explained in Chapter 2: Discovery and development).102 |
| 4.48. | Professor Evans and Professor Prieto-Alhambra agreed that there was no evidence that the vaccine technologies had a harmful impact on a recipient’s genetics.103 This was echoed by Professor Wendy Barclay, Action Medical Research Chair of Virology at Imperial College London and a member of the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) from 2014, who also said that she was not aware of any credible evidence that Covid-19 vaccines or any parts of them “persist in the body and move to other parts of the body”.104 Dame June Raine explained that the Medicines and Healthcare products Regulatory Agency scientific assessors are experienced in making risk–benefit considerations in relation to innovative biological medicines, such as the novel Covid-19 vaccines. She stressed that “rigorous scientific consideration” was given during the authorisation process to how these technologies may affect the body.106 |
| 4.49. | Sometimes, pharmaceutical companies make changes to the process by which they manufacture vaccines and therapeutics. A company may make such changes to adjust the scalability, robustness and productivity of the manufacturing process in preparation for large-scale manufacture.107 The Inquiry heard concerns that such a change in process may, in effect, have meant that a different vaccine was deployed from the one that was authorised.108 |
| 4.50. | However, any changes to the manufacturing process of the vaccines submitted for authorisation (produced by ‘process 1’) and those intended for deployment at scale (produced by ‘process 2’) were monitored by the Medicines and Healthcare products Regulatory Agency. Dame June Raine explained that the process 2 substance was required to be shown to be comparable through side-by-side comparability studies and heightened testing.109 In addition, the Medicines and Healthcare products Regulatory Agency conducted inspections of vaccine manufacturing sites to ensure that they complied with good manufacturing practices (ie the minimum standard that a medicines manufacturer must meet in its production processes) and that products were manufactured in accordance with the approved marketing authorisation.110 |
Routes to authorisation
| 4.51. | Before the UK left the European Union (EU) on 31 January 2020, it was subject to the EU medicines regulatory regime. From 1 January 2021, the Medicines and Healthcare products Regulatory Agency was able to grant its own authorisations. However, these applied to Great Britain only; Northern Ireland remained within the EU system.111 |
| 4.52. | Covid-19 vaccines and therapeutics could be authorised via a number of routes during the pandemic and following the UK’s exit from the EU. These were:
|
| 4.53. | In addition to the above processes, since April 2014, the UK has operated an early access to medicines scheme. This aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation, when there is a clear unmet medical need. The Medicines and Healthcare products Regulatory Agency is responsible for the scientific aspects of the scheme and will give a scientific opinion on the risk–benefit balance of the medicine.120 This scheme was used once during the pandemic – allowing patients to have early access to the antiviral medication remdesivir in May 2020.121 |
| 4.54. | In relation to regulation 174 specifically, Dame June Raine explained that amendments to the Human Medicines Regulations in October 2020 added conditions and safeguards that “precisely mirrored” those of a normal authorisation.122 When it came to the Covid-19 vaccines, for example, Dame June Raine said that the disapplication of the standard authorisation procedure via regulation 174 “had no impact” on the Medicines and Healthcare products Regulatory Agency’s “rigorous assessment” of the safety of the vaccines.123 Professor Evans agreed, noting that “there was no slippage in standards” in respect of efficacy or safety when it came to regulation 174 authorisation of the Covid-19 vaccines.124 In practice, there was no difference in substance between the UK’s authorisation process and that used in Europe or other countries.125 Professor Evans explained:
“The basic principles of assuring efficacy, safety and quality which apply to medicine regulation outside of a pandemic were applied to the authorisations of the Covid-19 vaccines.”126 |
| 4.55. | Regulation 174 enabled people across the four nations of the UK to have access to Covid-19 vaccines and therapeutics at the same time. In the future, the use of this temporary authorisation procedure will not be necessary to achieve the same effect. This is because the authorisation of medicines is addressed in the Windsor Framework, the agreement between the UK and the EU aimed at resolving issues related to trade and governance in Northern Ireland following the UK’s exit from the EU. It came into effect on 1 January 2025 and from this date novel medicines can only be authorised on a UK-wide basis.127 |
| 4.56. | Dame June Raine said that common to all the authorisation procedures set out above is “the continuous focus” on the evaluation of the robustness of the evidence presented on the safety, quality and effectiveness of the product. She said that this focus was “never compromised” during the Covid-19 pandemic.128 |
Rolling review
| 4.57. | The key innovation introduced by the Medicines and Healthcare products Regulatory Agency to meet the urgent demands of the pandemic was the ‘rolling review’ of authorisation application data from pharmaceutical companies. |
| 4.58. | Under normal circumstances, the Medicines and Healthcare products Regulatory Agency would ask companies to put together a finalised set of packages of information covering all the required types of evidence before submitting their marketing authorisation application. However, Dame June Raine explained that, during the pandemic, the agency received packages of application data from pharmaceutical companies on a rolling basis as and when they were ready, so that its review process could begin “as early as possible”, with the provision of further data packages as the review was ongoing.129 |
| 4.59. | Professor Evans observed that rolling review was the “key operational process” that led to a reduced time to obtain authorisation:
“[D]ata from the initial lab and clinical studies were submitted to regulators who assessed them as soon as they became available, rather than waiting for the full trial programme to be completed. This enabled the usual scrutiny of, say, the preclinical studies to be done well before the phase 3 trials were assessed.”130 |
| 4.60. | This significantly expedited the authorisation process. Outside of a public health emergency, it usually takes approximately 210 days from receipt of a final set of packages of data to determination of the application. However, using the rolling review procedure, the authorisation process was accelerated. For example, the Pfizer/BioNTech vaccine was authorised in only 58 days and the antivirals Paxlovid and molnupiravir in 37 days and 127 days, respectively.131 |
Figure 1: Vaccine development timelines
a) Traditional vaccine development timeline
b) SARS-CoV-2 accelerated vaccine development timeline
Source: INQ000485977_0016
| 4.61. | The expedited rolling review process involved the same level of scrutiny as a traditional sequential approach.132 It did not impact on the rigour of the scrutiny applied by the Medicines and Healthcare products Regulatory Agency or the degree of safety assessment it conducted. Indeed, Dame June Raine explained that it may actually have increased that rigour, as the regulator was receiving so much information from the vaccine companies so frequently.133 Professors Prieto-Alhambra and Evans agreed.134 Professor Evans said:
“[T]here was no reduction in the clinical studies, or in the scrutiny … It was simply that the ‘rolling’ production of information and data … meant that it could carry out its scrutiny in a more efficient manner, without having to wait until it had received the totality of all the data before commencing its review.”135 |
| 4.62. | Dame June Raine explained that rolling reviews are “more challenging” and “require a greater level of resources than standard procedure”.136 For example, they often involve “significant duplication of work” for assessors, partly because the same datasets may need to be reviewed on multiple occasions as new data packages are received. Furthermore, during the pandemic, additional project management was needed to support more frequent interactions with manufacturers. It is therefore the Medicines and Healthcare products Regulatory Agency’s position that rolling reviews should be used in cases of high public health need or during pandemics.137 The Inquiry agrees – while not practicable under normal circumstances, a rolling review process should be adopted in the event of a future pandemic. |
Setting the stage for mass vaccination and life-saving treatment
| 4.63. | The Inquiry heard positive evidence about how effective the Medicines and Healthcare products Regulatory Agency was during the pandemic. Professor Whitty said that the agency had a “difficult technical job”, which it conducted “in an exemplary and rapid fashion”.138 |
| 4.64. | Dame Kate Bingham (Chair of the Vaccine Taskforce from May to December 2020) said that Dame June Raine had “pioneered a new ‘close partnership’ approach” between the regulator and the vaccine companies to “accelerate the ordinary timetable” for authorisation.139 Eddie Gray (Chair of the Antivirals Taskforce from May 2021 to April 2022) considered that the emergency management of the agency’s processes to respond to a pandemic situation was “extremely impressive”.140 |
| 4.65. | This view accorded with voices from the pharmaceutical industry. Dr Justin Green (Global Product Lead for the Oxford/AstraZeneca vaccine) said that AstraZeneca’s relationship with the Medicines and Healthcare products Regulatory Agency throughout the authorisation process was “professional, robust and collaborative”.141 Ben Osborn (President of the International Commercial Office at Pfizer) explained that the agency’s use of rolling review procedures was “highly efficient” and allowed regulatory assessment of the Pfizer/BioNTech vaccine to be “accelerated”.142 In the context of the antiviral Paxlovid, Susan Rienow (former Pfizer UK Managing Director and Country President) referred to the agency’s rolling review as an “innovative procedure”.143 |
| 4.66. | The processes the Medicines and Healthcare products Regulatory Agency adopted led to the UK being the first country in the world to authorise the new Covid-19 treatment molnupiravir and the first Western country to authorise Covid-19 vaccines before the end of 2020 – the Pfizer/BioNTech and Oxford/AstraZeneca vaccines.144 Authorisation of the Moderna vaccine followed in the first few weeks of 2021.145 This set the stage for the mass vaccination rollout considered in Chapter 5: Delivery. |
| 4.67. | The innovation and partnership working achieved by the Medicines and Healthcare products Regulatory Agency and the Commission on Human Medicines during the crisis context of the pandemic must not be allowed to roll back. There will be another pandemic. |
- INQ000474707_0018 para 2.35
- INQ000474337_0033-0034 para 101
- INQ000474337_0007-0008, 0038 paras 12-13, 120
- INQ000474337_0029 para 84a
- INQ000474337_0030 para 88
- INQ000474337_0030 para 87
- INQ000474337_0030 para 8
- June Raine 22 January 2025 117/20-118/2
- INQ000474337_0007 para 11
- INQ000071886
- INQ000474401_0027 para 6.27
- INQ000474337_0014 para 31. The relevant health ministers are the Secretary of State for Health and Social Care in the UK government (for England, Scotland and Wales) and the Minister for Health, Social Services and Public Safety in Northern Ireland.
- June Raine 22 January 2025 118/11-22; INQ000474337_0015 para 35. The role of ‘licensing minister’ was held by a number of individuals during the pandemic (INQ000474337_0015 para 34).
- June Raine 22 January 2025 118/18-22
- INQ000474434_0010-0011 para 27
- INQ000474337_0015 para 35
- INQ000474337_0054 para 175
- June Raine 22 January 2025 123/20-124/15
- INQ000474337_0024 para 67
- INQ000474337_0023 para 63
- INQ000474336_0003-0004 para 11
- INQ000474336_0013-0023 paras 30-35; INQ000474337_0017-0018 paras 43-44
- INQ000474336_0006 para 21
- INQ000474336_0007 para 23
- INQ000474336_0007 para 23
- INQ000474336_0007-0008 para 24
- INQ000474337_0007 para 13
- June Raine 22 January 2025 117/5-15
- INQ000474337_0038 para 119
- June Raine 22 January 2025 128/8-129/1
- INQ000474337_0034 para 103
- INQ000474707_0010-0011 para 2.12
- INQ000474337_0034 para 104
- INQ000474337_0038 para 120; Stephen Evans 22 January 2025 23/20-24
- INQ000474337_0007-0008, 0038 paras 13, 120
- June Raine 22 January 2025 136/12-137/18; see also Daniel Prieto-Alhambra 22 January 2025 84/12-22
- INQ000474743_0067 para 6.2
- INQ000474337_0033-0034 para 101
- INQ000474337_0037 para 115
- INQ000474337_0039 para 122
- INQ000474337_0039 para 122
- INQ000474337_0039 para 123; June Raine 22 January 2025 137/19-138/6
- INQ000474337_0034-0035 para 105
- INQ000474707_0011 para 2.13
- INQ000474337_0044 para 143
- INQ000474337_0060 para 199
- INQ000474337_0044-0045 para 143
- INQ000474337_0045 para 144
- INQ000474337_0044-0045 para 143
- INQ000474707_0016 para 2.28; Stephen Evans 22 January 2025 14/13-16/1; INQ000474337_0044 para 143
- INQ000474707_0075 para 7.2
- June Raine 22 January 2025 149/10-20; Daniel Prieto-Alhambra 22 January 2025 42/2-21; INQ000474404_0026-0027 para 2.43; INQ000474337_0168 para 599
- INQ000474337_0066 para 222; June Raine 22 January 2025 149/21-150/5; INQ000474707_0031-0032 paras 3.16-3.17
- INQ000400208_0025-0027 paras 22.1.6, 22.1.12; INQ000474337_0169 para 601
- INQ000474707_0032 para 3.17. The post-authorisation regulatory response to transverse myelitis is addressed in Chapter 7: Post-authorisation safety and surveillance systems.
- INQ000474337_0060, 0066 paras 199, 224
- INQ000474743_0035 para 5.13
- Munir Pirmohamed 29 January 2025 175/11-178/6; INQ000474336_0029-031 paras 49-56; INQ000409486_0001, 0015-0017; INQ000474743_0057 para 5.59
- Munir Pirmohamed 29 January 2025 178/7-11, 178/18-179/21; INQ000474336_0030-0031 paras 51, 56-57
- INQ000474707_0013 para 2.21. Most adverse reactions to vaccines occur soon after vaccination, usually within 2 to 3 weeks (INQ000474707_0012 para 2.17).
- INQ000474707_0013 para 2.21
- Stephen Evans 22 January 2025 27/16-25
- INQ000474707_0014 para 2.22. Rare adverse effects are those affecting 1 in 1,000 to 1 in 10,000 people; very rare adverse effects are those affecting fewer than 1 in 10,000 people (INQ000474703_0031 para 5.2).
- Ben Osborn 23 January 2025 128/1-10; Justin Green 23 January 2025 161/16-162/12; Darius Hughes 27 January 2025 4/3-21
- June Raine 22 January 2025 143/13-23; INQ000474336_0058 paras 139-140; INQ000474707_0050-0051 paras 6.1.2-6.1.3
- Stephen Evans 22 January 2025 13/9-14/7
- INQ000474707_0050-0051 para 6.1.2
- June Raine 22 January 2025 150/25-151/8
- Although often used interchangeably, ‘efficacy’ refers to a drug’s effect in a controlled research setting where its correct dosing and administration can be assured, and ‘effectiveness’ refers to how a prescribed medicine or vaccine performs in routine use (INQ000474743_0010 footnote 3).
- INQ000474337_0264-0267; INQ000474336_0040 paras 74-76
- INQ000474703_0016 para 4.3
- INQ000474703_0017 para 4.8; ‘Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine’, FP Polack, SJ Thomas, N Kitchin, J Absalom, A Gurtman, S Lockhart et al, The New England Journal of Medicine (2020), 383(27), 2603-2615, p2603 (https://www.doi.org/10.1056/NEJMoa2034577; INQ000408420)
- INQ000474703_0016 para 4.5; ‘Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: An interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK’, M Voysey, SAC Clemens, SA Madhi, LY Weckx, PM Folegatti, PK Aley et al, The Lancet (2020), 397(10269), p1 (https://www.doi.org/10.1016/S0140-6736(20)32661-1; INQ000153551)
- INQ000474703_0016 para 4.9; ‘Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine’, LR Baden, HM El Sahly, B Essink, K Kotloff, S Frey, R Novak et al, The New England Journal of Medicine (2020), 384(5), 403-416, p403 (https://www.doi.org/10.1056/NEJMoa2035389; INQ000408427)
- INQ000474336_0042-0043 para 83
- INQ000474337_0062-0063, 0067-0068, 0070-0071 paras 207-210, 227-231, 241-243
- INQ000474336_0045 para 97; ‘Interim findings from first-dose mass COVID-19 vaccination roll-out and COVID-19 hospital admissions in Scotland: A national prospective cohort study’, E Vasileiou, CR Simpon, T Shi, S Kerr, U Agrawal, A Akbari et al, The Lancet (2021), 397(10285), 1646-1657, p1646 (https://www.doi.org/10.1016/S0140-6736(21)00677-2; INQ000147546)
- INQ000474336_0044 para 89; ‘Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on Covid-19 related symptoms, hospital admissions, and mortality in older adults in England: Test negative case-control study’, J Lopez Bernal, N Andrews, C Gower, C Robertson, J Stowe, E Tessier et al, British Medical Journal (2021), 373(1088), p1 (https://www.doi.org/10.1136/bmj.n1088; INQ000408421)
- INQ000474336_0046 para 102; ‘Real-world effectiveness of COVID-19 vaccines: A literature review and meta-analysis’, C Zheng, W Shao, X Chen, B Zhang, G Wang and W Zhang, International Journal of Infectious Diseases (2022), 114, 252-260, p254 (https://www.doi.org/10.1016/j.ijid.2021.11.009; INQ000408377)
- Daniel Prieto-Alhambra 22 January 2025 84/23-86/25; INQ000474703_0016-0019 paras 4.1-4.18
- INQ000474703_0016 paras 4.2-4.3
- INQ000474703_0017-0018, 0023-0024 paras 4.12-4.16, 4.36-4.39; see also ‘Real-world effectiveness of COVID-19 vaccines: A literature review and meta-analysis’, C Zheng, W Shao, X Chen, B Zhang, G Wang and W Zhang, International Journal of Infectious Diseases (2022), 114, 252-260, p254 (https://www.doi.org/10.1016/j.ijid.2021.11.009; INQ000408377); ‘Assessing COVID-19 vaccine uptake and effectiveness through the North West London Vaccination Program: Retrospective cohort study’, B Glampson, J Brittain, A Kaura, A Mulla, L Mercuri, SJ Brett et al, JMIR Public Health and Surveillance (2021), 7(9), e300100 (https://www.doi.org/10.2196/30010; INQ000056469); ‘Pfizer-BioNTech and Oxford AstraZeneca COVID-19 vaccine effectiveness and immune response amongst individuals in clinical risk groups’, HJ Whitaker, RSM Tsang, R Byford, NJ Andrews, J Sherlock, PS Pillai et al, Journal of Infection (2022), 84(5), 675-683 (https://www.doi.org/10.1016/j.jinf.2021.12.044; INQ000660032)
- INQ000474703_0026-0029 paras 4.47-4.59
- INQ000474703_0023-0024 paras 4.36-4.39
- INQ000474703_0024 para 4.38; ‘Estimated number of lives directly saved by COVID-19 vaccination programmes in the WHO European Region from December, 2020, to March, 2023: A retrospective surveillance study’, MMI Meslé, J Brown, P Mook, MA Katz, J Hagan, R Pastore et al, The Lancet Respiratory Medicine (2024) 12(9), 714-727 (corrected 23 June 2025) (https://www.doi.org/10.1016/S2213-2600(24)00179-6; INQ000660020). Wales and Northern Ireland were not included in the study.
- INQ000474703_0024 para 4.39; Daniel Prieto-Alhambra 22 January 2025 76/23-25
- INQ000474743_0017 para 3.15; INQ000474337_0046 para 146
- INQ000474337_0045-0046 para 146. However, Professor Prieto-Alhambra noted that the Oxford/AstraZeneca trials included low numbers of elderly people (INQ000474703_0020 para 4.23).
- INQ000474703_0020 para 4.26; INQ000474707_0054, 0056-0057 paras 6.7, 6.11-6.14; INQ000485977_0037 para 107; INQ000474337_0046 para 147. Later trials were conducted specifically for children; see Daniel Prieto-Alhambra 22 January 2025 86/19-25.
- INQ000474337_0046 para 149. This is addressed in Chapter 7: Post-authorisation safety and surveillance systems.
- INQ000474703_0018 para 4.17
- Daniel Prieto-Alhambra 22 January 2025 106/13-25; INQ000474703_0066-0068 paras 5.174-5.181
- INQ000474703_0018 para 4.15
- INQ000474707_0056 para 6.13
- INQ000474703_0018 para 4.15
- INQ000474337_0238 para 853
- INQ000474337_0238 para 853
- INQ000474337_0045-0046 para 146
- June Raine 22 January 2025 144/4-145/1
- INQ000474707_0055 para 6.10
- Ruth O’Rafferty 15 January 2025 136/10-137/3
- Ben Osborn 23 January 2025 123/17-124/4; INQ000474401_0025 paras 6.17; INQ000474537_0009 para 22
- Stephen Evans 22 January 2025 68/24-69/8; Daniel Prieto-Alhambra 22 January 2025 83/22-84/2
- INQ000474315_0013 paras 52-53
- INQ000474337_0042 para 135
- June Raine 22 January 2025 162/17-163/7
- INQ000474337_0035 para 106
- Ruth O’Rafferty 15 January 2025 135/13-20
- INQ000474337_0035 para 106; see also INQ000485977_0015 para 49; INQ000474537_0017-0018 footnote 30; INQ000474453_0011 para 49
- INQ000474337_0050-0051 para 163
- INQ000474337_0035 para 108
- INQ000474337_0036 para 110
- INQ000474337_0036 paras 110-112
- INQ000474337_0078 para 277
- INQ000474337_0072 para 248
- INQ000474337_0077 para 272
- INQ000474337_0047 paras 151-152
- INQ000474337_0031 para 92
- INQ000474337_0063, 0068, 0071, 0264-0265 paras 210, 231, 242-243
- INQ000474337_0038 para 118
- INQ000474337_0074 para 259
- INQ000474337_0047-0048 paras 153-154
- INQ000474337_0047-0048 para 154
- INQ000474707_0059 para 6.17
- Stephen Evans 22 January 2025 36/24-37/7, 38/6-16
- INQ000474707_0075 para 7.1
- INQ000474337_0048 para 156
- INQ000474337_0037 para 115
- INQ000474337_0048-0049 para 157
- INQ000474707_0028 para 3.5
- INQ000474337_0049 para 158
- INQ000474707_0028, 0050-0052, 0075 paras 3.5, 6.1-6.1.5, 7.2
- June Raine 22 January 2025 146/1-15
- Stephen Evans 22 January 2025 39/7-40/17; Daniel Prieto-Alhambra 22 January 2025 40/18-41/10
- INQ000474707_0028 para 3.5
- INQ000474337_0052 para 168
- INQ000474337_0052 para 168
- INQ000474401_0027 para 6.27
- INQ000474406_0055 para 45.1
- INQ000474342_0029 para 79
- INQ000474537_0019 para 46
- INQ000485977_0017 para 56
- INQ000485978_0005 para 20
- ‘First oral antiviral for COVID-19, Lagevrio (molnupiravir), approved by MHRA’, Medicines and Healthcare products Regulatory Agency, 4 November 2021 (https://www.gov.uk/government/news/first-oral-antiviral-for-covid-19-lagevrio-molnupiravir-approved-by-mhra; INQ000257098); INQ000474337_0063, 0068 paras 210, 231; INQ000474250_0008-0009 para 28; INQ000474703_0029-0030 para 4.61
- INQ000474337_0071 para 243
Chapter 5: Delivery
Introduction
| 5.1. | Thanks to those who planned it, and the extraordinary efforts of people across the UK who delivered it, the delivery programme for vaccines was a huge achievement. |
| 5.2. | The Covid-19 vaccination programme started on 8 December 2020 in each of the four nations of the UK. Phase 1 of the programme aimed to vaccinate the highest priority groups – which included residents in care homes, health and social care workers, the clinically extremely vulnerable and a series of groups categorised by age. It covered approximately 32 million people across the UK.1 These priority groups were estimated to represent 99% of preventable mortality from Covid-19 – ie 99% of people whose deaths could be avoided through vaccination.2 |
| 5.3. | In all four nations of the UK, vaccination of people in the Phase 2 cohort began by mid-April 2021.3 This phase was also age based, starting with those aged 40 to 49 years and moving down younger age groups in sequence.4 |
| 5.4. | By July 2021, 86.8% of the adult population in England, 89% in Scotland, 90.1% in Wales and 81.6% in Northern Ireland had received at least one vaccination dose, which offered significant protection against the severe effects of Covid-19.5 By August 2021, 72% of adults aged 18 and over had received two doses of the vaccine in England, Scotland and Northern Ireland; 81% of people aged 16 and over in Wales were fully vaccinated by 7 August.6 About 132 million Covid-19 vaccinations had been given across the four nations of the UK by the end of 2021, making it the largest vaccination programme in UK history.7 |
| 5.5. | Analysis of data from the World Health Organization estimated that, by March 2023, the lives of about 475,000 people aged 25 years or older had been saved as a result of Covid-19 vaccinations in England and Scotland.8 In Wales, the number of lives saved was estimated to be about 7,000 by June 2022.9 |
| 5.6. | However, the system was not perfect. It depended on placing groups of people into cohorts to prioritise those deemed most at risk from Covid-19. Deciding eligibility for some cohorts – such as pregnant women, unpaid carers and children and young people – was far from straightforward. The vaccine offer was not taken up by everyone who was eligible because some people were hesitant about taking the vaccine; the disparities in uptake across the UK are explored in Chapter 6: Disparities in vaccine uptake. |
| 5.7. | In relation to therapeutics, initially available treatments were targeted at those in hospital. Once new drugs with the potential to be used in the community were available, access was limited to narrowly defined groups according to clinical vulnerability. There was some confusion as to who might be eligible for antivirals within the community, and the need to ensure access at the outset of infection also presented its own set of challenges. |
| 5.8. | It cannot be assumed that the next pandemic disease will be similar to Covid-19 or that a system of prioritisation based on clinical vulnerability will be the best way of delivering vaccines (assuming that any such vaccines are available). The logistical and storage requirements of a future vaccine, if available, may also be very different. If no vaccine is available, the pathogen may have to be fought exclusively with therapeutics. This chapter does not, therefore, attempt to define a model for prioritising and delivering vaccines and drugs that can be replicated in the next pandemic. Instead, it examines the systems and processes by which the four governments of the UK decided matters of eligibility and prioritisation and considers the overarching lessons that can be learned for next time. |
The Joint Committee on Vaccination and Immunisation
| 5.9. | The Joint Committee on Vaccination and Immunisation gives advice on whether a particular vaccine should be delivered and, if so, when and how it should be delivered.10 It devised the programme for the prioritisation of the delivery of the Covid-19 vaccines following a request from the Department of Health and Social Care in late April 2020.11 |
| 5.10. | In England, the Secretary of State for Health and Social Care is required to accept the advice of the committee so far as is practicable (although during the Covid-19 pandemic there was no strict obligation to do so).12 The committee also advises the Welsh Government, although there is no obligation for its advice to be accepted.13 It has no statutory role in Northern Ireland or Scotland.14 |
| 5.11. | The Joint Committee on Vaccination and Immunisation’s meeting minutes and advice were published online, making its decision-making open to the public.15 Government officials played no part in advice and attended only to observe meetings or provide information on request.16 Committee members could take no part in decisions where there was a conflict of interest.17 For example, Professor Wei Shen Lim (Consultant Respiratory Physician at Nottingham University Hospitals NHS Trust and Honorary Professor of Respiratory Medicine for the University of Nottingham) became Chair of the Covid-19 sub-committee because the existing Chair, Professor Sir Andrew Pollard (Professor of Infection and Immunity at the University of Oxford), was leading on clinical development of the Oxford/AstraZeneca Covid-19 vaccine and recused himself.18 The transparent and non-political decision-making of the Joint Committee on Vaccination and Immunisation resulted in advice free from political or commercial influence – or the appearance of such influence – which might have otherwise undermined trust in the fairness or objectivity of its decision-making. |
| 5.12. | By 6 May 2020, a Covid-19 main committee had been formed. Its first interim advice about priority groups was delivered by 18 June 2020, before any vaccine had been authorised – enabling governments to better prepare for deployment.19 |
| 5.13. | The Covid-19 committee Chair, Professor Lim, was a member of the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG), advising the UK government on the Covid-19 threat from an early stage of the pandemic.20 This gave him up-to-date knowledge of the Covid-19 response from the outset but, as he told the Inquiry:
“[M]any other members … had not had similar opportunities to get to grips with newly emerging knowledge on COVID-19, including as yet unpublished material. Intense briefings to transfer a substantial amount of knowledge on the nature of COVID-19, including the epidemiology, risk factors for poor outcomes and observed inequalities, were required to ready the JCVI [Joint Committee on Vaccination and Immunisation] COVID-19 committee to respond optimally to the needs of the Government and the public.”21 In a future pandemic, the Joint Committee on Vaccination and Immunisation may not be able to appoint a Chair already familiar with the data behind the virus response. The Inquiry agrees with Professor Lim’s suggestion that, as soon as the threat of a pandemic becomes high, the committee should start considering the pandemic response.22 |
| 5.14. | The expertise of the Joint Committee on Vaccination and Immunisation will be an important resource in any future pandemic. Its members are selected for their expertise across a range of areas, including infectious diseases, epidemiology, virology and public health, with specialisms in different types of disease.23 The unknown nature of ‘Disease X’ (an infectious disease that is currently not known to infect humans but could cause a serious epidemic or pandemic) requires the committee to retain a wide pool of experts from which to establish an expert sub-committee or to review an existing group quickly. |
| 5.15. | The committee benefited from its readiness to draw on external expertise in vaccinology, immunology and ethics. It invited external experts to make presentations on emerging issues in vaccine deployment, such as vaccination programme delivery and public acceptability.24 This engagement enabled the committee to have as full and accurate a picture as possible about the vaccines as the pandemic progressed, as well as to advise health departments on who was eligible to receive vaccines and the order in which they received them.25 |
Setting the principles for prioritisation of vaccines
| 5.16. | The guiding principles for the advice on prioritisation were the prevention of deaths from Covid-19 and the maintenance of the health and social care systems.26 |
| 5.17. | The Joint Committee on Vaccination and Immunisation considered two strategic options: prioritising groups at high risk of serious illness and death from Covid-19 or prioritising economically active people who were likely to be younger and therefore less vulnerable but would be more likely to spread Covid-19.27 |
| 5.18. | A model targeting those most likely to spread the virus was not likely to be viable, because there was insufficient evidence that the Covid-19 vaccines would effectively block transmission. However, strong evidence emerged that the vaccines helped to prevent people from becoming severely ill if they contracted Covid-19.28 The committee therefore concluded that the direct protection of the vulnerable (those most at risk of death and serious illness from Covid-19) through vaccination would be the most effective strategy in preventing deaths.29 It indicated from its earliest interim advice in June 2020 that those at greatest risk of serious disease and death from Covid-19 were people aged over 50 and those with particular underlying medical conditions.30 As the risk of death from Covid-19 increased with age, prioritisation for vaccination was primarily based on age.31 |
| 5.19. | In December 2020, the Joint Committee on Vaccination and Immunisation published advice on prioritisation that would form the foundation of the vaccination programme.32 Prioritisation was broken down into two main phases. |
| 5.20. | In Phase 1 (from the first vaccines in December 2020), vaccination was offered to all those aged 50 and over, the clinically extremely vulnerable or those with underlying health conditions that put them at higher risk, their carers and front-line health and social care workers.33 |
Table 1: Vaccine priority groups – advice on 2 December 2020 (Phase 1)
| Priority cohort | People included in the cohort |
|---|---|
| 1. | Residents in care homes for older adults and their carers |
| 2. | All those aged 80 and over and front-line health and social care workers |
| 3. | All those aged 75 and over |
| 4. | All those aged 70 and over and all clinically extremely vulnerable people |
| 5. | All those aged 65 and over |
| 6. | All those aged 16 to 64 with underlying health conditions that put them at higher risk of serious disease and mortality |
| 7. | All those aged 60 and over |
| 8. | All those aged 55 and over |
| 9. | All those aged 50 and over |
Source: Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, p8 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__ COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638)
| 5.21. | In Phase 2 (which began by mid-April 2021 in each nation), vaccination was offered to all other people aged under 50.34 This was again age based, starting with the oldest adults aged 40 to 49 years first, then those aged 30 to 39 years and subsequently those aged 18 to 29 years.35 |
| 5.22. | The mainly age-based approach was simple and easily understandable for the public. It was also relatively straightforward for healthcare providers and central booking systems to identify people who fitted into each priority cohort by age and with reference to their medical records. As Professor Lim noted, more people were likely to take up the offer of the vaccine:
“if there is a simple-to-deliver message, because that enables understanding across a wide range of society. And that understanding then promotes confidence, and therefore vaccine uptake.”36 |
| 5.23. | This prioritisation order was followed in each of the four nations of the UK in respect of key dates and prioritisation groups, with some operational variations to meet the needs of each nation’s geography and population type.37 |
| 5.24. | In Scotland, a policy panel group (which included clinical, policy and operational experts, and was established in March 2021) advised the Scottish Government on the implementation of prioritisation advice and on areas not explicitly covered by Joint Committee on Vaccination and Immunisation advice – for example, prioritisation of foster carers, hospital patients and people resident in mental health wards.38 Advice from the panel led, for example, to Scotland vaccinating all unvaccinated groups of prisoners in Phase 2 from the summer of 2021 regardless of whether their age group had been reached in the Scotland-wide vaccination programme, given the slightly higher mortality and morbidity rate among prisoners and the advantages of reducing transmission in a prison setting.39 Another example of flexibility in Scotland was the decision to extend the definition of an ‘unpaid carer’ for the purposes of vaccination to align with its own legal definition.40 |
| 5.25. | In Wales, ministers also accepted all advice from the Joint Committee on Vaccination and Immunisation, but a Vaccine Clinical and Prioritisation Group was formed to advise on the interpretation and implementation of advice.41 Examples of flexibility in the application of the Joint Committee’s advice in Wales included widening the definition of unpaid carers included in priority group 6 and allowing more than one carer per cared-for person to be vaccinated in this cohort where they held joint caring roles.42 |
| 5.26. | In Northern Ireland, ministers similarly followed the Joint Committee on Vaccination and Immunisation’s advice during the pandemic.43 There were some minor deviations from the timing of delivery where to do otherwise would waste resources. For example, delivery of vaccinations to care homes retained a shorter dosage interval timetable even when the committee changed its advice on this at the end of December 2021, to avoid planned second doses to care homes being wasted.44 |
Consideration of occupation-based prioritisation
| 5.27. | Research conducted by Public Health England provided to the Joint Committee on Vaccination and Immunisation in October 2020 concluded that healthcare workers were at the highest risk of infection during the pandemic.45 There were clusters of other workers identified as being at high risk of infection, for example food-processing workers, and a higher risk of death in some occupations, including taxi drivers and security guards. However, across all occupation groups, the greatest indicator of mortality from Covid-19 was being in the over-50 age group.46 |
| 5.28. | Front-line health and social care workers were prioritised in Phase 1 for vaccination on the basis that they were at high risk of acquiring infection or transmitting infection to patients.47 The Joint Committee on Vaccination and Immunisation recognised the absence of clear evidence on the effects of vaccination on transmission but reasoned that even a small reduction in transmission would reduce the risk for very vulnerable patients, particularly in adult care homes.48 The decision was also justified by the need to protect the health systems in all four nations by keeping staff in the workforce.49 |
| 5.29. | The committee considered whether to depart from the simple age and clinical vulnerability-based system to prioritise people who worked in non-healthcare professions likely to be exposed to Covid-19. A number of groups representing occupations such as teachers and police officers called for priority vaccination because of their higher risk of exposure.50 The committee concluded that prioritisation of occupations beyond health and social care was not justified because people in these occupations who fell into a clinically vulnerable group (including all those aged over 50) would already be eligible for priority vaccination in Phase 1.51 |
| 5.30. | In Scotland, it was acknowledged that many occupations would consider themselves to be at increased risk and seek to be prioritised and that, if a policy decision was made to follow the Joint Committee’s advice, the Scottish Government would need to be consistent in this approach as the delivery programme progressed. Ministers were advised to follow the final Joint Committee recommendation and that there was a “strong desire” and a “sensible case” for all four governments to adopt a united approach.52 The advice was accepted by the Scottish Cabinet on 1 December 2020.53 |
| 5.31. | Following a request for input by the UK government in January and February 2021 about subsequent amendment to the order of prioritisation, the Office of the Chief Medical Officer advised that including additional occupations in the priority list would slow down vaccine deployment and it would be difficult to implement without opening up priority vaccination to an unworkable number of professions. Crucially, given the shortage of supply and deployment capacity at the beginning of the vaccine rollout, every low-risk person prioritised would mean that a high-risk individual was not vaccinated.54 In light of this advice, the UK government did not seek any reconsideration of the Phase 1 priority order by the Joint Committee on Vaccination and Immunisation.55 |
| 5.32. | At the request of the UK government, the Joint Committee on Vaccination and Immunisation reconsidered the issue of occupation and mortality when forming its Phase 2 advice. It issued interim advice in February 2021 and final advice in April 2021, in which it did not recommend additional prioritisation for particular occupations.56 The committee relied on modelling that suggested that rapid vaccine deployment was the best way to protect the public against severe outcomes from Covid-19. A mass vaccination strategy targeting specific occupational groups would have been complex to devise and deliver. The advice reasoned that introducing additional prioritisation by occupation group would slow down vaccine delivery to the population as a whole, leaving some unvaccinated for longer. It concluded that the priority order for vaccination should be age based for adults under 50.57 |
| 5.33. | This advice was followed by the UK government and devolved administrations.58 The UK government also took into account the views of the Moral and Ethical Advisory Group, a committee of experts in law and bioethics and members of faith and community organisations appointed to provide independent advice to the UK government on moral, ethical and faith issues in health and social care.59 It advised that prioritising by age was ethical and that the wider potential harm caused by delaying the vaccination programme to introduce occupation-based prioritisation should on balance be avoided.60 |
| 5.34. | The decision not to prioritise workers outside health and social care was properly considered by the Joint Committee on Vaccination and Immunisation and it was reasonable for the UK government and devolved administrations to follow its advice. |
| 5.35. | The Inquiry acknowledges that people in public-facing jobs, who made significant personal sacrifices during the Covid-19 pandemic, were concerned at their exposure to the virus. Analysis by the Office for National Statistics, conducted in May 2025, further highlighted that mortality rates varied between occupations and that this may in part have been due to the characteristics of people working in particular types of occupations, such as their income level. Those living in deprived areas were more likely to catch and become very unwell with Covid-19.61 |
| 5.36. | However, key worker occupations potentially represented 33% of the total workforce across the UK.62 It would have been difficult to identify effectively those most at risk from occupational exposure, and the task of categorising these groups according to risk of mortality or exposure to Covid-19 would have been significant. The implementation of such categorisation would have complicated the rollout process and diverted vaccines from those at greatest risk. |
| 5.37. | The approach to prioritisation was properly and sensibly based on the clear rationale of vaccinating the most clinically vulnerable – and those caring for them – as quickly as possible. |
Allocation of vaccines to the four nations
| 5.38. | Matt Hancock MP, Secretary of State for Health and Social Care from July 2018 to June 2021, met with ministers of the devolved administrations on 5 November 2020 to decide on the approach to allocation of vaccines between the four nations.63 It was suggested that the Barnett formula – which allocates finances to the Scottish Government, Welsh Government and Northern Ireland Executive according to population – would be used to divide up the available supply of vaccines according to the percentage of the UK population in each nation.64 The Cabinet Secretary for Health and Sport in the Scottish Government questioned whether the Barnett formula would work for a population cohort, but was keen to ensure that all four nations followed the same process. Mr Hancock informed ministers that other options had been reviewed and the differences in outcome were small.65 The decision was made, without any record of disagreement from any of the devolved administrations, to allocate vaccine supply between the four nations using the Barnett formula.66 |
| 5.39. | Professor Dr Gillian Richardson, Senior Responsible Owner for the Covid-19 vaccination programme in the Welsh Government from June 2020 to April 2021 (leading vaccine deployment in Wales), told the Inquiry that this had not been the best system of allocation to use. Wales had an older population and therefore a greater percentage of people in the higher priority cohorts. She suggested that the formula should have been adjusted to take into account differences in age and clinical vulnerability within each population, to prevent countries with a higher percentage in the first priority cohorts running out of vaccines before completing vaccination of a cohort.67 In November 2020, it was estimated that Wales would be entitled to 4.94% of the UK supply of vaccines by population share, but if the proportion of over-50s in the population in Wales was factored in, it would be entitled to about 5.13% of vaccines.68 The Inquiry heard that, in fact, the Welsh Government did not run out of vaccines and was, on occasion, provided with extra doses that were close to expiry by the UK government.69 |
| 5.40. | The leaders of the Covid-19 vaccination programmes in Scotland and Northern Ireland did not identify significant difficulties with the application of the Barnett formula.70 Derek Grieve (Senior Responsible Officer for the Covid-19 vaccination programme in Scotland, leading vaccine deployment in Scotland from June 2020 to November 2022) recognised that, with further time, a more complex model might have better represented the difference in population. He felt that deployment was not slowed down because of the way vaccines were allocated:
“It’s probably important to say that it would have been a problem if BEIS [the Department for Business, Energy and Industrial Strategy] and the UK Government had only secured enough vaccine for the total population, but they didn’t. They secured more vaccine than we needed.”71 |
| 5.41. | The advantage of the Barnett formula was its simplicity, at a time when the UK government and devolved administrations needed to make quick decisions about the allocation and transportation of vaccines. While more complex models might have more accurately reflected the age and health populations of each of the four nations, the differences between populations were not so pronounced that the use of the Barnett formula led to shortfalls or to delays in the allocation of vaccines. |
Variations in the approach to vaccine eligibility and prioritisation
| 5.42. | The Joint Committee on Vaccination and Immunisation took longer to consider its advice on the use of vaccines for some groups where safety issues emerged or where further scientific data were needed. For example, the committee advised a pause on vaccination of those aged under 50 without clinical risk factors in response to concerns over thrombosis with thrombocytopenia syndrome.72 These safety issues are explored in detail in Chapter 7: Post-authorisation safety and surveillance systems. |
Children and young people
| 5.43. | The Joint Committee on Vaccination and Immunisation also took a cautious approach to the vaccination of children. |
| 5.44. | Covid-19 vaccines were not authorised by the Medicines and Healthcare products Regulatory Agency for use in children at the same time as the adult population.73 In July 2021, the Joint Committee on Vaccination and Immunisation noted uncertainties about the medium and long-term outcomes of Covid-19 vaccination for children in relation to any side effects, because there had not been time to amass sufficient data on risk (ie on rates of adverse events) globally.74 This was set against the relatively small benefit from vaccination for children, given that those aged under 18 were at low risk of serious outcomes from Covid-19.75 It was therefore less urgent to offer vaccination to protect their individual health. |
| 5.45. | The committee’s approach was that, once authorised by the Medicines and Healthcare products Regulatory Agency, the vaccination of children should only be advised if, on balance, it would benefit the child receiving the vaccination. It concluded that it would not be acceptable for children to be vaccinated on the basis of a benefit that was primarily to others (ie by preventing transmission to adults who could be directly protected by receiving vaccination).76 |
| 5.46. | The Joint Committee on Vaccination and Immunisation advised in July 2021 that, until more data on safety and effectiveness became available, there should not be routine vaccination of those aged under 18.77 Further advice followed on 4 August 2021 after a request from the Office of the Chief Medical Officer to accelerate the wider review of vaccination for children. The committee noted that older children were more likely to benefit from vaccination in comparison to younger children. It advised that those aged 16 to 17 should be offered a first dose of the Pfizer/BioNTech vaccine (which was the only vaccine authorised at that time for those aged under 18).78 |
| 5.47. | The vaccination of younger children was considered again on 2 September 2021, in response to updated data on the risks and benefits of the vaccine to this age group.79 The Joint Committee on Vaccination and Immunisation concluded that the clinical benefits of vaccination for children under 16 remained marginal and did not, by themselves, necessitate large-scale vaccination. However, it referred the issue to the Chief Medical Officers for the four nations for advice on the wider educational and public health benefits of vaccination.80 This was a departure from its usual process, but Professor Lim told the Inquiry that it was justified by the “very difficult … hugely fine balance” of clinical risk and benefit to children in comparison to adults.81 |
| 5.48. | The Chief Medical Officers considered wider issues relevant to public health – including access to education and interlinked mental health issues – and gathered evidence via the Department for Education in England. Their advice, published on 13 September 2021, concluded that education was one of the most important drivers of improved public health. Disrupted education had a “massive impact” and the negative impact was “especially great” in areas of relative deprivation. For all children:
“The effects of disrupted education, or uncertainty, on mental health are well recognised. There can be lifelong effects on health if extended disruption to education leads to reduced life chances.”82 Vaccination would likely help reduce surges of infection in schools and therefore reduce closures and educational disruption, although there was “marginal advantage at an individual level”.83 The Chief Medical Officers therefore recommended that ministers extend the offer of one dose of the Pfizer/BioNTech Covid-19 vaccine to all children and young people aged 12 to 15 not already covered by existing Joint Committee on Vaccination and Immunisation advice.84 The advice was followed by the UK government and devolved administrations and vaccinations were made available from 13 September 2021.85 |
| 5.49. | In January and February 2022, the vaccination of children aged 5 to 11 years was considered.86 Children in this group were at the very lowest risk from Covid-19.87 Vaccination would prevent a small number of hospitalisations and intensive care admissions. It would also give short-term protection against less severe infection. The extent of this protection was uncertain but the benefits of preventing hospital and intensive care admission would be enhanced in the event of a more severe outbreak in the future:
“The potential benefits from vaccination would apply mainly to a future wave of infection; the more severe a future wave, the greater the likely benefits from vaccination.”88 The Joint Committee advised that the health benefits, although lower than in other age groups, still outweighed the health risks. It recognised that the potential educational benefit was less certain than with 12 to 15 year olds.89 On 16 February 2022, the Joint Committee on Vaccination and Immunisation issued advice that an offer of a Pfizer/BioNTech vaccine should be made to children aged 5 to 11 years if they were not already vaccinated in a priority group. However, in light of the small margin of benefit, this offer should be non-urgent; the offer should not displace the delivery of other childhood vaccination programmes.90 |
| 5.50. | Sir Sajid Javid MP, Secretary of State for Health and Social Care from June 2021 to July 2022, told the Inquiry that he had been reluctant to offer vaccination to the 5 to 11-year age group because the decision was so finely balanced. He said the Joint Committee on Vaccination and Immunisation was of the view that the need to vaccinate this group might become more pressing at a later date, for example because of a more harmful variant, but it might then be too late to vaccinate the group.91 He also told the Inquiry that there was a “huge amount” of pressure from Boris Johnson MP (Prime Minister from July 2019 to September 2022) to vaccinate the group as quickly as possible.92 Ultimately, Sir Sajid Javid said that he was not unduly influenced by that pressure but accepted the advice as it came from the independent body tasked with assessing the evidence and because it was being framed as a “non-urgent offer” guided by parental choice.93 This approach, along with the timing of the advice, contributed to lower numbers of children than adults being vaccinated.94 |
| 5.51. | The Inquiry considers that the approach taken to the vaccination of children was justified. While vaccination was appropriate, given the risk of Covid-19 to children, the relatively low level of that risk did not require a faster or more prescriptive vaccination programme. Of course, in a future pandemic, the disease might pose a greater risk of severe outcomes for children and then a more urgent offer may be appropriate. |
People experiencing homelessness
| 5.52. | The Joint Committee on Vaccination and Immunisation recognised that some groups were taking up the vaccine offer in lower numbers. These disparities in uptake, considered in detail in Chapter 6: Disparities in vaccine uptake, prompted the committee to support “flexibility in delivery of the programme to ensure every opportunity is utilised” to offer vaccines to groups with lower uptake.95 It therefore advised the UK government on 1 March 2021 that it should consider allowing local vaccination teams to offer the vaccine to people of all ages experiencing homelessness at the same time as priority cohort 6, even if they were not diagnosed with a health condition that placed them at higher risk.96 The rationale was that many thousands of people were in emergency accommodation, providing:
“a unique opportunity to in-reach vaccination to a population that is otherwise often unable to access basic healthcare”.97 People experiencing homelessness were also more likely to have undiagnosed health conditions that would place them in priority cohort 6.98 |
| 5.53. | The issue of undiagnosed health conditions and poor health outcomes did not only apply to people experiencing homelessness. The association of social exclusion with the poorest health outcomes had been identified by Public Health England as affecting a number of groups, including vulnerable migrants and people in contact with the justice system.99 However, people experiencing homelessness were placed in temporary accommodation and could more readily access healthcare than at any other time. The advice that local vaccination teams should be able to offer vaccinations to people experiencing homelessness at the same time as priority cohort 6, if operationally appropriate, was therefore a reasonable decision that produced a clear public health benefit. |
Concerns about eligibility and prioritisation
Prioritisation of unpaid adult carers for vaccination
| 5.54. | People who care for adults as part of their employment work in a wide variety of settings, including care homes, hospitals and one-to-one assistance in people’s homes. Those working in care homes or providing other front-line health or social care were included in cohorts 1 and 2. However, the status of unpaid adult carers (eg those caring for a partner or adult family member) for priority vaccination was less clear. |
| 5.55. | Unpaid adult carers were not explicitly mentioned in the Joint Committee on Vaccination and Immunisation’s advice of 2 December 2020, but ‘adult carers’ were included in priority cohort 6 by a reference in the advice that led to a list of eligible conditions.100 This list was contained in the UK Health Security Agency’s Immunisation Against Infectious Disease (known as the ‘Green Book’, the handbook on vaccination for UK health professionals).101 Generally, these were medical conditions that would be included in patient records, such as chronic respiratory, heart, liver or kidney disease, diabetes, immunosuppression and morbid obesity. |
| 5.56. | On 30 December 2020, further advice was issued and adult carers were explicitly mentioned in cohort 6. In both instances, according to the Green Book, they were defined as:
“[t]hose who are in receipt of a carer’s allowance, or those who are the main carer of an elderly or disabled person whose welfare may be at risk if the carer falls ill”.102 On 12 February 2021, the definition of adult carers was changed to: “those who are eligible for a carer’s allowance, or those who are the sole or primary carer of an elderly or disabled person who is at increased risk of COVID-19 mortality and therefore clinically vulnerable”.103 |
| 5.57. | Dr Mary Ramsay, Director of Public Health Programmes at the UK Health Security Agency from October 2021 and Editor of the Green Book since 2006, told the Inquiry that the first definition had been in place for many years before the Covid-19 pandemic for use in influenza vaccinations, and needed to be sufficiently wide to allow for the four nations’ different methods of identifying carers. She explained that the change in definition resulted from a request from the NHS for greater clarity of the definition.104
In Northern Ireland, the definition from the Joint Committee on Vaccination and Immunisation’s advice of November and December 2020 was adopted and, by the time of delivery to priority cohort 6, was “the main carer of an elderly or disabled person, whose welfare may be at risk if you as carer fall ill”.106 In Scotland, the definition was broader – “those who provide or intend to provide care” – and was not limited to particular types of caring.107 |
| 5.58. | A register of unpaid adult carers was not held in any of the four nations. In England, there were a number of overlapping sources of data on the total number of unpaid carers, including individuals identified as carers in GP records, those eligible for Carer’s Allowance according to the Department for Work and Pensions, and those who had received a carer’s assessment through their local authority. In February 2021, the Office of the Chief Medical Officer estimated that about 1 million people could be identified through these sources but that the true number of adult unpaid carers who were not otherwise included in a priority cohort may be more like 2.3 million.108 Identifying and reaching people who were not in one of these officially recognised groups were therefore operationally challenging. |
| 5.59. | In Northern Ireland, the Department of Health concluded in mid-February 2021 that individuals in receipt of Carer’s Allowance or Carer’s Credit or registered as a care home care partner should be encouraged to book a vaccination. In light of the difficulties in clearly identifying this group, people were allowed to self-identify as carers with no requirement to provide proof.109 This option was initially available via the online booking system, but it was transferred to telephone booking systems because of concerns about large numbers of people booking as carers online in the first few days of the initiative.110 On 13 May 2021, it was agreed to discontinue this dedicated arrangement because the group should by then have received their vaccination.111 |
| 5.60. | Similar issues were encountered in Scotland, where there was considerable uncertainty about the number of unpaid carers. The Minister for Public Health advised that “with local data patchy and no universal means of verification of their role, this is a challenging group to reach”.112 |
| 5.61. | By mid-March 2021, England, Scotland and Wales had set up online systems allowing people to self-identify as unpaid carers.113 |
| 5.62. | Disability Rights UK, Disability Action Northern Ireland, Disability Wales and Inclusion Scotland told the Inquiry that differences in the definition of unpaid carers across the four nations and the changes to the definition in England between December 2020 and February 2021 caused confusion among disabled people and their carers about whether they were included in priority cohort 6.114 |
| 5.63. | Unpaid adult carers played an important role in caring for vulnerable people during the pandemic. In future vaccination programmes in which adult carers are prioritised, governments should agree on a consistent definition of an unpaid adult carer before delivery of vaccines begins. |
| 5.64. | The Inquiry encourages governments to work with groups representing disabled people and their carers when formulating prioritisation systems, to ensure that the language used is clear and unambiguous for these groups from the outset of vaccine rollout. The basis of inclusion in a priority group should also be set out accurately in published government advice about prioritisation. |
| 5.65. | The Inquiry also supports the development of a better system to identify unpaid carers, as called for by its expert witness on vaccine delivery and disparities in coverage, Dr Ben Kasstan-Dabush.115 A fuller record of unpaid carers would make it easier to support this group, including with the offer of vaccines or other medicine during the next pandemic. Governments should explore practical and reliable ways to do this, for instance through GP records or healthcare provider apps such as the NHS app (a digital tool that can be downloaded onto a mobile phone or other electronic device and used to access a range of NHS services in England and the Isle of Man).116 |
Prioritisation of people with learning disabilities for vaccination
| 5.66. | A Public Health England report published in November 2020 estimated that the Covid-19 death rate for people with learning disabilities was up to six times higher than in the general population.117 The Joint Committee on Vaccination and Immunisation’s advice in December 2020 therefore included people with learning disabilities in priority cohort 6, but only if they had a “severe and profound learning disability”.118 |
| 5.67. | The Joint Committee on Vaccination and Immunisation considered that the Public Health England higher rate of mortality risk was likely to be among people with “severe or profound” learning disabilities, rather than applying to all people with learning disabilities.119 If a learning disability was “mild or moderate”, that person did not fall into cohort 6 and (unless they had another condition that placed them in the cohort) would be vaccinated in accordance with their age group.120 |
| 5.68. | The categories ‘severe and profound’ and ‘mild or moderate’ learning disabilities were not always used in medical records across the UK, making it operationally challenging to issue invitations for vaccination to everyone in this group.121 A further issue was that some people with disabilities that might have been classified as severe or profound were not registered as such with their GP.122 |
| 5.69. | In England, most GPs used a list of codes to classify types of disability in medical records.123 In 2020, guidance on this coding system recommended the use of different descriptions of learning disability, but only some of the recommended codes included the terms severe, profound, mild and moderate.124 There was a further list of hundreds of specific conditions that GPs could reflect in medical records.125 It was recognised in the Welsh Government’s ‘Vaccination Clinical Advisory and Prioritisation Group (VCAP): Severe mental illness and learning disability guidance’ (February 2021) that there was no standardised or shared definition of these groups in medical records, meaning that it was difficult for coding systems to identify people who were included in cohort 6 for earlier vaccination.126 In Scotland, there was no learning disability register, making it particularly challenging to categorise patients in this way.127 |
| 5.70. | The categorisation of people with learning disabilities into different groups was also confusing for many disabled people and their carers.128 It led to some adult carers being invited for vaccination in cohort 6 before the person they cared for, if the cared-for person was not deemed to have ‘severe’ or ‘profound’ learning disabilities.129 |
| 5.71. | Professor Lim told the Inquiry that concerns were raised with the Joint Committee on Vaccination and Immunisation by NHS England about the coding of severity of learning disability on GP systems. He recognised that there were known to be gaps in data held by GPs on learning disability.130 |
| 5.72. | This required resolution through an amendment to the Joint Committee on Vaccination and Immunisation’s advice.131 On 23 February 2021, after a campaign by disabled people’s groups and the intervention of ministers, the committee altered its advice to invite all of those on the GP Learning Disability Register for vaccination in priority cohort 6, whatever the nature of their disability. The committee said that the change was made to achieve operational simplicity.132 In the following days, the Welsh and Scottish governments expanded the group to be included in cohort 6 to include all people with learning disabilities.133 |
| 5.73. | The general confusion and difficulties that arose might have been avoided if the Department of Health and Social Care and the Joint Committee on Vaccination and Immunisation had consulted with groups representing disabled people and their carers. In future, they should consult on the clarity of language and the workability of definitions within prioritisation guidance affecting disabled groups, before such advice is put into action. |
Access to therapeutics
| 5.74. | Unlike vaccines, which were used on a widespread basis, the use of therapeutics was more limited during the Covid-19 pandemic. |
| 5.75. | It was vital to provide access to treatments as quickly as possible. An initiative for rapid access to therapeutics introduced during the pandemic was the ‘research to access pathway for investigational drugs for COVID-19’ (RAPID C-19). As explained in Chapter 3: Securing supplies, RAPID C-19 assessed the clinical effectiveness of potential therapeutics and provided advice to England’s Chief Medical Officer and the Department of Health and Social Care. Where the decision was taken to provide access to a particular therapeutic, RAPID C-19 was responsible (largely through NHS England’s specialised commissioning) for preparing clinical policy for its use. Each of the four nations was involved in the process of developing clinical policy on the use of therapeutics.134 |
| 5.76. | RAPID C-19 enabled the production of clinical policy quicker than would have been the case outside of a pandemic, and in some cases was able to expedite this even further by working with those undertaking the clinical trials. For example, through its work with the RECOVERY trial team, RAPID C-19 was able to develop the access policy for dexamethasone so that it was ready to be used to treat patients on the same day the trial results were published.135 |
Systems and processes for determining eligibility
Confusion about eligibility for antivirals
| 5.77. | At the beginning of the Covid-19 pandemic, available treatments were focused on those experiencing serious symptoms in hospitals (often in intensive care). The use of such drugs was therefore based on clinical decisions relating to the severity of symptoms, for example blood oxygen levels.136 |
| 5.78. | Therapeutics with the potential to be used in the community – such as monoclonal antibodies (antibodies produced in a laboratory through a cell line of immune cells) and oral antivirals (medicines used to treat or prevent viral infections) – were identified later. It was therefore necessary to consider which high-risk groups might receive the most benefit from treatment in the community upon infection.137 |
| 5.79. | The question of which groups should be prioritised for monoclonal antibodies, both in hospital and community settings, was explored by NHS England in June 2021, following RAPID C-19’s recommendation that proposals for access to such treatment should be developed.138 |
| 5.80. | Eligibility decisions relating to those in the community were less straightforward than decisions relating to earlier treatments, and had an impact on the Therapeutics Taskforce’s decision-making in relation to securing supplies.139 Professor (later Sir) Jonathan Van-Tam, Deputy Chief Medical Officer for England from October 2017 to March 2022, therefore established the Covid-19 Neutralising Monoclonal Antibodies and Antivirals Access Independent Advisory Group in October 2021, comprising clinicians with expertise relevant to Covid-19. It was given the task of identifying those patient cohorts, in the community, that were deemed to be at the very highest risk of hospitalisation and death.140 Subsequently, the Therapeutics Clinical Review Panel was established by the Department of Health and Social Care in December 2021 to oversee and review the work of the advisory group.141 |
| 5.81. | In order to identify the most at-risk cohorts, the Covid-19 Neutralising Monoclonal Antibodies and Antivirals Access Independent Advisory Group evaluated the risk of poor outcome and considered which groups might be at most risk despite vaccination, as well as clinical capacity to benefit from a therapeutic agent.142 This was a substantial undertaking. Professor Sir Nicholas White, expert witness on therapeutics, referred to the Covid-19 Neutralising Monoclonal Antibodies and Antivirals Access Independent Advisory Group’s published report in May 2022 as a “comprehensive piece of work from a large team of eminent experts”.143 |
| 5.82. | The recommendations made by the Covid-19 Neutralising Monoclonal Antibodies and Antivirals Access Independent Advisory Group were accepted by the Chief Medical Officers for the four nations and directly informed eligibility for new therapeutics across all four nations.144 In addition, the Therapeutics Clinical Review Panel later commissioned modelling work to investigate other groups that had a risk of severe Covid-19 outcomes either equal to or higher than the risk to those groups previously identified.145 An updated advisory report was also produced and the panel closed in March 2023.146 |
| 5.83. | The Therapeutics Clinical Review Panel was a temporary solution, devised during an emergency, and the deployment of therapeutics within the community took place on a smaller scale than the vaccination programme. In the event of a future pandemic, more widespread use of therapeutics such as antivirals may be required at the outset – including as a preventative measure – particularly if there is no vaccine available. On that basis, in advance of the next pandemic, the Department of Health and Social Care should consider the most appropriate decision-making body on prioritisation for therapeutics. There is also merit in the suggestion made by Eddie Gray, Chair of the Antivirals Taskforce from May 2021 to April 2022, that those who are most vulnerable are identified as soon as a particular Disease X becomes high risk and, if possible, given antivirals at the outset. 147 |
Confusion about eligibility for antivirals
| 5.84. | Lara Wong, founder and leader of Clinically Vulnerable Families (a group that supports and campaigns for people who are clinically vulnerable, clinically extremely vulnerable or severely immunosuppressed, and those in their households, across all four nations), referred to the eligibility criteria for antivirals as “yet another list” of conditions, different from previous vaccine priority lists. She told the Inquiry that some of the group’s members were confused as to whether they were eligible for antiviral treatments. They assumed that being previously identified as clinically extremely vulnerable was sufficient to qualify for antiviral treatments.148 |
| 5.85. | Contributors to the Inquiry’s listening exercise, Every Story Matters, also expressed confusion about who was and was not eligible for treatment. Some understood themselves to be eligible based on information they had received from healthcare services and the Chief Medical Officer during the pandemic. However, when they contacted the healthcare services or spoke with test and trace services, they were told that they were not eligible for treatment. Those who experienced this felt angry and frustrated, but also scared about what might happen to them as their infection progressed. |
I felt very cross and disappointed when I learned that respiratory patients are not eligible for anti-viral medications. They were sent numerous letters telling them to shield yet were not considered ill enough to warrant anti-viral. All our friends were back to enjoying some sort of normality but still we were scared to mix much in fear of the effect Covid would have on a vulnerable person.”149
| 5.86. | In any future pandemic, messaging in relation to eligibility for therapeutics and antivirals and the extent to which this might differ from other criteria or lists should be clear and easily understandable. |
Delivery of vaccines
| 5.87. | On 8 December 2020, the UK government and devolved administrations began to deliver Covid-19 vaccines – the first to be given to patients anywhere in the world outside a clinical trial – just days after the first vaccines were approved.150 Each government operated a separate programme for delivery of vaccines, but all adopted a mixed model of delivery. The programmes started with hospital hubs and care homes but quickly expanded to GP delivery, mobile units, pharmacies, mass vaccination centres, smaller local clinics and pop-up centres, making up a network of delivery sites.151 |
Central control and local implementation
| 5.88. | Vaccine deployment was a devolved issue and the UK government and devolved administrations created their own structures and processes for vaccine delivery, although the timings of release to each cohort were coordinated and there were similarities in approach. |
| 5.89. | Each nation had a senior responsible officer or owner for Covid-19 vaccination. The four senior responsible officers had frequent and candid communication with each other to coordinate on delivery.152 The coordination of rollout between nations was an important part of ensuring public confidence – division between the nations on the timing of vaccination would have been confusing for the public. |
| 5.90. | In England, the UK government had to devise the largest and most geographically complex vaccine deployment programme of the four nations. Ordinarily, Public Health England was responsible for the supply and distribution of vaccines in routine vaccination programmes.153 However, NHS England took the main responsibility for planning the Covid-19 programme because it oversaw the nationwide network of staff and venues required to deliver a programme of this scale.154 |
| 5.91. | Implementation of the programme was undertaken mainly at regional level, involving work with local partners including primary care networks, integrated care systems and directors of public health in local authorities. The NHS in England was able to plan for delivery through tried and tested routes already in place for routine vaccination programmes. This meant it could quickly scale up deployment. For example, GP practices were experienced in fulfilling NHS England contracts for vaccination in routine immunisation programmes such as flu vaccination.155 |
| 5.92. | The structure of the NHS in England – a network of primary and secondary care providers – meant that models for the efficient and safe delivery of vaccines could be replicated across England. Training materials and guidance could be circulated and updated quickly through this network.156 Mass virtual meetings with those who were running vaccination centres allowed for streamlined transmission of information.157 Once established, the supply chain in England was able to deliver to 3,500 sites each week.158 Dame Emily Lawson (National Director for Covid Vaccine Deployment from November 2020 to July 2021 and vaccine Senior Responsible Officer) described it as akin to “building a medium sized supermarket chain and transporting gold”.159 |
| 5.93. | The programme was adapted to suit local needs, for example by setting up additional vaccination centres in neighbourhoods where uptake was lower.160 As the UK COVID-19 Vaccine Uptake Plan recognised, directors of public health (who were responsible for overseeing health in local authorities) and their teams had “deep experience of immunisation and screening programmes” that played “a critical role in understanding the whole population of an area”.161 NHS England worked with directors of public health to identify which communities in a particular area had lower uptake and were likely to need additional help to access vaccines.162 Local government representatives were also included on the programme’s Deployment Board and Equalities Advisory Board so they could have input into decision-making.163 |
| 5.94. | Scotland shared the principle applied in England of being “nationally led, but locally delivered”.164 Oversight of the delivery of the vaccination programme was the responsibility of the Scottish Government, NHS Scotland and Public Health Scotland. The Scottish Government set up a Covid-19 Vaccine Division in June 2020. This expanded to a directorate including all vaccination in February 2021. Territorial health and social care boards were responsible for implementing delivery, and representatives from each health board were involved in the decision-making process through membership of a programme delivery group.165 |
| 5.95. | The Welsh vaccine delivery programme similarly adopted the ethos of “national enabling, local delivery”.166 The Wales Covid-19 Vaccination Board was responsible for central oversight and included representation from the seven local health boards (which themselves included executive directors of public health) and special health authorities.167 The health boards were well placed to deliver vaccines through a variety of routes as they are formed of primary and community health services, secondary care and tertiary care. Implementation was somewhat less centralised than in England.168 |
| 5.96. | The Department of Health (Northern Ireland) established a Northern Ireland Covid-19 Vaccination Programme Oversight Board in July 2020. Vaccinations were principally delivered by the Department of Health, with oversight by the Northern Ireland Executive Committee.169 Initial delivery routes were via seven regional vaccination centres alongside GP practices, with one mass vaccination centre and hundreds of pharmacies later added to the programme.170 |
| 5.97. | The work of the military was an intrinsic part of the leadership of the vaccine delivery programme in all four nations. It was brought into the deployment programme to work with leadership teams and provide military planning assistance. It brought skills such as mapping and logistics tools to ensure that vaccination sites were appropriately located and accessible.171 The military’s role was described by Mr Grieve, for example, as “hugely supportive” and important.172 |
| 5.98. | In each of the four nations, the model of central control was effective in ensuring vaccine delivery in a fast and coordinated way, particularly in the early days of the pandemic. Implementation via the pre-existing networks of health providers in each nation – whether contained in a single national health service, health boards or trusts – meant that directions from the centre could be communicated efficiently, while allowing room for valuable local input.173 |
| 5.99. | However, the system of strong central control did not always work well for local providers in England, particularly in the first months of rollout. Regional health leaders characterised the vaccination programme as ‘top-down’, due to strong central oversight. They reported frustration over a lack of local control over issues such as appointment booking and supply management.174 Local health providers reported that they did not initially feel able to tailor delivery to the needs of their local community (eg through vaccine allocation and choice of delivery venues) in order to address local inequalities such as lower vaccine uptake among people from some ethnic minority groups.175 This central control had loosened by the end of Phase 1 in the spring of 2021, enabling greater flexibility and more tailored strategies to be put in place.176 |
Operational issues
| 5.100. | It is difficult to overstate the complexity and scale of the vaccination programme or the skill with which operational difficulties were overcome. |
Storage requirements
| 5.101 | The storage requirements of the Pfizer/BioNTech vaccine in the early stages presented particular challenges. The manufacturer’s advice in November 2020 was that the vaccine must be stored at -70 degrees Celsius. This required specialist refrigeration and there were limitations on how long it could be stored once defrosted and how many times it could be transported.177 Smaller delivery sites, such as GP practices, were recognised as being convenient for the public but they did not have suitable storage. There were, for example, only 23 freezers in Scotland capable of holding the vaccines at the required temperature (procured to assist with vaccine supply) and only 2 centres in Wales capable of such storage.178 Smaller sites could not guarantee that large quantities of vaccines could be administered within the storage limits, and unused vaccines would be wasted. In all four nations, delivery had to be initially planned through hospital hubs or clinics with the ability to store the vaccine.179 |
| 5.102. | In December 2020, changes in manufacturers’ storage advice meant that the vaccines could be repacked in smaller boxes and delivered to sites such as GP practices and care homes. This allowed governments to begin to plan for greater flexibility in storage and delivery.180 |
| 5.103. | The authorisation of the Oxford/AstraZeneca vaccine on 30 December 2020 further improved the efficiency of vaccine delivery. It had less stringent handling requirements; it could be stored in an ordinary refrigerator for up to six months.181 |
Care home residents
| 5.104. | Care home residents were in the first priority group for vaccination but the constraints on moving vaccines made it difficult to plan safe deployment to care homes in the first weeks of rollout. Movement of residents to hospitals for vaccination was not a safe or practical option.182 Only once the transport advice for Pfizer/BioNTech changed could the UK government and devolved administrations plan for mobile units to deliver vaccinations to care homes, with local care providers administering vaccines to residents and staff.183 |
| 5.105. | Northern Ireland was the first nation in the UK to deliver Pfizer/BioNTech vaccines in care homes via a hospital trust mobile team. Delivery in some care homes started on 8 December 2020, initially on a small scale with 683 residents vaccinated over the first two days.184 By 25 January 2021, all care homes in Northern Ireland had been visited to receive their first dose and by early March all eligible care home residents had been vaccinated with two doses.185 |
| 5.106. | In Wales, a decision was made on 24 November 2020 not to deliver vaccines to care homes for the first four weeks of rollout because of the difficulties with storing and transporting the Pfizer/BioNTech vaccine.186 Concern was expressed that this approach would lead to unnecessary delay in the delivery of vaccines to care homes in Wales.187 However, delivery ultimately began sooner than this initial indication – by 16 December 2020, just over one week after the first vaccinations were delivered in the UK.188 Wales was not alone in taking more than a week from the first vaccinations to set up delivery to care homes. In Scotland, delivery to care homes began in the same week as Wales; more than 90% of care home residents had been vaccinated by 19 January 2021.189 In England, a pilot scheme began vaccinating people in care homes in mid-December and was rolled out to all care homes on 21 December 2020.190 |
| 5.107. | Vaughan Gething MS, Minister for Health and Social Services in the Welsh Government from May 2016 to May 2021, acknowledged that by 26 January 2021 Wales had not reached the target of vaccinating 70% of people over 80 in care homes, and said a key reason was the disruption of appointments due to adverse weather.191 By this time, Wales had reported that more than 50% of care home residents and more than 80% of care home staff were vaccinated.192 However, by 12 February the vaccine had been offered to everyone in priority groups 1 to 4 in Wales, including all care home residents. It was the first of the four UK nations to do so.193 On 16 February 2021, the percentage vaccination rate for care home residents in Wales had reached 82%, which was about 8% behind that of the over-70s group and about 2% behind that of care home workers.194 Professor Richardson explained to the Inquiry that Wales sped up vaccination across the whole population by offering vaccination to the next cohort on the list once 50% of the previous cohort had been immunised and the rest of that cohort had been offered an appointment. She said that this was intended to avoid a lag in between inviting cohorts for vaccination.195 |
| 5.108. | Similarly, in Northern Ireland the ‘twin track approach’ involved a higher priority group being offered the vaccination via their GP while, simultaneously, the next priority cohort were allowed to book a vaccination through regional vaccination centres.196 |
Use of GPs
| 5.109. | Once the transport and storage of vaccines became easier, delivery via local GPs became possible, although levels of delivery differed between the four nations. As of the spring of 2024, 47% of vaccines in Northern Ireland had been delivered by GP practices.197 In England, by the end of June 2022, GP practices and primary care networks accounted for 53% of delivery.198 In Wales, GP practices played a significant role in local vaccine delivery from early January 2021, and about 90% of GP practices were participating in vaccine delivery by the spring of 2021.199 |
| 5.110. | Scotland’s approach was somewhat different. It restructured its routine vaccine delivery services in 2018 through the Vaccination Transformation Programme, which moved responsibility for vaccine delivery from GPs to dedicated clinics run by NHS boards and health and social care partnerships.200 Mr Grieve explained that this system had been introduced to allow GPs to focus on providing medical care and was important during Covid-19 because GP practices in Scotland often did not cover enough patients to allow for delivery of vaccines without a high level of wastage.201 By the end of June 2022, 69% of vaccines in Scotland had been delivered via dedicated centres, whereas GP practices accounted for just 12.7% of delivery.202 However, the Inquiry was told that people in the rural Scottish Highlands sometimes had to travel significant distances to reach vaccine centres and that a centralised “one-size-fits-all” policy of moving away from local GP delivery caused people in these communities to be less likely to access vaccinations.203 |
| 5.111. | The Inquiry recognises the advantages that come with having a specialist vaccination programme in each of the four nations and, in Scotland, there were found to be wider health benefits in taking the task of routine vaccination away from GPs. The data available to the Inquiry suggest that Scotland did not fall behind uptake in other nations because of this approach.204 However, what works at a nationwide level may not be effective for groups in remote areas. The Inquiry was informed in the course of its hearings in January 2025 that routine vaccine delivery had been restored to NHS Highland GPs and local healthcare providers following an intervention by the Scottish Secretary of State for Health and Social Care.205 NHS Highland now provides a mixed model of vaccination delivery with collaboration between its vaccination teams and general practice, allowing for more local delivery.206 The Inquiry welcomes these changes, which are an improvement to the accessibility of vaccinations in rural communities in Scotland. |
Mass vaccination centres
| 5.112. | As the programmes progressed, mass vaccination centres were set up in all four nations in large venues, such as sports grounds and leisure centres, with the ability to deliver large numbers of vaccines each day.207 These centres were an effective way of vaccinating people who valued convenience and online booking – for example, younger people and those trying to fit vaccine appointments around employment or childcare. Digital booking systems allowed them to book online and there were significant economies of scale in this approach. |
| 5.113. | Commercial contracts had to be negotiated for the use of centres and booking systems were required for access, so most were set up in the weeks and months following the beginning of vaccine rollout.208 In Wales, the majority of adults were offered their first dose of Covid-19 vaccination in the first half of 2021 at a mass vaccination centre, and by February 2022 the majority of vaccines delivered as part of the booster programme were delivered through a vaccination centre.209 In England, by June 2022, 21% of people receiving first or second doses were vaccinated via mass vaccination centres.210 By the same time in Scotland, 69% of vaccines had been delivered via mass or community vaccine centres.211 Mass vaccination centre sites were used in areas of higher population density, whereas health providers in rural and isolated areas made use of smaller local delivery pathways or mobile units.212 |
| 5.114. | Northern Ireland was much less reliant on mass delivery centres than other nations. It operated one centre from the end of March 2021 where up to 6,000 people per day could be vaccinated. Its operation was made possible by the assistance of military aid.213 Before this, delivery in Northern Ireland was managed through hospital trust-led sites and GP surgery teams – later complemented by community pharmacies and tailored delivery via pop-up or mobile clinics.214 |
| 5.115. | The Inquiry heard that there were some groups for whom mass vaccination centres were not convenient and were instead a source of concern about infection. |
| 5.116. | Ms Wong (on behalf of Clinically Vulnerable Families) explained that there were concerns about the lack of ventilation and proper use of face masks in mass vaccination centres in England on the part of those who had been shielding for many months. There were some settings, such as drive-through vaccination sites or tented outdoor vaccination venues, which were more accessible to these groups, but clinically vulnerable people might not have had those facilities available in their local area.215 |
| 5.117. | However, Nadhim Zahawi MP (Minister for Covid-19 Vaccine Deployment from November 2020 to September 2021) told the Inquiry that the safety of vaccine centres was not raised with him as a key concern by clinically vulnerable groups during consultations with local MPs.216 Dame Emily Lawson agreed that these were not issues that were reported at a national level as a widely experienced problem, although she said that reports of masking or social distancing not being adhered to in vaccine centres were “incredibly disappointing”.217 She explained that, in England, people who were clinically extremely vulnerable were included in cohort 4 and should therefore have been invited for vaccination by their GP – they would not ordinarily have been required to attend for vaccination at a mass vaccination centre. Similarly, housebound patients would be known to their GP and should have been visited for vaccination.218 |
| 5.118. | The Inquiry understands that exposure to infection was a particular concern, given that many vulnerable people had spent many months shielding themselves from Covid-19 infection when they were offered the vaccine. The precise means by which vaccines are delivered in the future are a matter for the specialists and clinicians responsible for designing delivery, according to the behaviour of the disease and the vaccine with which they are dealing. The UK government and devolved administrations should ensure that future systems of vaccine delivery pay close attention to the specific needs of the clinically vulnerable, to ensure that they are able to access the vaccine in a safe environment. |
Pharmacies
| 5.119. | During a ministerial roundtable about vaccine uptake on 8 January 2021, Mr Zahawi heard suggestions arising from lessons learned from the NHS Test and Trace programme. GPs and community pharmacists were identified as “by far” the most trusted health professionals in their communities.219 However, the Inquiry heard from the National Pharmacy Association (which represents the majority of the more than 7,000 independent community pharmacies across the UK) about concerns that pharmacies were underutilised, particularly in England, in the early stages of vaccine rollout.220 |
| 5.120. | Service specifications for pharmacies set by NHS England in January 2021 included requirements for pharmacies to operate minimum opening hours of 8am to 8pm 7 days a week and to vaccinate at least 1,000 people each week.221 This ruled out all but the largest pharmacies from delivery.222 In a meeting of the senior vaccine deployment team and Mr Johnson on 7 January 2021, it was noted that only about 200 of the more than 11,000 pharmacies in England were being set up for vaccine deployment; it appears that they subsequently started delivering vaccines on about 14 January 2021.223 Mr Johnson expressed concern about the need to maximise uptake and questioned whether enough was being done through community pharmacies. NHS England’s position was that the average pharmacy only injected about 260 flu vaccines per year, and pharmacies were likely to be less efficient at delivering high volumes of vaccinations compared with larger sites.224 |
| 5.121. | However, it did acknowledge that community pharmacies would be critical for reaching communities where uptake was lower. NHS England planned that further pharmacies would “be switched on as necessary as those communities were identified”.225 As explored in Chapter 6: Disparities in vaccine uptake, groups likely to have lower vaccine uptake were in fact already apparent to the UK government before vaccine rollout began. |
| 5.122. | At the end of January 2021, the National Pharmacy Association asked the UK government to make more use of pharmacies in light of their place at the heart of local communities, and pointed out that this would take pressure off GPs.226 The government response was that, in the context of limited vaccine supply at that time, it needed to concentrate on sites able to deliver at high volume and avoid the risk of wasted vaccines.227 |
| 5.123. | The service specifications restricting the involvement of pharmacies in the vaccine deployment programme were gradually relaxed for Phases 2 and 3, and expressions of interest from new, smaller pharmacies were actively sought during the spring of 2021.228 Community pharmacies played a greater role in Phases 2 and 3.229 Ultimately, 1,500 community pharmacy-led vaccination sites were established by the end of 2021 in England and were responsible for 20% of all Covid-19 vaccinations during the first year of rollout.230 |
| 5.124. | In Wales, pharmacies played a smaller role than GP practices in local delivery because of factors including the challenges in storing and transporting vaccines in small numbers, the pharmacy sector’s lack of experience in previous vaccination programmes in Wales, and the suitability of small pharmacy venues for significant footfall in the context of social distancing.231 |
| 5.125. | Pharmacies were not used to deliver vaccines at all until March 2021 in Northern Ireland, at which time about 350 pharmacies joined the delivery programme with the aim of providing more local points of vaccine delivery.232 |
| 5.126. | Scotland had a different model of vaccine delivery and therefore pharmacies were used to deliver only 0.1% of vaccines as at June 2022.233 |
| 5.127. | Dr Tracey Chantler, expert witness on vaccine delivery and disparities in coverage, agreed that in England the involvement of pharmacies was initially hampered by the operating requirements placed on them. She acknowledged that this was attributable to practical difficulties associated with storing and transporting the Pfizer/BioNTech vaccine and the desire to avoid wasted vaccines.234 |
| 5.128. | The Inquiry understands the concern that pharmacies were underutilised at the start of the pandemic. Pharmacies were a useful way of reaching people in a convenient and familiar way within their local community and proved to be integral to the delivery programme. However, the delivery and storage requirements of the vaccines acted as a constraint in the first few months of vaccine rollout. The desire to avoid waste and initially to restrict their use was reasonable. |
| 5.129. | In a future pandemic, vaccine deployment planners should use community pharmacies at an earlier stage, unless there are clear logistical or operational barriers to doing so. This will be especially effective in areas likely to have lower vaccine uptake and where travel may be a barrier to vaccine access, including, for example, areas of high deprivation. |
The role of the public
| 5.130. | The success of the vaccination programmes also relied on the engagement of members of the public, their motivation to come forward to accept the offer of vaccination and, in most cases, their willingness and ability to travel to a vaccine delivery point to receive it. The theme of the public coming together emerged from contributors to Every Story Matters. |
When I got to the centre it was all very well organised and the volunteers and the staff, the nurses, doctors, they were all so helpful and cheerful which was really good. There was no sense of doom really. It was like, you’re all here for this vaccination and we’ll just get on with it. And I think that was quite, well it was a relief for one thing to get the vaccine. But it was also quite optimistic, I think.”235
It was amazing how all those vaccination centres were set up and how well organised they were. It felt as if we were all working together to get on top of it.”236
| 5.131. | A large workforce had to be found in each nation to deliver vaccines at high volume. Healthcare workers – including redeployed professionals and retired healthcare workers, nurses, pharmacists and doctors – stepped forward to give up their time.237 In all four nations, volunteer organisations helped to recruit and coordinate members of the public to assist with the vaccine effort. Those with appropriate experience were trained to provide vaccinations and others acted as stewards and assistants helping to run large vaccination centres.238 |
| 5.132. | In England alone, 750,000 people signed up to the NHS Responder Programme within four days of the request for volunteers, with 400,000 then actively participating in the programme.239 |
| 5.133. | The Inquiry heard repeatedly about the public spiritedness of people who gave their time and resources to help others be vaccinated. Taxi drivers offered free transport to vaccination clinics for the vulnerable, restaurant owners gave out food with jabs to encourage their communities to be vaccinated, and businesses gave their premises as vaccination venues free of charge.240 These efforts were repeated in small and large gestures throughout the UK. Deployment programmes were able to operate quickly and effectively, thanks in large part to the altruism of members of the public and their enthusiasm for the vaccination programme. |
Changes to vaccine dosage interval
| 5.134. | The Medicines and Healthcare products Regulatory Agency’s authorisation for the vaccines in December 2020 included conditions that both the Oxford/AstraZeneca and Pfizer/BioNTech vaccines should be administered in two doses. For the Pfizer/BioNTech vaccine (authorised on 2 December), the interval between doses was required to be three weeks. The second dose of the Oxford/AstraZeneca vaccine (authorised on 30 December) was to be given between 4 and 12 weeks after the first. When the vaccine delivery programme began, it therefore aimed to provide the second dose of the vaccine three to four weeks after the first dose.241 |
| 5.135. | On 21 December 2020, the Department of Health and Social Care and 10 Downing Street officials contacted Professor Van-Tam to ask for advice on the possibility of extending the dosage interval. This was already under consideration by the Joint Committee on Vaccination and Immunisation and the Office of the Chief Medical Officer. Professor Van-Tam was of the view that the new, much more transmissible Alpha variant was a material change that warranted reconsideration of the dosage interval.242 Following a request from Professor Van-Tam and Antonia Williams (Director of Emergency Health Protection at the Department of Health and Social Care), the Medicines and Healthcare products Regulatory Agency reviewed the manufacturers’ data on the effect of extended dosage intervals and considered the views and experience of its scientific assessors in vaccine technology.243 It advised the UK government that conditions for the use of the Pfizer/BioNTech vaccine should change from a second dose 21 days after the first dose to a recommendation that the second dose be “at least” 21 days after the first – allowing the second dose to be given at the end of the 3 to 12-week range for both Pfizer/BioNTech and Oxford/AstraZeneca. The vaccines licensing minister accepted this advice.244 |
| 5.136. | The four UK Chief Medical Officers and lead Deputy Chief Medical Officers on vaccination met on 29 December 2020. They agreed with the Joint Committee on Vaccination and Immunisation that prioritising as many people as possible in the shortest time possible would have the greatest impact in preventing mortality and severe disease and in protecting health services.245 |
| 5.137. | The Joint Committee on Vaccination and Immunisation advice published on 31 December 2020 was accepted by the UK government and a letter was sent to the medical profession by the Joint Committee on Vaccination and Immunisation explaining the decision, which included the observation that:
“[A] model where we can vaccinate twice the number of people in the next 2 to 3 months is obviously much more preferable in public health terms than one where we vaccinate half the number but with only slightly greater protection.”246 |
| 5.138. | The decision to extend the dosage interval was, however, controversial for a number of reasons. People who had been vaccinated at the very beginning of the programme in December 2020 were due to receive their second dose in January 2021. They were among the most vulnerable and elderly individuals. Appointments booked for second doses needed to be rescheduled to several months later. Many front-line health and social care staff had also been given an appointment for their second dose in January. The British Medical Association voiced concern on behalf of its members that those staff at highest risk of exposure would be left with lower protection for several months.247 Concern was also raised that the extension of the dosage interval did not have approval from the vaccine manufacturer and that there were not sufficient data to support the effectiveness of the second dose if given at 12 weeks.248 |
| 5.139. | The Inquiry acknowledges the concerns expressed about the decision to extend the dosage interval and the operational impact of rearranging appointments and distribution of vaccines. However, it was a reasonable decision reached by appropriately qualified decision-makers after careful consideration by the Medicines and Healthcare products Regulatory Agency, the Joint Committee on Vaccination and Immunisation and the UK’s Chief Medical Officers.249 |
| 5.140. | The decision to extend the dosage schedule was a rapid adaptation to the emerging Alpha variant. Spacing out the doses in this way did not reduce the effectiveness of the vaccines and it enabled a greater number of people to receive the high level of protection given by a single dose sooner. The approach is likely to have saved lives and prevented hospital admissions.250 |
Clarity of messaging about vaccines during pregnancy
| 5.141. | Pregnant women are routinely excluded from clinical trials of vaccines and medications, as their inclusion is viewed by regulators and industry as inherently risky.251 This was no different in the case of the Covid-19 vaccination trials. |
| 5.142. | The advice for pregnant women about whether to have the Covid-19 vaccinations changed significantly during the course of the pandemic. Initially, they were advised not to take Covid-19 vaccinations.252 As pregnant women were not included in clinical trials for Covid-19 vaccines, the Medicines and Healthcare products Regulatory Agency concluded at the time of authorisation in December and January 2020 that there were not sufficient data to give reassurance of safe use of the vaccine in pregnant women.253 It planned to review post-authorisation surveillance and global studies to confirm whether there was any risk to pregnant women.254 This approach was echoed in the Joint Committee on Vaccination and Immunisation’s advice, published on 2 December 2020, which did not recommend the use of the Covid-19 vaccines in pregnancy at all.255 |
| 5.143. | The advice changed slightly in mid-December 2020, by which time data from animal studies had found that there were no Covid-19 vaccine-related effects on female fertility, pregnancy or embryo-foetal development. The Commission on Human Medicines (the UK government’s independent expert scientific advisory body on medicines) and the Medicines and Healthcare products Regulatory Agency advised that Covid-19 vaccines should be considered for use in pregnancy where the potential benefits outweighed potential risks.256 The Joint Committee on Vaccination and Immunisation advice, published on 30 December 2020, accordingly recommended that vaccination should be considered in pregnancy only where the risk of Covid-19 infection was high and unavoidable, or the woman had underlying conditions that put them at high risk of serious complications of Covid-19. Doctors were advised to discuss with these women the risks and benefits of vaccination and the absence of safety data for the vaccine in pregnant women.257 |
| 5.144. | The advice on 2 and 30 December 2020 followed the scientific evidence available at the time but understandably caused women who were pregnant or planning a pregnancy to feel concerned that the vaccines might be harmful to their health or the health of their baby. It proved difficult to shift this perception even when more data on the safety of vaccines for such women had become available.258 |
| 5.145. | By April 2021, there was a large amount of global data on the use of messenger ribonucleic acid (mRNA) vaccines in pregnant women from countries that had already authorised it.259 Studies including over 17 million pregnant women worldwide have found no increased risk of pregnancy complications or adverse effects for pregnant women and their babies following Covid-19 vaccination. mRNA-based vaccines have been shown to be as safe and beneficial for pregnant women as for the general population.260 |
| 5.146. | The Medicines and Healthcare products Regulatory Agency authorised the use of mRNA Covid-19 vaccines (ie Pfizer/BioNTech and Moderna) for pregnant women and, on 16 April 2021, the Joint Committee on Vaccination and Immunisation advised that all pregnant women should receive a vaccine.261 However, even at this stage, when the Joint Committee on Vaccination and Immunisation and the Medicines and Healthcare products Regulatory Agency were satisfied that the vaccines were sufficiently safe, the advice was not unqualified and it still recommended that pregnant women should discuss the risks and benefits of vaccination with their clinician.262 |
| 5.147. | The Royal College of Obstetricians and Gynaecologists, as well as a group representing pregnancy, baby and parent organisations, said that pregnant women felt uncertain about the reasons for these changes in advice, and had not received clear messages from healthcare providers.263 |
| 5.148. | The exclusion of pregnant women from early Covid-19 vaccine trials was interpreted by many to mean that the vaccines were not safe in pregnancy, which had a significant effect on their willingness to be vaccinated.264 Professor Daniel Prieto-Alhambra, expert witness on vaccine safety, told the Inquiry that the exclusion of pregnant women from clinical trials also resulted in uncertainty for healthcare professionals who were tasked with giving individual advice about risks and benefits.265 |
| 5.149. | Contributors to Every Story Matters who were pregnant after the authorisation of the vaccines said that the changes were sudden and confusing and that health professionals did not have clear answers to the questions they raised. This led them to doubt the safety of the vaccines for pregnant women. |
I remember them specifically saying, ‘Anyone who is pregnant or trying to conceive should not have the vaccine.’ … And then all of a sudden halfway through my pregnancy there was a change of circumstances and pregnant people were allowed the vaccine which I just thought was very, very strange and very worrying.”266
I was pregnant at the time so because they had said not to get it while you’re pregnant and then the decision was made very quickly to say that they could, that alarmed me. Because it was just a change in the decision, like, overnight. So, in my head I constantly thought about, ‘Well why did they say no in the first place?’ And then I decided, because I’d had a miscarriage and I didn’t want anything in my body that could cause anything to harm this pregnancy. So I decided not to get the vaccine while I was pregnant. I did get it after.”267
| 5.150. | The effect of these concerns was a significantly lower uptake among pregnant women. The UK Health Security Agency’s COVID-19 Vaccine Surveillance Report published in November 2021 found that, among all women giving birth in August 2021, only 22.2% had received at least one dose of the vaccine.268 This overall statistic masked even lower uptake in particular groups.269 Dr Chantler and Dr Kasstan-Dabush similarly reflected on lower vaccine uptake among pregnant women. For example, in October 2021, only 43% of women giving birth in Scotland had received at least one vaccine dose. In Wales, between April and December 2021, only 32.7% of pregnant women had received at least one dose during pregnancy.270 |
| 5.151. | The low rates of vaccination were particularly worrying in light of the potential consequences of Covid-19 infection for pregnant women. The Royal College of Obstetricians and Gynaecologists told the Inquiry that, by October 2021, one in five of the most critically ill Covid-19 patients in hospitals was a pregnant woman and 99% of pregnant women admitted to hospital with symptomatic Covid-19 were unvaccinated. High rates of severe Covid-19 outcomes were observed among pregnant women.271 In November 2021, the Chief Medical Officer, Chief Nursing Officer and Chief Midwifery Officer jointly warned:
“Almost all pregnant women admitted to hospital, including ICU [intensive care unit], with COVID are unvaccinated. This is a risk to you and your baby. It’s safer to be vaccinated.”272 In December 2021, the decision was made to prioritise pregnant women for booster vaccinations in recognition of the heightened clinical risk they faced from Covid-19.273 |
| 5.152. | Concerted efforts were made to encourage pregnant women to take the Covid-19 vaccines. These included public statements from medical experts, social media campaigns and work with healthcare providers aimed at reassuring women about the safety of the vaccines relative to the risks of Covid-19.274 |
| 5.153. | However, the messaging to pregnant women, or those treating them, ultimately did not bring vaccination rates for pregnant women in line with those of the general population. This is a matter of serious public health concern, given the potentially life-threatening or fatal outcomes for pregnant women who contracted Covid-19. |
| 5.154. | Professor Sir Christopher Whitty, Chief Medical Officer for England from October 2019, reflected on how government messaging to pregnant women in the early stages of the pandemic could have been less negative in order to encourage confidence in the vaccines when sufficient safety data later emerged.275 He said:
“I think the judgement was a perfectly reasonable one, but the way that it was phrased and the way that it was communicated I think made it much harder when subsequently we were confident (a) that this was a safe thing to do, relative to the risk of infection, and (b) that pregnant women, and therefore their unborn children additionally, were coming to harm because of Covid, preventably, because of not being vaccinated.”276 |
| 5.155. | Dame June Raine, Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency from September 2019 to March 2025, explained that future inclusion of pregnant women in trials required a system-wide change of research culture and practice.277 The Department of Health and Social Care has recognised the challenge of inclusion of pregnant women in trials and provided £2.6 million of funding to a National Institute for Health and Care Research project, which began in the spring of 2025, to develop a new data system to assist with understanding the safety of medications during pregnancy.278 The Medicines and Healthcare products Regulatory Agency is also participating in work to create a global framework to enable inclusion of pregnant women in clinical trials.279 |
| 5.156. | The Inquiry recognises that, at the time of the initial advice to pregnant women in December 2020 and the subsequent changes to advice, the Medicines and Healthcare products Regulatory Agency, the Joint Committee on Vaccination and Immunisation and the UK government and devolved administrations were following scientific safety recommendations. In a future pandemic, there may again be circumstances in which pregnant women are not included in trials, and authorisation for vaccines or new therapeutics is delayed while real-world data are awaited to confirm safety. The Inquiry encourages the UK government and devolved administrations to evaluate what public messaging might help create an environment in which many more pregnant women are receptive to taking a future vaccine when and if one is authorised for them. |
| 5.157. | Public messaging should aim to achieve an understanding among pregnant women and healthcare professionals that their exclusion from trials is not unique to that vaccine or new therapeutic. It should seek to combat any misconception among pregnant women that authorisation has been delayed due to a particular safety concern (as opposed to a lack of data) where this is not the case. Guidance for healthcare workers should also enable them to understand the rationale behind any changes in advice about the eligibility of pregnant women for vaccines, so that they can explain changes to women with confidence and clarity. |
| 5.158. | The precise nature of such messaging will depend on the characteristics of the disease and any vaccine or therapeutic drug, but the goal should be to provide comprehensive and forward-looking information for pregnant women at the earliest possible stage of its rollout. |
Deployment of antivirals in the community
| 5.159. | Early in the pandemic, existing drugs (known as ‘repurposed’ drugs) were given to hospitalised patients in line with clinical decisions. Later in the pandemic, new therapeutics – in particular oral antivirals – were used to provide treatment to those with Covid-19 within the community and to try to prevent hospitalisation. Given that antivirals are most effective when they are taken early in the course of an infection, it was crucial to get them to individuals as quickly as possible upon a positive Covid-19 test. |
| 5.160. | The Antivirals Expert Group (an ad hoc advisory group that considered the most effective use of antivirals in order to support the subsequent work of the Antivirals Taskforce) recommended that more data should be gathered from a large-scale Phase 3 UK trial to identify who would benefit most from antivirals before moving to wide-scale deployment. This was because the UK already had a mostly vaccinated adult population and the available trial data were largely based on an unvaccinated population. These data would also help decision-making on future clinical access and the cost-effectiveness of these treatments.280 This led to the establishment of a community trial referred to as PANORAMIC, launched on 8 December 2021. It was open to individuals who had tested positive for Covid-19 and were either aged over 50 or aged between 18 and 50 with comorbidities.281 In December 2022, the trial reported that molnupiravir (the first of the two antivirals trialled) led to a faster recovery time and reduced the viral load for some, but did not reduce hospitalisations or deaths among higher-risk vaccinated adults.282 |
| 5.161. | Importantly, the Antivirals Expert Group also recognised that the most vulnerable patient cohorts needed direct access to Covid-19 oral antiviral treatments outside the PANORAMIC trial.283 Eligibility for treatment was based on the UK-wide patient cohorts identified by the Covid-19 Neutralising Monoclonal Antibodies and Antivirals Access Independent Advisory Group as being at the very highest risk from Covid‑19.284 However, as with vaccines, deployment of therapeutics was a devolved issue. In England, this took place through NHS Covid Medicine Delivery Units (discussed below) and, in Wales, through the National Antiviral Service and each health board’s monoclonal antibody services.285 In Scotland, Public Health Scotland identified those eligible for treatment, then each health board made deployment arrangements.286 In Northern Ireland, deployment was led by an operational group established by the former Health and Social Care Board and the Public Health Agency, with input from the Department of Health (Northern Ireland) and each Health and Social Care trust.287 |
| 5.162. | Particular concerns were raised about the deployment of antivirals through the NHS Covid Medicine Delivery Units. These opened in England on 16 December 2021, within days of the launch of the PANORAMIC trial and less than two weeks after the first supply of oral antivirals arrived in the UK.288 |
| 5.163. | In order to support timely access to treatment through these units, NHS England commissioned NHS Digital to develop new digital infrastructure to allow the delivery units proactively to contact potentially eligible patients who had tested positive for Covid-19. It also allowed NHS England to contact the majority of people considered at highest risk and to distribute free Covid-19 tests to potentially eligible patients (which it did until early 2023). NHS England also wrote to integrated care boards, GPs and hospital specialists to raise awareness of potential eligibility. GPs and hospital specialists were able to directly refer patients to the units.289 |
| 5.164. | However, the operation of the delivery units was not without its challenges. Gareth Arthur (Director and Senior Responsible Officer of Antivirals Deployment, NHS England) referred to issues such as workforce capacity, awareness of referral requirements among GPs and other health professionals, and clarity for patients in relation to the eligibility criteria. Some of these issues were also reflected in feedback from groups and patients. Their concerns included an inability to access treatments, either because patients were not referred locally or because they had missed the treatment window, as well as an inability to access testing.290 These concerns were echoed in evidence provided to the Inquiry by clinically vulnerable individuals.291 |
| 5.165. | NHS England took action to try to address some of these issues, including providing additional advice and guidance to clinicians, contacting identifiable patients in high-risk cohorts by letter as well as by text message if they tested positive, and monitoring mechanisms.292 By 26 June 2023, the delivery units had provided almost 115,000 community-based treatments to Covid-19-positive patients from the highest-risk cohort, including 73,000 oral antivirals.293 However, the extent to which the actions resolved issues for individual patients is unclear. |
| 5.166. | James Bethell, Lord Bethell (Parliamentary Under Secretary for Technology, Innovation and Life Sciences from March 2020 to September 2021, who had junior ministerial responsibility for the establishment of NHS Test and Trace) told the Inquiry that “within the NHS we could have been more creative about test, trace and treat”.294 He recalled early discussions about the potential for the delivery by bike of antivirals and thought it unfortunate that this approach was not pursued. He acknowledged that, in the pandemic, the vaccine had got “it mostly covered” and that “NHS and primary care in particular were flat out in their response”.295 However, he emphasised the need to be better prepared next time:
“By the time of the next epidemic, we should be in a place where we are studying the right antivirals against the right diseases in advance, and have the delivery mechanism stood up beforehand so that we have this alternative platform to respond to a disease. Otherwise we’ll be scrambling again, as we were. And we shouldn’t put all of our eggs in the vaccine basket because next time round, maybe the vaccine won’t be the one that comes through; we’ll be relying on therapeutics and antivirals for our primary response.”296 |
| 5.167. | The Inquiry agrees that it is necessary to prepare for the deployment of therapeutics, such as antivirals, within the community in the event of a future pandemic. An effective vaccination may take years to develop, and even when available may not be suitable for many thousands of people. Therapeutics, including antivirals, are therefore a vital tool in responding to a pandemic. The UK government and devolved administrations must ensure that any future pandemic strategies and exercises, as recommended by the Inquiry in its Module 1 Report, involve planning for the delivery of antivirals within the community – both to high-risk individuals and on a more widespread basis. In doing so, they should draw on the lessons of the vaccine delivery programme, including the need for clear prioritisation and eligibility criteria, engagement with the public and an approach that can adapt quickly as the scale and nature of the pandemic evolve. |
- UK COVID-19 Vaccines Delivery Plan, Department of Health and Social Care, 13 January 2021, pp29-30 (https://www.gov.uk/government/publications/uk-covid-19-vaccines-delivery-plan/uk-covid-19-vaccines-delivery-plan; INQ000411678). Clinically extremely vulnerable people were those identified by the UK government in March 2020 as having medical conditions that meant they were particularly likely to develop severe illness or to die from Covid-19 (see INQ000410237_0084 para 9.8; INQ000273807_0083-0085 paras 8.54-8.64).
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 30 December 2020, p13 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020; INQ000354469); INQ000652093_0008
- JCVI Final Statement on Phase 2 of the Covid-19 Vaccination Programme, Department of Health and Social Care, 13 April 2021 (https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/jcvi-final-statement-on-phase-2-of-the-covid-19-vaccination-programme-13-april-2021; INQ000257445); INQ000377248_0041 para 5.4; INQ000492870_0001-0004; INQ000474334_0080 para 301
- JCVI Final Statement on Phase 2 of the Covid-19 Vaccination Programme, Department of Health and Social Care, 13 April 2021 (https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/jcvi-final-statement-on-phase-2-of-the-covid-19-vaccination-programme-13-april-2021; INQ000257445); see also JCVI Interim Statement on Phase 2 of the COVID-19 Vaccination Programme: 26 February 2021, Joint Committee on Vaccination and Immunisation, updated 13 April 2021, pp3-4 (https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/jcvi-interim-statement-on-phase-2-of-the-covid-19-vaccination-programme; INQ000354488)
- INQ000466966_0006; INQ000257507_0003; INQ000474420_0036 para 136; INQ000147412_0004; see also Chapter 4: Authorisation. There was a recommended eight-week gap between the first and second doses; as a result, some over-18s would not have been eligible to receive their second dose (eg 18 to 24 year olds were not eligible for the first dose until 18 June (see INQ000330416_0001)).
- INQ000330424_0003; INQ000065597_0011-0012 para 35; COVID-19 Wales Situational Report: 12 August 2021, Welsh Government, 17 August 2021, p29 (https://www.gov.wales/covid-19-wales-situational-report-12-august-2021-html; INQ000066234)
- ‘UK marks 132 million life-saving COVID-19 vaccinations in 2021’, Department of Health and Social Care, 2 January 2022
(https://www.gov.uk/government/news/uk-marks-132-million-life-saving-covid-19-vaccinations-in-2021; INQ000660016) - INQ000474703_0024 para 4.38; ‘Estimated number of lives directly saved by COVID-19 vaccination programmes in the WHO European Region from December, 2020, to March, 2023: A retrospective surveillance study’, MMI Meslé, J Brown, P Mook, MA Katz, J Hagan, R Pastore et al, The Lancet Respiratory Medicine (2024) 12(9), 714-727 (corrected 23 June 2025) (https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(24)00179-6/fulltext; INQ000660020). The study did not include comparable statistics for Wales and Northern Ireland because of the different methods of reporting vaccine uptake data in those nations.
- ‘Written statement: Statement about vaccine equity’, Welsh Government, 1 June 2022 (https://www.gov.wales/written-statement-statement-about-vaccine-equity; INQ000660017)
- INQ000145984_0004 para 6. It is supported by a secretariat, which assists in the preparation of agendas, meeting minutes, potential vaccination strategies and public statements. The secretariat also acts as an intermediary between the committee and the UK government and, during its work on Covid-19 vaccines, was in daily contact with policy officials in the Department of Health and Social Care and in regular contact with Professor Jonathan Van-Tam, Deputy Chief Medical Officer for England from October 2017 to March 2022 (see INQ000471988_0009 para 28).
- INQ000471988_0010 para 35. The Joint Committee on Vaccination and Immunisation is an independent departmental expert committee and a statutory body constituted for the purpose of advising the Secretary of State on the “provision of vaccination and immunisation services being facilities for the prevention of illness”. See The National Health Service (Standing Advisory Committees) Order 1981 (https://www.legislation.gov.uk/uksi/1981/597/schedule/made); see also its Code of Practice, June 2013 (INQ000145984).
- The Health Protection (Vaccination) Regulations 2009 (https://www.legislation.gov.uk/uksi/2009/38/contents/made). The requirement for the UK government to follow the committee’s advice is subject to certain conditions, including a cost-effectiveness assessment, but these were not met during the pandemic. See also INQ000145984_0004-0005 paras 7-9; INQ000474334_0030, 0054 paras 103-104, 202-203; INQ000184643_0031 paras 167-170.
- INQ000474558_0022-0025 paras 79-90; INQ000145984_0004-0005 para 8
- INQ000145984_0004-0005 para 9
- ‘Joint Committee on Vaccination and Immunisation’, HM Government (https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation; INQ000652088)
- INQ000145984_0010-0011 para 29; INQ000471988_0009-0010 paras 29-31
- INQ000145984_0012-0016 paras 35, 38-42
- INQ000471988_0010-0011 para 36
- INQ000471988_0010-0011 para 36. In addition, a specialist Covid-19 sub-committee (formed of the same members as the main committee and some additional experts) first met on 24 September 2020 and looked at key Covid-19 data in detail. Between the start of May 2020 and the end of June 2022, the main committee met 59 times and the sub-committee met 39 times (INQ000471988_0014 paras 48-49). See also Joint Committee on Vaccination and Immunisation: Interim Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 18 June 2020 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi/interim-advice-on-priority-groups-for-covid-19-vaccination; INQ000106485)
- INQ000475169_0001 para 2
- INQ000475169_0001-0002 para 3
- INQ000475169_0001-0002 paras 2-6
- ‘Joint Committee on Vaccination and Immunisation’, HM Government (https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation; INQ000652088); INQ000471988_0012-0013 paras 41-44
- INQ000471988_0015 para 53
- INQ000471988_0015 paras 53-54
- Joint Committee on Vaccination and Immunisation: Interim Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 18 June 2020, p3 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi/interim-advice-on-priority-groups-for-covid-19-vaccination; INQ000106485); INQ000471988_0018 paras 64-65
- INQ000471988_0017-0018 para 62
- Wei Shen Lim 23 January 2025 80/14-81/13; Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 30 December 2020, pp3-5 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020; INQ000354469)
- Wei Shen Lim 23 January 2025 81/19-82/3
- Joint Committee on Vaccination and Immunisation: Interim Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 18 June 2020, pp2-4 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi/interim-advice-on-priority-groups-for-covid-19-vaccination; INQ000106485)
- INQ000471988_0019-0020 paras 66-69; Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, p10 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204 fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638)
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638); Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 30 December 2020 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020; INQ000354469)
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, p8 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638); Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 30 December 2020, p13 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020; INQ000354469)
- INQ000330416_0001; JCVI Final Statement on Phase 2 of the Covid-19 Vaccination Programme, Department of Health and Social Care, 13 April 2021 (https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/jcvi-final-statement-on-phase-2-of-the-covid-19-vaccination-programme-13-april-2021; INQ000257445); ‘Northern Ireland vaccination programme expanded to 45-49 age group’, Department of Health (Northern Ireland), 31 March 2021 (https://www.health-ni.gov.uk/news/northern-ireland-vaccination-programme-expanded-45-49-age-group; INQ000382907); INQ000492870_0001-0004; INQ000474334_0080 para 301
- JCVI Final Statement on Phase 2 of the Covid-19 Vaccination Programme, Department of Health and Social Care, 13 April 2021, pp3-4 (https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/jcvi-final-statement-on-phase-2-of-the-covid-19-vaccination-programme-13-april-2021; INQ000257445)
- Wei Shen Lim 23 January 2025 83/19-23
- INQ000474401_0070 para 6.111; INQ000474558_0024-0025 para 90
- INQ000474350_0014 para 48
- INQ000376375_0003-0004; INQ000474350_0052 para 204
- INQ000474350_0065-0066 paras 269-270
- INQ000474558_0032 para 119
- INQ000474558_0060, 0066-0067 paras 224, 248-252; INQ000116605_0004-0005 paras 8-13
- INQ000474249_0042 para 124
- INQ000474249_0049 para 145
- INQ000477149_0016; INQ000477085_0005-0006 paras 22-31
- INQ000477149_0001, 0016
- These groups were captured in priority cohort 1 (care home workers) and priority cohort 2 (front-line health and social care workers); see also Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 vaccination, HM Government, 2 December 2020, pp3, 8 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638).
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, p3 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638)
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, p18 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638)
- INQ000474401_0034-0036 paras 6.40-6.41
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, p7 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638); Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 30 December 2020, p12 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020; INQ000354469)
- INQ000232664_0002-0003, 0008 paras 5-11, 37
- INQ000474350_0014 para 46
- INQ000474401_0034-0036 paras 6.40-6.41; INQ000072914
- INQ000474375_0043 para 134
- INQ000412276; JCVI Interim Statement on Phase 2 of the COVID-19 Vaccination Programme: 26 February 2021, Joint Committee on Vaccination and Immunisation, updated 13 April 2021, pp3, 9-10 (https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/jcvi-interim-statement-on-phase-2-of-the-covid-19-vaccination-programme; INQ000354488); JCVI Final Statement on Phase 2 of the Covid-19 Vaccination Programme, Department of Health and Social Care, 13 April 2021, pp3, 9-11 (https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/jcvi-final-statement-on-phase-2-of-the-covid-19-vaccination-programme-13-april-2021; INQ000257445)
- JCVI Final Statement on Phase 2 of the Covid-19 Vaccination Programme, Department of Health and Social Care, 13 April 2021, pp3-4, 10-11 (https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/jcvi-final-statement-on-phase-2-of-the-covid-19-vaccination-programme-13-april-2021; INQ000257445)
- Scotland’s COVID-19 Vaccine Deployment Plan 2021: Update – March 2021, NHS Scotland and Scottish Government, March 2021, p15 (https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2021/03/coronavirus-covid-19-vaccine-deployment-plan-update-march-2021/documents/coronavirus-covid-19-vaccine-deployment-plan-update—march-2021/coronavirus-covid-19-vaccine-deployment-plan-update—march-2021/govscot%3Adocument/COVID-19%2Bvaccine%2Bdeployment%2Bplan%2B-%2Bupdate%2B-%2B24%2BMarch%2B2021.pdf; INQ000376301); INQ000474558_0061-0062 para 229; INQ000474249_0042, 0045 paras 124, 135
- INQ000474339_0003 para 11
- INQ000399280_0005 paras 15-17
- INQ000271436_0037-0038; ‘Number of deaths and age standardised mortality rates for death involving COVID-19 by occupation group, England: 24 January 2020 to 28 February 2022’, Office for National Statistics, 28 May 2025 (https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/adhocs/2845numberofdeathsandagestandardisedmortalityratesfordeathinvolvingcovid19byoccupationgroupengland24january2020to28february2022; INQ000652397)
- A key worker (or critical worker) is defined as someone whose work was critical to the Covid-19 response. This was relevant to testing eligibility and the ability of children of such workers to attend early years settings and education during school closures. See ‘Children of critical workers and vulnerable children who can access schools or educational settings’, Department for Education and Cabinet Office, 2 January 2022, pp3-5 (https://www.gov.uk/government/publications/coronavirus-covid-19-maintaining-educational-provision/guidance-for-schools-colleges-and-local-authorities-on-maintaining-educational-provision; INQ000075731); INQ000477149_0002; ‘Coronavirus and key workers in the UK’, Office for National Statistics, 15 May 2020, p3 (https://www.ons.gov.uk/employmentandlabourmarket/peopleinwork/earningsandworkinghours/articles/coronavirusandkeyworkersintheuk/2020-05-15; INQ000652092)
- INQ000279800_0001-0002 paras 3-4
- INQ000399251_0004
- INQ000279800_0002 para 4
- INQ000474334_0081 para 303; INQ000276628_0001
- INQ000501330_0022-0023 paras 83-87; Gillian Richardson 28 January 2025 75/2-76/12
- INQ000396131
- Gillian Richardson 28 January 2025 75/2-24
- INQ000474249_0024 para 65
- Derek Grieve 28 January 2025 23/7-19
- INQ000474527_0013 para 35
- INQ000474337_0065, 0072-0073 paras 216-218, 250-251
- INQ000387481_0001
- INQ000471988_0028 para 100
- INQ000471988_0028 paras 100-102. Children who were vulnerable to the effects of Covid-19 were in a different category. On 30 December 2020, the committee advised that those under 16 could receive vaccines where there was a high risk of exposure and serious outcomes – for example, children with severe neurodisabilities who required residential care. Any such use was outside the product authorisation and therefore should only have been prescribed following assessment of risk and benefits by a treating doctor for ‘off-label’ use. See INQ000471988_0028 para 103; Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 30 December 2020, p9 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020; INQ000354469); Wei Shen Lim 23 January 2025 92/21-93/9
- INQ000387481_0002
- JCVI Statement on COVID-19 Vaccination of Children and Young People Aged 12 to 17 Years: 4 August 2021, Department of Health and Social Care, 4 August 2021, p3 (https://www.gov.uk/government/publications/jcvi-statement-august-2021-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years/jcvi-statement-on-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-4-august-2021; INQ000401363)
- INQ000354535
- Wei Shen Lim 23 January 2025 99/9-20, 101/2-102/5; INQ000354535_0006
- Wei Shen Lim 23 January 2025 98/1-3
- ‘Universal vaccination of children and young people aged 12 to 15 years against Covid-19’, Department of Health and Social Care, 13 September 2021, pp6-7 (https://www.gov.uk/government/publications/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19; INQ000257035)
- ‘Universal vaccination of children and young people aged 12 to 15 years against Covid-19’, Department of Health and Social Care, 13 September 2021, pp6-7 (https://www.gov.uk/government/publications/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19; INQ000257035)
- ‘Universal vaccination of children and young people aged 12 to 15 years against Covid-19’, Department of Health and Social Care, 13 September 2021, pp5-8 (https://www.gov.uk/government/publications/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19; INQ000257035)
- ‘Young people aged 12 to 15 to be offered a COVID-19 vaccine’, Department of Health and Social Care, 13 September 2021 (https://www.gov.uk/government/news/young-people-aged-12-to-15-to-be-offered-a-covid-19-vaccine; INQ000414488); INQ000485842; INQ000492245; ‘Vaccinations for 12-15 year olds’, Scottish Government, 14 September 2021 (https://www.gov.scot/news/vaccinations-for-12-15-year-olds; INQ000420535)
- INQ000471988_0030 para 112
- JCVI Statement on Vaccination of Children Aged 5 to 11 Years Old, Department of Health and Social Care, 16 February 2022, p5 (https://www.gov.uk/government/publications/jcvi-update-on-advice-for-covid-19-vaccination-of-children-aged-5-to-11/jcvi-statement-on-vaccination-of-children-aged-5-to-11-years-old; INQ000257287)
- JCVI Statement on Vaccination of Children Aged 5 to 11 Years Old, Department of Health and Social Care, 16 February 2022, p4 (https://www.gov.uk/government/publications/jcvi-update-on-advice-for-covid-19-vaccination-of-children-aged-5-to-11/jcvi-statement-on-vaccination-of-children-aged-5-to-11-years-old; INQ000257287)
- JCVI Statement on Vaccination of Children Aged 5 to 11 Years Old, Department of Health and Social Care, 16 February 2022, pp3-10 (https://www.gov.uk/government/publications/jcvi-update-on-advice-for-covid-19-vaccination-of-children-aged-5-to-11/jcvi-statement-on-vaccination-of-children-aged-5-to-11-years-old; INQ000257287)
- JCVI Statement on Vaccination of Children Aged 5 to 11 Years Old, Department of Health and Social Care, 16 February 2022 (https://www.gov.uk/government/publications/jcvi-update-on-advice-for-covid-19-vaccination-of-children-aged-5-to-11/jcvi-statement-on-vaccination-of-children-aged-5-to-11-years-old; INQ000257287)
- Sajid Javid 23 January 2025 20/13-19
- Sajid Javid 23 January 2025 20/20-25
- Sajid Javid 23 January 2025 17/22-25, 20/2-19, 21/1-25
- INQ000474623_0052-0054
- JCVI Final Statement on Phase 2 of the Covid-19 Vaccination Programme, Department of Health and Social Care, 13 April 2021, pp5-6 (https://www.gov.uk/government/publications/priority-groups-for-phase-2-of-the-coronavirus-covid-19-vaccination-programme-advice-from-the-jcvi/jcvi-final-statement-on-phase-2-of-the-covid-19-vaccination-programme-13-april-2021; INQ000257445); see also Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, pp7, 9 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638)
- INQ000061309
- INQ000061309_0001
- INQ000061309_0001-0002
- Annex A: COVID-19 Vaccine and Health Inequalities: Considerations for Prioritisation and Implementation, Department of Health and Social Care, 30 December 2020, p8 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/annex-a-covid-19-vaccine-and-health-inequalities-considerations-for-prioritisation-and-implementation; INQ000256951); see also Wei Shen Lim 23 January 2025 112/7-113/16
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, pp5-6, 8 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638); Immunisation Against Infectious Disease (the ‘Green Book’), UK Health Security Agency, November 2020, Chapter 14a, pp8-10 (INQ000059136). Priority cohort 6 included people aged 16 to 64 years with underlying health conditions that put them at higher risk of serious disease and mortality.
- INQ000496177_0012-0013 para 3.2; Immunisation Against Infectious Disease (the ‘Green Book’), UK Health Security Agency, November 2020, Chapter 14a, pp8-10 (INQ000059136)
- Immunisation Against Infectious Disease (the ‘Green Book’), UK Health Security Agency, November 2020, Chapter 14a, p10 (INQ000059136); Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 30 December 2020, p10 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020; INQ000354469)
- Immunisation Against Infectious Disease (the ‘Green Book’), UK Health Security Agency, 12 February 2021, Chapter 14a, p11 (INQ000474586)
- Mary Ramsay 21 January 2025 101/11-102/9
- INQ000492866_0004-0005. Those caring for children under 16 with complex medical needs or severe neurodisabilities were also captured within this definition.
- ‘All carers can book a vaccine at a trust centre’, Department of Health (Northern Ireland), 19 February 2021 (https://www.health-ni.gov.uk/news/all-carers-can-book-vaccine-trust-centre; INQ000417401)
- INQ000376371_0001-0002 para 8
- INQ000386402
- INQ000474249_0079, 0083 paras 230, 242
- INQ000276659_0002 paras 1-4
- INQ000474249_0083-0084 paras 243-244
- INQ000376371_0002 para 10
- Derek Grieve 28 January 2025 42/9-43/1; INQ000376371_0002 paras 14-15; Gillian Richardson 28 January 2025 96/7-25; INQ000329462_0006
- Kamran Mallick 15 January 2025 179/6-181/17
- Ben Kasstan-Dabush 28 January 2025 161/17-162/7; INQ000474623_0021-0022 para 54
- Fit for the Future: 10 Year Health Plan for England, UK Government and NHS, July 2025, pp36, 51 (https://assets.publishing.service.gov.uk/media/6888a0b1a11f859994409147/fit-for-the-future-10-year-health-plan-for-england.pdf; INQ000650755)
- ‘People with learning disabilities had higher death rate from COVID-19’, Public Health England, 12 November 2020 (https://www.gov.uk/government/news/people-with-learning-disabilities-had-higher-death-rate-from-covid-19; INQ000279971); Deaths of People Identified as Having Learning Disabilities with COVID-19 in England in the Spring of 2020, Public Health England, 12 November 2020, p65 (https://assets.publishing.service.gov.uk/media/5fa91fcc8fa8f578988a866c/COVID-19__learning_disabilities_mortality_report.pdf; INQ000089700). This estimate was arrived at after researchers adjusted for factors such as age and sex and allowed for likely under-notification.
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, pp5-6 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638)
- INQ000059943
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, pp5-6 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638); INQ000059943_0002. People with Down’s syndrome were included in priority cohort 4 from the beginning of rollout following advice from the Chief Medical Officer that they should be included on the clinically extremely vulnerable list (INQ000058815; INQ000354465_0005).
- INQ000354465_0005 para 22
- INQ000397416; INQ000060237_0007-0008; ‘Risks of Covid-19 hospital admission and death for people with learning disability: Population based cohort study using the OpenSAFELY platform’, EJ Williamson, HI McDonald, K Bhaskaran, AJ Walker, S Bacon, S Davy et al, British Medical Journal (2021), 374(1592) (https://www.bmj.com/content/374/bmj.n1592; INQ000381220)
- Improving Identification of People with a Learning Disability: Guidance for General Practice, NHS England and NHS Improvement, pp3-4, 8 (https://www.england.nhs.uk/wp-content/uploads/2019/10/improving-identification-of-people-with-a-learning-disability-guidance-for-general-practice.pdf; INQ000658622)
- Improving Identification of People with a Learning Disability: Guidance for General Practice, NHS England and NHS Improvement, p8 (https://www.england.nhs.uk/wp-content/uploads/2019/10/improving-identification-of-people-with-a-learning-disability-guidance-for-general-practice.pdf; INQ000658622)
- INQ000354465_0005 para 22; Improving Identification of People with a Learning Disability: Guidance for General Practice, NHS England and NHS Improvement, pp4-20 (https://www.england.nhs.uk/wp-content/uploads/2019/10/improving-identification-of-people-with-a-learning-disability-guidance-for-general-practice.pdf; INQ000658622). In England, guidance on the NHS website explained that a learning disability could be mild, moderate or severe but also used the term “profound and multiple learning disability”, defined as “when a person has a severe learning disability and other disabilities that significantly affect their ability to communicate and be independent”. See ‘Overview: Learning disabilities’, NHS, updated 24 September 2025 (https://www.nhs.uk/conditions/learning-disabilities; INQ000658623)
- INQ000410090; Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 30 December 2020 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020; INQ000354469); see also INQ000474558_0067 para 252
- INQ000506900_0009-0010 para 36; INQ000474256_0009 para 28
- INQ000474256_0008 paras 26-27; Kamran Mallick 15 January 2025 176/8-15; INQ000354465_0005 para 22
- INQ000474256_0008 para 26
- INQ000471988_0054; Wei Shen Lim 23 January 2025 107/19-110/12
- ‘Letter from the JCVI to the Health and Social Care Secretary: 23 February 2021’, Department of Health and Social Care, 24 February 2021 (https://www.gov.uk/government/publications/letter-from-the-health-and-social-care-secretary-on-covid-19-vaccination-in-people-with-learning-disabilities/letter-from-the-jcvi-to-the-health-and-social-care-secretary-23-february-2021; INQ000354486)
- ‘Letter from the JCVI to the Health and Social Care Secretary: 23 February 2021’, Department of Health and Social Care, 24 February 2021 (https://www.gov.uk/government/publications/letter-from-the-health-and-social-care-secretary-on-covid-19-vaccination-in-people-with-learning-disabilities/letter-from-the-jcvi-to-the-health-and-social-care-secretary-23-february-2021; INQ000354486)
- INQ000417450; ‘Coronavirus (Covid-19): Immunisation programme for people with learning disabilities’, Scottish Government, 25 February 2021 (https://www.gov.scot/publications/coronavirus-covid-19-immunisation-programme-for-people-with-learning-disabilities; INQ000376360)
- INQ000474312_0009, 0011 paras 19, 28; INQ000474611_0013, 0017 paras 41, 57; INQ000474335_0056 para 173. A clinical policy statement defined access to a treatment for a particular group of patients during the Covid-19 pandemic or provided clinical policy guidance more broadly.
- INQ000474312_0011 para 39
- INQ000474312_0013 para 34
- INQ000474312_0013 para 34
- INQ000474312_0013 para 34; INQ000479899
- INQ000474312_0013 para 34
- INQ000474312_0013 paras 34-35; Defining the Highest-Risk Clinical Subgroups upon Community Infection with SARS-CoV-2 when Considering the Use of Neutralising Monoclonal Antibodies (nMABs) and Antiviral Drugs: Independent Advisory Group Report, Department of Health and Social Care, 30 May 2022, pp4, 15 (https://www.gov.uk/government/publications/higher-risk-patients-eligible-for-covid-19-treatments-independent-advisory-group-report/defining-the-highest-risk-clinical-subgroups-upon-community-infection-with-sars-cov-2-when-considering-the-use-of-neutralising-monoclonal-antibodies; INQ000479904)
- This panel, which provided advice to the Chief Medical Officers for the four nations on the eligible patient cohorts for new therapeutics, comprised senior clinicians from the four nations (with broader expertise than those in the Covid-19 Neutralising Monoclonal Antibodies and Antivirals Access Independent Advisory Group). See INQ000474312_0013 paras 33, 35; INQ000474335_0026 para 87; INQ000474401_0083 para 7.35
- Defining the Highest-Risk Clinical Subgroups upon Community Infection with SARS-CoV-2 when Considering the Use of Neutralising Monoclonal Antibodies (nMABs) and Antiviral Drugs: Independent Advisory Group Report, Department of Health and Social Care, 30 May 2022, pp4, 6 (https://www.gov.uk/government/publications/higher-risk-patients-eligible-for-covid-19-treatments-independent-advisory-group-report/defining-the-highest-risk-clinical-subgroups-upon-community-infection-with-sars-cov-2-when-considering-the-use-of-neutralising-monoclonal-antibodies; INQ000479904)
- INQ000474743_0078-0079 paras 6.30-6.31; see also INQ000474335_0057-0058 para 179. An earlier interim report was produced in November 2021 and its recommendations, which were largely reproduced in the May 2022 report, formed the basis of the clinical access policy for treatment from NHS Covid Medicine Delivery Units and their equivalents in the devolved administrations.
- INQ000474312_0014 para 36b; INQ000474335_0057-0059 paras 179, 186-187
- INQ000474312_0014-0015 para 36c
- INQ000474312_0013, 0015-0016 paras 33, 36f
- INQ000474342_0033 para 93
- INQ000474526_0025-0026 para 56
- Every Story Matters: Vaccines and Therapeutics, p49 (INQ000474465). The Inquiry understands that updated recommendations in 2023 identified some respiratory conditions, for example chronic obstructive pulmonary disease and severe asthma requiring immune suppression, as conditions with higher risk of poorer outcome. See Defining the Highest-Risk Clinical Subgroups upon Community Infection with SARS-CoV-2 when Considering the Use of Neutralising Monoclonal Antibodies (nMABs) and Antiviral Drugs (updated March 2023), Department of Health and Social Care, 19 September 2023, p6 (https://www.gov.uk/government/publications/higher-risk-patients-eligible-for-covid-19-treatments-independent-advisory-group-report-march-2023/defining-the-highest-risk-clinical-subgroups-upon-community-infection-with-sars-cov-2-when-considering-the-use-of-neutralising-monoclonal-antibodies; INQ000479903)
- INQ000474401 _0018; INQ000474558_0044 para 163; INQ000474350_0001 para 2; INQ000474249_0065 para 190
- INQ000492335_0044-0045 para 148a; INQ000474228_0055 para 201; INQ000474558_0047-0048 paras 177-181; INQ000474429_0010, 0012 paras 31, 38; INQ000474350_0010-0011 paras 32-35
- Derek Grieve 28 January 2025 27/20-28/13; INQ000492335_0084-0085 paras 283-284
- INQ000474334_0022 para 70. In October 2021, the UK Health and Security Agency took over the functions of Public Health England.
- INQ000474334_0064, 0076-0077 paras 243, 282; INQ000474228_0018 para 83; INQ000474375_0039 para 123. NHS England had extensive advice and guidance from Public Health England on large-scale immunisation programmes (INQ000496177_0017 para 4.7) and was overseen by a multi-organisational Oversight Board (INQ000474228_0020 para 91).
- INQ000474228_0018-0019 para 85
- INQ000492335_0032, 0095-0096 paras 108, 328
- INQ000492335_0028-0029 para 96
- INQ000492335_0038 para 129
- INQ000492335_0006-0007 para 22; The Covid 19 Vaccination Programme: Trials, Tribulations and Successes, The King’s Fund, January 2022 (https://assets.kingsfund.org.uk/f/256914/x/ba99cdeea2/covid-19_vaccination_programme_trials_tributions_successes_2022.pdf; INQ000283354)
- INQ000492335_0044-0046 para 148
- UK COVID-19 Vaccine Uptake Plan, Department of Health and Social Care, 13 February 2021 (https://www.gov.uk/government/publications/covid-19-vaccination-uptake-plan/uk-covid-19-vaccine-uptake-plan); INQ000474334_0084 para 314
- INQ000414427_0003-0004 paras 14-18
- INQ000474228_0125-0126 para 443
- INQ000474396_0008-0009 para 22
- INQ000474396_0004-0008 paras 11-14, 17-19
- INQ000501330_0015 para 63
- INQ000474558_0029-0031 paras 107-109, 114; INQ000499055_0005 para 12
- INQ000501330_0056-0057 paras 255-259
- INQ000474429_0005-0007 paras 10-18
- INQ000377248_0041 para 5.4; INQ000276660
- INQ000492335_0092-0093 paras 313-315; INQ000501330_0029-0030 paras 123-126
- Derek Grieve 28 January 2025 48/12-24
- INQ000501330_0056-0057 paras 257-259; INQ000492335_0093, 0095-0096 paras 316-319, 328; INQ000474350_0001-0002, 0010 paras 1-3, 32
- INQ000474623_0033-0034 paras 102, 106
- INQ000474623_0033 para 103
- INQ000474623_0033 paras 102-103; ‘Covid-19 vaccine roll-out in England: A qualitative evaluation’, S Mounier-Jack, P Paterson, S Bell, L Letley, B Kasstan and T Chantler, PLoS ONE (2023), 18(6) (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0286529; INQ000417414)
- INQ000090898_0006-0007; INQ000492335_0021 paras 65-66
- INQ000501312_0009; INQ000350524_0014
- INQ000492335_0022-0023 paras 71-75; INQ000232664_0003-0004 para 14; INQ000474396_0054-0055 paras 137-138; INQ000474566_0044-0046 paras 180-186; INQ000474429_0011-0012 paras 34-35
- INQ000492335_0023 para 75
- INQ000474623_0028 para 86; The Covid 19 Vaccination Programme: Trials, Tribulations and Successes, The King’s Fund, January 2022, p24 (https://assets.kingsfund.org.uk/f/256914/x/ba99cdeea2/covid-19_vaccination_programme_trials_tributions_successes_2022.pdf; INQ000283354)
- INQ000492335_0021-0022 paras 68-71; INQ000474249_0067 para 195
- INQ000492335_0023 para 75; Coronavirus (COVID-19): Vaccine Deployment Plan 2021, Scottish Government, 14 January 2021, p9 (https://www.gov.scot/publications/coronavirus-covid-19-vaccine-deployment-plan-2021; INQ000147414); INQ000410079_0009; INQ000474476_0010 para 30
- INQ000477804_0001
- INQ000377248_0041 para 5.8
- INQ000493687_0023 paras 93-94; INQ000361639_0003-0004 paras 12-15; INQ000474566_0045-0046 para 184
- INQ000574779_0002-0003; INQ000413805_0004-0006 paras 14-18
- INQ000485992_0001; INQ000410048_0001
- INQ000477804_0002; ‘Coronavirus (COVID-19) update: First Minister’s statement – 19 January 2021’, Scottish Government, 19 January 2021 (https://www.gov.scot/publications/20210119fm-chamber-rmrks; INQ000354302)
- INQ000492335_0031 para 104; INQ000421372_0001
- INQ000493687_0034 para 141
- INQ000412268
- INQ000493687_0037-0038 paras 153-155
- INQ000410143_0001-0002 para 2.1; INQ000412273; Sam Smith-Higgins 15 January 2025 116/6-118/14
- Gillian Richardson 28 January 2025 94/12-95/12
- INQ000276655_0001-0002; INQ000474476_0026 paras 103-104
- INQ000474589_0012 para 29; INQ000479140; see also INQ000474249_0084-0085 paras 246-247
- INQ000474623_0033 para 100
- INQ000474566_0065 para 259; INQ000474558_0054-0055 paras 204-205
- INQ000492099_0006
- Derek Grieve 28 January 2025 10/25-11/7; INQ000499465
- Evaluation of the COVID-19 Vaccination Programme (October 2022), Public Health Scotland, 12 October 2022, p55 (https://publichealthscotland.scot/publications/evaluation-of-the-covid-19-vaccination-programme-october-2022/evaluation-of-the-covid-19-vaccination-programme-october-2022; INQ000283320)
- Melanie Newdick 15 January 2025 65/20-25, 67/5-17, 71/6-17
- INQ000474623_0046 paras 160-161; ‘Estimated number of lives directly saved by COVID-19 vaccination programmes in the WHO European Region from December, 2020, to March, 2023: A retrospective surveillance study’, MMI Meslé, J Brown, P Mook, MA Katz, J Hagan, R Pastore et al, The Lancet Respiratory Medicine (2024) 12(9), 714-727 (corrected 23 June 2025) (https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(24)00179-6/fulltext; INQ000660020)
- Scottish Covid Bereaved Closing Submissions 30 January 2025 208/4-209/5
- ‘Immunisation and vaccines’, NHS Highland, March 2025 (https://www.nhshighland.scot.nhs.uk/health-and-wellbeing/immunisation-and-vaccines; INQ000652091)
- Scotland’s COVID-19 Vaccine Deployment Plan 2021: Update – March 2021, NHS Scotland and Scottish Government, March 2021, p10 (https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2021/03/coronavirus-covid-19-vaccine-deployment-plan-update-march-2021/documents/coronavirus-covid-19-vaccine-deployment-plan-update—march-2021/coronavirus-covid-19-vaccine-deployment-plan-update—march-2021/govscot%3Adocument/COVID-19%2Bvaccine%2Bdeployment%2Bplan%2B-%2Bupdate%2B-%2B24%2BMarch%2B2021.pdf; INQ000376301); INQ000410079_0008; UK COVID-19 Vaccines Delivery Plan, Department of Health and Social Care, 13 January 2021, p7 (https://www.gov.uk/government/publications/uk-covid-19-vaccines-delivery-plan/uk-covid-19-vaccines-delivery-plan; INQ000411678); INQ000276660
- INQ000492335_0021-0022 paras 66-69
- INQ000474623_0042 para 139; INQ000338050_0009
- INQ000474623_0033 para 100
- INQ000474623_0040; Evaluation of the COVID-19 Vaccination Programme (October 2022), Public Health Scotland, 12 October 2022, p55 (https://publichealthscotland.scot/publications/evaluation-of-the-covid-19-vaccination-programme-october-2022/evaluation-of-the-covid-19-vaccination-programme-october-2022; INQ000283320)
- INQ000474623_0030, 0042, 0096 paras 94, 138-139, 324-325
- INQ000474476_0014 para 51; INQ000474249_0070 para 204
- INQ000474249_0029 para 83
- Lara Wong 16 January 2025 48/1-19; INQ000474526_0013-0014 paras 29-31. For the Green Book definition of clinically extremely vulnerable people subject to shielding, see Immunisation Against Infectious Disease (the ‘Green Book’), UK Health Security Agency, 12 February 2021, Chapter 14a, pp9-11 (INQ000474586); Immunisation Against Infectious Disease (the ‘Green Book’), UK Health Security Agency, 26 April 2023, Chapter 14a, pp24-27 (INQ000408795).
- Nadhim Zahawi 27 January 2025 125/18-26/19
- Emily Lawson 27 January 2025 203/9-204/9
- Emily Lawson 27 January 2025 204/10-205/4
- INQ000499497_0002
- INQ000474318_0008-0009 paras 30-33
- INQ000477608_0014
- INQ000474318_0009 paras 32-33
- INQ000234278_0002-0003; INQ000474228_0025 para 113; INQ000474318_0008 para 29
- INQ000234278_0002-0003
- INQ000234278_0002-0003
- INQ000477610
- INQ000477611; Nadhim Zahawi 27 January 2025 108/10-22
- ‘Further opportunity for community pharmacy to contribute to the COVID-19 vaccination programme – extended in specific areas’, NHS England, 12 April 2021 (https://www.england.nhs.uk/coronavirus/documents/further-opportunity-for-community-pharmacy-to-contribute-to-the-covid-19-vaccination-programme-extended-in-specific-areas; INQ000652087)
- INQ000474228_0071 para 258
- INQ000474662_0005 para 25
- INQ000474566_0066 paras 263-264
- ‘Community pharmacy vaccine service launches’, Department of Health (Northern Ireland), 29 March 2021 (https://www.health-ni.gov.uk/news/community-pharmacy-vaccine-service-launches; INQ000390032)
- Evaluation of the COVID-19 Vaccination Programme (October 2022), Public Health Scotland, 12 October 2022, p55 (https://publichealthscotland.scot/publications/evaluation-of-the-covid-19-vaccination-programme-october-2022/evaluation-of-the-covid-19-vaccination-programme-october-2022; INQ000283320)
- Tracey Chantler 28 January 2025 173/16-174/21
- Every Story Matters: Vaccines and Therapeutics, p40 (INQ000474465)
- Every Story Matters: Vaccines and Therapeutics, p40 (INQ000474465)
- INQ000492335_0032 para 108; INQ000474249_0002-0003 para 5
- INQ000474476_0018 para 66; INQ000501330_0058 paras 268-269; INQ000474364_0020-0021 paras 85-88; INQ000474429_0021 paras 72-74; INQ000492335_0032-0033 para 109
- INQ000492335_0032-0033 para 109
- INQ000501330_0059 para 275; ‘“Jab cabs” and “jabs with kebabs” to get thousands more their vital vaccines’, NHS England, 22 January 2022 (https://www.england.nhs.uk/2022/01/jab-cabs-and-jabs-with-kebabs-to-get-thousands-more-their-vital-vaccines; INQ000472323); INQ000474318_0014 para 47
- INQ000474401_0051 paras 6.56-6.57; INQ000492335_0039-0040 paras 132-133; INQ000471988_0023-0024 paras 83-85. For authorisation dates, see INQ000474337_0062-0063, 0067-0068 paras 207-210, 227-231.
- INQ000474401_0052-0053 para 6.61
- INQ000416131. The Oxford/AstraZeneca vaccine was authorised on 30 December 2020 (INQ000474337_0068 para 231), so this request related to the Medicines and Healthcare products Regulatory Agency’s guidance on dosage interval once the imminent authorisation had taken place (INQ000416132).
- INQ000400197_0005-0006 para 10; INQ000474337_0041-0042 paras 131-135
- ‘Statement from the UK Chief Medical Officers on the prioritisation of first doses of COVID-19 vaccines’, Department of Health and Social Care, 30 December 2020 (https://www.gov.uk/government/news/statement-from-the-uk-chief-medical-officers-on-the-prioritisation-of-first-doses-of-covid-19-vaccines; INQ000203969)
- INQ000474401_0054-0057 para 6.68
- INQ000474589_0073-0074 paras 165-168
- INQ000474589_0073-0074 para 166
- INQ000471988_0022-0025 paras 81-87
- INQ000471988_0024-0025 paras 88-89
- INQ000474713_0008 para 29
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, pp4-5 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638)
- INQ000474337_0046 para 147
- INQ000474337_0046 para 149
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, HM Government, 2 December 2020, p5 (https://assets.publishing.service.gov.uk/media/5fec54b4e90e071204fcc317/Priority_groups_for_coronavirus__COVID-19__vaccination_-_advice_from_the_JCVI__2_December_2020.pdf; INQ000234638)
- INQ000474337_0046 paras 147-148
- Joint Committee on Vaccination and Immunisation: Advice on Priority Groups for COVID-19 Vaccination, Department of Health and Social Care, 30 December 2020, p8 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020; INQ000354469)
- INQ000474623_0064-0065 paras 201-203; Christopher Whitty 20 January 2025 79/6-18
- INQ000474337_0237 paras 851-852; INQ000474401 _0060 para 6.80
- INQ000474703_0067 paras 5.176-178
- INQ000474401 _0060 para 6.80
- ‘JCVI issues new advice on COVID-19 vaccination for pregnant women’, Public Health England, 16 April 2021 (https://www.gov.uk/government/news/jcvi-issues-new-advice-on-covid-19-vaccination-for-pregnant-women; INQ000354500)
- INQ000474713_0009, 0014-0015 paras 32, 57; INQ000474695_0011-0012 paras 50-55
- INQ000474713_0008-0009 paras 30-32; INQ000474695_0011-0012 paras 50-58
- INQ000474703_0018, 0066 paras 4.17, 5.175
- Every Story Matters: Vaccines and Therapeutics, p16 (INQ000474465)
- Every Story Matters: Vaccines and Therapeutics, p17 (INQ000474465)
- COVID-19 Vaccine Surveillance Report, UK Health Security Agency, 25 November 2021, p18 (https://assets.publishing.service.gov.uk/media/619f91b68fa8f5037ffaa161/Vaccine_surveillance_report_-_week_47.pdf; INQ000354625)
- In women giving birth in June to August 2021 living in areas with the highest level of deprivation, the percentage who had received one dose was only 7.8%, compared with 26.5% in the least deprived areas. Among women whose ethnicity was recorded as Black, 5.5% of those giving birth in this period had taken one dose of the vaccine, compared with 17% in the White group. See COVID-19 Vaccine Surveillance Report, UK Health Security Agency, 25 November 2021, p19 (https://assets.publishing.service.gov.uk/media/619f91b68fa8f5037ffaa161/Vaccine_surveillance_report_-_week_47.pdf; INQ000354625)
- INQ000474623_0064-0065 paras 201-203. By May 2022, the percentage of women giving birth who had received at least one dose of the vaccine was higher in Scotland (76.8% had received at least one dose, 70% at least two doses), England (73.2% had received at least one dose, 66.9% at least two doses) and Wales (81% had received at least one dose, 77% at least two doses). Part of the reason for this increase may have been that women had already received the vaccine before becoming pregnant. There were no comparable data for Northern Ireland. See Public Health Scotland COVID-19 Statistical Report: As at 26 September 2022, Public Health Scotland, 28 September 2022, p57 (https://www.publichealthscotland.scot/media/15346/2022-09-28-covid-19-publication_report.pdf; INQ000357277)
- INQ000474713_0009, 0011 paras 33, 40, 42
- INQ000203954_0010
- ‘Pregnant women urged to come forward for COVID-19 vaccination’, UK Health Security Agency, 16 December 2021 (https://www.gov.uk/government/news/pregnant-women-urged-to-come-forward-for-covid-19-vaccination; INQ000354556)
- INQ000474401_0060-0061 paras 6.81-6.82; INQ000474333_0059-0063 paras 147-157; ‘Pregnant women urged to come forward for COVID-19 vaccination’, UK Health Security Agency, 16 December 2021 (https://www.gov.uk/government/news/pregnant-women-urged-to-come-forward-for-covid-19-vaccination; INQ000354556)
- Christopher Whitty 20 January 2025 78/21-79/18
- Christopher Whitty 20 January 2025 79/6-13
- INQ000474337_0231 paras 824-826
- INQ000658636; ‘Safety of medications in pregnancy – A novel approach to improving shared decision making’, National Institute for Health and Care Research, April 2025 (https://www.fundingawards.nihr.ac.uk/award/NIHR205013; INQ000659847)
- INQ000474337_0231 paras 824-826; ‘Consultation on the International Council for Harmonisation (ICH) E21 guideline on the inclusion of pregnant and breast-feeding individuals in clinical trials’, Medicines and Healthcare products Regulatory Agency, 3 July 2025 (https://www.gov.uk/government/consultations/consultation-on-the-international-council-for-harmonisation-ich-e21-guideline-on-the-inclusion-of-pregnant-and-breast-feeding-individuals-in-clinica; INQ000659846)
- INQ000474335_0017, 0033-0035 paras 56, 113, 119; INQ000474342_0007-0009 paras 23, 27.2
- INQ000474381_0075 para 259; INQ000474479_0013-0014 paras 7.6-7.7
- INQ000474525_0043 para 161
- INQ000474335_0035 para 119
- INQ000474743_0078 para 6.30; INQ000474335_0013, 0057-0058 paras 36, 179; INQ000474328_0042 para 160
- INQ000493334_0023 para 86
- INQ000474447_0024-0026 paras 94-99
- INQ000474533_0018 para 50
- INQ000474328_0043 para 163
- INQ000474328_0042-0045 paras 161, 164, 168-170
- INQ000474328_0043-0046 paras 165, 171, 173
- INQ000474526_0028-0031 paras 63-66
- INQ000474328_0043-0047 paras 165, 172-179
- INQ000474328_0043 para 163
- James Bethell 29 January 2025 49/17-50/17
- James Bethell 29 January 2025 52/25-54/9
- James Bethell 29 January 2025 53/11-25
Chapter 6: Disparities in vaccine uptake
Introduction
| 6.1. | The UK’s Covid-19 vaccination programmes aimed to get as many people as possible safely vaccinated, as quickly as possible. By late June 2022, about 87% of the UK population aged over 12 years had been vaccinated with two doses, with coverage reaching more than 90% in older age groups by mid-2021.1 This is above other vaccination programmes, which typically achieve 75% of target population cohorts.2 |
| 6.2. | However, there were barriers to achieving even higher figures. They included:
|
| 6.3. | Vaccine hesitancy – indecision about whether or not to get vaccinated – was a key driver in people not taking up the vaccine offer. The factors that caused people not to be able to, or want to, take up a Covid-19 vaccine were complex and varied. They included socio-cultural and political influences, distrust in healthcare systems, past experiences with vaccines or healthcare encounters, understanding and perceptions of risks and benefits, societal norms and pressures, and personal beliefs. |
| 6.4. | This chapter explores the barriers to vaccine uptake and why some groups have lower average vaccine uptake, as well as how trust in vaccination might be increased and practical barriers reduced. It addresses the important issues of vaccine misinformation and disinformation and of the mandatory vaccination of care home staff. |
The scale of disparities in uptake
| 6.5. | The UK government and devolved administrations had anticipated lower uptake of vaccines in some ethnic minority groups and in communities where inclusion in health programmes was historically low.3 As recognised in the Inquiry’s Module 1 Report, emergencies such as pandemics often expose and amplify pre-existing health inequalities.4 |
Ethnicity
| 6.6. | In England, uptake of Covid-19 vaccines among those aged over 50 was highest in the ‘White – British’ group, with 95.4% having received one dose by 27 June 2021. By the same date, uptake was more than 15% lower in the ‘White – Other’, ‘Asian or Asian British – Pakistani’ and ‘Chinese’ ethnic groups and more than 20% lower in the ‘Black or Black British – African’ group. There was more than a 29% gap between people identifying as ‘Black or Black British – Caribbean’ and the ‘White – British’ group.5 |
| 6.7. | In May 2021, the UK government’s Third Quarterly Report on Progress to Address COVID-19 Health Inequalities noted that the ‘Black – African’ population had 65.9% uptake among 70 to 79 year olds and 65.6% among those aged over 80 in England, compared with 96.8% and 97.4% respectively in the ‘White – British’ group for the same ages.6 |
| 6.8. | As the vaccination offer opened to younger age groups, the disparities in uptake between some ethnicities widened further in England. For example, by June 2022, the percentage of people aged 18 or above in the ‘White – Other’ group who had received one vaccination was 66.2%, against uptake of 91.1% in the ‘White – British’ group of the same age. Uptake in the ‘Black or Black British – Caribbean’ group was the lowest of all groups at 58.6%.7 |
| 6.9. | In Scotland, slightly different terminology was used to describe ethnic groups, but the statistics on vaccine uptake showed a similar trend of lower vaccine uptake in some ethnic minority groups across all ages.8 As at 24 August 2021, uptake for the first dose across all age groups was highest in the ‘White’ ethnic groups. For those aged 50 or above, uptake was lowest in the ‘African’ ethnic groups. For those aged younger than 50, uptake was lowest in the ‘Caribbean or Black’ ethnic groups. In the 18 to 29 age group, 75.2% of people in the ‘White’ ethnic groups and 53.1% in the ‘Caribbean or Black’ ethnic groups had received one dose. Within each ethnic group there was a variation of uptake rates across age groups, generally with higher uptake at older ages.9 These trends were mirrored for second doses.10 |
| 6.10. | Public Health Scotland reported some limited data on additional groups, including the ‘Gypsy, Roma and Traveller’ and ‘Polish’ groups. This showed that, as of June 2022, 44.9% of the Gypsy, Roma and Traveller population in Scotland had taken one dose of the vaccine. Uptake of one dose of the vaccine was 52% in the Polish group.11 |
| 6.11. | In Wales, vaccine uptake data were reflected in different descriptions of ethnicity: ‘White’, ‘Black’, ‘Asian’, ‘Mixed’ or ‘Other’. The different approach to definitions in Wales makes direct comparisons with England and Scotland difficult, but the same general trends can be observed. Uptake was lower in ethnic minority groups and lowest among the ‘Black’ and ‘Other’ groups. In the most at-risk group, those aged 80 or over, by 21 May 2021 uptake of one dose was 97.2% in the ‘White’ group compared with 80.7% in the ‘Black’ group and 82.5% in the ‘Other’ group. 12 |
| 6.12. | In Northern Ireland, figures on the percentage of uptake by ethnicity were not available to the Inquiry or its expert witnesses. Northern Ireland’s Public Health Agency noted in May 2022 that there was a lack of accurate data on vaccine uptake by nationality or ethnicity and analysis of uptake was instead conducted by looking at uptake in each geographical area of Northern Ireland.13 The need to gather accurate data on ethnicity and vaccine uptake is considered below. However, using the data available on uptake by area, the parts of Northern Ireland with lowest uptake very strongly correlated with areas with high ethnic minority and migrant worker populations (as well as high social deprivation, as addressed below).14 |
| 6.13. | The gap in vaccine confidence (the trust individuals have in the importance, effectiveness and safety of vaccines) and uptake between different ethnic groups lessened over time.15 Research conducted by the Office for National Statistics covering England, Scotland and Wales found that vaccine confidence and uptake increased in every ethnic group from the first to the second year of the vaccination programme. By July 2021, the confidence gap between people from White and ethnic minority groups still existed but had narrowed.16 |
Figure 2: Ethnic differences in vaccine hesitancy over time
Source: Final Report on Progress to Address COVID-19 Health Inequalities, Race Disparity Unit and Equality Hub, 3 December 2021, p34, Figure 1: ‘Percentage of people who said they were likely to accept or had already accepted the Covid-19 vaccine, by ethnicity and research period’ (https://www.gov.uk/government/publications/final-report-on-progress-to-address-covid-19-health-inequalities/final-report-on-progress-to-address-covid-19-health-inequalities; INQ000089747)
| 6.14. | Across all four nations of the UK, by whatever metric was used, there were significant disparities in uptake, particularly in the early stages of rollout, and some ethnic minority groups received the vaccine in significantly lower numbers. |
Socio-economic status
| 6.15. | Each nation used tools to measure the level of economic and social deprivation (by indicators such as income, health and living environment) in each small local area (usually of an average 1,500 people), against which vaccine uptake in that area could be compared.17 Lower rates of vaccine coverage were linked to higher deprivation in each of the four nations over the whole course of the vaccination programmes.18 |
| 6.16. | The difference was most pronounced in England, where, as of June 2022, adult uptake of two vaccine doses in the most deprived areas was 79.3%, compared with 92.9% in the least deprived areas.19 These disparities appeared across age groups in England. As at 22 April 2021, 83% of those aged 50 or older in the most deprived parts of the population had received one dose of a vaccine, compared with 94% in the least deprived parts.20 Children aged 12 to 15 in the most deprived areas were half as likely to be vaccinated with one dose of the vaccine (when made available to them) as those in the least deprived.21 |
| 6.17. | The picture in Scotland was similar.22 As of May 2022, 81.2% of those aged 12 and over in the least deprived areas had received their second dose of the vaccine, compared with 69.4% in the most deprived areas. For the third dose, across those aged 16 and over, the figures widened further to 76.2% and 56.1% respectively.23 |
| 6.18. | The COVID-19 Vaccination Equity Strategy for Wales recognised that pre-existing, poor health outcomes were exacerbated during Covid-19 by socio-economic disadvantage. It noted the emerging Covid-19 vaccine uptake gap between the most and least deprived communities, observing in March 2021:
“Inequity gaps exist in routine childhood vaccination programmes in Wales … and routine adult vaccination programmes in the UK … Action is needed now to ensure that these emerging inequities do not become embedded within the COVID-19 vaccination programme.”24 By April 2021, uptake of first dose Covid-19 vaccines in Wales was 89.7% in the most deprived areas compared with 94% in the least deprived. 25 |
| 6.19. | In Northern Ireland, monitoring of uptake data by geographical area showed vaccine uptake was lowest in areas of higher deprivation.26 |
| 6.20. | The results of these comparisons mirrored the socio-economic inequalities in health about which the Inquiry heard in Module 1.27 As Professor Clare Bambra and Professor Sir Michael Marmot, expert witnesses on health inequalities, put it:
“There is a clear socio-spatial gradient in health – the more deprived local authorities in the UK have worse health than the less deprived.”28 |
| 6.21. | Across all ethnic groups, higher levels of deprivation were associated with lower vaccine uptake. There was therefore a compounding of inequality of uptake in the most deprived ethnic minority groups. 29 |
Disabled people
| 6.22. | The Equality Act 2010 defines someone as disabled if they have a physical or mental impairment that has a substantial and long-term adverse effect on their ability to do normal day-to-day activities. By this definition, approximately 21% of the UK population are disabled.30 |
| 6.23. | Analysis published by the Office for National Statistics indicated that from January 2020 to March 2022 the majority of Covid-19 deaths in England occurred among disabled people. They had a significantly greater risk of death from Covid-19 than non-disabled people, even after accounting for factors including socio-economic and demographic characteristics and vaccination status. This was the case across the different waves of the pandemic.31 These statistics reinforce the importance of ensuring that disabled people do not face barriers to vaccine uptake. |
| 6.24. | The Inquiry has already identified in its combined Report relating to Modules 2, 2A, 2B and 2C that there were significant gaps in data and knowledge across the UK about the impact of the Covid-19 pandemic on disabled people.32 |
| 6.25. | There were also limited data on disability and vaccine uptake available to the Inquiry’s expert witnesses, due to a lack of data disaggregated by disability in routine vaccine uptake monitoring across all four nations (explored further below). The Office for National Statistics compared vaccine uptake status with census data in England. This was based on 2011 census answers but not linked to medical records.33 It found that, as of March 2021, disabled people in England over the age of 70 had slightly lower levels of vaccine uptake than non-disabled people of the same age, despite the heightened risk in this age group. 34 Within the group, 89.9% of disabled people who were ‘limited a little’ in their activities had taken a dose of the vaccine and 86.6% of those ‘limited a lot’ in their activities had done so, compared with an uptake of 91% in the rest of the population in the same age bracket. 35 |
| 6.26. | However, Office for National Statistics data among disabled people in England revealed that, by March 2023, more disabled people had received four or more doses of a Covid-19 vaccine when compared with non-disabled people. Disabled people were also less likely to be totally unvaccinated than non-disabled people by this stage.36 |
| 6.27. | In Wales, data from about 80% of GP practices were available about people with a learning disability.37 The Inquiry was told that vaccine coverage was eventually higher among this group than in the general population, and this was attributed to the support provided to people with a learning disability and their families and carers.38 |
| 6.28. | The limited data that are available suggest that there was a desire among disabled people to take the vaccine but some disabled people faced barriers which slowed down uptake in earlier stages of rollout. These barriers are addressed below. |
Reasons for lower confidence in vaccines
| 6.29. | In the decade preceding the Covid-19 pandemic, the UK had a relatively high level of uptake of vaccines in comparison to the rest of the world.39 Before the Covid-19 pandemic, the UK population had “stronger beliefs in the importance, safety, and effectiveness of vaccines” than the European Union average and a “very high ranking in overall perceptions” of the influenza vaccine.40 |
| 6.30. | However, there was some decline in UK uptake of childhood immunisation programmes in the decade before 2023.41 Two historic controversies in childhood vaccines fed into vaccine hesitancy in the UK. The first concerned the pertussis vaccine, which is routinely administered to pregnant women to protect against whooping cough, a deadly disease from which babies are particularly at risk. Although found by regulators to be ‘acceptably safe’ for use, there were concerns in the 1970s and 1980s that it could cause brain damage in children. The second, in the 2000s, involved claims of a link between the combined measles, mumps and rubella vaccine (often referred to as MMR) and autism. Such concerns have been entirely discredited in a number of studies conducted over decades, but wide publicity about the disproven claims led to a dip in vaccination levels and left a legacy of more widespread vaccine hesitancy in some communities.42 |
| 6.31. | Lower rates of childhood immunisation have historically existed in ethnic minority and migrant communities.43 London has persistently had the lowest rates of childhood vaccinations in England, closely followed by other urban centres such as Birmingham and Manchester.44 Professor Heidi Larson, expert witness on vaccine hesitancy and confidence, explained that there were limited available data and evidence to explain why these inequalities were occurring but identified a link between ethnic diversity and lower uptake in these urban areas.45 |
| 6.32. | These disparities in childhood vaccination have persisted – despite government efforts to reduce them – and rates of uptake and confidence in routine childhood vaccination programmes have fallen further since Covid-19.46 |
| 6.33. | In the UK and Europe, younger people were also more likely to express hesitant views about Covid-19 vaccinations, with a gradual reduction in hesitancy levels as people got older and particular confidence in vaccines in the over-65s. The difference in attitudes may well be explained by the comparatively lower risk of severe effects of Covid-19 to younger people and the fact that the timing of the offer to them suggested a reduced sense of urgency.47 |
| 6.34. | According to the World Health Organization, vaccine hesitancy involves the ‘3Cs’:
|
| 6.35. | During the Covid-19 pandemic, there was no ‘one size fits all’ approach to the delivery of vaccinations that appealed to all members of society. Younger people, for example, were more likely to take the vaccine via a walk-in slot at a mass vaccination centre.49 Older people or those living in remote areas preferred local delivery. For those on lower incomes, additional travel costs and time missed from work were particular barriers to access and they too were more likely to take the vaccine at a smaller local delivery point.50 As discussed in Chapter 5: Delivery, the mixed model of delivery, with a variety of types of venue and a focus on enabling people to access a convenient delivery point, in a setting which appealed to them the most, was therefore the most effective approach. 51 |
| 6.36. | Across the UK, the central issues driving Covid-19 vaccine hesitancy among a small part of the population were both complacency about the need for vaccines and a lack of confidence in the safety of Covid-19 vaccinations. 52 |
Vaccine safety concerns
| 6.37. | As explained by Professor Larson, an important factor for people deciding whether to receive a vaccination is their view of whether the risks of vaccination are outweighed by the risks of infection.53 Safety concerns about the Covid-19 vaccines were “key drivers” of vaccine hesitancy.54 |
| 6.38. | Some people told the Inquiry’s listening exercise, Every Story Matters, that the speed of the development of the vaccines made them concerned that the vaccines may not be safe.
“I didn’t have an issue with having the vaccine. My issue was, ‘was the vaccine safe enough for me to have it?’ Had it gone through all the checks for it to be safe for me to have it, because I know vaccines work and they do help. So, that was my dilemma but at the time the vaccine was being rolled out I was sceptical that it had gone through all the ethical checks and all the checks that were needed for it to be safe for me to have. So, that was my issue at the beginning.” 55 Contributor, Every Story Matters “I think it’s fair to say that the speed at which it came out did leave a little bit of reticence with some people. It was rolled out very quickly, where other vaccines have taken years to get to market. So there was naturally a little bit of I think general fear.”56 Contributor, Every Story Matters |
| 6.39. | Information about the risk profile of the UK Covid-19 vaccines was conveyed to the public through a number of means, including press briefings, government and departmental websites, the Medicines and Healthcare products Regulatory Agency’s online weekly summaries of Yellow Card reports (see Chapter 7: Post-authorisation safety and surveillance systems), statements from public health bodies and patient information leaflets provided at vaccination centres.57 |
| 6.40. | The Medicines and Healthcare products Regulatory Agency worked in cooperation with other government health bodies such as the UK Health Security Agency (previously Public Health England) to ensure that up-to-date safety information about the Covid-19 vaccines was included in materials for healthcare professionals, such as the UK Health Security Agency’s Immunisation Against Infectious Disease (known as the ‘Green Book’, which provides authoritative information on immunisation for front-line health professionals in the UK). This enabled the public to receive vaccine safety information directly from healthcare professionals.58 |
| 6.41. | Overall, there was a great deal of information about risk in the public domain. However, this did not necessarily mean that government messaging was properly understood. Given the proliferation of government routes by which issues such as safety and risks are communicated and the degree of disinformation and misinformation in the public sphere, there is a need for even more effective methods of informing the public about risks.59 |
| 6.42. | Protocols were in place throughout the UK which required patient information leaflets to be given to people who attended an appointment to be vaccinated, so they could be informed about the risks.60 However, the Inquiry heard evidence that these leaflets were not always provided.61 Furthermore, Professor Stephen Evans, expert witness on vaccine safety, considered that it was very likely that the majority of people receiving a Covid-19 vaccination did not read the patient information leaflet even if they were provided with one.62 |
| 6.43. | There should be greater communication to the public about the importance of the information contained in patient information leaflets and better promotion of them at vaccination sites. Consideration should be given to integrating patient information leaflets with digital resources to ensure that information remains current and easily accessible.63 |
| 6.44. | Relative risk figures can provide a misleading impression without the context of absolute risk figures. To take a hypothetical example: taking a medicine may double the risk of developing an adverse condition compared with not taking it (the relative risk), which sounds like a significant increase. However, if that condition occurs in only one in a million people who do not take the medicine, the doubled risk means that only two people in a million would experience the adverse condition (the absolute risk). This is therefore still a very rare risk64 Conveying risk to the public is complex. To avoid confusion, both figures should be used – and explained – when public health bodies and the government are communicating the risks of serious adverse events to the public.65 |
| 6.45. | An excellent example of effective risk communication was a UK government press conference on 7 April 2021, when diagrams created by the Winton Centre for Risk and Evidence Communication at the University of Cambridge were used to convey the risks of thrombosis with thrombocytopenia syndrome and the benefits of vaccination by age (this is addressed further in Chapter 7: Post-authorisation safety and surveillance systems).66 Similar methods of communication should be utilised more broadly in the event of a future pandemic. |
| 6.46. | It is difficult to overstate the importance of clear and trusted safety information when it comes to instilling confidence in vaccines. In the context of growing global vaccine hesitancy and online misinformation, the government should make every effort to communicate the safety profile of the vaccines to the public. As the Inquiry explores later in this chapter, the key to addressing this is for governments and healthcare providers to forge links with local communities to communicate the safety profiles and benefits of vaccines in a way that is tailored to them. |
| 6.47. | Lack of trust in governments or healthcare providers offering the vaccine tends to make the recipient less receptive to their advice about the risks and benefits of vaccinations.67 Dr Ben Kasstan-Dabush and Dr Tracey Chantler, expert witnesses on vaccine delivery and disparities in coverage, explained:
“Perceptions and experiences of exclusion in one sector or across sectors of statutory services (e.g. healthcare, education, policing and justice) can have legacies that then raise questions for individuals and communities about confidence in government recommendations concerning vaccination and health protection.”68 |
| 6.48. | According to Dr Kasstan-Dabush and Dr Chantler, ethnic minority communities experienced barriers to accessing primary care and poorer-quality healthcare than other groups before Covid-19. These experiences of feeling discriminated against and neglected by healthcare institutions eroded trust and made communities less likely to be confident in an offer of vaccines made by healthcare providers and backed by the government.69 |
| 6.49. | The issues undermining trust were not limited to healthcare. Experiences of racism and discrimination across society as a whole also contributed to vaccine hesitancy in some ethnic minority communities. As Dr Kasstan-Dabush and Dr Chantler told the Inquiry, events that have particularly affected Black people, such as the Windrush scandal and the Grenfell Tower fire disaster, have created a perception that governments have not acted in the best interests of Black communities and have caused a higher level of reluctance to engage with statutory services.70 In addition, there is a shared memory or understanding of historical, unethical medical research targeted at ethnic minority groups (for example, the Tuskegee syphilis scandal in the USA in which hundreds of Black men were subjected to harmful research without their knowledge or consent, then denied proper medical treatment). This led to fears about ethnic minority groups being misled about the nature of the vaccines by the government.71 As Dr Kasstan-Dabush and Dr Chantler described, a lack of confidence in vaccines in this context:
“is a consequence of lived experience of exclusion that affects how government recommendations are viewed”.72 |
| 6.50. | This perception of the reliability of government advice in turn fed into safety concerns. Across all ethnic minority groups with lower vaccine uptake, concerns relating to the safety of vaccines, including side effects and long-term effects, were an important factor leading to vaccine hesitancy.73 People felt that they lacked clear and trustworthy information about the vaccines, including over the speed of development.74 |
| 6.51. | The Federation of Ethnic Minority Healthcare Organisations told the Inquiry that its members were also concerned about a lack of ethnic minority representation in UK vaccination trials.75 The Inquiry’s expert witnesses on vaccine delivery and disparities in coverage and vaccine hesitancy and confidence described lack of representation in clinical trials as a widespread concern in ethnic minority groups which led to anxiety about whether the vaccine was safe.76 These findings were echoed in UK government research into perceptions of vaccines: concerns about the side effects of the vaccines and the speed at which they were developed were “no doubt exacerbated by the lower proportion of ethnic minorities participating in clinical trials”.77 |
| 6.52. | As set out in Chapter 2: Discovery and development and Chapter 4: Authorisation, global trials of the vaccine were sufficiently diverse from a regulatory and safety perspective, but there was under-representation of ethnic minority groups in the trials that took place in the UK. This damaged confidence in the Covid-19 vaccines. Governments should, wherever possible, seek to ensure that manufacturers and clinical trial groups increase the diversity of such trials. |
Vaccine misinformation and disinformation
| 6.53. | Covid-19 was the first pandemic to take place in the digital age, when information can be shared instantly and globally on social media and via instant messaging. People had access to a very wide pool of information outside official government communications.78 |
| 6.54. | One consequence of this was the rapid spread of misinformation (ie inadvertent spreading of false or misleading information) and disinformation (ie false or inaccurate information that is deliberately spread to deceive people). Many false narratives emerged throughout the pandemic, ranging from assertions concerning the effectiveness of vaccines, their chemical constitution and certain side effects, to more grandiose claims that vaccine-related deaths were being concealed or that Covid-19 vaccinations alter DNA.79 In some cases, people posting online may have stood to gain materially – for example, by increasing their own public profile or monetising alternative therapies – by promoting misinformation about vaccines.80 |
| 6.55. | Both misinformation and disinformation thrive in circumstances where lack of trust and access to quality information leaves a vacuum. People who were excluded from official communications because of language or literacy barriers, or who lacked trust in government communications, were more likely to look to alternative sources of information. Notably, those who felt disconnected were then more likely to rely on word of mouth or social media, which then led to heightened exposure to misinformation, thereby fuelling mistrust and further hesitancy. Research by Ofcom on attitudes to communications about Covid-19 found that ethnic minority groups were more likely to rely on social media or people they knew for information.81 Younger people have been found to be more susceptible to misinformation and also to be the most exposed to social media.82 Professor Larson told the Inquiry that it is a challenge to assess the extent to which online misinformation and disinformation causes people not to take up a vaccine, but it is clear that online misinformation and disinformation negatively affected attitudes towards the Covid-19 vaccines and allowed false narratives about the safety and long-term effects of vaccines to be amplified.83 |
| 6.56. | The four nations all adopted the approach across government communications – having considered advice from behavioural specialists – of providing and repeating clear advice and information about the vaccines via public health channels and of not directly engaging with disinformation or misinformation campaigns, in order not to amplify their importance.84 |
| 6.57. | The UK government also had a dedicated team – the Counter Disinformation Unit, within the Security and Online Harms Directorate of the Department for Digital, Culture, Media and Sport – to tackle the issue of online misinformation and disinformation.85 It dealt with online activity in a number of public health areas, including Covid-19 vaccinations. The unit had three main functions in relation to Covid-19 vaccines:
|
| 6.58. | Susannah Storey (Permanent Secretary to the Department for Culture, Media and Sport from June 2023) as well as representatives from Meta (which owns Facebook and Instagram), X (formerly Twitter), Google, YouTube and TikTok told the Inquiry about steps taken to combat misinformation and disinformation. These steps, which differed for each social media company, included monitoring trends in misinformation and disinformation, ranking search results to provide reliable government information to users first, removing content which breached policies on harmful or false information, or labelling content which appeared to be unreliable.87 |
| 6.59. | The Counter Disinformation Unit had ‘trusted flagger’ status with these social media platforms, meaning that when the UK government flagged content as potential misinformation or disinformation, it received attention from the social media companies more quickly than a referral from a member of the public. However, whether to label flagged content as possibly unreliable and offer a link to official government advice – or to remove content altogether – remained exclusively a decision for each social media platform.88 |
| 6.60. | The Inquiry recognises that some of the vaccine injured and bereaved sharing their experiences online felt stigmatised and ignored when their content was labelled as misinformation.89 The Inquiry accepts the need to ensure that action taken to tackle misinformation and disinformation does not silence members of the public expressing genuine public health concerns. |
| 6.61. | However, there was, in principle, nothing unlawful or inappropriate in the government monitoring publicly available social media to identify potential trends in disinformation or misinformation and flagging to social media companies posts and other online content that the Counter Disinformation Unit believed posed a risk of harm to public health, public safety or national security. Its activities were overseen by ministers and scrutinised by relevant parliamentary committees and parliamentarians. Its work was subject to relevant legal obligations, including the Human Rights Act 1998 (which incorporates the rights contained in the European Convention on Human Rights into UK law) and data protection legislation, its civil servants were bound by the Civil Service Code and it was answerable to the Information Commissioner’s Office.90 |
| 6.62. | The unit also had clear policies governing the scope of its functions which ensured that staff had to be satisfied that all data monitoring and analysis which they conducted was lawful, necessary and proportionate and that they had the appropriate internal legal advice and senior approvals.91 Most importantly, it did not access private data and only flagged up information that had already been posted on public platforms.92 The number of posts that it flagged was dwarfed by the millions of pieces of Covid-19 and vaccine-related content that were removed by the social media companies themselves.93 |
| 6.63. | In order to combat misinformation and disinformation, it is essential to engage with communities who may be more vulnerable to it. Targeted ‘myth busting’ at a local level is likely to enhance understanding within these communities and be the most effective way of countering disinformation and misinformation. Educational initiatives on misinformation, such as ‘pre-bunking’ particularly prevalent false narratives, would also help to reduce public susceptibility to misinformation. |
Practical barriers to accessing vaccines
Accessible communication and digital literacy
| 6.64. | Language barriers made access to vaccination more difficult for ethnic minority communities and people who were recent migrants to the UK.94 Covid-19 vaccinations were new, and information about Covid-19 was unfamiliar to the public. This presented an additional challenge in reaching people who did not speak English well.95 |
| 6.65. | Disabled people and recently arrived migrants were also disadvantaged by some of the communication methods that were deployed. Disabled people reported receiving letters and invitations for vaccination in non-accessible formats, delays in receiving QR codes for audio readings of communications, and online booking systems that lacked features for enhanced access, such as easy-to-read translations and telephone options. These are considered further below. Barriers for recently arrived migrants included difficulties with online booking systems. While they offered convenience and ease of access for most, they were not initially available in non-English formats.96 |
| 6.66. | These difficulties were experienced firsthand by some contributors to Every Story Matters.
“[I]f I think about my broader community, some of them don’t necessarily understand English that well, and it was difficult for them, and I didn’t come across the information in a different format … it would be nice if they had thought to find the opportunity to make that information available for people who don’t speak English, to find a community link leader, an Imam, or something like that.”97 Contributor, Every Story Matters “In future we need a lot clearer messaging, especially for disadvantaged communities. People get weary of trusting medical professions and different communities have different language barriers. There was this sense of communities being culled, family members were saying ‘they are out here to get us, do not get the vaccine’. Very little was done to reassure people in their own language, a lot of young people took on the burden of translating this.”98 Contributor, Every Story Matters |
| 6.67. | People who had difficulty with reading faced a barrier accessing printed and digital vaccine information and invitations. These issues were particularly pronounced in communities where the literacy rate is lower, such as the Gypsy, Roma and Traveller ethnic groups.99 |
| 6.68. | The UK government and devolved administrations did take steps to translate information into different languages. Innovative and effective examples included:
|
| 6.69. | However, these strategies were not in place from the beginning of the rollout of the vaccination programme but evolved as it progressed. In a future pandemic, this work should be built upon by using simple messages in a variety of media, translated into community languages, to communicate key messages about vaccination from the earliest possible stage of rollout. In its combined Module 2ABC Report, the Inquiry recommended that the UK government and devolved administrations should each develop action plans for how government communications will be made more accessible during a pandemic, to include the translation of key announcements into the most frequently spoken languages in the UK.105 |
Lack of GP registration
| 6.70. | Clinical information about patients – for example, whether they had a medical condition that might place them in a priority group for Covid-19 vaccination – was generally (but not always) held in GP records. Vaccine management systems used this information to identify patients with health conditions that placed them in a priority group and triggered an invitation to be sent for Covid-19 vaccination.106 Lack of GP registration meant that people who were eligible for a vaccine did not receive an invitation and missed out on receiving information about Covid-19 through a valuable local point of contact. |
| 6.71. | The Inquiry heard that there was a significant lack of GP registration in migrant groups, people in the Gypsy, Roma and Traveller communities and people experiencing homelessness.107 Yvonne MacNamara, Chief Executive Officer of the Traveller Movement (which advocates on behalf of the Gypsy, Roma and Traveller ethnic groups), described the effect of this, saying that if “you’re not on a system; you’re invisible”, and services such as SMS messages with information about Covid-19 did not reach most Gypsies and Travellers.108 |
| 6.72. | One key reason for lack of registration was that GP practices declined to register people if they did not have proof of address or identification. This was despite a requirement in all four nations that GPs register people within their catchment area, even if they did not have the necessary documentation.109 Research conducted in England by the Migrant Primary Care Access Group, a group of campaign organisations advocating for migrant rights to primary healthcare, found that one‑fifth of a sample of applications by vulnerable migrants were rejected, predominantly on the basis of insufficient paperwork.110 |
| 6.73. | In Scotland, similar problems existed, as recognised by a Public Health Scotland report in 2024 on vaccine resources and how they might better serve Gypsy and Traveller communities. It found that the pandemic highlighted pre-existing barriers for these communities, including difficulties accessing GP services in Scotland, and that GPs regularly refused registration due to a lack of identification or proof of fixed address. In one study, as many as 50% of people in the Gypsy and Traveller community were refused registration with a primary care centre.111 |
| 6.74. | Lack of GP registration in migrant and homeless communities and being members of the Gypsy, Roma and Traveller communities were also recognised as barriers to accessing Covid-19 vaccinations in Northern Ireland. The Public Health Agency accepted that this was sometimes the result of the improper refusal of GP practices to register patients, particularly in migrant communities.112 |
| 6.75. | In Wales, lack of GP registration was recognised in its 2021 Vaccine Equity Action Plan as a barrier to vaccination in vulnerable communities. The reasons identified for lack of registration included language barriers and a lack of confidence in the system or lack of understanding of the right to register, rather than refusal to register by GP practices.113 |
| 6.76. | The Inquiry heard about two other interlinked issues particularly affecting migrants which prevented them from accessing a GP. Firstly, people were deterred from registering with a GP because of concerns about their immigration status, an issue explored in more detail below. Secondly, people did not understand their rights or were unable to register because of language barriers, a lack of understanding of the UK health systems or the digitalisation of GP services, which they may not have the technology to access.114 |
| 6.77. | These challenges were recognised in guidance on health inequalities that informed the Joint Committee on Vaccination and Immunisation’s Covid-19 vaccine prioritisation advice of December 2020. It observed that ease of identifying and contacting eligible individuals was essential and that GPs hold the most comprehensive population-based health information systems. It noted:
“Data on inclusion health groups, such as belonging to a Gypsy, Roma or Traveller community, being homeless, or being a refugee, is almost non-existent in GP systems … Incomplete or inaccurate data … increase the likelihood of increasing existing inequalities, reducing public confidence, and slowing the pace of vaccine roll out.”115 |
| 6.78. | NHS England took steps to encourage GP registration among vulnerable groups. It launched the ‘Everyone Is Welcome in General Practice’ campaign in February 2021 to encourage GP practices to train staff to understand that people could register without an address, to advertise this to patients on GP practice websites and to raise awareness via outreach programmes. Access cards were circulated for people to present at their GP surgery to assert their right to registration without an address or identification and regardless of immigration status.116 People were able to attend walk-in centres and be allocated an NHS number at the point of vaccination. Local authorities in England were given the task of keeping records of vaccine uptake in local vulnerable populations among people without an NHS number.117 |
| 6.79. | ‘Access to Healthcare’ cards were introduced by the Scottish Government in 2019. They were intended to assist vulnerable groups, including those experiencing homelessness, people seeking asylum, refugees, and the Gypsy, Roma and Traveller communities. They could be presented at GP surgeries and stated: “I do not need a fixed address, my immigration status does not matter, and I do not need ID.”118 In 2024, Public Health Scotland recommended that GPs and front-of-house staff such as receptionists should be aware of these cards and receive training on the cultural needs of community members.119 The Welsh Government similarly developed GP access cards to support vulnerable groups to register with a GP as part of its 2021 Covid-19 vaccination strategy.120 |
| 6.80. | The success of efforts to register people with a GP depends in large part on the awareness of GP practice staff and members of vulnerable communities that they are entitled to be registered. The Inquiry encourages primary care providers across the four nations to include health inclusion in staff training for those managing GP registration or communicating with patients, to enable them appropriately to register people with no fixed address, no identification or no proof of immigration status, and to communicate these rights to vulnerable individuals. |
Concerns about overseas healthcare charges for migrants
| 6.81. | The Inquiry heard evidence about the effect of The National Health Service (Charges to Overseas Visitors) Regulations 2015.121 These regulations establish a charging regime whereby overseas visitors are required to pay for some NHS services in England. Where a person is in debt for payment of healthcare services, NHS care providers (via the Department of Health and Social Care) are obliged to share that information with the UK government in some circumstances. The existence of debt can form part of Home Office decision-making on immigration status.122 |
| 6.82. | However, primary care (eg GP care) is one of the parts of healthcare to which these charges do not apply. Treatment for Covid-19, including vaccination, was also exempt from the charging regime: no one had to pay for Covid-19 vaccines.123 NHS England put measures in place to ensure that vaccination sites were aware of migrants’ right to receive the vaccine regardless of their immigration status.124 |
| 6.83. | Initially, information about the exemption was available on a public health website accessible to clinicians. When there was wider publicity from February 2021, it was via press releases in newspapers unlikely to be accessed by migrants.125 The UK government created videos to share with migrants explaining their entitlement to free primary care and vaccination, and there were some pop-up clinics to vaccinate migrants housed in hotels.126 There were also examples of targeted community events encouraging people to receive the vaccine in locations with large migrant populations, as the Inquiry explores in more detail below. |
| 6.84. | Nonetheless, the charging regime in England and its application to other non-Covid-19 conditions appears to have deterred some migrants from seeking Covid-19 vaccination. Some migrants were concerned that, if they approached a healthcare provider for vaccination, their details would be shared with the Home Office or they might face immigration checks.127 |
| 6.85. | The Inquiry received evidence from Doctors of the World, the Joint Council for the Welfare of Immigrants, Kanlungan (consisting of Filipino and South-East and East Asian grassroots community organisations) and Medact (a membership organisation for health professionals) that the exemptions to the charging provisions for Covid-19 vaccinations were not properly communicated to migrants.128 The combination of confusion about whether the vaccines were chargeable, lack of trust in the government and concern that their details would not be shared with the Home Office led to vaccine hesitancy in this group.129 |
| 6.86. | These fears also had the potential to cause vaccine hesitancy in Wales, Scotland and Northern Ireland, where the same charging regime did not apply but migrants may have been unaware of the differences in law between the nations.130 |
| 6.87. | It has not been possible to separate out the effect of perceptions of the charging regime from the other barriers to vaccination sometimes experienced by people in migrant groups, such as language barriers or a more general lack of trust in government messaging. These complex and interlinked barriers to vaccination are explored in more detail below when the Inquiry examines why there was disparity in vaccine uptake between some ethnic groups. However, the Inquiry is satisfied that communication should have been more carefully targeted to reach migrants from an early stage of the rollout, in order to reassure them that charging provisions did not apply to Covid-19 vaccines and that their health data would not be shared with the Home Office if they attended to receive the vaccine. In a future pandemic, the UK government should consult with groups representing migrant communities before rollout begins, to plan how best to deliver this targeted information from trusted sources in a variety of community languages. |
Physical accessibility and accessible communications
| 6.88. | Each of the four nations had laws and procedures in place which required healthcare providers to make reasonable adjustments to venues to ensure that they were accessible to disabled people. This meant that existing vaccination venues, such as GP practices and pharmacies, should have had appropriate adaptations in place and, during the pandemic, newly commissioned mass vaccination centres, for example, could be accessed via ramps or lifts where possible.131 However, the Inquiry was told of concerns about the physical accessibility of vaccine venues. Kamran Mallick, Chief Executive Officer of Disability Rights UK, told the Inquiry about the experience of a member in England who had cerebral palsy and was an electric wheelchair user, who attended a mass vaccination centre that did not have working wheelchair access, despite there being no indication of the limitations of the venue on its website.132 |
| 6.89. | Similar concerns were expressed by some contributors to Every Story Matters, who shared their experiences.
“I couldn’t access the pharmacy vaccination service because I am mobility disabled and car parking is not guaranteed … all disability accessible vaccination centres were fully booked for months!”133 Disabled contributor, Every Story Matters |
| 6.90. | Accessibility requirements also applied to communications – for example, requiring British Sign Language users to be provided with access to interpreters at vaccination centres and GP practices.134 However, one Every Story Matters contributor told the Inquiry that this was not their experience.
“When I got to the vaccine centre I was so paranoid about everybody being in a mask, I had to take my daughter with me, and she had to interpret because we couldn’t get any interpreters at all. I shouldn’t really have been using my children to interpret for me. That’s not appropriate at all.”135 Deaf contributor, Every Story Matters |
| 6.91. | There were concerns from Disability Rights UK, Disability Action Northern Ireland, Disability Wales and Inclusion Scotland that the communication accessibility standards set by the four governments were not always met during the vaccine rollout.136 The Inquiry heard that, in England, some disabled people received invitations for the vaccination in non-accessible formats – for example, in standard font which those with sight loss were unable to read.137 |
| 6.92. | As the vaccine delivery programmes progressed, each nation made efforts to tailor communication to people with learning disabilities and autism, including producing communication guides and videos for people delivering the vaccine and producing vaccine information in easy read format.138 In some areas, temporary pop-up clinics, home visits and quiet rooms at clinics were also used for those who needed extra support or found busy vaccination sites challenging.139 |
| 6.93. | However, most measures aimed at ensuring accessible communications were not in place from the beginning of delivery – they evolved as the vaccination programmes developed. |
| 6.94. | For example, in February 2021, in Scotland, the Chief Medical Officer and Chief Nursing Officer created specific guidance on adjustments for people with learning disabilities and introduced an initiative under which learning disability nurses vaccinated the service users under their care, rather than requiring them to attend venues which may not be tailored to their needs.140 A Public Health Scotland evaluation – An Inclusive Approach to Flu and COVID-19 Vaccination Service Delivery in Scotland, published in October 2021 – recognised improvements made in the spring and summer of 2021: for example, better recording of communication preferences and improving the accessibility of vaccine invitations (following consultation with the Royal National Institute of Blind People).141 Disabled people’s organisations were included in the National Vaccine Inclusion Steering Group in Scotland from March 2021 and were able to provide ideas for accessible methods of vaccination.142 |
| 6.95. | In Wales, people from disabled people’s organisations were represented on the Vaccine Equity Committee (a committee of experts and interest group representatives established to provide advice to the Welsh Government on fair access to vaccines by addressing barriers to traditionally underserved groups) when it began meeting in the spring of 2021.143 In one example of its work, Learning Disability Wales reported to the committee on the best methods to enable vaccination of learning-disabled people, including those with severe autism, thereby assisting in the development of communications.144 |
| 6.96. | The inclusion of representatives in these groups was a positive step and resulted in disabled people directly feeding into government approaches to equality of access. It provided a valuable opportunity to challenge practices that were not working for disabled people. |
| 6.97. | Many of the barriers faced by disabled people are predictable. As far as possible in a pandemic scenario, work on ensuring that vaccines are accessible to disabled people should start in advance of vaccine rollout and continue throughout the delivery programme. It should include direct engagement with organisations representing disabled people by inviting them onto committees and groups dedicated to increasing access to vaccines. This could then inform how vaccine invitations, booking systems and vaccination sites can be designed to be accessible to as many people as possible and act as a platform for any difficulties to be raised. |
| 6.98. | As noted in the Inquiry’s combined Module 2ABC Report, it is imperative that key public health communications are accessible to disabled people. This did not happen at the outset of the pandemic, although the accessibility of the UK government’s communications approach improved as the pandemic progressed. The Inquiry has already recommended the development of action plans for how government communications will be made more accessible in a future pandemic.145 This should extend to communications about vaccination. |
Vaccination as a condition of deployment in England
| 6.99. | Care home staff were included in priority cohort 1 for vaccination and were among the first people in the country entitled to receive a vaccine.146 |
| 6.100. | From December 2020, mobile units delivered vaccines to residents and staff in care homes across a number of visits to each home.147 There was no facility to record occupation at the point of vaccination, so the UK government relied on care homes to report the number of staff vaccinated via the adult social care Capacity Tracker tool, which had been first introduced in England in the spring of 2020 to report bed vacancies and manage capacity in care homes during Covid-19.148 The Association of Directors of Adult Social Services told the Inquiry that its members in England had concerns over potential under-reporting of vaccine uptake by care home staff via this tool because the reporting system was difficult to use and placed a burden of work on care home managers during the pandemic.149 The Inquiry notes that the UK government has now made changes to the Capacity Tracker in recognition of the potential for gaps in quality social care data under the system of self-reporting. Since July 2022, regulated adult social care providers in England have a statutory duty to provide mandatory information to the Capacity Tracker, including on staff and resident vaccination status, and there has been investment in the management of the data to seek to reduce the administrative burden on care homes.150 |
| 6.101. | In February 2021, the UK government discussed the introduction of legislation requiring people working in adult care homes in England to be vaccinated as a condition of their deployment.151This proposal was prompted by what was perceived to be a low rate of Covid-19 vaccination among care home staff, which was identified as 66% in a meeting with Boris Johnson MP, Prime Minister from July 2019 to September 2022, on 10 February 2021.152 |
| 6.102. | On 25 February 2021, Helen Whately, Minister for Social Care from February 2020 to September 2021, told Mr Johnson that 72% of adult care home staff who were eligible for vaccination (70% of all staff) were vaccinated.153 Some staff could not be vaccinated – for example, because they were pregnant or had tested positive for Covid-19 in the last 28 days. It was estimated that “6–8% of staff have refused”.154 Approaches taken to encourage or enable staff to take up the vaccine included:
|
| 6.103. | By the beginning of March 2021, the Department of Health and Social Care was, in parallel to these measures, pursuing development of a policy to mandate vaccination for care home staff following a “clear steer” from Mr Johnson to do so.156 |
| 6.104. | The Social Care Working Group of the Scientific Advisory Group for Emergencies (SAGE) advised in March 2021 that a staff uptake rate of 80% for a single dose was needed in each individual care home to provide a minimum level of protection to residents against outbreaks of Covid-19.157 |
| 6.105. | The discussions about whether to introduce vaccination as a condition of deployment were political decisions which were not led by clinical advice.158 Advice from the Office of the Chief Medical Officer on the issue in March 2021 was confined to stressing that the UK government should be “extremely upfront” about the fact that some people would have side effects as a result of the vaccination.159 |
| 6.106. | On 14 April 2021, the UK government launched a consultation on making vaccination a condition of deployment in care homes with older adults.160 The majority of healthcare staff and members of the public were opposed to the policy, whereas care home providers were, overall, strongly supportive of the policy.161 Unions representing care home workers suggested that workers were more likely to decline the vaccination if they felt threatened by employers.162 |
| 6.107. | By June 2021, the overall figure for uptake among eligible staff of a single dose was 84.1%, which exceeded the SAGE Social Care Working Group threshold, and 70.2% for two doses.163 |
| 6.108. | Nonetheless, the UK government remained concerned that there was significant variation at the regional, local and individual care home levels. It was thought that the average figures masked the fact that only 64.7% of older adult care homes in England were meeting the threshold of 80% of staff and 90% of residents being vaccinated with at least one dose as set by SAGE’s Social Care Working Group, falling to 44.1% for London.164 |
| 6.109. | The issue facing the UK government was how to strike a balance between the need to:
|
| 6.110. | On 16 June 2021, the UK government announced vaccination as a condition of deployment in care homes.166 This meant that anyone working in a Care Quality Commission-registered care home in England was required to have two doses of a Covid-19 vaccine unless they had a medical exemption. The policy came into effect on 11 November 2021.167 |
| 6.111. | On 9 November 2021, the UK government announced that the vaccination as a condition of deployment policy for care home staff would be extended to all front-line health and social care workers in England (ie those who came into contact with patients or service users), unless the worker was medically exempt.168 However, on 1 March 2022, one month before it was due to come into effect, the UK government announced that the policy would not be implemented and that the existing policy for care home workers would be revoked.169 This reversal was based on departmental advice on 20 January 2022 to Sajid Javid MP (later Sir Sajid Javid, Secretary of State for Health and Social Care from June 2021 to July 2022). It set out the updated evidence about the reduced effectiveness of the vaccines on transmission of the new dominant Omicron variant of Covid-19 and the anticipated impact on the workforce. It was estimated that 50,000 NHS workers who would fall under the policy would not be vaccinated by the start of February 2022. There was a real risk of service disruption if workers could not be deployed and needed to be dismissed at the planned implementation date.170 |
| 6.112. | Sir Sajid Javid told the Inquiry that the main reason that the UK government did not proceed with the policy for front-line health and social care workers was scientific advice that the vaccines were less effective against transmission of the Omicron variant. There was no longer sufficient justification to continue or extend the policy.171 |
| 6.113. | England was the only nation of the UK to introduce mandatory vaccination for care home staff. In Scotland, Wales and Northern Ireland, vaccination as a condition of deployment was considered but not pursued. The Scottish Government noted the difficulties in enforcement and potential loss to the workforce and doubted such a measure would be proportionate.172 Instead, it:
“focused on working with health and social care employers, providers, trade unions and professional organisations to encourage uptake of the Covid-19 vaccination”.173 |
| 6.114. | In Wales, rates of vaccination among care home staff were higher than in England and the Welsh Government concluded that, for the 9.7% of care home staff who had not received a vaccine:
“there were alternative avenues to improve vaccination take-up that were yet to be fully exploited and that those options should be exhausted before a change in policy mandating vaccination”.174 The Welsh Government noted that public trust in vaccination is “very important” and people should “not feel forced into vaccination”.175 Similarly, in Northern Ireland, there were “concerns the measure could have been counterproductive and lead to workforce challenges”.176 |
| 6.115. | The Inquiry heard from Professor Larson about the impact of such policies on trust and confidence in the vaccination programme. Research from across Europe indicated that mandatory requirements increase vaccine uptake in the short term. In the longer term, however, mandatory requirements can lead to resentment and a feeling of regret at having been compelled to take the vaccine. Professor Larson described such policies as a “trust breaker”, which could harden sentiments against vaccines and lead to a lack of confidence in government vaccination programmes.177 |
| 6.116. | The policy of vaccination as a condition of deployment did not command wide support from professionals in England, and is likely to have contributed to alienation and increased vaccine hesitancy in some groups. It would have been more effective to focus on co-delivery of vaccinations to staff and patients in care homes, along with targeted schemes to increase vaccine confidence among health and social care workers in areas of lower uptake. The Inquiry encourages education on vaccination programmes to feature in routine training for staff in front-line health and social care work in all four nations. |
Building trust and enabling access
| 6.117. | The UK government and devolved administrations were aware, from the earliest stages of vaccine delivery, of the historically lower rates of vaccination in ethnic minority groups, in areas of higher deprivation, and among people who were socially excluded.178 |
| 6.118. | The Vaccine Equalities Committee was created by NHS England in January 2021 to advise and guide the vaccine deployment programme on addressing inequalities, with representatives from government departments, local authorities and non-government organisations. In February 2021, the UK government published its UK COVID-19 Vaccine Uptake Plan, which, alongside the work of the committee, aimed to set out the plan for increasing vaccine confidence across all communities.179 The plan to increase uptake involved empowering local health providers and directors of public health to develop strategies to meet the needs of their own communities, informed by UK-wide coverage data showing gaps in uptake.180 The Inquiry heard that, in England, there was an initial lag in providing detailed coverage data from central government to local authorities, but this was improved as the programme and IT systems developed.181 |
| 6.119. | The emphasis of the UK COVID-19 Vaccine Uptake Plan was to tailor communications and services to the communities the government wanted to reach, using trusted voices from that community. Examples of this outreach work include:
|
| 6.120. | The Community Champions Scheme in England provided specific funding for projects designed to reach communities with lower uptake. It was launched in January 2021 with £23.75 million in funding to share between 60 local authorities. A further £22.5 million was allocated in the same way via a second scheme, the Community Vaccines Champions Scheme, in January 2022.187 Evaluations of the schemes found that they had a positive impact on vaccination rates by supporting local vaccination pop-ups, translating and circulating information, and responding to misinformation. Most importantly, the schemes helped to build trust in the vaccines and answered questions raised within communities about the safety of the vaccines. The flexibility to allocate funding locally and set aims according to local needs was central to this success.188 |
| 6.121. | In Scotland, a Vaccine Equalities and Inclusion Team was set up in February 2021 and a National Vaccine Inclusion Steering Group held its first meeting in March 2021. Local health boards in Scotland were asked to formulate their own inclusion and delivery plans.189 Some examples of work done by Public Health Scotland and health boards to reach communities with lower uptake included:
|
| 6.122. | The Covid-19 Vaccination Equity Strategy for Wales mapped out the approach to identifying and reaching communities with lower uptake.191 The introduction of the strategy coincided with the formation by the Welsh Government of the Vaccine Equity Committee. A Wales-wide Covid-19 Vaccine Equity Action Plan was developed to ensure uniformity of approach in the strategies used to reach communities with lower uptake, which were devised and carried out by local health boards.192 This work involved developing specific messages for dissemination through a network of community leaders and third sector organisations – for example, work with Muslim Doctors Cymru, using social media to disseminate positive messages appealing for people to come forward for vaccination and webinars in the Bengali language aimed at people from the Bangladeshi community.193 |
| 6.123. | In Northern Ireland, a Covid-19 Vaccine Low Uptake Working Group was set up within the Public Health Agency. There were projects to enable migrant workers to receive vaccination, vaccination sites at rural farmers’ events, pop-up sites in urban areas identified as having high levels of deprivation, and myth-busting and communication toolkits aimed at pooling resources and information to address low uptake.194 |
| 6.124. | Despite these efforts, the disparities in uptake between White British and ethnic minority groups and people living in areas of greater and lower deprivation persisted throughout the Covid-19 pandemic. This requires urgent action. The process of building trust with 4communities and reducing vaccine hesitancy will take time and it is not known when the next pandemic will hit. If governments delay the formation of a more effective strategy to address vaccine hesitancy, it may come too late to be effective for a future vaccination programme. |
| 6.125. | The UK government and devolved administrations and the Inquiry’s own experts shared a common view about what overall strategy appeared to work best to increase uptake: outreach tailored to individual communities and informed by local knowledge. Whether the communication was virtual or in person, the key to the success of these efforts was:
|
| 6.126. | The experience of Covid-19 in the UK demonstrates that one cannot expect to see high coverage by acting only during a public health emergency. Long-running and entrenched inequalities need to be tackled between emergencies by using local, place-based partnerships. There needs to be a frank recognition of how to build trust with marginalised communities and what investment is required. There must be a better and clearer process of direct consultation between health and public health agencies and representatives of those groups facing barriers to vaccine uptake, or with lower vaccine uptake, leading to the formation of partnerships and strategies for increased vaccination. |
| 6.127. | Dr Kasstan-Dabush and Dr Chantler told the Inquiry that health visitors (specialist public health nurses who support pregnant women and families with children under five years old and offer advice on development and family health) had the potential to play an important role in enhancing vaccine confidence and uptake within communities with historically lower vaccine coverage.196 As they often have regular contact with families in their homes and build trust, hold local knowledge and already play a role in discussing routine childhood vaccinations, health visitors are well placed to offer routine childhood vaccines to families who have not responded to invitations to vaccination, and could have offered vaccination to eligible pregnant women or children in the Covid-19 pandemic.197 |
| 6.128. | On 1 January 2026, the UK government announced a £2 million pilot scheme which will run in five regions in England, offering the most vulnerable families routine childhood vaccination by health visitors in children’s homes. The scheme specifically aims to reach families who have “fallen through the cracks”, including those not registered with a GP, struggling with travel costs, or with language barriers or other “tough circumstances that stop them getting to the doctor”.198 The pilot is due to be extended across England in 2027.199 This is a promising example of how to deliver vaccines, and reliable vaccine information, via trusted health professionals in a way which is convenient to groups who experience barriers to vaccination. If the scheme is a success, it will help enhance confidence in vaccination programmes, better enabling groups with historically lower vaccine uptake to take up the vaccine offer when the next pandemic hits. |
| 6.129. | The Inquiry welcomes the publication in July 2025 of the UK Health Security Agency’s Immunisation Equity Strategy: Commitments for 2025 to 2030 for England.200 The strategy sets out aims and measures for achieving effective vaccine-preventable disease surveillance and efficient vaccine delivery, and for addressing the root causes of disparities in vaccine uptake which were exposed during the Covid-19 pandemic. The key principles of the strategy include collaboration with communities and local vaccine providers in areas of lower vaccine uptake and timely access to high-quality data in order better to identify areas of lower uptake. The Inquiry encourages the UK government to work towards its aims as quickly as possible. |
| 6.130. | All four governments should coordinate their policies and ensure that relevant immunisation policies are in place to improve equality in the uptake of vaccines, particularly by building and maintaining links with community organisations, both in routine vaccination campaigns and in a future pandemic. |
Recommendation 2: Formalise work with communities about vaccine equity strategies
The UK government, Scottish Government, Welsh Government and Northern Ireland Executive should maintain networks with local communities to produce targeted vaccination strategies and communications.
To achieve this:
- The Scottish Government, Welsh Government and Northern Ireland Executive should establish local community networks, mirroring the approach being taken by the UK Health Security Agency.
- All four governments should work with their networks to identify specific and measurable actions to improve vaccine uptake and reduce inequalities and consult with these networks on communications campaigns and delivery approaches.
All four governments should publish a report annually on progress against these actions.
Data for monitoring and evaluating vaccine uptake
| 6.131. | In order for any strategy aimed at increasing vaccine uptake to be effective, governments need to be able to identify parts of the population with lower vaccine uptake, in both routine vaccination and pandemic scenarios. Attitudes to vaccines change over time and it is therefore important that public health agencies monitor confidence on an ongoing basis to detect and take action on dips in confidence.201 |
| 6.132. | Accurate data about demographics are key to spotting trends. Although the systems for the collation and analysis of vaccine delivery data were good, there are nevertheless still some gaps across the UK in the recording of data on ethnicity and disability. |
Data systems to monitor uptake
| 6.133. | During the Covid-19 pandemic, the governments of each of the four nations adapted or developed data collection and IT systems in order to monitor vaccine uptake – including details such as age, gender and location. Statistics on uptake were published on vaccine surveillance ‘dashboards’ in each nation. These reports became more detailed as technology developed. Transparency about levels of uptake was important to allow members of the public and public health professionals to understand how the vaccination programme was progressing and to identify where uptake was lower.202 |
| 6.134. | In England, the National Immunisation Management System was used. It had been developed for the influenza vaccination programme and performed a number of functions, including issuing invitations for vaccination and recording the details of each vaccination in the NHS England data store.203 The National Immunisation Management System was able to estimate the population within a particular ethnic or age group by using NHS England data from people who were registered with a GP and had an NHS number.204 |
| 6.135. | Office for National Statistics data were also used in England to provide population estimates and demographic information. At the time of the Covid-19 vaccine rollout, the data came from the last UK-wide census in 2011 and were therefore out of date. Nonetheless, they were combined with the National Immunisation Management System data to give vaccine delivery planners in England as much information as possible to assess where the vaccines were required and which geographical areas or groups had lower uptake.205 |
| 6.136. | As the vaccination programme developed, a Vaccine Equalities Tool was added to the NHS England monitoring system. It was available to NHS England leaders and directors of public health from March 2021. This tool allowed data on who had received the vaccine to be broken down by priority group, geography, ethnicity and deprivation so that local vaccine providers could take steps to engage groups taking up the vaccine offer in smaller numbers.206 |
| 6.137. | A further source of information about disparities in uptake in England was the OpenSAFELY research platform, created through collaboration between a number of academic and public health research bodies. It pooled anonymised GP electronic patient records to analyse vaccine coverage by age, ethnicity, deprivation and health conditions. From the end of January 2021, the OpenSAFELY platform produced reports – at that time covering about 40% of GP practices in England – which indicated that disparities in coverage (eg in ethnicity and deprivation levels) could be seen from the beginning of the vaccine rollout programme.207 |
| 6.138. | In Scotland, the Scottish Vaccine Management Tool was used to collate uptake data. However, the Scottish Government did not publish statistics on uptake by ethnicity until March 2021 and the Vaccine Management Tool did not initially record ethnicity data. Instead, ethnicity data were gathered by linking census data and medical records – and therefore covered only about 70% of patients.208 This gap in the available data was recognised and acted on by Public Health Scotland and, by November 2021, the Vaccine Management Tool directly recorded ethnicity.209 |
| 6.139. | Prior to the introduction of the Covid-19 vaccination programme, Northern Ireland did not have a population-wide vaccination programme data system. The Northern Irish Vaccine Management System was introduced from January 2021. It compiled Health and Social Care trust and GP data, based on the list of all patients registered with a Health and Care Number in Northern Ireland.210 The Vaccine Management System was capable of collecting data on ethnicity from these sources, but its use was limited because it too was based on data on demographics from the 2011 census.211 |
| 6.140. | Wales developed the Welsh Immunisation Service, which recorded vaccine uptake and supported the invitation system.212 The Welsh Immunisation Service included all patients registered with the NHS in Wales. People who were not already registered with the NHS could be issued with a temporary NHS number. It did not hold complete data on ethnicity. The Welsh Government therefore worked with Swansea University’s Secure Anonymised Information Linkage Databank, which contained anonymised health and social care data for Wales, to map uptake by ethnicity and deprivation factors as fully as possible.213 |
| 6.141. | These innovations in data systems during the Covid-19 vaccination programmes were positive and should be retained so that they can be used in the event of a future mass vaccination programme. The Inquiry was told that the development of the digital infrastructure needed to support vaccine uptake monitoring systems was a priority in each nation and that improvement of these systems was ongoing.214 |
| 6.142. | However, three generic issues prevented these systems from holding a comprehensive picture of uptake across the UK:
|
Defining ethnicity in uptake data
| 6.143. | As observed by the Federation of Ethnic Minority Healthcare Organisations, in the context of a pandemic, “you can’t fix what you can’t see”.218 Without accurate representation of ethnic minority groups in healthcare data, it is more difficult to identify which communities have lower vaccination rates and to make vaccine access easier and more appealing. |
| 6.144. | There are specific challenges in keeping accurate and consistent definitions of ethnic groups in public health records. As noted in the UK government’s Third Quarterly Report on Progress to Address COVID-19 Health Inequalities, published in May 2021, there were different levels of detail in the ethnic groups recorded in health records (varying from 5 to 18 categories of ethnicity) and the level of detail in classification was often dependent on the number of participants in surveys or analysis.219 Broad categories such as ‘White’, ‘Black’ and ‘Other’ mean that people who have distinct ethnic and cultural backgrounds within these groups are homogenised. A failure to capture important distinctions makes it more difficult to spot trends in uptake and address disparities.220 |
| 6.145. | Professor Larson told the Inquiry:
“[W]hile an individual may be recorded in the UK Census as part of a specific ethnic group, they may be categorised as something else (e.g., ‘Other’) in the health records depending on the coding framework in place. Such discrepancies hinder the ability to produce reliable and consistent population and health data, which is crucial for identifying and addressing disparities.”221 |
| 6.146. | These difficulties are not easily overcome because ethnicity can encompass nationality, heritage, geography and religious group, which often “do not align neatly with predefined categories”. Self-identification and identification by others depend on the context and can change over time.222 |
| 6.147. | This was a particular issue for people in the Gypsy, Roma and Traveller communities. The NHS England data dictionary (the bank of codes used by GPs to record ethnicity in patient records) reflects the ethnic categories used in the 2001 census and does not therefore include a category for people in the Gypsy, Roma or Traveller ethnic groups.223 If they were registered, their ethnic identity was often recorded as ‘any other’ or ‘any other White’. What limited data are available suggest that Gypsy, Roma and Traveller groups may have the lowest vaccine uptake of all communities.224 |
| 6.148. | The improvement of ethnicity coding was described as a “high priority next step” in the UK government’s Final Report on Progress to Address COVID-19 Health Inequalities.225 The Inquiry is pleased to learn that updates to the system of recording ethnicity in health records, including adopting the 2021 census ethnic group categorisations, are currently under consideration by the Department of Health and Social Care.226 The Inquiry encourages the Department of Health and Social Care to ensure that the Gypsy, Roma and Traveller ethnic groups are included in categories of ethnicity in health records so as to improve the visibility of these groups in vaccine surveillance efforts. |
Data on disability
| 6.149. | There were major gaps in collection of data about disabled people and levels of impairment throughout the pandemic, and this extended to vaccine uptake data.227 The National Immunisation Management System, Scottish Vaccine Management Tool and Northern Irish Vaccine Management System did not record disaggregated data on disability at the point of vaccination.228 The Office for National Statistics figures from the 2011 census provided no more than “estimates for vaccine coverage by … disability status”.229 As the Cabinet Office Disability Unit recognised in March 2021, the assessment of vaccine uptake among disabled people relied on matching data from often incomplete healthcare databases with near decade-old census returns. People had specific health conditions recorded in their GP patient record, but there was no method for recording whether someone was disabled or non-disabled. Primary care data were therefore not helpful in monitoring vaccine uptake among disabled people and did “not adequately cover the breadth of disability by Equality Act 2010 definition”.230 |
| 6.150. | NHS England confirmed to the Inquiry that physical disability data were not captured on GP records or at the point of vaccination. It was suggested that doing so would be difficult because of the absence of agreed definitions of disability or types of disability and the added work this would place on GPs.231 |
| 6.151. | However, it should be possible to agree on a definition of disability and to keep a record of the fact of that disability in primary care records. The definition adopted by the Office for National Statistics, for example, is “a self-reported long-standing illness, condition or impairment that causes difficulty with day-to-day activities”. This is consistent with the Equality Act 2010 definition.232 |
| 6.152. | There is a large spectrum of conditions and levels of impairment that might be captured by any definition of disability, but the fact that a record of disability would not provide an absolutely clear picture does not mean it should not be gathered at all. Data on uptake of vaccines according to disability would be helpful in identifying gaps in vaccine uptake and cross-checking the impact of disability against other factors, such as age, deprivation and ethnicity, to identify trends. |
| 6.153. | The UK government and devolved administrations should consider adding a facility for disability status to be recorded in primary care records. This is an area in which the introduction of a single location for patient data, linked across health and social care providers, has the potential to enable governments to record disability status in a comprehensive way and monitor the impact of disability on vaccination uptake during a pandemic. |
Evaluating the different efforts to improve uptake
| 6.154. | Governments took action in a number of ways in a short space of time to try to increase vaccine uptake. One challenge recognised by vaccination programme leaders during the pandemic was the difficulty in separating the impact of one government intervention designed to increase uptake from another.233 Where vaccine uptake did increase in a particular community, that change might have happened for a number of possible reasons, including increased confidence in the safety of vaccines over a period of time. It is difficult to know what did and did not work so that governments can repeat and improve on successful strategies. |
| 6.155. | Dr Kasstan-Dabush explained that – in part due to the speed of the rollout – evaluation processes were not built into the vaccination programmes.234 He identified proper evaluation as a crucial missing part of the picture which would allow governments to build towards better outreach strategies:
“We know across the four nations that there were disparities among particular minority populations. So to understand … how effective were those outreach strategies, what did we learn, what was trialled in one jurisdiction and how could that inform approaches in another, the ability to have that information in front of us … we didn’t have it. It was limited.”235 He told the Inquiry that access to vaccines would be best improved by a UK-level approach to evaluation of vaccination programmes, with some “minimum standard requirements for evaluation”.236 |
| 6.156. | As Professor Larson explained, measuring vaccine hesitancy is essential to identify trends and make targeted interventions. Ongoing monitoring can also help evaluate the effectiveness of interventions – whether a particular government action built confidence in vaccine safety and reduced hesitancy. There is no “quick fix” to vaccine hesitancy and it requires “ongoing vigilance”.237 |
| 6.157. | In its 10 Year Health Plan for England, the UK government announced that a new ‘single patient record’ will be introduced in England, bringing all of a patient’s medical records into one place and making them accessible to patients via the ‘NHS App’ (a digital tool which can be downloaded onto a mobile phone or other electronic device and used to access a range of NHS services in England and the Isle of Man). It has been described as a “patient passport” which will ensure that clinicians can access patient information from anywhere in the NHS in England to provide “seamless care” by 2035.238 It is planned that by 2028 the NHS App will apply to the entire NHS in England and will include tools for management of medication, booking appointments, communication with health teams and storing records.239 |
| 6.158. | The single patient record has the potential to be transformative for recording patient ethnicity data and ensuring linkage of data across different healthcare providers, so that data recorded in one healthcare setting are accessible to the whole healthcare system. This in turn will improve the ability of governments to evaluate interventions to increase vaccine uptake and confidence. The Inquiry recognises that these innovations will only reach those patients who are engaged with healthcare systems and registered with the NHS – efforts must therefore continue to encourage people who have been excluded from healthcare in the past to register with a GP. |
| 6.159. | In Wales, the 2023 Digital and Data Strategy for Health and Social Care set out a similar aim. The Welsh Government is currently working towards a system of holding a comprehensive single digital health and social care record.240 |
| 6.160. | In Scotland, an Expert Reference Group on COVID-19 and Ethnicity made recommendations endorsed by the Scottish Government, including making ethnicity a mandatory field for health databases, ensuring linkage of ethnicity data across sources and ensuring that data are quickly accessible to the government in a pandemic.241 The first health and social care data strategy in Scotland in 2023 included the explicit aim of improving the quality and consistency of protected characteristics data, including ethnicity data.242 As part of its strategy, the Scottish Government is working towards the integration of electronic health records to provide a single view of relevant patient data across all parts of health and social care.243 |
| 6.161. | Northern Ireland created a data strategy for health and social care for 2022 to 2030, which set out its plan for a new data institute to lead on digital changes. These include a single point of access for healthcare data, unified sharing of demographic data, and maintaining the same method of recording data across primary and secondary care.244 |
| 6.162. | Drawing on lessons learned during Covid-19, significant steps are being taken to improve the use of data in healthcare. The Inquiry nevertheless encourages the healthcare systems in all four nations to seek to improve linkage of health data, including about ethnicity, across the UK as part of this work. |
| 6.163. | In 2023, the UK Health Security Agency produced a standardised evaluation framework for interventions designed to reduce inequalities in immunisation uptake which might meet this aim, if fully adopted and embedded in such programmes across the UK.245 This would enable – to the extent possible with the different health and social care systems involved – the four governments to work together to understand which interventions are likely to work to increase vaccine uptake in communities where vaccine coverage was lower during the Covid-19 pandemic. That work should start as soon as possible, to embed understanding of what does and does not work in advance of the next pandemic. |
| 6.164. | The UK vaccine delivery programmes had to be delivered at speed and this meant that comprehensive evaluations were not built into the rollout process. Evaluations could, with sufficient planning, be built into future emergency vaccination programmes. Even evaluations which are less comprehensive than would be the case outside a pandemic would be of value in understanding what interventions are effective. The UK government and devolved administrations should adopt a UK-level, aligned approach to the evaluation of vaccination programmes, with shared standards for evaluation. |
Recommendation 3: Improve monitoring and evaluation of vaccine uptake and delivery
Each of the four UK public health or health security agencies should work together to:
- maintain accurate, UK-wide insight into the state of vaccine uptake and hesitancy; and
- understand the measures proven to be effective in increasing uptake across the four nations of the UK.
There should be collaboration and some standardisation in the agreed approach across the four nations for monitoring and publishing routine vaccine uptake and vaccine confidence levels in order to better understand regional variations and patterns. Each nation should set and regularly review its minimum acceptable standards of vaccine uptake, which would trigger targeted uptake campaigns if not reached.
The effectiveness of vaccine uptake campaigns should be evaluated against clear, standardised measures. This includes retrospective analysis of the Covid-19 uptake campaigns, as well as evaluation of routine vaccination uptake campaigns.
- ‘Coronavirus (Covid-19) latest insights: Vaccines’, Office for National Statistics, 27 March 2023 (https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/articles/coronaviruscovid19latestinsights/vaccines; INQ000662002): see the heading ‘Nearly 9 in 10 people aged 12 years and over in the UK have received two doses of a COVID-19 vaccine’. For formulation of these statistics, see INQ000474591_0020-0021 paras 67-73. See also Coronavirus (COVID-19): Vaccine Deployment Plan: Update – July 2021, Scottish Government, 23 July 2021, pp8-11 (https://www.gov.scot/publications/coronavirus-covid-19-vaccine-deployment-plan-update—july-2021; INQ000147412); Covid 19 Vaccination Equity Strategy for Wales, Welsh Government, March 2021, p2 (https://www.gov.wales/sites/default/files/publications/2021-03/covid-19-vaccination-equity-strategy-wales.pdf; INQ000182538); Coronavirus (Covid-19): Analysis, State of the Epidemic in Scotland – 17th September 2021, Scottish Government, September 2021, p16 (https://www.gov.scot/publications/coronavirus-covid-19-state-epidemic-17-september-2021/documents; INQ000350989); INQ000065597_0011-0012 para 35
- UK COVID-19 Vaccines Delivery Plan, Department of Health and Social Care, 13 January 2021, p30 (https://www.gov.uk/government/publications/uk-covid-19-vaccines-delivery-plan/uk-covid-19-vaccines-delivery-plan; INQ000411678)
- INQ000474623_0084-0085 paras 282-283
- Module 1: The resilience and preparedness of the United Kingdom, UK Covid-19 Inquiry, July 2024, Chapter 3 (https://covid19.public-inquiry.uk/documents/module-1-full-report); see also INQ000195843_0074 para 179
- INQ000474623_0056 para 180. People may identify as ‘White – Other’ if, for example, they were born in an Eastern European country: ‘People identifying as ‘Other White’ has increased by over a million since 2001’, Office for National Statistics, 26 June 2015 (https://www.ons.gov.uk/peoplepopulationandcommunity/culturalidentity/ethnicity/articles/peopleidentifyingasotherwhitehas increasedbyoveramillionsince2001/2015-06-26; INQ000652150).
- Third Quarterly Report on Progress to Address COVID-19 Health Inequalities, Race Disparity Unit, Equality Hub and Government Equalities Office, 3 September 2021, pp14-15 (https://www.gov.uk/government/publications/third-quarterly-report-on-progress-to-address-covid-19-health-inequalities/third-quarterly-report-on-progress-to-address-covid-19-health-inequalities; INQ000089776)
- INQ000474623_0057
- INQ000283320_0021-0022
- INQ000474427_0052 para 189
- INQ000474427_0053 para 190
- INQ000283320_0022-0023
- INQ000474623_0059
- INQ000390122_0001, 0006-0007
- INQ000390122_0007; INQ000474429_0025 para 88; INQ000474476_0038 para 155
- For the definition of vaccine confidence, see INQ000474705_0006 para 2.1.
- Final Report on Progress to Address COVID-19 Health Inequalities, Race Disparity Unit and Equality Hub, 3 December 2021, pp23-24, 33-34 (https://www.gov.uk/government/publications/final-report-on-progress-to-address-covid-19-health-inequalities/final-report-on-progress-to-address-covid-19-health-inequalities; INQ000089747)
- INQ000474623_0062-0064 paras 196-200; INQ000474364_0027-0028 para 115; ‘English indices of deprivation 2019’, Ministry of Housing, Communities and Local Government, 26 September 2019, pp4, 12 (https://www.gov.uk/government/statistics/english-indices-of-deprivation-2019; INQ000652160); ‘Statistical geographies: An overview of the statistical geographies in the four countries of the UK’, Office for National Statistics, undated (https://www.ons.gov.uk/methodology/geography/ukgeographies/statisticalgeographies#england-and-wales; INQ000652162)
- INQ000474623_0062-0063 paras 196-199; INQ000390122_0007
- INQ000660006; INQ000660007
- INQ000111080_0006
- INQ000474623_0063-0064 para 200
- INQ000474623_0063 paras 198-199
- COVID-19 and Flu 2022-2023 Vaccination Programme: Equality Impact Assessment, Scottish Government, May 2024, pp15-16, paras 57-64 (https://www.gov.scot/publications/equality-impact-assessment-covid-19-flu-vaccination-2022-2023/documents; INQ000502212)
- Covid 19 Vaccination Equity Strategy for Wales, Welsh Government, March 2021, p5 (https://www.gov.wales/sites/default/files/publications/2021-03/covid-19-vaccination-equity-strategy-wales.pdf; INQ000182538)
- INQ000474623_0062 para 197
- INQ000474429_0025-0026 paras 88-94; INQ000474476_0025 para 99
- Module 1: The resilience and preparedness of the United Kingdom, UK Covid-19 Inquiry, July 2024, Chapter 3 (https://covid19.public-inquiry.uk/documents/module-1-full-report)
- INQ000195843_0005 para 9
- INQ000111080_0007; Covid 19 Vaccination Equity Strategy for Wales, Welsh Government, March 2021, pp2-3 (https://www.gov.wales/sites/default/files/publications/2021-03/covid-19-vaccination-equity-strategy-wales.pdf; INQ000182538)
- INQ000083885_0003
- INQ000271436_0005, 0032-0033 paras 7d, 105
- Modules 2, 2A, 2B, 2C: Core decision-making and political governance, UK Covid-19 Inquiry, November 2025, Vol II, Chapter 10 (https://covid19.public-inquiry.uk/documents/module-2-full-report)
- ‘Coronavirus and vaccination rates in people aged 70 years and over by socio-demographic characteristic, England: 8 December 2020 to 11 March 2021’, Office for National Statistics, 29 March 2021, p10 (https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthinequalities/bulletins/coronavirusandvaccinationratesinpeopleaged70yearsandoverbysociodemographic characteristicengland/8december2020to11march2021; INQ000652163). Disability status was defined using the self-reported answers to the 2011 census question ‘Are your day-to-day activities limited because of a health problem or disability which has lasted, or is expected to last, at least 12 months? – Include problems related to old age. See ‘Coronavirus and vaccination rates in people aged 70 years and over by socio-demographic characteristic, England: 8 December 2020 to 11 March 2021’, Office for National Statistics, 29 March 2021, p7 (https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthinequalities/bulletins/coronavirusandvaccination ratesinpeopleaged70yearsandoverbysociodemographiccharacteristicengland/8december2020to11march2021; INQ000652163)
- INQ000083885_0010; ‘Coronavirus and vaccination rates in people aged 70 years and over by socio-demographic characteristic, England: 8 December 2020 to 11 March 2021’, Office for National Statistics, 29 March 2021, pp1, 7-8 (https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthinequalities/bulletins/coronavirusandvaccinationratesinpeople aged70yearsandoverbysociodemographiccharacteristicengland/8december2020to11march2021; INQ000652163)
- INQ000474623_0066-0067 para 210; INQ000083885_0010
- INQ000474705_0043 para 97
- INQ000401529_0003
- INQ000474311_0038 para 154; INQ000499055_0055 para 161
- INQ000474705_0014 para 30
- INQ000474705_0018-0019 paras 44.1-44.2
- ‘Childhood vaccination coverage statistics’, NHS England, 28 September 2023 (https://app.powerbi.com/view?r=eyJrIjoiZTI3NW ZhNzItMTIyZS00OWM2LTg0MzMtOGY5YTJjMGY0MjI1IiwidCI6IjUwZjYwNzFmLWJiZmUtNDAxYS04ODAzLTY3Mzc0OGU2MjllMiIsIm MiOjh9; INQ000652164)
- INQ000474705_0010-0011, 0022 paras 18.1-18.2, 49.1
- INQ000474705_0012 para 22
- INQ000474705_0016 para 39
- INQ000474705_0016 para 39
- INQ000474705_0020-0023 paras 48-49.3; INQ000474623_0067-0068 para 213; see also ‘14th meeting of the European Regional Verification Commission for Measles and Rubella Elimination (RVC)’, World Health Organization, September 2025 (https://www.who.int/europe/news-room/events/item/2025/09/15/default-calendar/14th-meeting-of-the-european-regional-verification-commission-for-measles-and-rubella-elimination-(rvc); INQ000660166)
- INQ000474705_0011, 0039 paras 19, 84
- INQ000474705_0006 para 1; INQ000474333_0009 para 27
- INQ000474228_0028 para 125
- INQ000474427_0121, 0128-0129
- INQ000474350_0047 para 187; INQ000474623_0076 para 249; INQ000492355_0044-0047 paras 148-149; INQ000474476_0010-0011 para 35; INQ000474396_0046-0048 paras 112-117
- INQ000474705_0039 paras 82-83
- INQ000474705_0006 para 1
- INQ000474705_0039 paras 82-83
- Every Story Matters: Vaccines and Therapeutics, p12 (INQ000474465)
- Every Story Matters: Vaccines and Therapeutics, p13 (INQ000474465)
- June Raine 22 January 2025 161/4-162/13; INQ000496177_0046 paras 9.11-9.13
- INQ000474337_0117 para 403; INQ000496177_0045 para 9.8
- Munir Pirmohamed 29 January 2025 180/24-181/12
- INQ000474707_0073 para 6.63
- Ruth O’Rafferty 15 January 2025 138/13-24
- Stephen Evans 22 January 2025 108/24-110/1; INQ000474707_0022 para 2.48
- INQ000474707_0076 para 7.7
- INQ000474401_0058 para 6.73; Christopher Whitty 20 January 2025 108/4-109/9
- Christopher Whitty 20 January 2025 109/10-110/6. This would be consistent with the approach required by the Code of Practice for the Pharmaceutical Industry, which is the system of industry self-regulation in relation to the promotion of prescription medicines (INQ000474742_0002, 0012 paras 7-8, 43).
- ‘Communicating the potential benefits and harms of the Astra-Zeneca COVID-19 vaccine’, University of Cambridge, 7 April 2021, p2 (https://wintoncentre.maths.cam.ac.uk/news/communicating-potential-benefits-and-harms-astra-zeneca-covid-19-vaccine; INQ000497993)
- INQ000474705_0006 para 2
- INQ000474623_0074 para 240
- INQ000474623_0079 para 259; INQ000474705_0041 para 90
- INQ000474623_0079 para 260
- INQ000474705_0041 para 90; INQ000492283_0014 para 47; The US Public Health Service Untreated Syphilis Study at Tuskegee, Centers for Disease Control and Prevention, 4 September 2024 (https://www.cdc.gov/tuskegee/about/index.html; INQ000652152)
- INQ000474623_0079 para 260
- INQ000492283_0013-0014 paras 43-48
- INQ000474705_0040-0041 paras 88-91
- INQ000485278_0010 para 31
- INQ000474623_0079 para 261; INQ000474705_0041 paras 90-91
- INQ000492283_0014 para 48
- INQ000474705_0046 para 109
- INQ000474705_0044, 0046 paras 101, 109
- INQ000474705_0045 paras 101-102
- ‘Covid-19 news and information: Consumption and attitudes – previous results’, Ofcom, 22 June 2021, p2 (https://www.ofcom.org.uk/media-use-and-attitudes/attitudes-to-news/previous-results; INQ000420912)
- INQ000474705_0046 para 107
- INQ000474705_0045 paras 103-106
- INQ000474333_0077 paras 203-204; INQ000474396_0074, 0077-0078 paras 191, 200; INQ000502085_0001-0005
- INQ000474309_0002-0003 para 1.1
- INQ000474309_0017 para 1.56
- INQ000474460; INQ000474410; INQ000474435; INQ000474622; INQ000474461
- INQ000474309_0015 para 1.47
- Ruth O’Rafferty 15 January 2025 129/12-130/7; INQ000474462_0132, 0134-0135, 0147-0148 paras 292, 297, 324; INQ000497102_0029-0030, 0054 paras 85, 163
- INQ000474309_0008 para 1.22
- INQ000474309_0010 para 1.31
- INQ000361185_0004-0007; INQ000361184_0001-0003
- INQ000474309_0021-0022 paras 1.69-1.70
- INQ000474623_0065 para 204; ‘Language, England and Wales: Census 2021’, Office for National Statistics, 29 November 2022 (https://www.ons.gov.uk/peoplepopulationandcommunity/culturalidentity/language/bulletins/languageenglandandwales/census2021; INQ000652153)
- INQ000474705_0047 para 113
- INQ000474623_0075 para 245
- Every Story Matters: Vaccines and Therapeutics, p14 (INQ000474465)
- Every Story Matters: Vaccines and Therapeutics, p15 (INQ000474465)
- INQ000474770_0003-0004 paras 16-18
- INQ000492283_0009-0010 para 25
- INQ000474228_0151 paras 539-541; INQ000492335_0054-0055 para 176e
- INQ000474228_0151 para 541
- INQ000474311_0035 para 142
- INQ000474476_0047 para 202; INQ000474429_0035 para 137
- See Modules 2, 2A, 2B, 2C: Core decision-making and political governance, UK Covid-19 Inquiry, November 2025, Vol II, Chapter 12 (https://covid19.public-inquiry.uk/documents/module-2-full-report)
- INQ000492335_0033-0034 paras 112-113; INQ000387496_0002
- INQ000474407_0006, 0029-0030 paras 5, 134-141; INQ000474770_0006 para 27
- Yvonne MacNamara 16 January 2025 25/8-14
- INQ000474407_0029; INQ000474789_0011-0012 para 54
- INQ000474407_0029 paras 137-140; ‘UK GPs “refused registration to Gypsy, Roma and Traveller patients” during Covid-19 pandemic’, The Independent, 8 July 2021 (https://www.independent.co.uk/news/uk/home-news/covid-uk-gps-gypsy-travellers-b1880030.html; INQ000474813)
- What Do Gypsy/Travellers Think About Vaccine Information Resources and How Can They Be Improved to Reflect Cultural Realities?, Public Health Scotland, 26 March 2024, pp13-14, para 6b (https://publichealthscotland.scot/publications/what-do-gypsytravellers-think-of-vaccine-information-resources-and-how-can-they-be-improved-to-reflect-cultural-realities/what-do-gypsytravellers-think-of-vaccine-information-resources-and-how-can-they-be-improved-to-reflect-cultural-realities; INQ000474816)
- INQ000390075_0004-0007, 0010
- INQ000387496_0002
- INQ000474407_0029 paras 137-140; INQ000474705_0042-0043 para 95
- Annex A: COVID-19 Vaccine and Health Inequalities: Considerations for Prioritisation and Implementation, Department of Health and Social Care, 6 January 2021, p10 (https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/annex-a-covid-19-vaccine-and-health-inequalities-considerations-for-prioritisation-and-implementation; INQ000256951)
- INQ000492335_0056 para 180; ‘Everyone is welcome in General Practice’, NHS England, 17 February 2021 (INQ000414497)
- INQ000474228_0098 para 344
- ‘Improving access to healthcare’, Scottish Government, 15 September 2019 (https://www.gov.scot/news/improving-access-to-healthcare; INQ000652165); INQ000660002
- What Do Gypsy/Travellers Think About Vaccine Information Resources and How Can They Be Improved to Reflect Cultural Realities?, Public Health Scotland, 26 March 2024, pp12-14, paras 5e-6b (https://publichealthscotland.scot/publications/what-do-gypsytravellers-think-of-vaccine-information-resources-and-how-can-they-be-improved-to-reflect-cultural-realities/what-do-gypsytravellers-think-of-vaccine-information-resources-and-how-can-they-be-improved-to-reflect-cultural-realities; INQ000474816)
- INQ000401715_0014
- The National Health Service (Charges to Overseas Visitors) Regulations 2015 (https://www.legislation.gov.uk/uksi/2015/238/contents)
- INQ000474623_0081-0082 para 268
- INQ000474381_0019, 0050 paras 53, 160-161; ‘COVID-19: Migrant health guide’, UK Health Security Agency, 17 February 2021 (https://www.gov.uk/guidance/covid-19-migrant-health-guide; INQ000480650)
- INQ000329481_0011-0012, 0045
- Anna Miller 15 January 2025 96/20-98/17
- INQ000492283_0010 para 27
- INQ000474623_0081 para 267; see also INQ000477304_0160-0161 paras 400-402
- INQ000474407_0003-0005 paras 10, 15(2)
- INQ000474705_0014 para 28
- Gillian Richardson 28 January 2025 91/6-22; INQ000474454_0025-0026 para 60; INQ000474427_0129
- In England, Scotland and Wales, Equality Act 2010, section 20, Part 3 and Schedule 2 (https://www.legislation.gov.uk/ukpga/2010/15/contents); in Wales, The Primary Care (Contracted Services: Immunisations) Directions 2021 (https://www.gov.wales/sites/default/files/publications/2022-02/21-07-the-primary-care-contracted-services-immunisations-directions-2021.pdf) as supplemented by Schedule 1 (8(s)) of the Primary Care Contracted Services: Immunisations (Covid-19 Vaccines) Specification 2021 (https://www.gov.wales/sites/default/files/publications/2022-02/schedule-1-primary-care-contracted-services-immunisations-covid-19-vaccines-specification_0.pdf); in Northern Ireland, the Disability Discrimination Act 1995 (https://www.legislation.gov.uk/ukpga/1995/50/contents); see also INQ000329393_0008-0011 para 2.3; INQ000474956_0002, 0007 paras 1.1, 4.5.1; INQ000492335_0059-0060 paras 193-196; Covid 19 Vaccination Equity Strategy for Wales, Welsh Government, March 2021, p5
(https://www.gov.wales/sites/default/files/publications/2021-03/covid-19-vaccination-equity-strategy-wales.pdf; INQ000182538) - Kamran Mallick 15 January 2025 184/2-185/14
- Every Story Matters: Vaccines and Therapeutics, p41 (INQ000474465)
- INQ000474228_0156 paras 569-572
- Every Story Matters: Vaccines and Therapeutics, p41 (INQ000474465)
- INQ000474256_0011-0012 paras 36-40
- INQ000474256_0011-0012 paras 36-37, 39
- INQ000474333_0054 para 129; INQ000474350_0052 para 205; INQ000492335_0057 paras 183-186; INQ000474311_0038 para 156(a)
- INQ000474228_0154-0155 paras 559-562; INQ000474350_0050 para 195
- INQ000474350_0050 para 195
- INQ000474427_0032, 0120 para 133; An Inclusive Approach to Flu and COVID-19 Vaccination Service Delivery in Scotland: Recommendations from 2020/21, Public Health Scotland, 6 October 2021, pp3-5, 24 (https://publichealthscotland.scot/publications/an-inclusive-approach-to-flu-and-covid-19-vaccination-service-delivery-in-scotland-recommendations-from-2020-and-2021-report; INQ000427223)
- INQ000474256_0022 para 73; INQ000474396_0036 para 87
- INQ000182550
- INQ000501330_0052 para 231
- Modules 2, 2A, 2B, 2C: Core decision-making and political governance, UK Covid-19 Inquiry, November 2025, Vol II, Chapter 12 (https://covid19.public-inquiry.uk/documents/module-2-full-report)
- INQ000234638_0008
- INQ000492335_0031 para 104; INQ000474228_0070 para 254; Third Quarterly Report on Progress to Address Covid-19 Health Inequalities, Equality Hub, Government Equalities Office and Race Disparity Unit, 3 September 2021, p15, para 19 (https://www.gov.uk/government/publications/third-quarterly-report-on-progress-to-address-covid-19-health-inequalities/third-quarterly-report-on-progress-to-address-covid-19-health-inequalities; INQ000411770)
- INQ000528401_0003; INQ000587737_0142 para 544; INQ000273897_0015, 0093 paras 61-62, 396
- INQ000485166_0011-0012 paras 25-28; see also INQ000587737_0044 para 187
- INQ000273897_0093 para 396
- INQ000562876_0005-0007
- INQ000354664
- INQ000328072_0001-0002
- INQ000328072_0002
- INQ000273897_0075 para 326
- INQ000273897_0076 paras 327-330
- Social Care Working Group Consensus Statement, March 2021, Department of Health and Social Care, March 2021, updated 9 November 2021 (https://www.gov.uk/government/consultations/making-vaccination-a-condition-of-deployment-in-older-adult-care-homes/social-care-working-group-consensus-statement-march-2021; INQ000652168)
- INQ000474401_0072-0073 para 6.118
- INQ000073054
- Consultation Outcome: Making Vaccination a Condition of Deployment in Care Homes: Government Response, Department of Health and Social Care, 9 November 2021, pp1, 3-9 (https://www.gov.uk/government/consultations/making-vaccination-a-condition-of-deployment-in-older-adult-care-homes/outcome/making-vaccination-a-condition-of-deployment-in-care-homes-government-response; INQ000652166)
- INQ000474705_0049 para 121
- INQ000474705_0049-0050 para 123
- Consultation Outcome: Making Vaccination a Condition of Deployment in Care Homes: Government Response, Department of Health and Social Care, 9 November 2021, p3 (https://www.gov.uk/government/consultations/making-vaccination-a-condition-of-deployment-in-older-adult-care-homes/outcome/making-vaccination-a-condition-of-deployment-in-care-homes-government-response; INQ000652166); ‘COVID-19 vaccinations of residents and staff in older adult care homes by NHS region’, NHS England, 15 June 2021 (https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2021/06/Older-Adult-Care-Homes-Vaccinating-80-of-staff-and-90-of-residents-June-2021.xlsx; INQ000330406)
- INQ000468682_0002 para 5; Consultation Outcome: Making Vaccination a Condition of Deployment in Care Homes: Government Response, Department of Health and Social Care, 9 November 2021, p3 (https://www.gov.uk/government/consultations/making-vaccination-a-condition-of-deployment-in-older-adult-care-homes/outcome/making-vaccination-a-condition-of-deployment-in-care-homes-government-response; INQ000652166). At that time, the proportion of care homes with 80% of staff vaccinated with one dose (as opposed to the combined figure for 80% of staff and 90% of residents) was 72.5% across England, falling to 53.7% in London; see ‘COVID-19 vaccinations of residents and staff in older adult care homes by NHS region’, NHS England, 15 June 2021 (https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2021/06/Older-Adult-Care-Homes-Vaccinating-80-of-staff-and-90-of-residents-June-2021.xlsx; INQ000330406).
- INQ000474401_0072-0073 para 6.118
- ‘Everyone working in care homes to be fully vaccinated under new law to protect residents’, Department of Health and Social Care, 16 June 2021 (https://www.gov.uk/government/news/everyone-working-in-care-homes-to-be-fully-vaccinated-under-new-law-to-protect-residents; INQ000086730)
- INQ000593180_0001-0003
- ‘Government to introduce Covid-19 vaccination as a condition of deployment for all frontline health and social care workers’, Department of Health and Social Care and NHS England, 9 November 2021 (https://www.gov.uk/government/news/government-to-introduce-covid-19-vaccination-as-a-condition-of-deployment-for-all-frontline-health-and-social-care-workers; INQ000086799)
- ‘Regulations making Covid-19 vaccination a condition of deployment to end’, Department of Health and Social Care, 1 March 2022 (https://www.gov.uk/government/news/regulations-making-covid-19-vaccination-a-condition-of-deployment-to-end; INQ000257312)
- INQ000497213
- Sajid Javid 23 January 2025 25/10-25; INQ000091577_0004-0005
- INQ000474350 0022-0023 paras 83-88
- INQ000474350 0022 para 88
- INQ000474558_0093-0094 paras 351-353
- INQ000485794
- INQ000474476_0008 para 26d
- Heidi Larson 16 January 2025 160/1-165/16
- INQ000501330_0050 para 224
- INQ000492335_0052-0053 paras 170-171; see also UK COVID-19 Vaccine Uptake Plan, Department of Health and Social Care, 13 February 2021 (https://www.gov.uk/government/publications/covid-19-vaccination-uptake-plan/uk-covid-19-vaccine-uptake-plan)
- INQ000474333_0010-0011 paras 29-33
- INQ000499498_0001; INQ000474430_0011-0015 paras 39-54; INQ000474299_0013-0014 paras 42-44
- INQ000492335_0054 para 175
- INQ000492283_0016-0017 para 56
- INQ000492335_0054-0055 para 176
- INQ000492335_0056 para 179
- INQ000414509
- INQ000492283_0022-0023 paras 82-87
- INQ000474623_0098 para 337
- INQ000474396_0035 paras 84-85
- INQ000474427_0033-0034 paras 137-138
- Covid 19 Vaccination Equity Strategy for Wales, Welsh Government, March 2021 (https://www.gov.wales/sites/default/files/publications/2021-03/covid-19-vaccination-equity-strategy-wales.pdf; INQ000182538)
- INQ000501330_0040 para 174; INQ000499055_0048 para 133
- INQ000474311_0046 para 190; INQ000501330_0054 paras 249-250
- INQ000474429_0027 paras 95-99; INQ000474364_0019-0020
- INQ000474623_0102-0103 para 359; INQ000474705_0065, 0068; Covid 19 Vaccination Equity Strategy for Wales, Welsh Government, March 2021, pp7-9 (https://www.gov.wales/sites/default/files/publications/2021-03/covid-19-vaccination-equity-strategy-wales.pdf; INQ000182538)
- INQ000474623_0100-0102 paras 349-354; see also ‘Families to have better access to childhood vaccinations’, Department of Health and Social Care, 1 January 2026 (https://www.gov.uk/government/news/families-to-have-better-access-to-childhood-vaccinations; INQ000660012); ‘Maternal and child health: Universal health visiting service’, Scottish Government, undated (https://www.gov.scot/policies/maternal-and-child-health/universal-health-visiting-service; INQ000660013); ‘Who are health visitors and what do they do?’, NHS Wales, undated (https://ctmuhb.nhs.wales/services/childrens-health-visiting/resources/who-are-health-visitors-and-what-do-they-do; INQ000660014); ‘About health visitors’, Family Support (Northern Ireland), 15 December 2022
(https://www.familysupportni.gov.uk/Support/33/about-health-visitors; INQ000660011) - INQ000474623_0101-0102 paras 350-354
- ‘Families to have better access to childhood vaccinations’, Department of Health and Social Care, 1 January 2026 (https://www.gov.uk/government/news/families-to-have-better-access-to-childhood-vaccinations; INQ000660012)
- ‘Families to have better access to childhood vaccinations’, Department of Health and Social Care, 1 January 2026 (https://www.gov.uk/government/news/families-to-have-better-access-to-childhood-vaccinations; INQ000660012)
- Immunisation Equity Strategy: Commitments for 2025 to 2030, UK Health Security Agency, 31 July 2025 (https://assets.publishing.service.gov.uk/media/6890634f486754ec2887839a/Immunisation_Equity_Strategy_2025-30.pdf; INQ000654124)
- INQ000474705_0008-0009
- INQ000474623_0071-0072 para 227
- INQ000474228_0019-0020, 0093 paras 89, 332
- INQ000474228_0097-0098 paras 342-343
- INQ000474228_0097, 0099 paras 340-341, 347
- INQ000474228_0099-0100 paras 350-351
- INQ000474623_0071 para 225
- INQ000474427_0049-0050 paras 180-182; INQ000506900_0026-0027 para 117
- Evaluation of the COVID-19 Vaccination Programme: 2020/22 Report, Public Health Scotland, 12 October 2022, p80 (https://publichealthscotland.scot/publications/evaluation-of-the-covid-19-vaccination-programme-october-2022/evaluation-of-the-covid-19-vaccination-programme-october-2022; INQ000283320); INQ000474396_0011, 0069-0070 paras 29, 178
- INQ000474249_0008-0009, 0073 paras 20, 212-214; INQ000390121
- INQ000474364_0027-0028 para 115; INQ000390122_0007
- INQ000474311_0031 para 121
- INQ000474311_0043 para 177
- INQ000474973_0012 para 43; INQ000574792_0013 para 42; INQ000574788_0019 para 111
- INQ000474623_0072 para 228
- This is in line with the Sudlow Review, Uniting the UK’s Health Data: A Huge Opportunity for Society, Cathie Sudlow, November 2024, p108 (https://www.hdruk.ac.uk/helping-with-health-data/the-sudlow-review; INQ000474861), which states that “linking different sources of data together provides a more complete picture than any single source alone”.
- INQ000474228_0156 para 568; INQ000474591_0021-0022 paras 72-74; INQ000083885_0004, 0006, 0036
- Salman Waqar 16 January 2025 5/2-6
- Third Quarterly Report on Progress to Address COVID-19 Health Inequalities, Race Disparity Unit, Equality Hub and Government Equalities Office, 3 September 2021, pp34-39 (https://www.gov.uk/government/publications/third-quarterly-report-on-progress-to-address-covid-19-health-inequalities/third-quarterly-report-on-progress-to-address-covid-19-health-inequalities; INQ000089776)
- INQ000474623_0060 para 186
- INQ000474705_0013-0014 para 27
- INQ000474705_0013-0014 para 27
- ‘NHS data model and dictionary: Ethnic category’, NHS, undated (https://www.datadictionary.nhs.uk/data_elements/ethnic_category.html; INQ000652363); Yvonne MacNamara 16 January 2025 29/20-31/10
- INQ000474623_0058
- Final Report on Progress to Address COVID-19 Health Inequalities, Race Disparity Unit and Equality Hub, 3 December 2021, p134 (https://www.gov.uk/government/publications/final-report-on-progress-to-address-covid-19-health-inequalities/final-report-on-progress-to-address-covid-19-health-inequalities; INQ000089747)
- INQ000574788_0006 para 27; Third Quarterly Report on Progress to Address COVID-19 Health Inequalities, Race Disparity Unit, Equality Hub and Government Equalities Office, 3 September 2021, pp34, 39 (https://www.gov.uk/government/publications/third-quarterly-report-on-progress-to-address-covid-19-health-inequalities/third-quarterly-report-on-progress-to-address-covid-19-health-inequalities; INQ000089776); Ethnicity Coding in English Health Service Datasets, NHS Race and Health Observatory and Nuffield Trust, 7 June 2021 (https://www.nuffieldtrust.org.uk/sites/default/files/2021-06/1622731816_nuffield-trust-ethnicity-coding-web.pdf; INQ000089781); ‘Quality of ethnicity data in health-related administrative data sources, England; November 2023’, Office for National Statistics, 6 November 2023 (https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthinequalities/articles/understandingconsistencyofethnicitydatarecordedinhealthrelatedadministrativedatasetsinengland2011to2021/november2023; INQ000654127)
- Modules 2, 2A, 2B, 2C: Core decision-making and political governance, UK Covid-19 Inquiry, November 2025, Vol II, Chapter 10 (https://covid19.public-inquiry.uk/documents/module-2-full-report)
- INQ000474228_0156 para 568; INQ000474249_0008-0009 para 20
- INQ000474591_0021-0022 paras 72-74
- INQ000083885_0004, 0006
- INQ000475117_0002 para 5; INQ000474228_0156 para 568
- ‘Improving disability data in the UK: 2019’, Office for National Statistics, 2 December 2019 (https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/disability/articles/improvingdisabilitydataintheuk/2019; INQ000652159); ‘Definition of disability under the Equality Act 2010’, HM Government (https://www.gov.uk/definition-of-disability-under-equality-act-2010; INQ000652161)
- INQ000111080_0012
- Ben Kasstan-Dabush 28 January 2025 153/8-156/23
- Ben Kasstan-Dabush 28 January 2025 155/12-20
- Ben Kasstan-Dabush 28 January 2025 156/11-17
- INQ000474705_0007-0009 paras 5-6
- Fit for the Future: 10 Year Health Plan for England, Secretary of State for Health and Social Care, July 2025, pp47-48, 116
(https://assets.publishing.service.gov.uk/media/6888a0b1a11f859994409147/fit-for-the-future-10-year-health-plan-for-england.pdf; INQ000650755) - Fit for the Future: 10 Year Health Plan for England, Secretary of State for Health and Social Care, July 2025, p49 (https://assets.publishing.service.gov.uk/media/6888a0b1a11f859994409147/fit-for-the-future-10-year-health-plan-for-england.pdf; INQ000650755)
- Digital and Data Strategy for Health and Social Care in Wales, Welsh Government, 27 July 2023, pp29-30 (https://www.gov.wales/sites/default/files/pdf-versions/2024/1/2/1705403312/digital-and-data-strategy-health-and-social-care-wales.pdf; INQ000652155)
- Greater Access, Better Insight, Improved Outcomes: A Strategy for Data-Driven Care in the Digital Age, Scottish Government, February 2023, p12 (https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2023/02/data-strategy-health-social-care-2/documents/greater-access-better-insight-improved-outcomes-strategy-data-driven-care-digital-age/greater-access-better-insight-improved-outcomes-strategy-data-driven-care-digital-age/govscot%3Adocument/greater-access-better-insight-improved-outcomes-strategy-data-driven-care-digital-age.pdf; INQ000652157); Improving Data and Evidence on Ethnic Inequalities in Health: Initial Advice and Recommendations from the Expert Reference Group on Ethnicity and COVID-19, Scottish Government, pp5-10 (https://www.gov.scot/binaries/content/documents/govscot/publications/research-and-analysis/2020/09/expert-reference-group-on-covid-19-and-ethnicity-recommendations-to-scottish-government/documents/improving-data-and-evidence-on-ethnic-
inequalities-in-health-initial-advice-and-recommendations-from-the-expert-reference-group-on-covid-19-and-ethnicity/improving-data-and-evidence-on-ethnic-inequalities-in-health-initial-advice-and-recommendations-from-the-expert-reference-group-on-covid-19-and-ethnicity/govscot%3Adocument/Improving%2BData%2Band%2BEvidence%2Bon%2BEthnic%2BInequalities%2Bin%2BHealth%2B-%2BInitial%2BAdvice%2Band%2BRecommendations%2Bfrom%2Bthe%2BExpert%2BReference%2BGroup%2Bon%2BCOVID-19%2Band%2BEthnicity.pdf; INQ000182802) - Greater Access, Better Insight, Improved Outcomes: A Strategy for Data-Driven Care in the Digital Age, Scottish Government, February 2023, p57 (https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2023/02/data-strategy-health-social-care-2/documents/greater-access-better-insight-improved-outcomes-strategy-data-driven-care-digital-age/greater-access-better-insight-improved-outcomes-strategy-data-driven-care-digital-age/govscot%3Adocument/greater-access-better-insight-improved-outcomes-strategy-data-driven-care-digital-age.pdf; INQ000652157)
- Greater Access, Better Insight, Improved Outcomes: A Strategy for Data-Driven Care in the Digital Age, Scottish Government, February 2023, p18 (https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2023/02/data-strategy-health-social-care-2/documents/greater-access-better-insight-improved-outcomes-strategy-data-driven-care-digital-age/greater-access-better-insight-improved-outcomes-strategy-data-driven-care-digital-age/govscot%3Adocument/greater-access-better-insight-improved-outcomes-strategy-data-driven-care-digital-age.pdf; INQ000652157)
- Data Strategy: HSC Northern Ireland 2022–2030, Health and Social Care (Northern Ireland), 13 July 2022, updated 20 October 2022, pp18, 29 (https://www.health-ni.gov.uk/sites/default/files/publications/health/doh-hscni-data-strategy.pdf; INQ000183443)
- Immunisation Evaluation Framework, UK Health Security Agency, 2 August 2023, updated 19 October 2023 (https://www.gov.uk/government/publications/immunisation-evaluation-framework; INQ000659844); INQ000659843
Chapter 7: Post-authorisation safety and surveillance systems
Introduction
| 7.1. | Covid-19 vaccines saved many millions of lives worldwide.1 It is nevertheless important to recognise and acknowledge that, in rare or very rare instances, the vaccines did have serious adverse effects.2 The Inquiry heard moving evidence from representatives of the vaccine injured and bereaved Core Participants, who have often felt silenced or ignored. Similar experiences were also described to the Inquiry through its listening exercise, Every Story Matters.3 Nothing that is said about the rarity of side effects should be taken to diminish the pain and loss of those who suffered injury, or whose loved ones died, after receiving a vaccine. |
| 7.2. | The issue of vaccine safety also highlights the importance of the system of post-authorisation surveillance of medicines in clinical use known as ‘pharmacovigilance’.4 It serves to detect and analyse emerging information about a medicine’s effects and weigh the benefits and risks on an ongoing and timely basis, in order to enable appropriate responses. It is key to fostering confidence in new medicines and vaccines during a pandemic and encouraging uptake. Pharmacovigilance plays a particularly important role during a pandemic, when a range of new drugs are likely to be developed and deployed rapidly and at scale. |
| 7.3. | The Inquiry’s focus is on examining the systems and processes of post-authorisation safety monitoring. In doing so, it is neither proportionate nor practicable for the Inquiry to reach a view on the safety of particular vaccines or on causation in specific cases of alleged injury or death, or to attempt to quantify the precise risks of vaccination. Moreover, any conclusion on the safety of specific vaccines, as opposed to the relevant systems and processes, may be of limited value in the context of preparing for a future – perhaps non-coronavirus – pandemic. |
| 7.4. | While post-authorisation safety monitoring applies to both vaccines and therapeutics, during the Covid-19 pandemic it was vaccines that were rolled out across almost the entire population and in respect of which particular safety concerns arose. The lessons from the Covid-19 pandemic should be applied equally to the safety monitoring of therapeutics. This chapter considers the system of pharmacovigilance, particularly the extent to which the UK’s systems and processes of post-authorisation safety monitoring during the Covid-19 pandemic properly detected and responded to safety concerns raised in connection with the use of Covid-19 vaccines. |
Robust systems and strategies
| 7.5. | All medicines, including vaccines, may give rise to unwanted side effects, known as ‘adverse effects’.5 Not all adverse effects can be known before a medicine is authorised for use. Clinical trials can only study a finite number of patients over a defined period, so rare or very rare adverse effects are unlikely ever to be identified by them. A reaction or condition that only occurs in 1 in 100,000 people may not be apparent in a clinical trial involving 30,000 people. Such reactions may only become apparent when a drug has been deployed at a population level.6 For this reason, and because certain groups – such as those with underlying chronic conditions, those who are immunocompromised or pregnant women – may have been excluded from clinical trials, post-authorisation surveillance of the safety of the medicine in clinical use is a crucial part of the regulatory process. |
| 7.6. | As explained in Chapter 4: Authorisation, the primary body responsible for the safety of the vaccines and therapeutics developed in response to Covid-19 was the Medicines and Healthcare products Regulatory Agency. It is responsible for regulating medical products (including vaccines, medicines and medical devices) in the UK by ensuring that they work and are ‘acceptably safe’.7 This responsibility begins at the authorisation stage and continues throughout the period for which a product remains authorised for use in the UK.8 |
| 7.7. | During the pandemic, the Medicines and Healthcare products Regulatory Agency received advice from the Commission on Human Medicines (the UK government’s independent expert scientific advisory body on medicines). The commission established expert working groups to assist it in giving advice; these included the Vaccine Benefit Risk Expert Working Group, which advised on, among other things, the emerging safety data concerning the Covid-19 vaccines.9 |
| 7.8. | As not all adverse effects will be identified in clinical trials, medicines are authorised with a requirement that there is a robust post-authorisation surveillance system in place through which the risk–benefit balance can be revised as clinical usage expands and real-world data become available.10 |
| 7.9. | In addition, every medicine is accompanied by ‘product information’ that includes the conditions for use, contraindications (situations in which a medicine should not be used) and potential adverse effects. There are two principal documents that make up this information:
The Medicines and Healthcare products Regulatory Agency regulates these documents – after receiving advice from the Commission on Human Medicines – and ensures that they are updated to reflect information about adverse effects that comes to light as a result of post-authorisation monitoring.11 |
Monitoring for Covid-19 vaccines: the four-pillar approach
| 7.10. | Well in advance of the envisaged availability of Covid-19 vaccines, the Medicines and Healthcare products Regulatory Agency began developing a post-authorisation safety monitoring strategy for the vaccines.12 In May 2020, the Commission on Human Medicines established an expert working group to advise on the strategy. This resulted in a four-pillar approach, the aim of which was to rapidly detect, confirm, characterise and quantify any new risks that were not detected in clinical trials, to weigh these against the expected benefits, and to take any necessary action to minimise risks to individuals.13 |
| 7.11. | Pillar 1 involved enhanced passive surveillance using the Yellow Card scheme – the means by which members of the public and healthcare professionals can report suspected adverse effects to the Medicines and Healthcare products Regulatory Agency. A Covid-19 interface was developed for the scheme and the agency undertook continual review of reports using statistical techniques. This included analysing the observed number of reports of a suspected adverse effect in comparison with what would be expected in a given population (known as ‘observed versus expected’ analysis).14 |
| 7.12. | Pillar 2 required rapid-cycle analysis and ecological analysis. Rapid-cycle analysis involved proactive, weekly analysis of anonymised electronic health records for a range of theoretical adverse effects in order to quickly identify likely adverse effects. Ecological analysis involved monitoring trends of particular adverse events among certain populations.15 |
| 7.13. | Under Pillar 3, there was targeted active monitoring through the Yellow Card vaccine monitor. Randomly selected individuals were invited to agree to post-vaccination follow-up and monitoring for suspected adverse effects. There was a particular focus on groups that had not been represented in the clinical trials, such as pregnant women.16 |
| 7.14. | The first three pillars might identify an association, but this association could be coincidental rather than causal. Pillar 4 therefore required formal epidemiological studies, aimed at establishing whether particular adverse events were caused by the Covid-19 vaccines.17 |
| 7.15. | Some of these processes were already in place for vaccines that had been authorised before the pandemic. The four pillars were brought together to ensure that “the most robust proactive pharmacovigilance system” was in place in respect of the Covid-19 vaccines.18 Professor Stephen Evans, expert witness on vaccine safety, said that the strategic approach was “reasonable and built upon tried and trusted methods of analysis” and that, in practice, the four pillars ensured that everything that could be done to pick up on safety-related issues was done.19 |
| 7.16. | The four-pillar strategy was a timely, reasonable and comprehensive approach to the task of post-authorisation safety monitoring. The Medicines and Healthcare products Regulatory Agency indicated that this approach “would form the basis” of any model during a future pandemic.20 The Inquiry endorses that approach. |
| 7.17. | The Inquiry was told that there were concerns that specific batches of the Covid-19 vaccines were associated with adverse effects.21 However, the Medicines and Healthcare products Regulatory Agency’s laboratories tested each batch of the Covid-19 vaccines, before the batch was distributed, to ensure that it met the quality standards defined in marketing authorisations.22 This testing – which was independent from that conducted by the manufacturers – was for purity and potency, in order to ensure that everyone who had a vaccine would receive one that would work and that would be free of impurities.23 The Inquiry was told by Professor Evans that the agency’s laboratories are “the world leaders in the field”.24 Dame June Raine, Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency from September 2019 to March 2025, explained that ongoing safety monitoring of Covid-19 vaccines had not identified any batch-specific safety concerns.25 |
Effectiveness of the Yellow Card scheme
| 7.18. | The Yellow Card scheme, first introduced in 1964, was described to the Inquiry as the “cornerstone” of pharmacovigilance in the UK.26 It is operated jointly by the Medicines and Healthcare products Regulatory Agency and the Commission on Human Medicines.27 Reports can be made online through the Yellow Card website, via the Yellow Card app, by telephone or on paper.28 |
| 7.19. | A report to the Yellow Card scheme of a suspected adverse event associated with a medicine or vaccine does not mean that the event has been caused by that medicine or vaccine. It may have occurred coincidentally or, in the case of Covid-19, it may have been caused by the disease itself.29 The purpose of the scheme is therefore not to establish causation but to provide an early warning that the safety of a medicine may require further investigation.30 |
| 7.20. | The Medicines and Healthcare products Regulatory Agency regularly published analysis of Yellow Card reporting on the Covid-19 vaccines on its website during the pandemic. In the period from December 2020 to June 2022, for the Covid-19 vaccines, the overall reporting rate was about two to five Yellow Cards per 1,000 doses administered.31 It is important to note that Yellow Card data cannot be used to derive side effect rates or to compare the safety profile of Covid-19 vaccines, as many factors can influence reporting.32 |
Table 2: Yellow Card reports by vaccine
| Vaccine |
December 2020 to June 2022 |
|
|---|---|---|
| Number of vaccines administered | Number of Yellow Card reports | |
| Pfizer/BioNTech | Estimated first doses: 27 million
Estimated second doses: 24.5 million Estimated third doses: 30.5 million Total: 82 million |
171,913 |
| Oxford/AstraZeneca | Estimated first doses: 24.9 million
Estimated second doses: 24.1 million Estimated third doses: 57,900 Total: 49 million |
245,771 |
| Moderna | Estimated first doses: 1.7 million
Estimated second doses: 1.5 million Estimated third doses: 9.3 million Total: 12.5 million |
39,809 |
| Brand of vaccine not specified | N/A | 1,768 |
| Total | 143.5 million | 459,261 |
Source: INQ000474336_0055 para 128; Coronavirus Vaccines: Summary of Yellow Card Reporting, Medicines and Healthcare products Regulatory Agency, 7 July 2022, pp11-12 (INQ000408385)
| 7.21.. | The vast majority of Yellow Card reports in relation to the Covid-19 vaccines concerned mild or temporary effects – such as reddening at the injection site, flu-like symptoms and headache – which typically resolved in a day or two.33 These types of reaction reflect the normal immune response triggered by the body to the vaccines and are typically seen with most types of vaccines.34 |
| 7.22. | During the pandemic, the Medicines and Healthcare products Regulatory Agency had in place a dedicated team analysing Yellow Card reports in relation to the Covid-19 vaccines on a daily basis.35 Dame June Raine explained that scientific and clinical assessors continually reviewed Yellow Card and other adverse effect data associated with the Covid-19 vaccines received from all sources, to consider whether reports could represent new safety concerns or a change in the safety profile, as assessed from the clinical trials.36 |
| 7.23. | The Inquiry heard evidence about a lack of follow-up to Yellow Card reports.37 Dame June Raine explained that there was follow-up where appropriate, but that not all Yellow Card reports required follow-up: for example, a reporter might have provided a comprehensive account of the clinical details upon first submission.38 The Inquiry was also told that obtaining further information about an individual report could be challenging if, as was often the case, the reporter did not respond (for example, if they were a doctor or nurse who had been moved to a different hospital).39 |
| 7.24 | Dame June Raine and Professor Sir Munir Pirmohamed (Chair of the Commission on Human Medicines from February 2021) explained that scrutiny was particularly intense when it came to reports of a fatal outcome, with every such report being considered “with great care”.40 Coroners may report using the Yellow Card scheme – indeed, it was initially established for coroners, doctors and dentists – and can also write directly to the Medicines and Healthcare products Regulatory Agency to raise any concerns.41 The agency may also receive and review reports from coroners on the prevention of future deaths where such reports are relevant to medical products. The findings of inquests are also reviewed and post-mortem data, if available, are followed up for potential ‘safety signals’ (ie information on a new or known adverse event that may be caused by a medical product and requires further investigation).42 |
| 7.25. | One possible flaw in the Yellow Card scheme is that it is not mandatory for healthcare professionals to use it to report suspected adverse effects.43 However, there are already professional guidelines in place for healthcare professionals to report safety issues in relation to medicines. Studies have also suggested that mandatory reporting has no additional effect on national reporting rates.44 Further, mandatory reporting might raise issues about enforcement measures for non-compliance, which could inadvertently criminalise healthcare professionals and add an administrative burden for healthcare systems in the four nations of the UK.45 The Inquiry therefore considers that there is no basis for introducing mandatory reporting of suspected adverse effects using the Yellow Card scheme. |
| 7.26. | Another option to encourage reporting is a payment scheme. Professor Pirmohamed explained that a study in Ireland had paid people to make reports of suspected adverse events, which had led to an increase in reporting. However, as soon as the payments were withdrawn, the number of reports went down again.46 In any event, Professor Evans noted that simply increasing the number of spontaneous reports “does not necessarily provide a public health gain” as the number of reports does not measure the likelihood of a reported event being caused by the medicine in question, nor does it necessarily markedly improve the ability of a spontaneous reporting system to find signals of potential problems.47 It is therefore neither necessary nor sustainable to introduce payment for reporting. |
| 7.27. | Another possible flaw in the Yellow Card scheme is low awareness among the general public and decision-makers.48 Notably, Sir Sajid Javid said that he was unaware of the scheme while he held the office of Secretary of State for Health and Social Care from June 2021 to July 2022.49 Dr Salman Waqar, Joint-Secretary of the Federation of Ethnic Minority Healthcare Organisations, said that the Yellow Card scheme was not well known and stressed the link between ensuring that there are mechanisms in place to allow people to express concerns about the safety of vaccines and boosting vaccine confidence, particularly among certain communities.50 Dr Waqar said:
“I don’t think many people are aware of the Yellow Card Scheme even now, and this isn’t just amongst ethnic minority health workers or patients, I think amongst the general healthcare workforce the Yellow Card Scheme is perhaps not particularly well understood … it’s currently still only available in English. If you go today on the MHRA [Medicines and Healthcare products Regulatory Agency] website, it asks you to use Google Translate to translate the Yellow Card Scheme if you wish to report it online.”51 |
| 7.28. | The Medicines and Healthcare products Regulatory Agency has taken some steps to raise awareness of the Yellow Card scheme and to improve its operation. During the pandemic, it published guidance for healthcare professionals on reporting adverse events using the scheme. It also provided information on the scheme to all vaccinators and those receiving the vaccine at the point of administration through information leaflets.52 Modifications made in February 2022 included a simplified reporting process, the ability to complete the form using dictation via a mobile device, and allowing users to update their own reports with new information or corrections as needed.53 A person completing a report is also asked to record their ethnicity, as well as their age, weight, height, pregnancy, past medical history and comorbidities. This information may produce a safety signal among particular patient groups.54 |
| 7.29. | Professor Daniel Prieto-Alhambra, expert witness on vaccine safety, noted that, overall, the Yellow Card scheme “worked really well” during the pandemic.55 He said:
“In terms of post-marketing surveillance, the continuous and enhanced review and analysis of spontaneous reports submitted using the bespoke Covid-19 vaccine Yellow Card scheme enabled very rapid identification of potential adverse effects. This was equivalent to the work done by other countries in Europe, such as Spain and its system for the notification of suspected adverse reactions.”56 |
| 7.30. | While the Yellow Card scheme was generally effective at detecting safety signals associated with the Covid-19 vaccines and acting as a prompt for further investigation, there is nevertheless still room for improvement.57 In particular, the Medicines and Healthcare products Regulatory Agency and the Commission on Human Medicines should do more to raise awareness of the scheme and should ensure that the Yellow Card reporting form is available in a wide range of languages, without recourse to third party translation tools. |
| 7.31. | The regulatory response to particular safety concerns is explored in more detail below. |
Obligations on pharmaceutical companies
| 7.32. | Pharmaceutical companies that hold marketing authorisation for a medicinal product are required to provide a range of safety surveillance data to the Medicines and Healthcare products Regulatory Agency. These requirements are a crucial source of safety signals and analysis and form a key part of the post-authorisation monitoring system. The obligations on pharmaceutical companies include:
|
| 7.33. | Professor Evans told the Inquiry that these requirements ensured a high level of confidence that any relevant knowledge in the possession of manufacturers was brought to the attention of the regulator.59 The rigorous obligations above applied to the manufacturers of the Covid-19 vaccines and, in some respects, were more stringent than in non-pandemic times. For example, periodic safety update reports are normally submitted every six months, but they were initially provided on a monthly basis for the Covid-19 vaccines.60 In addition, pharmaceutical companies were in regular and frequent communication with the Medicines and Healthcare products Regulatory Agency regarding emerging safety data.61 |
Responding to safety concerns
| 7.34. | The effectiveness of any pharmacovigilance system is assessed by its response to reported adverse events, which are “bad outcomes that occur during a trial or in general clinical use of a vaccine, but which are not necessarily caused by that vaccine”.62 |
| 7.35. | Professor Prieto-Alhambra examined the UK regulatory and advisory response to a range of safety signals that emerged in connection with the Covid-19 vaccines.63 The responses to particularly high-profile safety signals – anaphylaxis, thrombosis with thrombocytopenia syndrome, myocarditis and pericarditis – are examined in detail below. |
Anaphylaxis
| 7.36. | On the first day of the vaccination campaign, 8 December 2020, the Medicines and Healthcare products Regulatory Agency received two reports of suspected anaphylaxis and one report of a suspected allergic reaction following administration of the Pfizer/BioNTech vaccine.64 Anaphylaxis is a serious, systemic hypersensitivity reaction that is usually rapid in onset; severe anaphylaxis is characterised by potentially life-threatening failure of the circulation and breathing, which may result in death if it is not treated as a medical emergency. The condition is a known – but very rare – possible adverse effect of other vaccines, but it had not been observed during the Covid-19 vaccine clinical trials.65 |
| 7.37. | The response to the reports was rapid. On 9 December 2020, an urgent meeting of the Vaccine Benefit Risk Expert Working Group was convened. The expert working group concluded that there was a causal association between the three cases and the Pfizer/BioNTech vaccine – drawing such a conclusion was more straightforward than with other suspected adverse effects due to the nature of the reaction and the proximity in time between the vaccination and the adverse event.66 An updated warning was sent to the NHS and a press release was issued by the Medicines and Healthcare products Regulatory Agency to advise that vaccine recipients should be monitored for 15 minutes after vaccination. The product information was updated the following day, on 10 December 2020.67 As a precaution, similar warnings were included in the product information for the Moderna vaccine, as it was based on a similar messenger ribonucleic acid (mRNA) technology to the Pfizer/BioNTech vaccine.68 |
| 7.38. | The observation period slowed down the number of vaccines that could be administered each day and concerns were raised that it might increase the risk of the spread of the virus through close contact between people waiting in the observation area.69 Following advice from the Commission on Human Medicines, the Medicines and Healthcare products Regulatory Agency issued a press release on 14 December 2021 stating that, during the emergency response to the Omicron variant, the 15-minute observation period would be suspended for the Pfizer/BioNTech and Moderna vaccines for most people, because the benefits of vaccinating people as efficiently as possible outweighed the very small risks of anaphylaxis.70 |
| 7.39. | The Medicines and Healthcare products Regulatory Agency kept the suspension under review as younger cohorts became eligible for vaccination. Data indicated that the risk was lower in these age groups and the suspension became permanent in 2022.71 |
| 7.40. | Professor Prieto-Alhambra’s expert opinion was that the response to reports of anaphylaxis was “appropriate, fast and more aggressive than that taken by other countries”.72 |
Thrombosis with thrombocytopenia syndrome
| 7.41. | Thrombosis with thrombocytopenia syndrome – or ‘vaccine-induced thrombocytopenia and thrombosis’ – is a new and very rare condition that was identified following the rollout of the Covid-19 vaccination programme. It involves a blood clot or clots (thrombosis) occurring together with a low platelet count (thrombocytopenia) and can be fatal unless rapidly diagnosed and treated.73 |
| 7.42. | Professor Prieto-Alhambra explained that there is moderate to high-quality evidence of an association between the Oxford/AstraZeneca vaccine and thrombosis with thrombocytopenia syndrome.74 According to the last published summary of Yellow Card reporting, as of 23 November 2022 the estimated rate of thrombosis with thrombocytopenia syndrome after the Oxford/AstraZeneca vaccine was 21.8 per million doses in adults under 50, and 11.3 per million doses in those aged 50 or older.75 The Medicines and Healthcare products Regulatory Agency estimated that the overall case fatality rate was about one in five cases (18%) of people who developed the condition.76 |
| 7.43. | There were concerns that the UK had been too slow in responding to the thrombosis with thrombocytopenia syndrome safety signal, particularly when compared with the response in other European countries. Importantly, thrombotic events were not identified in the course of any of the clinical trials for the Covid-19 vaccines. However, conditions that affect the blood system have been associated with other vaccines in the past and were therefore treated as adverse events of special interest for the Covid-19 vaccines.79 |
| 7.44. | The Medicines and Healthcare products Regulatory Agency first received Yellow Card reports of suspected thrombotic events occurring with thrombocytopenia associated with the Oxford/AstraZeneca vaccine in February 2021. It sought the advice of the Vaccine Benefit Risk Expert Working Group, which recommended on 25 February 2021 that these events should be closely monitored but that, given the limited reports available in the context of the widespread deployment of the vaccine, no immediate regulatory action was advised. By that point, three Yellow Card reports had been received and an estimated 8.4 million doses of the Oxford/AstraZeneca vaccine had been administered in the UK.80 |
| 7.45. | Similar reports emerged in other countries, however, and from early March 2021 a number of European nations, including Denmark, Norway, Iceland, Estonia, Lithuania and Italy, suspended use of the Oxford/AstraZeneca vaccine. The Netherlands, Ireland, Germany, Spain, Sweden and others followed suit.81 |
| 7.46. | The Medicines and Healthcare products Regulatory Agency conducted an initial review of the latest available evidence on thrombosis with thrombocytopenia syndrome from the UK and other countries and sought expert advice from the Vaccine Benefit Risk Expert Working Group on 17 March 2021. Having considered a range of analyses presented by the Medicines and Healthcare products Regulatory Agency and Public Health England, the expert working group advised that – while the number of reports of suspected thrombosis with thrombocytopenia syndrome was small (by this point, five Yellow Card reports), particularly in the context of 11.7 million doses of the Oxford/AstraZeneca vaccine administered – further information should be rapidly gathered, with the assistance of expert haematologists.82 This advice was in line with advice published by the European Medicines Agency (the European Union’s medicines regulator).83 |
| 7.47. | The UK public was informed of the latest developments. At a 10 Downing Street televised briefing on 18 March 2021, Dame June Raine explained that a causal relationship between a “blood clot in the sinuses … occurring with lowered platelets” and the Oxford/AstraZeneca vaccine had not yet been established and a further review was ongoing. She explained that “the benefits” – ie the prevention of Covid-19 with its associated risk of hospitalisation and death – “firmly remain to outweigh any risks” and that, as a precaution, anyone with a headache that lasted for more than four days after vaccination, or bruising beyond the site of vaccination after a few days, should seek medical attention.84 |
| 7.48. | At its meeting on 18 March 2021, the Joint Committee on Vaccination and Immunisation agreed to “hold off making a statement about the next phase of the vaccine rollout programme until [the Medicines and Healthcare products Regulatory Agency] could clarify the safety signal”. This, in effect, paused the rollout of the vaccination programme to those aged under 50 without clinical risk factors.85 |
| 7.49. | On 26 March 2021, the Medicines and Healthcare products Regulatory Agency convened an independent expert panel to agree the definition of what constitutes a case of thrombosis with thrombocytopenia syndrome and to adjudicate each Yellow Card report in light of the varying levels of clinical detail available.86 The case definition was agreed following a meeting of the Commission on Human Medicines on 27 March.87 By 29 March, 62 reports – 19 of which reported a fatal outcome – were considered to be ‘confirmed’, ‘probable’ or ‘possible’, according to the agreed case definition.88 |
| 7.50. | The Commission on Human Medicines also scrutinised the emerging evidence. On 1 April 2021 it advised that, while causality had not yet been established and cases remained very rare (about 4 in every 1 million doses administered), the number of reports was continuing to rise and the association appeared to be stronger as more data became available. In this context, the Commission on Human Medicines advised that the product information for the Oxford/AstraZeneca vaccine should be updated to include warnings about the condition and that information on the risk should be communicated to healthcare professionals and the public.89 |
| 7.51. | An issue arose as to the timing of such communication. The Joint Committee on Vaccination and Immunisation was keen to release a statement to the public as soon as possible. However, coordinated communications from the Joint Committee on Vaccination and Immunisation, the Medicines and Healthcare products Regulatory Agency, Public Health England and the Department of Health and Social Care were not going to be possible until after the Easter bank holiday weekend – for example, patient information leaflets about risks and benefits could not be updated, and nor would Public Health England be able to release updates to leaflets to coincide with any statement made before the bank holiday.90 On 1 April 2021, Professor Wei Shen Lim (Chair of the Joint Committee on Vaccination and Immunisation’s Covid-19 sub-committee from September 2020) wrote to Matt Hancock MP (Secretary of State for Health and Social Care from July 2018 to June 2021) noting that, in the circumstances and with “substantial discomfort”, the committee had come to the decision not to release an independent public statement immediately.91 |
| 7.52. | Mr Hancock responded the next day, agreeing that the balance of the public interest was in favour of a coordinated approach to public messaging. He observed that patients eligible for vaccination over the Easter weekend were still from priority cohorts 1 to 9 of Phase 1 of the vaccination programme, in respect of whom the Joint Committee on Vaccination and Immunisation’s advice on the balance of risks was unchanged. Mr Hancock also noted that information about the thrombosis with thrombocytopenia syndrome signal was already in the public domain, including the publication the previous day of the Medicines and Healthcare products Regulatory Agency’s weekly report on adverse events, which included a section on thromboembolic events and a link to specialist advice from the British Society for Haematology.92 (Previously, a letter had also been distributed to healthcare professionals containing the most up-to-date information regarding the emerging thrombosis safety signal.93) |
| 7.53. | Meanwhile, the appropriate response to the safety signal continued to be considered in light of the latest data. On 4 April 2021, having reviewed the latest analysis of risk broken down by age, the Commission on Human Medicines found that the risk–benefit balance remained favourable in recipients aged over 40 but was less so for those under 40, and the Oxford/AstraZeneca vaccine’s authorisation should be amended to reflect this.94 However, on 6 April, the commission reconsidered its conclusions in light of further analysis of global data provided by AstraZeneca. The commission advised that Oxford/AstraZeneca’s product information should be updated to explain the risks but it did not give a specific age cut-off for use. This advice was in recognition of the fact that the number of cases of thrombosis with thrombocytopenia syndrome was small in the context of the number of doses administered and that the overall risk–benefit profile remained positive.95 It noted the value of regulators taking a consistent approach to product information in the context of a global pandemic – no other regulator had introduced age-based restrictions on the Oxford/AstraZeneca vaccine.96 |
| 7.54. | On 7 April 2021, the anticipated coordinated approach to public communication took place; the latest advice was explained at a press conference held by Professor (later Sir) Jonathan Van-Tam (Deputy Chief Medical Officer for England from October 2017 to March 2022), Dame June Raine, Professor Lim and Professor Pirmohamed97. During the press conference, Dame June Raine explained that, by 31 March 2021, more than 20 million doses of the Oxford/AstraZeneca vaccine had been administered in the UK and there had been 79 reports of thrombosis with thrombocytopenia, 19 of which were associated with a fatal outcome. She said that, while it was a “strong possibility” that the Oxford/AstraZeneca vaccine had caused the reported cases of thrombosis with thrombocytopenia, more work was needed to establish this beyond all doubt and the balance of benefits and risks was very favourable for older people, but was “more finely balanced for the younger people”.98 |
| 7.55. | Professor Van-Tam used diagrams created by the Winton Centre for Risk and Evidence Communication at the University of Cambridge (see Figure 3) to convey the risks of the condition and the benefits of vaccination by age.99 This is one example of the Winton Centre diagrams discussed at the press conference (this concerns medium exposure risk; the others concerned low and high exposure risk). It showed, as ‘potential benefits’, intensive care admissions due to Covid-19 prevented by vaccination with the Oxford/AstraZeneca vaccine and, as ‘potential harms’, the risks of blood clots due to the vaccine. For all age groups, the potential benefits outweighed the potential harms.100 |
Figure 3: Winton Centre diagram – weighing up the potential benefits and harms of the Oxford/AstraZeneca Covid-19 vaccine
*At medium exposure (incidence of 6 in 10,000 per day – roughly the UK in February 2021)
Source: ‘News – Communicating the potential benefits and harms of the Astra-Zeneca COVID-19 vaccine’, Winton Centre for Risk and Evidence Communication, 7 April 2021 (https://wintoncentre.maths.cam.ac.uk/news/communicating-potential-benefits-and-harms-astra-zeneca-covid-19-vaccine; INQ000497993_0002)
| 7.56. | Professor Lim also explained at the press conference that, in light of the more finely balanced risk–benefit assessment for younger people, the Joint Committee on Vaccination and Immunisation was advising that it was preferable for people aged under 30 without underlying health conditions to be offered an alternative vaccine, if available.101 |
| 7.57. | The press conference was a clear and effective piece of public messaging. The Inquiry considers that it was appropriate to wait until after the Easter weekend to enable this coordinated approach to conveying the latest advice. If the public messaging had been mishandled, it could have damaged confidence in the vaccination programme, which might have led to a decrease in uptake and a corresponding increase in deaths from Covid-19. Importantly, those eligible for vaccination over the Easter weekend were predominantly aged over 50 so were unaffected by the new advice. Also, as noted above, information was already in the public domain about the risk of thrombosis with thrombocytopenia syndrome.102 |
| 7.58. | That same day, 7 April, the Medicines and Healthcare products Regulatory Agency published updated advice for healthcare professionals and people receiving the Covid-19 vaccines and added information about thrombosis with thrombocytopenia syndrome to the Oxford/AstraZeneca vaccine’s product information.103 |
| 7.59. | A month later, on 7 May 2021, new advice was issued. Following accrual and review of additional scientific data on thrombosis with thrombocytopenia syndrome from the Medicines and Healthcare products Regulatory Agency and academic groups in the UK, the Joint Committee on Vaccination and Immunisation advised that an alternative to the Oxford/AstraZeneca vaccine should be offered to all adults aged 40 and under. This was just before the UK-wide rollout of Phase 2 of the vaccination programme, when 18 to 39 year olds without underlying health conditions would be offered vaccination.104 The Inquiry received evidence that close monitoring and analysis of reports of thrombosis with thrombocytopenia syndrome then continued throughout 2021 and into 2022.105 |
| 7.60. | While some European countries suspended the use of the Oxford/AstraZeneca vaccine from early March 2021, it is important to note that these decisions were taken by their respective health authorities, not their medicines regulators. No regulator withdrew authorisation for the Oxford/AstraZeneca vaccine or restricted its use.106 Furthermore, the vaccine was being deployed in continental Europe among younger people from an earlier stage than in the UK; the balance of risk was therefore different for UK recipients, who were at greater risk from Covid-19 itself.107 As Professor Evans noted:
“It should not be expected that all countries will act in the same way and at the same time. The balance of harm and benefit will depend on the vaccination policy (what ages are being vaccinated for example), and the prevalence of the circulating virus with its impact on the local population.”108 |
| 7.61. | In Professor Evans’s view, the UK regulatory response to the thrombosis with thrombocytopenia syndrome signal was appropriate and timely.109 He noted that it was “easy, with hindsight” to say that action should have been taken sooner, but this “ignores the finely balanced nature of risk/benefit assessment in a pandemic”.110 |
| 7.62. | Similarly, Professor Prieto-Alhambra said that the Medicines and Healthcare products Regulatory Agency and other bodies, such as the Joint Committee on Vaccination and Immunisation, “took appropriate action” in response to emerging evidence about the condition.111 Analysis of the safety signal was complicated by the fact that blood clots, including those with low platelet levels, are even more commonly associated with Covid-19 itself in the unvaccinated population.112 This made the assessment of risk and benefit challenging, as Professor Prieto-Alhambra recognised:
“[T]here was a clear need for a fine benefit-risk balance in the decision making at a time when SARS-CoV-2 was circulating very rapidly in the UK.”113 |
| 7.63. | The steps taken by the Medicines and Healthcare products Regulatory Agency, the Commission on Human Medicines, the Vaccine Benefit Risk Expert Working Group and the Joint Committee on Vaccination and Immunisation demonstrate careful consideration of this delicate risk–benefit balance. In this context, the Inquiry considers that the UK’s regulatory and advisory systems responded appropriately to the thrombosis with thrombocytopenia syndrome safety signal. |
Myocarditis and pericarditis
| 7.64. | Myocarditis and pericarditis (collectively referred to in this Report as ‘myo/pericarditis’) are inflammatory disorders affecting the heart which commonly coexist.114 Both can be caused by Covid-19 itself.115 They emerged as a safety signal in 2021 and were particularly associated with the mRNA vaccines (ie the Pfizer/BioNTech and Moderna vaccines).116 Cases were more common in younger men and after a second dose. Although some instances of post-vaccination myocarditis needed hospital admission, large studies have found very low or no associated fatalities.117 |
| 7.65. | No cases of myo/pericarditis were reported during the clinical trials for the Covid-19 vaccines. However, the conditions have been associated with vaccines in the past and, therefore, myo/pericarditis were classed as adverse events of special interest for the Covid-19 vaccines prior to rollout.118 |
| 7.66. | The Medicines and Healthcare products Regulatory Agency acted promptly upon receipt of the first Yellow Card reports of myo/pericarditis. On 4 February 2021, the agency sought – and received – the advice of the Vaccine Benefit Risk Expert Working Group. By this stage, the Medicines and Healthcare products Regulatory Agency had received at least eight Yellow Card reports of suspected myo/pericarditis, seven of which were associated with the Pfizer/BioNTech vaccine.119 The expert working group advised that monitoring of these adverse events should continue.120 |
| 7.67. | The number of reports increased over the next few months. By 5 May 2021, the Medicines and Healthcare products Regulatory Agency had received 19 Yellow Card reports of suspected myocarditis and 16 reports of suspected pericarditis associated with the Pfizer/BioNTech vaccine. This was in the context of the administration of an estimated 11.4 million first doses and 8.7 million second doses of the Pfizer/BioNTech vaccine. One report of suspected myocarditis associated with the Moderna vaccine had been received (and none in respect of pericarditis) in the context of the administration of approximately 100,000 first doses of the Moderna vaccine. The Medicines and Healthcare products Regulatory Agency had also received 21 reports of suspected myocarditis and 41 reports of suspected pericarditis (2 with fatal outcomes) associated with the Oxford/AstraZeneca vaccine.121 An estimated 23.3 million first doses and 7.5 million second doses of the Oxford/AstraZeneca vaccine had been administered by this point.122 |
| 7.68. | The UK regulatory system also considered cases of suspected myo/pericarditis reported in other countries. On 7 May 2021, the Medicines and Healthcare products Regulatory Agency sought advice from the Vaccine Benefit Risk Expert Working Group on reports of suspected myocarditis in both the USA and Israel associated with the Pfizer/BioNTech vaccine, particularly after the second dose. The USA’s national public health agency, the Centers for Disease Control and Prevention, had indicated that there was no safety signal in its analysis for the mRNA vaccines (ie the Pfizer/BioNTech and Moderna vaccines). The Medicines and Healthcare products Regulatory Agency had also not identified a strong signal for an increased risk of myocarditis at this point. The Vaccine Benefit Risk Expert Working Group advised the continuation of the ongoing Yellow Card analysis and epidemiological monitoring.123 |
| 7.69. | That monitoring continued until, in early June 2021, the Medicines and Healthcare products Regulatory Agency presented the latest data on the myo/pericarditis risk to the Vaccine Benefit Risk Expert Working Group. This presentation included data from Yellow Card reports, the UK Health Security Agency and the vaccine manufacturers, as well as international data from the USA and Israel. The expert working group considered that the data from Israel suggested a possible signal of myo/pericarditis, but the same increased risk associated with a second dose had not been seen in the UK or European data. It therefore advised that no regulatory action was required but that reports should continue to be closely monitored.124 |
| 7.70. | On 21 June 2021, the Medicines and Healthcare products Regulatory Agency sought further advice from the Vaccine Benefit Risk Expert Working Group. Pfizer/BioNTech, AstraZeneca and Moderna provided analysis that continued to show no signal. However, data from the UK Health Security Agency, the European Medicines Agency and the US Centers for Disease Control and Prevention indicated an increased risk of myocarditis in younger age groups, in particular associated with the Pfizer/BioNTech and Moderna vaccines. Data from Israel had also shown a signal associated with the Pfizer/BioNTech vaccine in young males, particularly in the 16‑to‑19 age group.125 |
| 7.71. | As a result, the Vaccine Benefit Risk Expert Working Group advised that the product information for the Pfizer/BioNTech and Moderna vaccines should be updated to include a warning about the risk of myo/pericarditis. The available data for the Oxford/AstraZeneca vaccine did not indicate a risk, and the expert working group therefore did not support an update to the product information for this vaccine.126 This advice was endorsed by the Commission on Human Medicines on 23 June 2021 and accepted by the licensing minister on 25 June.127 The product information for the Pfizer/BioNTech and Moderna vaccines was updated on the same day.128 |
| 7.72. | The Medicines and Healthcare products Regulatory Agency continued to scrutinise emerging evidence about the myo/pericarditis signal, with further amendments being made to the product information for the Pfizer/BioNTech and Moderna vaccines as more information emerged and was analysed.129 The Joint Committee on Vaccination and Immunisation also paid close attention to developments with the myo/pericarditis safety signal when making decisions about recommending vaccination for children – for example, for those aged 12 to 15. The risk–benefit assessment was finely balanced among children, given the lower risk posed by Covid-19 to them.130 |
| 7.73. | Dame June Raine was asked about the period of time between the Medicines and Healthcare products Regulatory Agency first seeking the advice of the Vaccine Benefit Risk Expert Working Group on 4 February 2021 and the regulatory action of updating the product information on 25 June 2021. She said that such a period was “probably inevitable, given the rate at which evidence accrued”. As the UK had a more extended dose interval than Israel or the USA, data about the effects of second doses emerged in those countries first and the UK was “rather reliant on data from other regulatory authorities”.131 |
| 7.74. | Analysis of the myo/pericarditis safety signal was further complicated by the fact that these conditions can be difficult to diagnose and can be caused by Covid-19 itself. Viral infections, including Covid-19, are a leading cause of myo/pericarditis worldwide. Professor Sir Christopher Whitty (Chief Medical Officer for England from October 2019) told the Inquiry that rates of myocarditis are higher in people who get Covid-19. Similarly, Professor Prieto-Alhambra highlighted research from 2022 which showed that the risk of myocarditis after vaccination was much lower compared with the risk following Covid-19 infection in the unvaccinated, except in males aged under 40.135 Research also suggested that myo/pericarditis as a result of Covid-19 tended to be more severe than that associated with the Covid-19 vaccines.136 |
| 7.75. | However, any risk–benefit analysis had to do more than simply weigh the risk of developing myo/pericarditis from vaccination and from Covid-19. Professor Prieto-Alhambra explained that the risk–benefit analysis had to include “the overall benefits of vaccination”137. In this context, he said of the UK response:
“I think it was appropriate, partly because both the virus you were preventing with the vaccine and the vaccine itself could potentially cause this condition but also because, of course, the Covid vaccines also prevented many other problems, including, of course, heart failure and respiratory failure due to the infection. So the benefit-risk seemed to be consistent and balanced.”138 |
| 7.76. | Professor Evans’s opinion was also that the regulatory response was appropriate and timely.139 The action taken in the UK was in line with that of other regulators internationally. The Inquiry considers that the UK response to the myo/pericarditis safety signal was appropriate. |
Other conditions
| 7.77. | Professor Prieto-Alhambra also considered seven other serious adverse events, summarised below. |
| Guillain-Barré syndrome: A rare neurological condition leading to sensory loss or abnormality and muscle weakness, sometimes leading to life-threatening disease.141 The condition had been associated with non-Covid-19 vaccines and was identified as an adverse event of special interest from the outset of the vaccination programme.142 Upon receipt of Yellow Card reports about the condition following vaccination, the Medicines and Healthcare products Regulatory Agency sought the advice of the Vaccine Benefit Risk Expert Working Group in March 2021, which advised close monitoring of case reports. This monitoring continued and, in July 2021, following further advice from the expert working group, the product information for the Oxford/AstraZeneca vaccine was updated to include Guillain-Barré syndrome as an adverse effect.143 Professor Prieto-Alhambra explained that the condition can also be caused by Covid-19 itself, as well as by the vaccine, and that such situations are challenging for regulators when making risk–benefit assessments.144 Professor Prieto-Alhambra’s view was that the UK regulatory action taken in relation to the condition was “appropriate”, taking into account “the risk-benefit balance of the available vaccines at the time”.145
Bell’s palsy: A rare weakness or lack of movement in one side of the face caused by a paralysis of the facial nerve, which was identified as a potential adverse drug reaction during clinical trials for the Covid-19 vaccines. Subsequently, ‘temporary one-sided facial drooping’ was added to the product information for the Pfizer/BioNTech and Moderna vaccines, and ‘facial paralysis’ was listed as a rare adverse drug reaction for the Oxford/AstraZeneca vaccine. Professor Prieto-Alhambra’s view was that the UK regulatory action taken in relation to the condition was appropriate, “given the rarity and relatively low-moderate severity” of the condition and the fact that “it could also be caused by Covid-19 itself”.146 Transverse myelitis: A serious, very rare disease caused by inflammation of parts of the spinal cord. As explained in Chapter 4: Authorisation, reports of the condition had halted the clinical trials of the Oxford/AstraZeneca vaccine. It had been associated with previous viral infections and vaccines and was monitored as an adverse event of special interest during the rollout of the Covid-19 vaccines. Following receipt of Yellow Card reports concerning the condition, the Medicines and Healthcare products Regulatory Agency consulted the Vaccine Benefit Risk Expert Working Group in February and May 2021, but no regulatory action was recommended. However, in October 2021, the expert working group advised the addition of the condition to the Oxford/AstraZeneca vaccine’s product information and that a second dose should not be offered to those who had experienced transverse myelitis after the first dose.147 Professor Prieto-Alhambra explained that the UK regulatory action taken in relation to the condition was appropriate given the “extreme rarity of this event” and the potential that Covid-19 itself might cause the condition.148 Immune thrombocytopenia: An autoimmune blood disorder characterised by abnormally low levels of platelets, which are important for blood clotting. It is a condition known to be associated with previous non-Covid-19 vaccines.149 It was treated as an adverse event of special interest and monitored from the outset of the Covid-19 vaccination campaign.150 Following consultation with the Vaccine Benefit Risk Expert Working Group, the condition was added to the product information for the Oxford/AstraZeneca vaccine on 29 October 2021.151 Professor Prieto-Alhambra noted that, while decisions were made in the UK approximately one month later than they had been by the European Medicines Agency, his view was that the UK regulatory response to the condition was “appropriate” and in line with that of other international regulators.152 Thrombosis (blood clots) without thrombocytopenia (low platelet levels): No evidence of a risk of blood clots was found in the large randomised trials before authorisation; however, blood clots were monitored as potential adverse events of interest for the Covid-19 vaccines.153 Unusual blood clots in the brain called cerebral venous sinus thromboses were reported in association with the Oxford/AstraZeneca vaccine. In January 2022, the Medicines and Healthcare products Regulatory Agency updated the Oxford/AstraZeneca information for healthcare professionals and vaccine recipients to include a warning about cerebral venous sinus thrombosis without thrombocytopenia. Professor Prieto-Alhambra explained that Covid-19 itself can cause blood clots and this necessitated a careful balancing of risks and benefits on the part of the regulator. In his view, the Medicines and Healthcare products Regulatory Agency “took appropriate action” relating to the finding of an increased risk of blood clots.154 The regulatory response to blood clots with thrombocytopenia is examined in more detail above. Capillary leak syndrome: A very rare and potentially fatal condition where fluid leaks from small blood vessels, likely due to inflammatory reactions. In early June 2021, the Vaccine Benefit Risk Expert Working Group discussed the safety signal and advised the addition of a precautionary statement in the product information for the Oxford/AstraZeneca vaccine about the condition.155 Professor Prieto-Alhambra noted that good-quality studies are needed to further our understanding of the potential causality and mechanisms involved in this association. However, the UK regulatory action was “appropriate” and similar to that proposed by other countries and regulators.156 Acute disseminated encephalomyelitis: An extremely rare but serious inflammation of specific parts of the central nervous system. The condition has been associated with viral infections including Covid-19 and was monitored closely as an adverse event of special interest for the Covid-19 vaccines. The Medicines and Healthcare products Regulatory Agency added the condition as an extremely rare event in the ‘special warnings and precautions for use’ section of the Oxford/AstraZeneca vaccine’s product information in November 2023. Professor Prieto-Alhambra explained that the UK regulatory action relating to the potential risk of the condition was “appropriate and more proactive” than that taken by international regulators.157 |
| 7.78. | In respect of each safety signal scrutinised, Professor Prieto-Alhambra’s view was that the UK’s response had been appropriate and timely. He noted that “UK agencies reacted promptly to safety events” and said:
“[T]he UK national vaccine regulatory and public health systems reacted in a similar manner to those in other comparable nations when it came to the approval and postmarketing surveillance of vaccines.”158 Professor Prieto-Alhambra considered, in particular, that the formation of the Vaccine Benefit Risk Expert Working Group and other advisory groups was “fundamental to positively inform decision-making”.159 |
| 7.79. | Similarly, Professor Evans said that, in his view, the UK regulatory system “responded effectively to safety concerns”. He also said: “Safety signals were examined … in a timely and thorough manner with the assistance of expert working groups.”160 |
| 7.80. | In addition to scrutinising the response to the safety signals noted above, the Inquiry gave Professor Prieto-Alhambra the task of addressing 81 other conditions that had been reported to the Inquiry – including by groups representing the vaccine injured and bereaved – as suspected adverse effects of the Covid-19 vaccines.161 |
| 7.81. | In order to understand, with respect to each condition or harm, whether there appeared to be a genuine issue and the scale of the problem, he carried out a comprehensive review of the most relevant scientific and medical literature and studies. His review focused on those conditions for which there were at least moderate-quality studies on the association between Covid-19 vaccination and the risk of developing the condition.162 |
| 7.82. | Professor Prieto-Alhambra noted that many of these conditions are rare or have multiple contributing causes, which made it challenging to investigate them and establish the requisite degree of causation to permit the conclusion that they were directly related to the Covid-19 vaccines.163 |
| 7.83. | His review revealed that there was moderate or high-quality evidence in respect of only 14 of the conditions. In relation to four of these, the evidence suggested that there was no association between Covid-19 vaccination and an increased risk of developing the condition.164 This left 10 conditions in respect of which there was some evidence of a possible association.165 |
| 7.84. | In most cases, the available evidence was inconsistent and Professor Prieto-Alhambra noted that further and better-quality research would be needed to clarify any potential association.166 The Medicines and Healthcare products Regulatory Agency should consider whether any of these conditions warrant further examination by way of systematic reviews and epidemiological studies.167 |
| 7.85. | As part of his work for the Inquiry, Professor Prieto-Alhambra also addressed prominent publicly reported side effects which, upon investigation, have been found not to be associated with the Covid-19 vaccines. These included adverse pregnancy outcomes and fertility problems, in relation to which there was no evidence of an association with the vaccines.168 Professors Evans and Prieto-Alhambra also both agreed that there was no evidence that the Covid-19 vaccines had caused an increase in excess deaths. On the contrary, studies had shown that the Covid-19 vaccines had saved many millions of lives across the globe.169 |
Improving data linkage for future safety monitoring
| 7.86. | While the UK’s systems and processes responded effectively to vaccine safety issues, the Inquiry concludes that there is nevertheless scope for improvement. This is particularly the case in relation to electronic healthcare records. |
| 7.87. | During the pandemic, the Medicines and Healthcare products Regulatory Agency drew upon its real-world data research service – the Clinical Practice Research Datalink – which collects “de-identified” patient data from a network of GP practices, along with other healthcare data sources, to provide a UK population health dataset for use in safety analysis.170 In conducting safety studies, it also took advantage of the independent data source OpenSAFELY (a secure platform for observational research using patient health records).171 Pseudonymised records from the National Immunisation Management System in England and the Vaccination Management Tool in Scotland also allowed for quality and timely research on the safety and effectiveness of the Covid-19 vaccines.172 |
| 7.88. | However, the Inquiry heard from a number of witnesses that improvements could be made when it came to the linkage of electronic healthcare data. Professor Evans told the Inquiry that there was insufficient linkage between, for example, GP practice and hospital records and between healthcare records across the four nations of the UK.173 Similarly, Professor Prieto-Alhambra said that there should be a drawing together of fragmented systems of healthcare data.174 |
| 7.89. | Professor Whitty told the Inquiry that there had always been a difficulty in “linking up primary care data, general practice data, with secondary care data”.175 Such linkage was crucial in order to identify rare adverse effects:
“Because the danger is otherwise, a doctor in York will see it one day and a doctor in Shrewsbury will see it the next day, and each one of them only sees one case and doesn’t put the pattern together. The faster you can actually put all these pieces of information together, the faster you will pick up something which is important but rare.”176 |
| 7.90. | Professor Sir Andrew Pollard (Professor of Infection and Immunity at the University of Oxford), who led the clinical development of the Oxford/AstraZeneca vaccine, called for better data on the expected or ‘background’ rates of medical conditions so that a more effective assessment could be made of whether reported cases of a condition represent an increase against the background rate and may therefore be attributable to a new drug. He said that this would require “a concerted effort to link primary care and hospital data across the NHS”.177 A greater linkage between patients’ GP practice medical records, hospital medical records and laboratory diagnosis records was also called for by Dr Justin Green, Global Product Lead for the Oxford/AstraZeneca vaccine from October 2022.178 |
| 7.91. | From the regulator’s perspective, Dame June Raine said that “a single UK vaccination registry” capturing data on all vaccines administered across healthcare settings, with sufficient patient demographic data and with “linkage to primary care and hospital admissions data”, would support a more rapid identification of adverse effects.179 This would also be achieved by increased capture and collation of data on diagnostic tests, imaging results and prescribing in secondary care, with linkage of these data on an “individual patient level basis” to data already collated across primary and secondary care. Dame June Raine noted that such linkage:
“needs to be UK-wide in order to support rapid surveillance of rare adverse events in patient subgroups”.180 |
| 7.92. | Similarly, the need for improved linkage of healthcare records data at an individual patient level was emphasised by Professor Pirmohamed. In relation to the example of the regulatory response to thrombosis with thrombocytopenia syndrome, he said:
“[W]e not only needed data on vaccine administration, but also when the patient was admitted to a hospital or needed medical attention, what was the cause of the admission, and what radiological and laboratory data for that patient were available to either confirm or refute the diagnosis. This was not available to the [Medicines and Healthcare products Regulatory Agency] or any Government department, and was only possible through manual evaluation of individual patient case records by haematologists and other healthcare professionals which was slow and not systematic (i.e. not all cases were identified).”181 In Professor Pirmohamed’s view, having the ability to link vaccine administration data to admission data, as well as to imaging and laboratory data, “would have been transformational” and would have allowed for the evaluation of the thrombosis with thrombocytopenia syndrome signal “more quickly”.182 |
| 7.93. | The benefits of data linkage were highlighted by Professor Cathie Sudlow, Chair of Neurology and Clinical Epidemiology at the University of Edinburgh, in her review of the UK’s health data landscape, Uniting the UK’s Health Data: A Huge Opportunity for Society, published in November 2024. She noted that the Medicines and Healthcare products Regulatory Agency, like other bodies, was hampered by “health data system gaps”:
“In some situations, nationwide monitoring across the whole population is important (for example for monitoring potential rare adverse effects of widely used vaccines). However, the [Medicines and Healthcare products Regulatory Agency] cannot currently access all the sources of national data needed for the most appropriate monitoring of the safety of all drugs and devices.”183 |
| 7.94. | Recent developments promise an improvement in the use of electronic healthcare records for research purposes. |
| 7.95. | In April 2025, the UK government announced that it and a global charitable foundation, Wellcome (formerly known as the Wellcome Trust), would be making a £600 million investment to create a new health data research service. The new service, which is due to be rolled out progressively from the end of 2026, aims to transform access to data by providing a secure, single access point to England-wide datasets, with robust protections in place to protect the anonymity of patients. The health data research service was a central recommendation of Professor Sudlow’s review.184 |
| 7.96. | In July 2025, the UK government published Fit for the Future: 10 Year Health Plan for England. This included proposals to create a ‘single patient record’, which will “bring together all a patient’s medical records into one place”. The aim of the single patient record is to facilitate more coordinated and personalised care; however, the linking of patients’ electronic healthcare records also has clear potential applications in the field of safety monitoring. |
| 7.97. | The Inquiry welcomes and endorses these developments in relation to health data research and patient records. However, it is unclear at present how, if at all, the improved linking of healthcare data will be utilised to enable the rapid analysis of safety signals. This must be a priority and therefore the Inquiry is recommending that regulatory bodies be given access to linked primary and secondary healthcare records (including data on vaccines and therapeutics administration) across the UK for use in the assessment of safety signals. |
Recommendation 4: Proportionate access to linked healthcare records for use in the assessment of safety signals
The UK government and devolved administrations should work together, with their respective health delivery services, to facilitate and coordinate regulatory bodies’ access to healthcare records in order to make the post-authorisation safety monitoring of new vaccines and therapeutics more efficient.
In particular, the Medicines and Healthcare products Regulatory Agency should be granted specific and proportionate access to comprehensive and comparable data from across the four nations of the UK, including linked primary and secondary healthcare data records. This should include data on vaccines and therapeutics administration. This improved linkage must be accompanied by strong safeguards for patient confidentiality, which the Information Commissioner’s Office should work with the four governments to ensure.
- INQ000474703_0024 para 4.39
- INQ000474703_0008 para 2.1. Rare adverse effects are those affecting 1 in 1,000 to 1 in 10,000 people; very rare adverse effects are those affecting fewer than 1 in 10,000 people (INQ000474703_0031 para 5.2).
- Every Story Matters: Vaccines and Therapeutics, pp44-45 (INQ000474465)
- INQ000474707_0006 para 1.19
- Stephen Evans 22 January 2025 23/20-24. The terms ‘adverse effect’ and ‘adverse reaction’ are regarded as attributable to a vaccine (INQ000474707_0011 para 2.13).
- Stephen Evans 22 January 2025 24/9-25/7
- INQ000474337_0007 paras 12-13. The meaning of this term is addressed in Chapter 4: Authorisation.
- INQ000474337_0038 paras 119-120
- INQ000474336_0018-0023 paras 34-35; INQ000474337_0017-0018 paras 43-44
- INQ000474337_0039 para 124
- INQ000474337_0040 para 125; Munir Pirmohamed 29 January 2025 166/21-167/20
- INQ000474337_0086-0087 paras 308-311
- INQ000474336_0051-0053 paras 116-121; Munir Pirmohamed 29 January 2025 131/2-132/18; INQ000474337_0099 para 338
- INQ000474336_0052 para 118; INQ000474337_0092-0093 para 328
- INQ000474336_0052-0053 para 119
- INQ000474336_0053 para 120; INQ000474337_0109-0110 para 375
- INQ000474336_0053 para 121
- Munir Pirmohamed 29 January 2025 132/8-18
- INQ000474707_0075 para 7.3; Stephen Evans 22 January 2025 62/5-9
- INQ000474337_0235 para 843
- June Raine 22 January 2025 132/18-133/1; see also Charlet Crichton 21 January 2025 156/17-23
- June Raine 22 January 2025 129/18-131/4; INQ000474337_0049-0050 para 160
- June Raine 22 January 2025 129/23-130/8
- Stephen Evans 22 January 2025 28/24-29/13
- INQ000474337_0111 para 381
- INQ000474336_0052, 0054 paras 118, 123
- INQ000474337_0088 para 314
- INQ000474336_0054 para 124
- June Raine 22 January 2025 154/19-155/4
- INQ000474336_0054 para 123
- INQ000474336_0055 para 128; Coronavirus Vaccines: Summary of Yellow Card Reporting, Medicines and Healthcare products Regulatory Agency, 7 July 2022, p14 (INQ000408385)
- Coronavirus Vaccines: Summary of Yellow Card Reporting, Medicines and Healthcare products Regulatory Agency, 7 July 2022, p13 (INQ000408385)
- June Raine 22 January 2025 153/20-154/1; Munir Pirmohamed 29 January 2025 136/11-15
- INQ000474336_0055 para 129
- June Raine 22 January 2025 155/18-156/3
- INQ000474337_0107 para 369
- Charlet Crichton 21 January 2025 157/16-158/6
- INQ000474337_0108 para 372
- Munir Pirmohamed 29 January 2025 137/9-138/14
- June Raine 22 January 2025 156/7-157/15; Munir Pirmohamed 29 January 2025 138/15-23
- Munir Pirmohamed 29 January 2025 139/2-12
- INQ000474337_0101, 0106 paras 346, 362
- Kate Scott 15 January 2025 164/6-12
- June Raine 22 January 2025 164/24-165/13; INQ000474337_0234 paras 836-837; Increasing Adverse Event Reporting (IAER) Subproject: Survey Report, International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmacovigilance (PV) Project, undated, pp33-34 (https://icmra.info/drupal/sites/default/files/2018-12/ICMRA%20PhV%20IAER%20SubWG%20Survey%20Final%20Report.pdf; INQ000507331); see also Stephen Evans 22 January 2025 70/19-71/12
- INQ000474337_0234 para 836
- Munir Pirmohamed 29 January 2025 141/8-12
- INQ000474707_0063 para 6.32
- Ruth O’Rafferty 15 January 2025 141/13-18; Charlet Crichton 21 January 2025 158/3-6
- Sajid Javid 23 January 2025 64/5-65/4
- Salman Waqar 16 January 2025 9/19-10/1
- Salman Waqar 16 January 2025 8/21-9/12
- INQ000474337_0108 para 371
- INQ000474337_0109 para 374
- INQ000474336_0057 para 135; INQ000474337_0107 para 368
- Daniel Prieto-Alhambra 22 January 2025 64/25-65/3
- INQ000474703_0014 para 3.17
- June Raine 22 January 2025 163/8-164/23, 184/4-11, 187/2-5; Munir Pirmohamed 29 January 2025 139/18-23
- INQ000474337_0083-0085 paras 296-305; INQ000474707_0041-0042 paras 4.26-4.27
- Stephen Evans 22 January 2025 61/14-18
- Ben Osborn 23 January 2025 133/5-135/5; Justin Green 23 January 2025 178/3-22; Darius Hughes 27 January 2025 17/11-19/18
- INQ000485977_0044-0045 para 130.2; INQ000474537_0026 para 65; INQ000474453_0032 paras 148-152
- INQ000474707_0011 para 2.13
- INQ000474703_0031 para 5.3; INQ000474337_0101 para 346
- INQ000474337_0199 para 710
- INQ000474337_0199 para 709
- INQ000474337_0199 para 711
- INQ000474337_0199-0200 paras 712-715
- INQ000474337_0203 para 724
- Munir Pirmohamed 29 January 2025 126/14-25; INQ000474336_0060 para 146
- INQ000474337_0206 para 735
- INQ000474337_0206-0208 paras 737-740
- INQ000474703_0055 para 5.116
- INQ000474337_0130 paras 452-453
- INQ000474703_0036-0037
- INQ000474337_0146 para 508; ‘ARCHIVED – Coronavirus vaccine – summary of Yellow Card reporting’, Medicines and Healthcare products Regulatory Agency, 8 March 2023, pp24-25 (https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting–2; INQ000421360)
- ‘ARCHIVED – Coronavirus vaccine – summary of Yellow Card reporting’, Medicines and Healthcare products Regulatory Agency, 8 March 2023, pp24-25 (https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting–2; INQ000421360); INQ000474703_0037-0038 para 5.30
- Kate Scott 15 January 2025 163/19-22; Charlet Crichton 21 January 2025 158/22-25
- June Raine 22 January 2025 165/16-18; INQ000474703_0037 para 5.28
- June Raine 22 January 2025 165/22-166/2; INQ000474337_0088-0089 paras 316-317; INQ000474703_0037 para 5.28
- INQ000474337_0131 paras 455-456
- INQ000474336_0061
- INQ000474337_0132-0133 paras 462-463; INQ000409517_0006-0007 paras 2.5.1-2.6.2
- INQ000474337_0133 para 466
- INQ000474337_0133-0134 para 467
- INQ000474527_0005-0007 paras 21-26
- INQ000474337_0135 para 472
- INQ000474337_0136 para 475
- INQ000474337_0137-0138 para 479
- INQ000474336_0062; Munir Pirmohamed 29 January 2025 154/11-155/3; INQ000409499_0007 paras 2.21-2.22
- INQ000474527_0011-0013 para 33
- INQ000416156
- INQ000416158
- June Raine 22 January 2025 170/12-18; INQ000474924_0002 para 6
- INQ000474337_0139 para 484; INQ000409500_0003, 0005 paras 2.2, 2.11-2.12
- INQ000474336_0071 para 161; INQ000474337_0140 paras 488-489; June Raine 22 January 2025 174/8-175/9; Munir Pirmohamed 29 January 2025 155/13-157/17; INQ000409501_0004-0005 paras 2.8-2.9
- INQ000474336_0071 para 161; INQ000474337_0140 para 489
- INQ000474336_0071 para 164; INQ000408460
- INQ000408460_0001-0002
- INQ000408460_0004; ‘News – Communicating the potential benefits and harms of the Astra-Zeneca COVID-19 vaccine’, Winton Centre for Risk and Evidence Communication, 7 April 2021 (https://wintoncentre.maths.cam.ac.uk/news/communicating-potential-benefits-and-harms-astra-zeneca-covid-19-vaccine; INQ000497993_0002)
- ‘News – Communicating the potential benefits and harms of the Astra-Zeneca COVID-19 vaccine’, Winton Centre for Risk and Evidence Communication, 7 April 2021 (https://wintoncentre.maths.cam.ac.uk/news/communicating-potential-benefits-and-harms-astra-zeneca-covid-19-vaccine; INQ000497993_0002)
- INQ000408460_0005
- Jonathan Van-Tam 20 January 2025 169/6-172/8
- ‘MHRA issues new advice, concluding a possible link between COVID-19 vaccine AstraZeneca and extremely rare, unlikely to occur blood clots’, Medicines and Healthcare products Regulatory Agency, 7 April 2021 (https://www.gov.uk/government/news/mhra-issues-new-advice-concluding-a-possible-link-between-covid-19-vaccine-astrazeneca-and-extremely-rare-unlikely-to-occur-blood-clots; INQ000408453); INQ000474337_0140-0141 para 490; INQ000474336_0063; June Raine 22 January 2025 176/14-177/4; INQ000474537_0034; INQ000474537_0043 para 79(d). The product information was further updated on 15 April 2021 (INQ000474537_0043 para 79(e)).
- INQ000471988_0040 para 162
- INQ000474337_0145-0147 paras 504-509
- INQ000474337_0142 paras 496-497
- Daniel Prieto-Alhambra 22 January 2025 97/18-98/13; INQ000474703_0037; INQ000474703_0041 para 5.49; Munir Pirmohamed 29 January 2025 149/3-150/8; Wei Shen Lim 23 January 2025 116/21-117/15
- INQ000474707_0067 para 6.40
- Stephen Evans 22 January 2025 73/3-12
- INQ000474707_0075-0076 para 7.5
- INQ000474703_0041 para 5.49; Daniel Prieto-Alhambra 22 January 2025 73/17-74/2
- INQ000474703_0037
- INQ000474703_0041 para 5.49
- INQ000474337_0179 para 642
- INQ000474703_0032
- INQ000474703_0032-0033 paras 5.8-5.10
- INQ000474703_0032
- INQ000474337_0180 para 644
- The figures provided are for the period up to and including 27 January 2021 (INQ000474337_0180 para 645).
- INQ000474336_0075 para 178
- INQ000474337_0181 para 648. Professor Pirmohamed noted that such reports associated with the Oxford/AstraZeneca vaccine probably reflected the background incidence of myo/pericarditis (INQ000474336_0076 para 183).
- INQ000474337_0181 para 648
- INQ000474337_0181 para 649; INQ000494348_0003 paras 3.1-3.6
- INQ000474337_0182 paras 650-652; INQ000409527_0004 paras 4.1-4.7
- INQ000474337_0183 paras 654-655
- INQ000474337_0183 para 656; INQ000409529_0004-0005 paras 3.1-3.5
- INQ000474337_0183-0184 paras 657-658; INQ000409504_0002-0003 paras 2.1.1-2.1.4; INQ000494303
- INQ000474337_0184 para 658; June Raine 22 January 2025 177/15-178/9; Munir Pirmohamed 29 January 2025 164/3-15; Ben Osborn 23 January 2025 140/18-142/9; Darius Hughes 27 January 2025 22/8-24
- INQ000474337_0184-0198 paras 659-707; Ben Osborn 23 January 2025 142/10-143/12
- Wei Shen Lim 23 January 2025 95/5-98/3; INQ000354535_0001-0007. Decision-making about the vaccination of children is addressed in detail in Chapter 5: Delivery.
- June Raine 22 January 2025 177/24-178/9. Subsequent analysis has shown a lower risk associated with a second dose with a longer dose interval, which has led to the suggestion that the UK’s longer dose interval inadvertently mitigated the myocarditis risk (INQ000474337_0182 para 652).
- Munir Pirmohamed 29 January 2025 162/2-15; INQ000474336_0075 para 179
- INQ000474337_0179-180 para 643
- Christopher Whitty 20 January 2025 127/10-12
- INQ000474703_0034 para 5.16. However, Dame June Raine highlighted a March 2022 study which showed that young males infected with the virus were up to six times more likely to develop myocarditis than those who had received the vaccine (INQ000474337_0185 para 663).
- Munir Pirmohamed 29 January 2025 163/1-19; INQ000474336_0077 para 185
- INQ000474703_0034-0035 para 5.19
- Daniel Prieto-Alhambra 22 January 2025 94/3-10
- Stephen Evans 22 January 2025 69/18-21
- Daniel Prieto-Alhambra 22 January 2025 94/11-12
- INQ000474703_0041
- INQ000474337_0089 para 317
- INQ000474703_0042 paras 5.52-5.54
- INQ000474703_0031-0032 para 5.5; INQ000474703_0041
- INQ000474703_0041
- INQ000474703_0044-0045
- INQ000474703_0045-0047
- INQ000474703_0046
- INQ000474337_0152 paras 532-533
- INQ000474337_0089 para 317
- INQ000474703_0049 para 5.87
- INQ000474703_0048-0049 para 5.91
- This type of blood clotting can also occur with thrombocytopenia (see, for example, INQ000474337_0130 para 453). The regulatory response to blood clots with thrombocytopenia is examined in more detail above.
- INQ000474703_0036-0041 paras 5.28-5.49
- INQ000474703_0050-0051 para 5.94
- INQ000474703_0050
- INQ000474703_0051-0052 para 5.104. Dame June Raine explained that ‘extremely rare’ means fewer than 1 report per 100,000 doses of each vaccine (INQ000474337_0173 para 617).
- INQ000474703_0070 paras 6.1, 6.4; see also Daniel Prieto-Alhambra 22 January 2025 68/6-16
- INQ000474703_0014 para 3.18
- INQ000474707_0075 para 7.5; see also Stephen Evans 22 January 2025 68/6-10
- INQ000474703_0056-0057 paras 5.117-5.120
- Daniel Prieto-Alhambra 22 January 2025 82/10-83/2; INQ000474703_0057 para 5.120
- INQ000474703_0056 para 5.118
- INQ000474703_0057-0063 paras 5.121-5.159
- The conditions were: varicella-zoster virus (infection and reactivation) (a virus that causes both chickenpox and shingles); tinnitus (the perception of sound when no external sound source is present); seizures; autoimmune connective tissue disorders leading to alopecia (a general medical term for hair loss, either temporary or permanent); rheumatoid arthritis (development and flares) (a chronic condition caused by the body’s immune system attacking the connective tissue in joints, causing inflammation, pain, swelling and irritation and leading to destruction of the joints over time); systemic lupus erythematosus (a chronic autoimmune disease where the body’s immune system attacks its own healthy tissues and organs, resulting in joint pain, rashes and fatigue; it can cause organ impairment or failure); fibromyalgia (a long-term condition – also known as fibromyalgia syndrome – that causes musculoskeletal pain all over the body); depression; postural orthostatic tachycardia syndrome (a condition which causes the heart rate to increase very quickly after getting up from sitting or lying down); and optic neuritis (inflammation of the optic nerve, causing damage to its structure and function).
- INQ000474703_0058-0063 paras 5.124-5.159
- INQ000474703_0071 para E
- Daniel Prieto-Alhambra 22 January 2025 106/13-25; INQ000474703_0066-0068 paras 5.174-5.181
- Stephen Evans 22 January 2025 75/1-22; Daniel Prieto-Alhambra 22 January 2025 75/23-76/25; INQ000474703_0068-0069 paras 5.182-5.186
- INQ000474337_0029, 0094 paras 84d, 329. ‘De-identified’ data have had their direct identifiers (such as names) removed, making it difficult to link the data to an individual without additional information.
- INQ000474337_0106 para 365; Stephen Evans 22 January 2025 54/13-56/5; INQ000474707_0047-0048 paras 5.17-5.19
- Daniel Prieto-Alhambra 22 January 2025 56/19-58/6; INQ000474703_0014 paras 3.19-3.21. ‘Pseudonymised’ means that personal data have been processed to replace identifying information with a pseudonym or code, in a way that the data can no longer be attributed to a specific individual without using separate, additional information.
- Stephen Evans 22 January 2025 79/20-80/10
- Daniel Prieto-Alhambra 22 January 2025 80/11-23
- Christopher Whitty 20 January 2025 50/20-53/14
- Christopher Whitty 20 January 2025 53/8-14
- INQ000474399_0061, 0063 paras 139, 144
- INQ000474537_0050 para 96
- INQ000474337_0234-0235 para 840
- INQ000474337_0235 para 841
- INQ000474336_0074 para 174
- INQ000474336_0074 para 174
- Uniting the UK’s Health Data: A Huge Opportunity for Society, Professor Cathie Sudlow, November 2024, pp27-29, 136
(https://zenodo.org/records/13353747; INQ000474861) - ‘Prime Minister turbocharges medical research’, Department of Health and Social Care, Prime Minister’s Office, Department for Science, Innovation and Technology, Office for Life Sciences and Office for Investment, 7 April 2025 (https://www.gov.uk/government/news/prime-minister-turbocharges-medical-research; INQ000651980)
- Fit for the Future: 10 Year Health Plan for England, UK Government and NHS, July 2025, pp47-48 (https://assets.publishing.service.gov.uk/media/6888a0b1a11f859994409147/fit-for-the-future-10-year-health-plan-for-england.pdf; INQ000650755)
Chapter 8: The Vaccine Damage Payment Scheme
Introduction
| 8.1. | The Vaccine Damage Payment Scheme was introduced in 1979, following the 1978 Royal Commission on Civil Liability and Compensation for Personal Injury (known as the Pearson Commission). The commission noted that there was:
“a special case for paying compensation for vaccine damage where vaccination is recommended by a public authority and is undertaken to protect the community”.1 This reflected the special nature of the social contract underlying mass vaccination and, it was suggested, would boost confidence in vaccination programmes. The scheme was intended to be an interim measure until more comprehensive legislation could follow but, after the 1979 general election, it was not revisited or amended by the incoming government.2 Having been originally designed for childhood vaccinations, the scheme was expanded periodically from 1990 to include further diseases and some vaccination programmes for those aged 18 and over, including Covid-19.3 |
| 8.2. | The scheme is not designed to be compensatory. Its purpose is to make available financial assistance for very serious injury resulting from a recommended vaccination.4 Entitlement to payment under the scheme – which operates across the whole of the UK and applies to vaccines given in the UK or the Isle of Man – is based on being able to establish that the person has suffered severe disablement of 60% or more and that, on a balance of probabilities, the vaccine caused the injury or death.5 These are not straightforward thresholds. The maximum award has gradually increased over time and the current award of £120,000 was last revised in 2007.6 |
| 8.3. | From December 2020, the scheme was further expanded to include vaccines for Covid-19.7 The number of applications to the Vaccine Damage Payment Scheme has increased significantly since the Covid-19 vaccination programme began. In the 10 years prior to Covid-19, there were fewer than 800 applications in total.8 By January 2025, there had been 17,519 applications to the scheme in respect of Covid-19 vaccines.9 This dramatic increase quickly led to backlog and delay. |
| 8.4. | It is in this context that this chapter examines the scheme and its UK-wide use in relation to Covid-19 vaccines, as well as the application process and thresholds required to be met for awards to be made. |
The Vaccine Damage Payment Scheme and Covid-19
| 8.5. | The UK government considered creating a separate, dedicated Covid-19 vaccine payment scheme. In July 2020, some thought was given to whether the existing scheme would be suitable to meet the demanding circumstances of a Covid-19 mass vaccination campaign. An internal note from the Department of Health and Social Care recommended the creation of a new support mechanism which would “go above and beyond” the scheme, not only to “ensure fair recompense” but also to “deal with the administrative burden” of the expected large size of the vaccination programme.10 The precise way in which this would be achieved was not set out in the departmental note.11 |
| 8.6. | The possibility of a new dedicated scheme for Covid-19 remained under consideration until at least October 2020, when work was still described as being at an early stage.12 The creation of a new mechanism was not, however, pursued further. |
| 8.7. | Advice to ministers in October 2020 acknowledged the possible risk that establishing a dedicated Covid-19 scheme might undermine vaccine confidence “if the rationale for establishing the scheme is misconstrued”.13 It noted that there was no need to rush to develop a new scheme, as there were plans in place to add Covid-19 to the existing scheme, “which would provide some financial support in the event of any adverse reaction”.14 |
| 8.8. | Matt Hancock MP, Secretary of State for Health and Social Care from July 2018 to June 2021, told the Inquiry that he supported using the existing Vaccine Damage Payment Scheme and “in the short time available it was not considered necessary to amend it during the pandemic”.15 He said, however, that the Vaccine Damage Payment Scheme might be described as a “blunt instrument” and that:
“[T]here is a reasonable case for compensation that is more proportionate to the damage caused to be provided by the Scheme.”16 |
| 8.9. | The UK government’s rationale for adding Covid-19 vaccines to the existing scheme in December 2020 was two-fold: to demonstrate its confidence in the safety of the Covid-19 vaccines; and to ensure that there was financial provision in the rare cases where any individual was severely disabled as a result of vaccination.17 |
| 8.10. | The UK government’s position in 2022 and 2023 was that reform to the Vaccine Damage Payment Scheme, including the possibility of a new dedicated Covid-19 scheme, was not necessary. The reasons provided in October 2022 were that reforms were under way to the existing Vaccine Damage Payment Scheme to make it more efficient by increasing staff levels and digitalisation and that setting up a distinct compensation scheme for Covid-19 would come with “risks of excessive delay” and “the potential for errors to creep in”.18 In May 2023, the Department of Health and Social Care said that it was “not the right time to implement reform” because it would require legislative and contract changes and “the pausing of all claims to the scheme”.19 |
Operation of the scheme
| 8.11. | There is no requirement for an applicant to the scheme to show negligence or any other wrongdoing. An award under the scheme is not regarded as compensation for all of the loss an individual has suffered – instead, it offers a fixed payment from the UK government to recognise the impact of death or injury and to give some financial support to the individual.20 The Inquiry was told that the rationale for that support was:
“to ease the financial burden on individuals where, on very rare occasions, vaccination has caused severe disablement. The VDPS [Vaccine Damage Payment Scheme] is not designed to cover all expenses associated with severe disablement, other Government support such as Statutory Sick Pay, Universal Credit, Employment and Support Allowance, Attendance Allowance, and Personal Independence Payments are available.”21 |
| 8.12. | An award under the Vaccine Damage Payment Scheme is therefore not a bar to an individual bringing a civil claim seeking damages, for example, against a vaccine manufacturer.22 However, the Inquiry was told that bringing civil cases against vaccine manufacturers was “extremely challenging” and, for some people, is not an option at all.23 There are potential costs involved in bringing civil claims and a claimant is required to prove that there has been negligence or a product defect.24 This underlines the importance of an effective payment scheme that people can use without recourse to litigation. |
Accessibility and the application process
| 8.13. | The scheme’s application process is intended to be user-friendly and accessible, without the need for legal assistance.25 |
| 8.14. | However, there have been practical difficulties for applicants or their representatives in trying to submit an application. At the start of the pandemic, applications were paper-based. The declaration on the first page of the form did not allow applicants to indicate that they were applying on behalf of a deceased loved one.26 Completing the form was also challenging for people who were suffering from injuries, including neurological conditions, or who were dealing with bereavement.27 |
| 8.15. | Some aspects of the application process have improved since the NHS Business Services Authority took over responsibility for administering the scheme at the end of 2021 – for example, with the digitalisation of application forms in 2023 and the introduction of named caseworkers to provide a clear point of contact for the applicant throughout the process.28 Since 2023, tailored forms have been in place for those claiming on behalf of someone else or someone who has died.29 |
| 8.16. | However, the Inquiry heard that the process was still “brutal” for people dealing with the consequences of vaccine injury.30 Sarah Moore (a lawyer who specialises in representing people who have suffered vaccine injury) told the Inquiry that many individuals she encountered felt overwhelmed by the application process and could only access the scheme with the assistance of peers or free legal advice.31 While the Scottish Social Security department provided a service to help people complete the forms in Scotland, Ms Moore was not aware of any equivalent systems in England, Wales or Northern Ireland.32 |
| 8.17. | The Inquiry was also told that, when the Covid-19 vaccines were rolled out, little was done to publicise the scheme and a significant number of those who had been injured or bereaved as a result of the vaccine were unaware of it.33 |
| 8.18. | The Inquiry recognises that applicants to the scheme are often dealing with life-changing injuries or events. It is therefore vital that it is accessible and easy to use. The digitalisation of the system and the introduction of allocated caseworkers have been positive steps. Those managing the scheme should also consider making administrative assistance available to help people to complete the application form where they request it and where additional assistance is required – for example, because of a medical condition. |
Eligibility
| 8.19. | After the application is submitted and checked to ensure that it meets certain basic eligibility criteria (eg that the individual was vaccinated in the UK), it is assessed by an independent medical assessor (who is a registered doctor).34 Based on medical records, the medical assessor determines whether:
|
| 8.20. | In the 10 years before the Covid-19 vaccination programme, about 2% of applications resulted in payment: of 790 applications, 16 resulted in awards being made.36 This rate remained broadly consistent when Covid-19 was added to the Vaccine Damage Payment Scheme. Of those who had been notified of a decision about whether their Covid-19 vaccine damage application had been accepted by the end of November 2024, the rate of those found eligible for payment was a little lower than 2%.37 |
The causation test
| 8.21. | Between 2021 and 2023, 125 applications resulted in payment and 2,266 applications were refused.38 |
| 8.22. | The main reason for Covid-19 vaccine damage applications being refused was because they did not meet the causation threshold.39 Only about 7% of the cases in which applicants were not awarded payment were because (causation having been accepted) the applicant was found to have less than 60% disablement.40 By November 2024, this percentage had reduced further: only about 4% of all Covid-19 vaccine damage applications were rejected on the basis that (causation having been accepted) the individual did not meet the 60% disablement threshold.41 |
| 8.23. | Under any vaccine damage payment scheme, there must be some basic test and standard of proof in order to establish eligibility. The requirement to show a causal link between vaccine and injury on a balance of probabilities is not itself unreasonable. The ‘more likely than not’ approach is the approach used in government-funded vaccine payment schemes in most other countries.42 |
The severely disabled test
| 8.24. | If the causation test is met, a person must also be assessed as “severely disabled” to be eligible for a payment under the Vaccine Damage Payment Scheme.43 The meaning of “severely disabled” is set out in legislation; currently, it requires disablement to the extent of 60% or more for any payments to be made.44 |
| 8.25. | There are two problems with the current approach. |
| 8.26. | The first is the model used by medical assessors to make findings. It is based on a schedule of types of injuries, matched to a degree of disablement percentage.45 A finding of 60% disablement is described as equivalent to partial limb amputation, such as the loss of a hand or amputation at the knee.46 If a person has died as a result of receiving a vaccine, the disablement threshold of 60% will be met and it is not necessary for medical assessors to decide on the precise percentage of disablement before the person’s death.47 |
| 8.27. | Professor Duncan Fairgrieve KC (an academic and barrister specialising in product liability) told the Inquiry that 60% disablement was a “very high threshold”.48 According to Ms Moore, the 60% threshold requires medical assessors to decide, for example, whether a brain injury is equivalent to below-the-knee amputation. This requires “a gymnastic calculation” which is “incredibly subjective”.49 It also makes the system opaque for applicants.50 |
| 8.28. | Ms Moore suggested that a tariff-based scheme (listing a range of categories of injury attracting different levels of payment) should be introduced, to balance the need for “transparency, speed and fairness to all applicants”.51 |
| 8.29. | Professor Fairgrieve explained that the Vaccine Damage Payment Scheme model of percentages of disablement comes from social security legislation relating to pensions – it can be traced back to pre-war schemes for industrial injuries and war pensions.52 He described the model as an “outdated reference point”, which was “not well adapted to the sphere of vaccine injury”.53 As he noted, the schedule of disablement percentages focuses on injuries such as amputation, and loss of sight and hearing, whereas neurological, fatigue and pain conditions vary in the level of disablement they cause and require a more nuanced approach.54 |
| 8.30. | The Inquiry agrees. Covid-19 vaccine injuries often involve neurological symptoms which do not sensibly fit into a percentage-based scheme designed to deal with the types of physical injuries associated with industrial accidents or combat. |
| 8.31. | The second problem identified is that someone who is deemed to have suffered an injury amounting to under 60% disablement could still be suffering significant consequences, such as being unable to work or to care for their children, but would nevertheless receive no payment. One contributor to the Inquiry’s listening exercise, Every Story Matters, explained the impact of vaccine injury.
“The aftermath of my vaccine injury was predominantly physical, with debilitating symptoms that left me unable to work for an extended period. This not only affected my well-being but also had a significant financial impact due to the loss of my job and the lack of support during this critical time.”55 Contributor, Every Story Matters |
| 8.32. | One member of the Vaccine Injured and Bereaved UK campaign and support group received a finding from the administrators of the scheme to the effect that a vaccine had caused her injury, but that her disability did not meet the 60% threshold. She described this decision as:
“extremely detrimental … a huge impact on a person’s mental health, making a person feel debilitating symptoms are not real, in your head or are exaggerated”.56 In the view of the Scottish Vaccine Injury Group: “The 60% threshold is unreasonable. Anyone who is injured should receive some recompense for the trauma, loss of working hours.”57 |
| 8.33. | There are other models for payments that already exist in the UK to support people following particular injury. |
| 8.34. | For example, the Industrial Injuries Disablement Benefit makes benefit payments to eligible applicants in England, Scotland or Wales who are ill or disabled because of an accident or disease at work or on an approved employment training scheme or course. The payments are weekly, ranging from a maximum of £225.30 to a minimum of £45.06. The level of payment is assessed according to the applicant’s level of disablement, on a range starting at 20% disablement. Applicants must be assessed to be at least 14% disabled in order to receive the benefit.58 This threshold for disablement is significantly lower than the 60% threshold in the Vaccine Damage Payment Scheme. It represents a fairer approach in recognising injuries that do not meet that threshold but which are nonetheless life-changing. |
| 8.35. | The Criminal Injuries Compensation Scheme, administered by the Criminal Injuries Compensation Authority, makes payments to people who have been the victims of violent crime in England, Scotland or Wales and have suffered mental or physical injury, physical or sexual abuse. It may also include additional payment for loss of earnings and expenses such as funeral costs.59 There is a tariff of injuries set out in a detailed table which lists the type of injury and the severity of each type of injury. Each category attracts a specific payment. The maximum payment available through the scheme for a single type of injury is £250,000 and the minimum is £1,000.60 The maximum total payable through the scheme – for example, through a combination of injuries, lost earnings and expenses – is £500,000.61 The tariff system in the Criminal Injuries Compensation Scheme allows for a more flexible approach to classifying injury than the schedule of disablement used in the Vaccine Damage Payment Scheme, and is a more suitable approach for categorising psychological and neurological injury. |
| 8.36. | The vCJD Compensation Trust was set up to pay compensation to the victims of variant Creutzfeldt–Jakob disease (a rare fatal condition that causes brain damage that worsens rapidly over time) and their families.62 It is a ‘no fault’ scheme. Applicants do not have to prove that any person or organisation was responsible, only that it is more likely than not that the person has suffered from variant Creutzfeldt–Jakob disease and was resident in the UK during the relevant period.63 The basic payment to all applicants who qualify is £125,000.64 The applicant or their family can then claim for other expenses, such as care costs, loss of earnings causing particular hardship, and psychiatric injury.65 |
| 8.37. | The Inquiry does not suggest any of these models would necessarily be appropriate for the Covid-19 vaccine injured. However, they illustrate that the Vaccine Damage Payment Scheme requirement for the disablement threshold to reach a 60% threshold is insufficiently flexible. It leaves those people with a significant injury that affects how they live, but does not meet the 60% threshold, with nothing. This part of the scheme should be reformed as a matter of urgency, and consideration should be given to a graduated threshold scheme. |
The amount payable
| 8.38. | The Vaccine Damage Payment Scheme has been described by the UK government as being intended to provide:
“a lump sum payment to be made to those who have been severely disabled by vaccinations against specified diseases, in order to ease the present and future burdens associated with such disability”.66 The one-off tax-free payment of £120,000 available through the Vaccine Damage Payment Scheme was last revised in 2007.67 |
| 8.39. | The Scottish Vaccine Injury Group explained that the costs of vaccine injury can be significant and that the sum of £120,000:
“is inadequate to cover household bills for any length of time, nor does it come close to compensating someone who has to rebuild their life following a bereavement. Nor does it cover the cost of adapting your home if you are now wheelchair bound or a myriad of other expenses. For example, travelling overseas with a medical condition can be significantly expensive.”68 The husband of a vaccine injured member of the Vaccine Injured and Bereaved UK group explained: “I have given up work to become her full-time carer.”69 |
| 8.40. | Professor Fairgrieve said that the current level of payment compares poorly with comparable vaccine damage payment schemes in other countries.70 Compensation for losses such as physical pain and suffering or poor quality of life is “available under some of the systems such as those of France, Germany, Switzerland, and most Nordic countries” and “a number of systems provide standardized amounts of compensation based on the extent of the injury”.71 |
| 8.41. | Sums awarded under the Vaccine Damage Payment Scheme also compare unfavourably to the damages that could be awarded if a civil claim were brought. Payments under the scheme are likely to be “significantly less” than would be awarded in the civil courts.72 However, the Vaccine Damage Payment Scheme has never been intended to constitute compensation. The whole point of the scheme is that it avoids the civil court process and any burden on a claimant to prove fault. It cannot compensate for all loss suffered by applicants. Nonetheless, the amount awarded under any scheme should be sufficient to provide meaningful financial support to the injured and bereaved. |
| 8.42. | None of the witnesses from whom the Inquiry heard suggested an exact figure for payment. It is clear, however, that the current maximum payment of £120,000 is too low. It should be raised at least to come into line with inflation. An inflationary adjustment, as at December 2025, would lead to a payment in excess of £200,000.73 |
Decision-making and delay
| 8.43. | The Vaccine Damage Payment Scheme quickly developed a growing backlog of applications for Covid-19 cases. This was due to the significant increase in the number of applications and the need to await the outcome of research to understand the causative effects of the new vaccines.74 While sufficient research on causation was being gathered, applications were paused.75 It was not until October 2021 that there was enough research for assessors to be able to make decisions on causation.76 However, the NHS Business Services Authority (the administrator of the scheme from November 2021) told the Inquiry that, even by the end of 2021, the Department of Health and Social Care had not reached a final position on issues such as the assessment of long-term prognosis for disablement and whether the physical administration of Covid-19 vaccines fell under the scheme, and decision-making in some cases remained on hold for this reason.77 |
| 8.44. | In the context of a UK-wide vaccination campaign using novel vaccines, an increase in the number of applications and a delay in coming to a settled position on the effects of the vaccines were entirely foreseeable when Covid-19 was added to the scheme in December 2020. Yet, at the time, the scheme had only four administrative staff. 78This was insufficient. |
| 8.45. | After the transfer of administration of the Vaccine Damage Payment Scheme to the NHS Business Services Authority in November 2021, new measures were introduced. These included the significant increase in staff (from 4 to over 80), the creation of an “easily searchable claims database”, named caseworkers to provide applicants with updates on the progress of their applications, and a new external provider to increase the capacity to conduct the specialist medical assessments from March 2022.79 |
| 8.46. | In relation to medical records, the NHS Business Services Authority explained that delay in the return of records following requests of healthcare providers was another major reason for the delay in processing many cases.80 Martin Kelsall, Director of Primary Care Services at the NHS Business Services Authority, explained that, in cases prior to the Covid-19 pandemic (usually involving childhood vaccines), “[h]istorically, on average, it took around six months to obtain these medical records” but processing timescales for a Covid-19 claim were longer because claimants were generally adults with longer medical histories.81 He noted that healthcare providers said lack of resources in the healthcare system to collate and to share the files was a factor contributing to delay.82 |
| 8.47. | In 2022, the NHS Business Services Authority started to submit subject access requests on behalf of applicants to ensure “robust timeframes” for healthcare providers to return medical records in an attempt to reduce the length of time taken to resolve applications.83 |
| 8.48. | These efforts were not sufficient to clear the backlog and delays in decision-making remained unacceptably long: by June 2023, the average time taken between an application being made and a request for payment was 462 days.84 As at January 2025, there had been 17,519 applications to the scheme in respect of Covid-19 vaccines, of which only 9,545 applicants had been notified of an outcome. Almost 8,000 applicants had not received a decision. Of these, 1,027 had been waiting for a decision for at least 12 months, 438 had been waiting for more than 18 months and 126 people had been waiting for more than 2 years.85 |
| 8.49. | The Inquiry heard about the impact of these delays from Vaccine Injured and Bereaved UK:
“A bereaved parent in our group explains that it took a year, various telephone calls, letters and eventually culminating into a Stage 2 complaint … together with various emails to their MP, to finally receive an outcome, that they were going to be awarded the VDPS Payment. All of this added additional trauma and distress to grieving parents is unacceptable.”86 |
| 8.50. | Ms Moore noted that, for some people who were applying on behalf of a loved one who had died, there had been an inquest which found a side effect of a Covid-19 vaccine was the cause of death, and they were in possession of a death certificate that referred to a Covid-19 vaccine as the cause of death.87 Delay in such cases is particularly difficult to understand. |
| 8.51. | Since March 2025, the Inquiry understands that the Department of Health and Social Care has agreed to refine the application process further, in an effort to reduce the delays associated with gathering full medical records. For example, where the issue reported is minor (such as a runny nose or minor headache), medical assessors may now determine whether the condition amounts to 60% disablement without the need to request and examine medical records.88 The Inquiry understands that, in cases where GP records have already been received and there is delay in receiving other records (eg hospital records), the NHS Business Services Authority now has the discretion to progress the claim to a medical assessor using GP records only, where appropriate and with the consent of the applicant. The Inquiry also understands that, following a policy clarification from the department, the NHS Business Services Authority now requests medical histories from 10 years prior to vaccination, rather than full medical records from birth. |
| 8.52. | It is obvious that delay can have a significant detrimental impact on rehabilitation and quality of life and on the lives of a family left behind when someone has died.89 Each application represents a real person, or a family, who is in dire need and seeking help. The Inquiry hopes that efforts will continue to reduce unnecessary delays. |
Reforming the scheme
| 8.53. | Sir Sajid Javid MP, Secretary of State for Health and Social Care from June 2021 to July 2022, told the Inquiry that problems with the Vaccine Damage Payment Scheme were brought to his attention after he became Secretary of State.90 He felt the scheme was not fit for purpose: the amount of payment was too low, the system was too slow and the disability threshold was too high.91 Advice was provided in May 2022 at his request, suggesting possible reforms to the existing scheme, including:
|
| 8.54. | It was noted in May 2022 that Mr Javid “strongly favoured” increasing the payment and he received further advice in June 2022 recommending that it be increased to £157,000.93 He left office very shortly after this advice was provided and no action was taken thereafter regarding the proposed payment increase.94 |
| 8.55. | In May 2024, Victoria Atkins MP, Secretary of State for Health and Social Care from November 2023 to July 2024, ordered another review of the Vaccine Damage Payment Scheme. However, there was a general election and change of government in July 2024 and it is unclear whether this review was ever initiated.95 Wes Streeting MP, Secretary of State for Health and Social Care from July 2024, met with vaccine injured and bereaved campaigners in September 2024 to discuss the scheme.96 However, as at February 2026, no formal announcement has been made regarding its reform. |
| 8.56. | The vaccination programme was an essential part of the response to Covid-19. It depended on the cooperation and goodwill of the people of the UK. Governments depended on them to accept the vaccine to protect themselves and those around them and halt the spread of the virus. Those who were damaged by the vaccine rather than protected deserve proper recognition. |
| 8.57. | The Vaccine Damage Payment Scheme requires reform. Opportunities have been missed to do so. The Inquiry recommends that this reform should include, as a minimum, increasing the payment amount and introducing levels of payment (often described as a tariff). |
Recommendation 5: Reform the Vaccine Damage Payment Scheme
The UK government must reform the Vaccine Damage Payment Scheme as soon as possible. The reform should include as a minimum:
- increasing the £120,000 payment, at least in line with inflation to date;
- subsequently applying annual increases in line with inflation;
- introducing multiple levels of payment, commensurate with the degree of injury suffered; and
- any transitional arrangements necessary to provide for fairness between applicants to the existing scheme and applicants to the revised scheme.
-
-
- INQ000474459_0004 para 16; Report / Royal Commission on Civil Liability and Compensation for Personal Injury, Royal Commission on Civil Liability and Compensation for Personal Injury, March 1978, p296, para 1398 (https://wellcomecollection.org/works/xsng5bdy/items?canvas=314; INQ000411782); Vaccine Damage Payments Act 1979, section 2 (https://www.legislation.gov.uk/ukpga/1979/17/contents)
- INQ000474459_0005 para 16
- INQ000399002_0008 para 3.14; The Vaccine Damage Payments (Specified Disease) Order 1990 (1990/623) (https://www.legislation.gov.uk/uksi/1990/623/contents/made); The Vaccine Damage Payments (Specified Disease) Order 2009 (2009/2516) (https://www.legislation.gov.uk/uksi/2009/2516/contents/made); and The Vaccine Damage Payments (Specified Disease) Order 2016 (2016/454) (https://www.legislation.gov.uk/uksi/2016/454/contents/made)
- INQ000474333_0087 para 240
- Vaccine Damage Payments Act 1979, sections 1(4) and 2(1) (https://www.legislation.gov.uk/ukpga/1979/17/contents). The threshold for disablement was decreased from 80% to 60% in 2002: see The Regulatory Reform (Vaccine Damage Payments Act 1979) Order 2002 (2002/1592), article 2 (https://www.legislation.gov.uk/uksi/2002/1592/contents/made); INQ000412228_0010 para 37.
- The Vaccine Damage Payments Act 1979 Statutory Sum Order 2007 (2007/1931), article 2 (https://www.legislation.gov.uk/uksi/2007/1931/contents/made); see also INQ000474333_0093 para 260
- The Vaccine Damage Payments (Specified Disease) Order 2020 (2020/1411), article 2 (https://www.legislation.gov.uk/uksi/2020/1411/contents/made)
- INQ000411701_0003 para 3
- Sarah Moore 29 January 2025 9/14-21
- INQ000485661_0005 para 11
- INQ000485661_0005. The Department for Work and Pensions was responsible for the scheme until 2014, when policy responsibility for the scheme was transferred to the Department of Health and Social Care. The Department for Work and Pensions continued to administer and fund the scheme until 2021 when the NHS Business Services Authority was tasked with administering it on behalf of the Department of Health and Social Care (INQ000474333_0088-0090 paras 242-248).
- INQ000468802_0002 para 12
- INQ000468802_0002 para 15
- INQ000468802_0002 para 15
- INQ000474375_0065 para 201
- INQ000474375_0065 para 201
- INQ000474333_0090-0091 paras 253-254; see also The Vaccine Damage Payments (Specified Disease) Order 2020 (2020/1411), article 2 (https://www.legislation.gov.uk/uksi/2020/1411/contents/made)
- INQ000414141
- INQ000468506
- INQ000474539_0005 paras 13-14
- INQ000474333_0087 para 240
- Vaccine Damage Payments Act 1979, section 6(4) (https://www.legislation.gov.uk/ukpga/1979/17/contents). Any Vaccine Damage Payment Scheme payment would be subtracted from the damages to be paid in the event of a successful civil claim.
- Sarah Moore 29 January 2025 5/15-6/18
- INQ000474539_0003 para 8
- INQ000474459_0014 para 56
- Kate Scott 15 January 2025 156/17-157/19; Sarah Moore 29 January 2025 21/6-22/3
- Ruth O’Rafferty 15 January 2025 143/5-17; INQ000474459_0014-0015 para 56
- INQ000474333_0095-0096 paras 268-269; INQ000412228_0023 para 81
- INQ000412228_0012 para 42. It is possible to make a claim on behalf of someone else if they are under 16, if they are unable to manage their own affairs or if they have died.
- Kate Scott 15 January 2025 157/9-19
- INQ000474459_0015 para 57
- Sarah Moore 29 January 2025 21/6-22/19
- Sarah Moore 29 January 2025 20/12-23
- A personal representative can apply on behalf of a deceased person: see the Vaccine Damage Payments Act 1979, sections 3(1) and 6(2) (https://www.legislation.gov.uk/ukpga/1979/17/contents); INQ000474333_0093-0094 paras 261-264.
- Vaccine Damage Payments Act 1979, sections 1 and 3 (https://www.legislation.gov.uk/ukpga/1979/17/contents)
- INQ000411701_0003 para 3; INQ000399002_0016 para 3.44
- ‘Freedom of information request (FOI-02431): The NHSBSA’s response’, NHS Business Services Authority, 24 January 2025, p3, questions 2-3 (https://opendata.nhsbsa.net/dataset/foi-02431; INQ000651976)
- INQ000412228_0017-0018 paras 65-66
- INQ000412228_0018 para 66. In 2,100 of the 2,266 refused cases, the reason given for the refusal of payment was that it had not been found on a balance of probabilities that Covid-19 vaccination had caused injury (and in a small number of cases the applicant did not meet the eligibility criteria – for example, because they had not received the vaccine in the UK).
- INQ000412228_0018 para 66
- ‘Freedom of information request (FOI-02431): The NHSBSA’s response’, NHS Business Services Authority, 24 January 2025, p3, questions 4-5 (https://opendata.nhsbsa.net/dataset/foi-02431; INQ000651976)
- ‘Comparing no-fault compensation systems for vaccine injury’, D Fairgrieve, J-S Borghetti, S Dahan, R Goldberg, S Halabi, S Holm et al, Tulane Journal of International and Comparative Law (2023), 31, 75-118, p98 (https://iris.uniupo.it/retrieve/ee9f09ec-52a6-4f38-bb24-ba4429b0ac92/Comparing%20No-Fault%20Compensation%20Systems%20for%20Vaccine%20Injury.pdf; INQ000414146)
- Vaccine Damage Payments Act 1979, section 1(4) (https://www.legislation.gov.uk/ukpga/1979/17/contents)
- Vaccine Damage Payments Act 1979, section 1(4) (https://www.legislation.gov.uk/ukpga/1979/17/contents); ‘Vaccine Damage Payment Scheme (VDPS) claim process’, NHS Business Services Authority, undated, p2 (https://www.nhsbsa.nhs.uk/vaccine-damage-payment-scheme-vdps-claim-process; INQ000659845); The Social Security (General Benefit) Regulations 1982 (1982/1408), schedule 2 (https://www.legislation.gov.uk/uksi/1982/1408/contents); see also INQ000474333_0091-0092 para 256
- The Social Security (General Benefit) Regulations 1982 (1982/1408), schedule 2 (https://www.legislation.gov.uk/uksi/1982/1408/contents)
- INQ000474539_0006 para 18
- ‘Vaccine Damage Payment Scheme principles of medical assessment’, NHS Business Services Authority, March 2025, p9, para 4.7.3 (https://www.nhsbsa.nhs.uk/sites/default/files/2025-04/Principles%20of%20medical%20assessment.docx; INQ000660110)
- INQ000474539_0006 paras 16-18
- Sarah Moore 29 January 2025 14/23-16/8
- Sarah Moore 29 January 2025 16/1-8
- INQ000474459_0026 para 100d; see also Sarah Moore 29 January 2025 30/12-20
- INQ000474539_0006-0007 paras 18-19
- INQ000474539_0007 para 19
- INQ000474539_0007 para 19; see also ‘The Vaccine Damage Payments Act 1979 and the coronavirus (COVID-19) vaccine’, Elizabeth Boulden and Cressida Mawdesley-Thomas, 30 December 2020, p2 (https://clinicalnegligence.blog/2020/12/30/the-vaccine-damage-payments-act-1979-and-the-coronavirus-covid-19-vaccine; INQ000509231)
- Every Story Matters: Vaccines and Therapeutics, p45 (INQ000474465)
- INQ000474371_0011 para 38
- INQ000497102_0064 para 195(e)
- ‘Industrial Injuries Disablement Benefit’, HM Government, undated (https://www.gov.uk/industrial-injuries-disablement-benefit; INQ000651981); Social Security Contributions and Benefits Act 1992, section 94 (https://www.legislation.gov.uk/ukpga/1992/4/contents)
- The Criminal Injuries Compensation Scheme 2012, Ministry of Justice, 13 November 2012 (as amended 13 June 2019), pp1-2, 8, 37, paras 4, 30, Annex B (https://assets.publishing.service.gov.uk/media/5d00c89ee5274a3cfa8a4ffe/criminal-injuries-compensation-scheme-2012.pdf; INQ000651974). Northern Ireland has its own similar scheme: The Northern Ireland Criminal Injuries Compensation (Amendment 2020) Scheme (2009), Northern Ireland Office, 1 April 2009 (https://www.justice-ni.gov.uk/sites/default/files/publications/justice/The%20Northern%20Ireland%20Criminal%20Injuries%20Compensation%20%28Amendment%202020%29%20Scheme%20%282009%29.pdf; INQ000662004).
- The Criminal Injuries Compensation Scheme 2012, Ministry of Justice, 13 November 2012 (as amended 13 June 2019), pp43-71 (https://assets.publishing.service.gov.uk/media/5d00c89ee5274a3cfa8a4ffe/criminal-injuries-compensation-scheme-2012.pdf; INQ000651974)
- The Criminal Injuries Compensation Scheme 2012, Ministry of Justice, 13 November 2012 (as amended 13 June 2019), p9, para 31 (https://assets.publishing.service.gov.uk/media/5d00c89ee5274a3cfa8a4ffe/criminal-injuries-compensation-scheme-2012.pdf; INQ000651974)
- ‘Glossary of Terms’, vCJD Trust, undated (https://www.vcjdtrust.co.uk/glossary-of-terms; INQ000660018). This disease affects the brain and can be caused by contracting bovine spongiform encephalopathy (often referred to as ‘BSE’) from contaminated beef products: ‘Causes Creutzfeldt-Jakob disease’, NHS UK, 7 September 2024 (https://www.nhs.uk/conditions/creutzfeldt-jakob-disease-cjd/causes; INQ000660054).
- ‘vCJD Trust Guidance Note for Compensation’, vCJD Trust, undated, p2 (https://www.vcjdtrust.co.uk/wp-content/uploads/2017/11/Guidance-Note-for-Compensation-On-or-Before-31-March-2010.pdf; INQ000651982)
- This can be £120,000, depending on the date of diagnosis: ‘vCJD Trust Guidance Note for Compensation’, vCJD Trust, undated, p4 (https://www.vcjdtrust.co.uk/wp-content/uploads/2017/11/Guidance-Note-for-Compensation-On-or-Before-31-March-2010.pdf; INQ000651982).
- ‘vCJD Trust Guidance Note for Compensation’, vCJD Trust, undated, pp4-8 (https://www.vcjdtrust.co.uk/wp-content/uploads/2017/11/Guidance-Note-for-Compensation-On-or-Before-31-March-2010.pdf; INQ000651982)
- Explanatory Memorandum to The Vaccine Damage Payments (Specified Disease) Order 2015, Department of Health, 2015, p2, para 7.1 (https://www.legislation.gov.uk/uksi/2015/47/pdfs/uksiem_20150047_en.pdf; INQ000660019); see also INQ000474333_0087 para 240
- The Vaccine Damage Payments Act 1979 Statutory Sum Order 2007 (2007/1931) (https://www.legislation.gov.uk/uksi/2007/1931/contents/made)
- INQ000497102_0065-066 para 195l
- INQ000474371_0008 para 26
- INQ000474539_0008-0009 para 23
- INQ000474539_0008-0009 para 23; ‘Comparing no-fault compensation systems for vaccine injury’, D Fairgrieve, J-S Borghetti, S Dahan, R Goldberg, S Halabi, S Holm et al, Tulane Journal of International and Comparative Law (2023), 31, 75-118, pp101-102 (https://iris.uniupo.it/retrieve/ee9f09ec-52a6-4f38-bb24-ba4429b0ac92/Comparing%20No-Fault%20Compensation%20Systems%20for%20Vaccine%20Injury.pdf; INQ000414146)
- INQ000474539_0008-0009 para 23; INQ000474459_0018 paras 67-69; Sarah Moore 29 January 2025 18/9-19/10
- This figure was calculated by the Inquiry, using the Bank of England inflation calculator, comparing the value of £120,000 in 2007 with that in December 2025.
- INQ000474333_0095-0096 paras 267-268
- INQ000411701_0004-0005 para 8; INQ000474333_0095-0096 para 268b
- INQ000474333_0095-0096 para 268b
- INQ000412228_0021 para 75
- INQ000474333_0095 para 268a; ‘Vaccine Damage Payment Scheme – media fact sheet’, Department of Health and Social Care, 9 May 2023 (https://healthmedia.blog.gov.uk/2023/05/09/vaccine-damage-payment-scheme-media-fact-sheet; INQ000508134)
- INQ000474333_0095-0097 paras 268, 269a-b; ‘Vaccine Damage Payment Scheme – media fact sheet’, Department of Health and Social Care, 9 May 2023 (https://healthmedia.blog.gov.uk/2023/05/09/vaccine-damage-payment-scheme-media-fact-sheet; INQ000508134); INQ000267763_0001-0002
- INQ000412228_0013, 0019-0020 paras 44, 70
- INQ000412228_0014-0015 para 51
- INQ000412228_0014-0015 para 51
- INQ000474333_0096-0097 para 269b; INQ000412228_0022-0023 para 79. Healthcare providers are required to respond to subject access requests within one month, although that period can be extended by up to an additional two months: see the UK General Data Protection Regulation (2016/679), article 12(3) (https://www.legislation.gov.uk/eur/2016/679/contents); ‘How to make a subject access request’, NHS England, 12 February 2025 (https://digital.nhs.uk/about-nhs-digital/corporate-information-and-documents/publication-scheme/how-to-make-a-subject-access-request; INQ000651977).
- INQ000412228_0016-0017, 0019 paras 62, 69
- Sarah Moore 29 January 2025 9/4-10/8. The NHS Business Services Authority now publishes periodic updates: https://opendata.nhsbsa.net/dataset/vdps-covid-19.
- INQ000474371_0007 para 24
- Sarah Moore 29 January 2025 12/10-20
- ‘Vaccine Damage Payment Scheme (VDPS) claim process’, NHS Business Services Authority, undated (https://www.nhsbsa.nhs.uk/vaccine-damage-payment-scheme-vdps-claim-process; INQ000659845)
- Sarah Moore 29 January 2025 9/4-11/6
- INQ000474381_0068 para 236
- Sajid Javid 23 January 2025 55/10-56/15
- INQ000399273_0002; INQ000399275_0003-0004
- INQ000411743; INQ000411744_0002, 0006
- Sajid Javid 23 January 2025 55/10-56/17; Clara Swinson 17 January 2025 124/10-127/9
- INQ000474459_0012 para 48
- INQ000474459_0012-0013 para 48
-
[…]
Appendix 1: The background to this module and the Inquiry’s methodology
Background
| A1.1. | The Right Honourable Boris Johnson MP, Prime Minister from July 2019 to September 2022, formally established the UK Covid-19 Inquiry in June 2022 to examine the preparations for and response to the Covid-19 pandemic in the UK and to learn lessons for the future. In December 2021, he appointed The Right Honourable the Baroness Hallett DBE, a retired judge of the Court of Appeal, as its Chair. |
| A1.2. | On 28 June 2022, the Prime Minister issued the final Terms of Reference for the Inquiry, establishing it under the Inquiries Act 2005.1 The Inquiry formally opened on 21 July 2022 to:
“examine, consider and report on preparations and the response to the pandemic in England, Wales, Scotland and Northern Ireland, up to and including the Inquiry’s formal setting-up date, 28 June 2022”.2 |
| A1.3. | To ensure a full and focused examination of the wide range of issues covered in the Terms of Reference and to produce regular reports, the Inquiry’s investigation has been divided into sections or ‘modules’. Each module gathers evidence, designates Core Participants and has both preliminary hearings (at which decisions about the procedure for the conduct of its investigations and public hearings are made) and full public hearings where evidence is heard. Details of public hearings are published by the Inquiry.3 |
| A1.4. | The Inquiry’s Module 1, which considered the UK’s resilience and preparedness, published its Report in July 2024.4 The Inquiry’s combined Report relating to Modules 2 (UK), 2A (Scotland), 2B (Wales) and 2C (Northern Ireland) – which addressed the UK’s core political and administrative decision-making – was published in November 2025.5 The Module 3 report relating to the impact of the Covid-19 pandemic on the healthcare systems of the UK was published in March 2026.6 This Module 4 Report relates to vaccines and therapeutics. |
| A1.5. | The Inquiry’s currently active modules are as follows:
|
| A1.6. | A public inquiry is established to examine the facts and to find out exactly what happened. It is an inquisitorial, not an adversarial, process. This Report’s conclusions and recommendations are based on an objective assessment of the totality of the evidence received by the Inquiry. |
Module 4
| A1.7. | This Report concerns the UK’s response to the Covid-19 pandemic specifically in relation to vaccines and therapeutics, and makes recommendations in relation to the UK’s preparedness to develop and deliver vaccines and therapeutics in the face of a future pandemic. |
Outline of Scope
| A1.8. | The Module 4 Provisional Outline of Scope was published on 5 September 2023.13 It set out the following specific matters which the investigation sought to examine:
|
| A1.9. | Module 4 focused its investigation on matters that took place between 30 January 2020 (the date upon which the first cases of Covid-19 were confirmed in the UK) and 28 June 2022, when the Inquiry was established. This is referred to as ‘the relevant period’. |
| A1.10. | In conducting its investigation in relation to vaccines, Module 4 has focused on the first three Covid-19 vaccines authorised for use in the UK and rolled out in the UK population. These were the Pfizer/BioNTech vaccine, the Oxford/AstraZeneca vaccine and the Moderna vaccine. These vaccines played the most significant role in vaccinating the UK population and the response to safety issues in relation to these vaccines had the most impact on the UK’s vaccine deployment strategies. |
Core Participants
| A1.11. | In accordance with rule 5 of the Inquiry Rules 2006 and the Inquiry’s Core Participant Protocol, the Chair designates a number of Core Participants – individuals, organisations or institutions with a specific interest – in each module.14 Core Participants have enhanced rights in the Inquiry process, including receiving disclosure of documents, being represented, making legal submissions and suggesting lines of enquiry. They are also able to apply to the Inquiry for funding to cover legal and other costs. |
| A1.12. | In Module 4, the Inquiry received 45 applications for Core Participant status and the Chair appointed 31 Core Participants. |
Table 3: Module 4 Core Participants
| Name of organisation/individual | Date of designation |
|---|---|
| British Medical Association | 17 July 2023 |
| Cabinet Office | 17 July 2023 |
| Clinically Vulnerable Families | 17 July 2023 |
| Covid-19 Bereaved Families for Justice Cymru | 17 July 2023 |
| Covid-19 Bereaved Families for Justice UK | 17 July 2023 |
| Department for Science, Innovation and Technology | 17 July 2023 |
| Department of Health and Social Care | 17 July 2023 |
| Department of Health (Northern Ireland) | 17 July 2023 |
| Disability Rights UK, Disability Action Northern Ireland, Inclusion Scotland, Disability Wales | 17 July 2023 |
| Federation of Ethnic Minority Healthcare Organisations | 17 July 2023 |
| Arlene Foster, The Rt Hon the Baroness Foster of Aghadrumsee DBE and Paul Givan MLA | 17 July 2023 |
| Medicines and Healthcare products Regulatory Agency | 17 July 2023 |
| Migrant Primary Care Access Group | 17 July 2023 |
| National Institute for Health and Care Excellence | 17 July 2023 |
| National Pharmacy Association | 17 July 2023 |
| NHS England | 17 July 2023 |
| Northern Ireland Covid-19 Bereaved Families for Justice | 17 July 2023 |
| Office of the Chief Medical Officer | 17 July 2023 |
| Public Health Agency (Northern Ireland) | 17 July 2023 |
| Public Health Scotland | 17 July 2023 |
| Public Health Wales | 17 July 2023 |
| Scottish Covid Bereaved | 17 July 2023 |
| Scottish Health Boards (Scottish territorial and special health boards) | 17 July 2023 |
| Scottish Ministers | 17 July 2023 |
| Secretary of State for Foreign, Commonwealth and Development Affairs | 17 July 2023 |
| Traveller Movement | 17 July 2023 |
| UK Health Security Agency | 17 July 2023 |
| Welsh Government | 17 July 2023 |
| HM Treasury | 4 August 2023 |
| UK CV Family, Scottish Vaccine Injury Group and Vaccine Injured and Bereaved UK | 4 August 2023 |
| Secretary of State for the Home Department | 7 December 2023 |
Public access to Inquiry proceedings
| A1.13. | In keeping with its public nature and the Chair’s commitment to conduct the Inquiry in as open and transparent a manner as possible, arrangements were made for the hearings to be accessible to all who wished to follow them. The hearings were broadcast via livestream on the Inquiry’s website or its YouTube channel (where they remain accessible) and members of the public were able to watch the hearings in person.15 |
Evidence gathering
| A1.14. | In Module 4, the Inquiry issued 158 requests for evidence, pursuant to rule 9 of the Inquiry Rules 2006, to 149 organisations and individuals. It received and considered 168 witness statements and 21,393 documents, containing 245,683 pages, of which 220,378 were disclosed to Core Participants. |
Every Story Matters
| A1.15. | As set out in the Terms of Reference, the Inquiry regards it as critical to its work to listen to and carefully consider the experiences of bereaved families and others who have suffered hardship or loss as a result of the pandemic. The Inquiry has done this in a number of different ways, including through its listening exercise, Every Story Matters, the largest public engagement exercise by a UK public inquiry. It heard from thousands of people about their experiences of the pandemic. |
| A1.16. | Stories were shared with the Inquiry through a webform (including accessible versions), a series of events across the UK and interviews with under-represented groups.16 Those aged 18 or older were invited to share as much or as little of their pandemic experience as they felt able, without the formality of giving evidence or attending a public hearing. More than 58,000 stories were shared with the Inquiry. The sharing of these experiences has helped the Inquiry to understand events and their impact and has aided the development of recommendations that could reduce suffering in the future. Experiences shared with the Inquiry were analysed and reports – called records – have been produced highlighting the themes that emerge, and telling people’s stories in their own words. Every Story Matters records have been used in evidence in relevant modules of the Inquiry.17 The Inquiry also undertook a bespoke and targeted research project, hearing directly from some of the children and young people most affected by the pandemic, to help inform its findings and recommendations.18 |
| A1.17. | The record summarising what had been heard to date from this listening exercise relevant to Module 4 has been published as Every Story Matters: Vaccines and Therapeutics. This has been referenced in this Report and has been published on the Inquiry website.19 |
Disclosure to Core Participants and publication of materials
| A1.18. | The Inquiry’s approach to documents is set out in its Protocol on Documents, which explains key principles for the delivery of documents to the Inquiry, including requests for documents or witness statements pursuant to rule 9 of the Inquiry Rules 2006.20 This should be read with the Inquiry’s Protocol on the Redaction of Documents, which details the approach to the redaction of documents for the purposes of both disclosure to Core Participants and publication.21 |
| A1.19. | The Inquiry discloses all witness statements and documents it considers relevant to Core Participants in full, subject to any redactions applied in accordance with the Inquiry’s Protocol on the Redaction of Documents.22 To comply with section 18 of the Inquiries Act 2005, the Chair is taking reasonable steps to ensure that members of the public are able to view documents provided to the Inquiry and attend Inquiry hearings.23 All documents shown on screen during the course of the hearings appear in the YouTube recording of the evidence and are published on the Inquiry’s website at the end of each day. The witness statements of those who give evidence each day are also published in full. Since the conclusion of the hearings, the Chair has granted permission for the publication of further materials, including those referenced within this Report, where she has been satisfied it is necessary to do so. 24 |
| A1.20. | In the event of an objection to the disclosure or publication of relevant material, an application must be made to the Chair for a restriction order in accordance with section 19 of the Inquiries Act 2005, following the Inquiry’s Protocol on Applications for Restriction Orders.25 In Module 4, the Chair issued a restriction order dated 20 January 2025 concerning the publication of irrelevant and sensitive material, and a general restriction order dated 31 January 2025 concerning the publication of redacted material.26 |
The instruction of expert witnesses
| A1.21. | To assist the Inquiry, six experts were appointed to cover a range of topics relevant to Module 4. |
Table 4: Expert witnesses
| Report details | Expert(s) appointed | Expert report |
|---|---|---|
| Vaccine hesitancy and confidence during the Covid-19 pandemic | Professor Heidi Larson (Professor of Anthropology, Risk and Decision Science at the London School of Hygiene & Tropical Medicine) | INQ000474705 |
| Vaccine safety – ‘Covid-19 vaccines: Risks, benefits and how to prepare for the next pandemic’ | Professor Daniel Prieto-Alhambra (Professor of Pharmacoepidemiology at the University of Oxford) | INQ000474703 |
| Vaccine safety – ‘Hurdles and nets: Authorising and monitoring vaccines’ | Professor Stephen Evans (Professor of Medical Statistics and Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine) | INQ000474707 |
| Vaccine delivery and disparities in coverage | Dr Ben Kasstan-Dabush (Assistant Professor in Public Health and Policy at the London School of Hygiene & Tropical Medicine) Dr Tracey Chantler (Associate | INQ000474623 |
| Expert report on the development and trials of new and repurposed therapeutics | Professor Sir Nicholas White KCMG (Professor of Tropical Medicine at the University of Oxford and Mahidol University, Bangkok) | INQ000474743 |
Witnesses at public hearings
| A1.22. | Witnesses are invited by the Inquiry to provide a statement if they have evidence relevant to a particular module. They give evidence under oath or affirmation and are questioned by Counsel to the Inquiry. Counsel for Core Participants can also ask questions with the Chair’s permission, pursuant to rule 10 of the Inquiry Rules 2006. |
| A1.23. | At its public hearings in Module 4 between 14 January and 30 January 2025, the Inquiry heard evidence from 47 witnesses, including representatives of bereaved groups, vaccine injured groups, groups representing the clinically vulnerable, communities who faced barriers to vaccination or had lower vaccine uptake, government ministers, officials and expert witnesses. |
Table 5: Module 4 witnesses from whom the Inquiry heard evidence
| Witness (organisation) | Date of evidence |
|---|---|
| Helena Rossiter (Covid-19 Bereaved Families for Justice UK) | 15 January 2025 |
| Melanie Newdick (Scottish Covid Bereaved) | 15 January 2025 |
| Fiona Clarke (Northern Ireland Covid-19 Bereaved Families for Justice) | 15 January 2025 |
| Anna Miller (Migrant Primary Care Access Group) | 15 January 2025 |
| Sam Smith-Higgins (Covid-19 Bereaved Families for Justice Cymru) | 15 January 2025 |
| Ruth O’Rafferty (Scottish Vaccine Injury Group) | 15 January 2025 |
| Kate Scott (Vaccine Injured and Bereaved UK) | 15 January 2025 |
| Kamran Mallick, Chief Executive Officer of Disability Rights UK (on behalf of the four Core Participant disabled people’s organisations) | 15 January 2025 |
| Dr Salman Waqar (Federation of Ethnic Minority Healthcare Organisations) | 16 January 2025 |
| Yvonne MacNamara (Traveller Movement) | 16 January 2025 |
| Lara Wong (founder and leader of Clinically Vulnerable Families) | 16 January 2025 |
| The Rt Hon Matt Hancock (Secretary of State for Health and Social Care from July 2018 to June 2012) | 16 January 2025 |
| Alok Sharma, The Rt Hon the Lord Sharma KCMG (Secretary of State for Business, Energy and Industrial Strategy from February 2020 to January 2021) | 17 January 2025 |
| Clara Swinson (Director General for Global Health and Health Protection at the Department of Health and Social Care from November 2016 to September 2024) | 17 January 2025 |
| Catherine Little (Director General of Public Spending at the Treasury from 2020 to October 2022, Second Permanent Secretary to the Treasury from October 2022 to 2024) | 17 January 2025 |
| Alexandra Jones (Director of Science, Research and Innovation at the Department for Business, Energy and Industrial Strategy from April 2019 to May 2023, Director General of Science, Innovation and Growth at the Department for Science, Innovation and Technology from June 2023) | 20 January 2025 |
| Professor Sir Christopher Whitty KCB (Chief Medical Officer for England from October 2019) | 20 January 2025 |
| Professor Sir Jonathan Van-Tam MBE (Deputy Chief Medical Officer for England from October 2017 to March 2022) | 20 January 2025 |
| Professor Dame Jenny Harries DBE (Chief Executive of the UK Health Security Agency from April 2021 to May 2025) | 20 January 2025 |
| Dame Kate Bingham DBE (Chair of the Vaccine Taskforce from May to December 2020) | 21 January 2025 |
| Dr Mary Ramsay (Director of Public Health Programmes at the UK Health Security Agency from October 2021) | 21 January 2025 |
| Susannah Storey (Permanent Secretary to the Department for Culture, Media and Sport from June 2023) | 21 January 2025 |
| Charlet Crichton (UKCV Family) | 21 January 2025 |
| Dame June Raine DBE (Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency from September 2019 to March 2025) | 22 January 2025 |
| The Rt Hon Sir Sajid Javid MP (Secretary of State for Health and Social Care from June 2021 to July 2022) | 23 January 2025 |
| Professor Wei Shen Lim KBE (Chair of the Joint Committee on Vaccination and Immunisation’s Covid-19 sub-committee from September 2020) | 23 January 2025 |
| Ben Osborn (President of the International Commercial Office at Pfizer) | 23 January 2025 |
| Dr Justin Green (Global Product Lead for the Oxford/AstraZeneca vaccine at AstraZeneca from October 2022) | 23 January 2025 |
| Darius Hughes (General Manager of Moderna Biotech UK) | 27 January 2025 |
| The Rt Hon Kemi Badenoch MP (Minister for Equalities from February 2020 to July 2022) | 27 January 2025 |
| The Rt Hon Nadhim Zahawi MP (Minister for Covid-19 Vaccine Deployment from November 2020 to September 2021) | 27 January 2025 |
| Dame Emily Lawson DBE (National Director for Covid Vaccine Deployment at NHS England from November 2020 to July 2021, Chief Operating Officer (Interim) for NHS England from November 2023 to March 2025) | 27 January 2025 |
| Derek Grieve CBE (Deputy Director of the Social Care Immediate Response and Improvement Division in the Scottish Government and Senior Responsible Officer for the Covid-19 vaccination programme) | 28 January 2025 |
| Professor Dr Gillian Richardson (Senior Responsible Owner for the Covid-19 vaccination programme in the Welsh Government from June 2020 to April 2021) | 28 January 2025 |
| Dr Naresh Chada (Deputy Chief Medical Officer for Northern Ireland from 2019, Senior Responsible Officer for the Covid-19 vaccination programme) | 28 January 2025 |
| Sarah Moore (Partner, Leigh Day solicitors) | 29 January 2025 |
| James Bethell, The Rt Hon the Lord Bethell (Parliamentary Under Secretary for Technology, Innovation and Life Sciences from March 2020 to September 2021) | 29 January 2025 |
| Eddie Gray (Chair of the Antivirals Taskforce from May 2021 to April 2022) | 29 January 2025 |
| Professor Sir Munir Pirmohamed (Chair of the Commission on Human Medicines from February 2021) | 29 January 2025 |
| Helen Knight (Director of Medicines Evaluation at the National Institute for Health and Care Excellence from March 2022) | 30 January 2025 |
| Dr Clive Dix (Chair of the Vaccine Taskforce from December 2020 to April 2021) | 30 January 2025 |
Criticisms
| A1.24. | Rule 13(3) of the Inquiry Rules 2006 prevents the inclusion of any “explicit or significant criticism” of any person in this Report unless a warning letter has been sent and the relevant person has been given a reasonable opportunity to respond.27 Warning letters were issued to persons identified in accordance with rule 13 and also with the Inquiry’s Protocol on Warning Letters.28 The Chair considered the responses to those letters before finalising this Report. |
The Inquiry team
| A1.25. | The Chair was greatly assisted in Module 4 by the Inquiry team of counsel, solicitors, paralegals and other members of the Secretariat. |
Table 6: Module 4 Counsel team
| Role | Name |
|---|---|
| Lead Counsel | Hugo Keith KC |
| Senior Counsel | Jacqueline Carey KC |
| Junior Counsel | Lois Williams Daniel Mansell Laura Stephenson |
Terminology and references
| A1.26. | The nature of the subject matter means that the evidence considered by the Inquiry contains technical and specialist language, which the Inquiry has tried to minimise in this Report. A number of witnesses and documents also used a range of abbreviations and acronyms. To avoid any confusion and to assist the reader, the Inquiry has set out names and other key phrases in full in this Report; a detailed glossary is also included at Appendix 2. |
| A1.27. | Some terminology that is particularly key to understanding this Report is explained below for ease of reference. |
Key terminology
| A1.28. | The virus that causes the coronavirus disease known as Covid-19 is SARS-CoV-2. However, where this specificity is not necessary, in accordance with the practice of the World Health Organization, the Inquiry uses ‘Covid-19’ to refer to both the virus and the disease. |
| A1.29. | Although the first Covid-19 patients in the UK were announced on 31 January 2020 and the outbreak was not characterised by the World Health Organization as a pandemic until 11 March 2020, for clarity, this Report refers to the time period beginning with the arrival of Covid-19 in the UK as the ‘Covid-19 pandemic’. |
| A1.30. | The Covid-19 pandemic required action by both the UK government and devolved administrations. Wales, Scotland and Northern Ireland each have a legislature and executive elected by their own electorates (referred to in this Report as the ‘devolved administrations’). Although each devolution settlement is different, each administration is responsible for a range of topics, including health, education and transport. England has no legislature of its own – instead, the UK Parliament legislates on UK-wide, ‘reserved’ (ie not devolved) issues such as defence and foreign affairs and legislates for England on issues devolved to other nations. The UK Parliament also, at times, legislates for other groupings – for example, in England and Wales on issues of justice. |
| A1.31. | The UK government is responsible for all aspects of government policy in England. At the time of the pandemic, the Department of Health and Social Care was responsible for policy on health and adult social care matters in England (and on a UK-wide basis for a few elements of the same matters that are not otherwise devolved). Prior to January 2018, the Department of Health and Social Care was known as the Department of Health – for clarity, the department is referred to throughout this Report using its current name. |
| A1.32. | ‘The NHS’ is the term used to refer collectively to the publicly funded healthcare systems in England, Scotland and Wales, comprising NHS England, NHS Scotland and the NHS in Wales (also known as ‘NHS Wales’). In Northern Ireland, the publicly funded healthcare system is Health and Social Care (Northern Ireland), with health and social care integrated under a single framework. |
References
| A1.33. | References such as ‘Alexandra Jones 20 January 2025 28/7-12’ or ‘INQ000474401_0003 para 1.1’ in the footnotes of this Report relate to material that is available on the Inquiry’s website. |
| A1.34. | The transcripts of the Inquiry’s hearings are referenced by person, hearing date, and internal page and line numbers. For example, ‘Alexandra Jones 20 January 2025 28/7-12’ refers to the evidence of Alexandra Jones on 20 January 2025, page 28, lines 7 to 12. |
| A1.35. | Documentary evidence is referenced by the document’s number and, where relevant, page and paragraph numbers. For example, ‘INQ000474401_0003 para 1.1’ refers to document INQ000474401, page 3, paragraph 1.1. |
| A1.36. | Publicly available documents are listed in the footnotes with both their wider internet and Inquiry website links. For example:
A Review of the Vaccine Taskforce, Department of Health and Social Care, 31 August 2023, p5 (https://www.gov.uk/government/publications/a-review-of-the-vaccine-taskforce/a-review-of-the-vaccine-taskforce; INQ000283321) |
- See ‘Covid-19 Inquiry Terms of Reference’, UK Covid-19 Inquiry, 20 July 2022 (https://covid19.public-inquiry.uk/documents/terms-of-reference), which includes translations of the Inquiry’s Terms of Reference; for the Inquiries Act 2005, see https://www.legislation.gov.uk/ukpga/2005/12/contents. A separate inquiry is taking place in Scotland, which will evaluate areas where policy was devolved to the Scottish Government, as set out in its Terms of Reference. The UK Covid-19 Inquiry works with the Scottish Covid-19 Inquiry to avoid duplication of work where possible.
- ‘Covid-19 Inquiry Terms of Reference’, UK Covid-19 Inquiry, 20 July 2022 (https://covid19.public-inquiry.uk/documents/terms-of-reference)
- For further information, see ‘Structure of the Inquiry’, UK Covid-19 Inquiry, July 2024 (https://covid19.public-inquiry.uk/structure-of-the-inquiry).
- Module 1: The resilience and preparedness of the United Kingdom, UK Covid-19 Inquiry, July 2024 (https://covid19.public-inquiry.uk/documents/module-1-full-report)
- Modules 2, 2A, 2B, 2C: Core decision-making and political governance, UK Covid-19 Inquiry, November 2025 (https://covid19.public-inquiry.uk/documents/module-2-full-report)
- Module 3: The impact of the Covid-19 pandemic on the healthcare systems of the United Kingdom, UK Covid-19 Inquiry, March 2026 (https://covid19.public-inquiry.uk/documents/module-3-full-report)
- ‘Procurement (Module 5)’, UK Covid-19 Inquiry, no date (https://covid19.public-inquiry.uk/modules/procurement-module-5)
- ‘Care sector (Module 6)’, UK Covid-19 Inquiry, no date (https://covid19.public-inquiry.uk/modules/care-sector-module-6)
- ‘Test, trace and isolate (Module 7)’, UK Covid-19 Inquiry, no date (https://covid19.public-inquiry.uk/modules/test-trace-and-isolate-module-7)
- ‘Children and young people (Module 8)’, UK Covid-19 Inquiry, no date (https://covid19.public-inquiry.uk/modules/children-and-young-people-module-8)
- ‘Economic response (Module 9)’, UK Covid-19 Inquiry, no date (https://covid19.public-inquiry.uk/modules/economic-response-module-9)
- ‘Impact on society (Module 10)’, UK Covid-19 Inquiry, no date (https://covid19.public-inquiry.uk/modules/impact-on-society-module-10)
- ‘Module 4: Provisional Outline of Scope’, UK Covid-19 Inquiry, 5 September 2023 (https://covid19.public-inquiry.uk/documents/module-4-provisional-outline-of-scope)
- Inquiry Rules 2006 (https://www.legislation.gov.uk/uksi/2006/1838/contents/made); ‘Core Participant Protocol’, UK Covid-19 Inquiry, 21 July 2022 (https://covid19.public-inquiry.uk/documents/uk-covid-19-inquiry-core-participant-protocol)
- ‘Vaccines and Therapeutics (Module 4) – Public Hearings’, UK Covid-19 Inquiry (https://covid19.public-inquiry.uk/hearings/vaccines-and-therapeutics-module-4-public-hearings; https://www.youtube.com/@UKCovid-19Inquiry)
- ‘Every Story Matters’, UK Covid-19 Inquiry, no date (https://covid19.public-inquiry.uk/every-story-matters)
- The Inquiry’s Every Story Matters records can be found at: https://covid19.public-inquiry.uk/every-story-matters/records.
- See ‘Hundreds of children and young people set to tell the Inquiry how the pandemic affected them’, UK Covid-19 Inquiry, 15 April 2024 (https://covid19.public-inquiry.uk/news/hundreds-of-children-and-young-people-set-to-tell-the-inquiry-how-the-pandemic-affected-them)
- Every Story Matters: Vaccines and Therapeutics, UK Covid-19 Inquiry, 14 January 2025 (https://covid19.public-inquiry.uk/documents/every-story-matters-vaccines-and-therapeutics-full-record)
- ‘Protocol on Documents’, UK Covid-19 Inquiry, 29 July 2022 (https://covid19.public-inquiry.uk/documents/protocol-on-documents); Inquiry Rules 2006 (https://www.legislation.gov.uk/uksi/2006/1838/article/9/made)
- ‘Inquiry Protocol on the Redaction of Documents’, UK Covid-19 Inquiry, 18 October 2022 (https://covid19.public-inquiry.uk/documents/inquiry-protocol-on-the-redaction-of-documents)
- ‘Inquiry Protocol on the Redaction of Documents’, UK Covid-19 Inquiry, 18 October 2022 (https://covid19.public-inquiry.uk/documents/inquiry-protocol-on-the-redaction-of-documents)
- Inquiries Act 2005 (https://www.legislation.gov.uk/ukpga/2005/12/contents)
- ‘Documents’, UK Covid-19 Inquiry, no date (https://covid19.public-inquiry.uk/documents)
- Inquiries Act 2005 (https://www.legislation.gov.uk/ukpga/2005/12/contents); ‘Inquiry Protocol on Applications for Restriction Orders’, UK Covid-19 Inquiry, 18 October 2022 (https://covid19.public-inquiry.uk/documents/inquiry-protocol-on-applications-for-restriction-orders)
- ‘Restriction Order’, UK Covid-19 Inquiry, 20 January 2025 (https://covid19.public-inquiry.uk/documents/restriction-order-issued-by-the-chair-of-the-uk-covid-19-inquiry-regarding-the-publication-of-information-regarding-commercially-sensitive-information-dated-20-01-2025); ‘Restriction Order’, UK Covid-19 Inquiry, 31 January 2025 (https://covid19.public-inquiry.uk/documents/module-4-general-restriction-order-dated-31-01-2025)
- Inquiry Rules 2006, rule 13(3) (https://www.legislation.gov.uk/uksi/2006/1838/contents/made)
- ‘Inquiry Protocol on Warning Letters’, UK Covid-19 Inquiry, 21 February 2025 (https://covid19.public-inquiry.uk/documents/inquiry-protocol-on-warning-letters)
Appendix 2: Glossary
| Term (acronym) | Description |
|---|---|
| Absolute risk | A statistic that predicts the probability of an individual experiencing a particular event (such as developing a certain medical condition). |
| Acceptably safe | Indicates that the benefits, or expected benefits, associated with a particular product are considered to outweigh any risks associated with that product at a population level, and that the risks are acceptable in the context of the expected benefits. |
| Adaptive platform trial | A type of clinical trial studying multiple drugs or medical interventions for a single disease. These interventions are studied continuously and in parallel within a single cohort of patients. Treatments are added and removed algorithmically based on efficacy and safety data. |
| Adenoviral vector | A modified version of an adenovirus which commonly causes respiratory infections. The virus’s ability to replicate and cause disease is typically removed. However, it is still able to enter the body’s cells and is genetically engineered to instruct cells to produce the spike protein associated with SARS‑CoV‑2. The presence of the protein stimulates the immune system to make antibodies and T cells against the SARS‑CoV‑2 virus. |
| Adjuvant | An ingredient in a vaccine that enhances the immune system response. |
| Adverse effect or reaction | Unwanted side effects arising from a medicine or vaccine. |
| Adverse events | Unintended effects that may be linked to medicines, including vaccines. Sometimes called adverse drug reactions or undesirable effects. For vaccines they are sometimes referred to as adverse events following immunisation. People can have reactions either as a direct result of the medicine itself or because the individual has an underlying medical condition. |
| Alpha variant | A variant of Covid-19 that emerged in Kent during the autumn of 2020. Designated by the World Health Organization as a ‘variant of concern’ on 18 December 2020. |
| Anaphylaxis | Anaphylaxis is a serious, systemic hypersensitivity reaction that is usually rapid in onset; severe anaphylaxis is characterised by potentially life-threatening failure of the circulation and breathing, which may result in death if it is not treated as a medical emergency. |
| Anti-inflammatory drugs | Drugs used to treat diseases caused by excessive inflammation. |
| Antibiotics | Medicines used to treat or prevent bacterial infections. |
| Antibody | A protein component of the immune system that is produced after infection or vaccine with a pathogen, or after direct inoculation with an antiviral, which identifies and helps to prevent future infections from the same pathogen. Elimination of the infection can either be a direct effect of antibodies binding to the pathogen causing it to no longer be infectious and harmful (neutralising antibodies), or an indirect effect of antibodies tagging pathogens for destruction by other immune cells (non-neutralising antibodies). Antibodies can be produced synthetically for diagnostic and therapeutic use. |
| Antigen | A foreign substance which induces an immune response in the body, especially the production of antibodies. In this case, the foreign object is the spike protein found on the surface of the SARS-CoV-2 virus. |
| Antivirals | Medicines used to treat or prevent viral infections. |
| Booster dose | An extra dose of vaccine administered after the primary course of vaccination. It is used to boost the immune response against a pathogen. |
| British Medical Association | A trade union and professional body for doctors and medical students in the UK. |
| Cabinet Office | A ministerial UK government department, supported by 28 agencies and public bodies. It supports the Prime Minister, ensures the effective running of government and takes the lead in certain critical policy areas. |
| Chief Medical Officer | A qualified medical practitioner, the most senior government adviser on health matters, and the professional head of all directors of public health in local government and the medical profession in government. There is a Chief Medical Officer for England, Wales, Scotland and Northern Ireland. The Chief Medical Officer for England is the UK government’s chief medical adviser. |
| Chief Scientific Advisers | Senior science advisers, working in most government departments, who provide oversight and assurance of science capability and activities. |
| Clinical trials | Trials used to examine the safety, efficacy and dosage of a prospective medical intervention identified in early stage research. They are broken down into three or four phases, each examining a distinct characteristic of the treatment. Their success is measured at each stage against primary (the specific event the study is looking to examine, eg reduction in mortality) and secondary endpoints (additional goals of the study, eg quality of life, symptom relief, biomarker changes). |
| Clinically extremely vulnerable | People identified by the UK government in March 2020 as having medical conditions that meant they were particularly likely to develop severe illness or to die from Covid-19. |
| Clinically vulnerable | People identified by the UK government in March 2020 as having medical conditions that might make them likely to develop severe illness from Covid-19, although not with the same predictability or to the same extent as the clinically extremely vulnerable. |
| COBR | The UK government’s national crisis management centre for responding to whole-system civil emergencies. It provides the coordination mechanism through which the UK government responds quickly to emergencies that require urgent decision-making. Its name was originally derived from its location in the Cabinet Office Briefing Rooms. |
| Coronaviruses | A family of viruses that cause respiratory illnesses in people. |
| Countermeasures | Measures taken to mitigate or suppress the effects of a pandemic, such as contact tracing, therapeutics and vaccines. |
| Covid-19 | The disease caused by the coronavirus, SARS-CoV-2. |
| Department for Business and Trade | A ministerial UK government department established on 7 February 2023. It is the department for economic growth, which supports businesses to invest, grow and export, creating jobs and opportunities across the country. |
| Department for Business, Energy and Industrial Strategy | A ministerial UK government department which was responsible for business, industrial strategy, science, research and innovation, energy, clean growth and climate change. It was abolished on 7 February 2023, when it was split into a number of other departments including the Department for Business and Trade and the Department for Science, Innovation and Technology. |
| Department for Science, Innovation and Technology | A ministerial UK government department established on 7 February 2023. It focuses on improving people’s lives by maximising the potential of science and technology. |
| Department of Health and Social Care | A ministerial UK government department with overall responsibility for health and care services. It sets strategy and funds and oversees the health and care system in England, with equivalent counterparts in the devolved nations. Known prior to January 2018 as the Department of Health – for clarity, the department is referred to throughout this report using its current name. |
| Department of Health (Northern Ireland) | A devolved government department in the Northern Ireland Executive with a statutory responsibility to promote the physical and mental health and social wellbeing of people in Northern Ireland. Also responsible for the prevention, diagnosis and treatment of illness. |
| Devolved administrations | The governments of Scotland, Wales and Northern Ireland. |
| Devolved nations | Scotland, Wales and Northern Ireland. |
| Dexamethasone | A steroid drug used to treat a range of inflammatory and allergic disorders. |
| Directors of public health | In England, specialists employed by every local authority with public health responsibilities, who have primary responsibility for the health of their communities and are accountable for the delivery of their authority’s public health duties. In Scotland and Wales, they are employed by NHS health boards. In Northern Ireland, the sole Director of Public Health is accountable to the Chief Medical Officer. |
| Disease X | An infectious disease that is currently not known to infect humans but could cause a serious epidemic or pandemic. |
| Drugs | Active substances that create physiological effects on the body (which can be positive or negative). |
| Ebola | Can refer to the Ebola virus or the disease it causes. The virus is transmitted from animals (such as bats or non-human primates) to people, and can spread from person to person through bodily fluids. It causes a severe and often fatal haemorrhagic fever. |
| Effectiveness | When discussing a drug such as a treatment or vaccine, this refers to how well the drug achieves the intended effect when it is used in real-world settings. Considers factors such as patient adherence, dosing, and interactions with other medications and conditions. |
| Efficacy | The extent to which a drug works as intended when it is tested in ideal circumstances such as in a controlled research study. Does not guarantee an identical level of effectiveness in real-world scenarios. |
| Epidemic | A sudden increase in incidence of a disease that is higher than expected in a geographical region. |
| Epidemiology | The study of the distribution, patterns and determinants of health and disease conditions in a defined population. |
| Four governments | The four governments of the UK: the UK government, Scottish Government, Welsh Government and Northern Ireland Executive. |
| Four nations | The four nations of the UK: England, Wales, Scotland and Northern Ireland. |
| Genetic sequencing | The process of reading and spelling out an organism’s genetic code. |
| Government Chief Scientific Adviser | The Government Chief Scientific Adviser is responsible for providing scientific advice to the Prime Minister and members of the Cabinet, advising the government on aspects of policy on science and technology, and ensuring and improving the quality and use of scientific evidence and advice in government. |
| Health and Social Care (Northern Ireland) | The publicly funded healthcare system in Northern Ireland, with health and social care integrated under a single framework. |
| Healthcare systems | The system of healthcare in each of the four nations of the UK, comprising NHS England, the NHS in Wales (NHS Wales), NHS Scotland, and Health and Social Care (Northern Ireland). |
| HM Treasury | A ministerial government department that acts as the economic and finance ministry, maintaining control over public spending and setting the direction of UK economic policy. |
| Home Office | A UK government department, supported by 29 agencies and public bodies. The lead government department for immigration and passports, drugs policy, crime, fire, counter-terrorism and police. |
| Human immunodeficiency virus (HIV) | A blood-borne or sexually transmitted virus that, if untreated, causes acquired immunodeficiency syndrome (AIDS) – a potentially fatal multi-system disease. |
| Hydroxychloroquine | A drug used in rheumatic disease treatments. |
| Immune response | The response developed by the body when infected by a pathogen. |
| Immunisation | When individuals become protected from a disease, following either natural infection or vaccination. |
| Immunity | The ability to defend the body from a pathogen’s infection. Acquired immunity describes how the body builds immunological memory – so that if the person is exposed to the same infection again, the body’s response is enhanced. This is the basis for immunisation with vaccines. |
| Influenza (flu) | A viral respiratory infection that infects humans and several other host species. It causes seasonal endemic waves of infection and also, when new strains emerge against which the population has little or no immunity, may cause epidemics or pandemics. |
| Joint Committee on Vaccination and Immunisation | A scientific committee that advises UK health departments on immunisation. |
| Key worker | Someone whose work was critical to the Covid-19 response. This was relevant to testing eligibility and the ability of the children of such workers to attend early years settings and education during school closures. |
| Lockdown | A mandatory stay-at-home order, a legal prohibition placing blanket restrictions on the whole population (apart from specified activities) for the purpose of limiting the spread of a disease. |
| Medicine | A drug used in the treatment of disease with the aim of alleviating symptoms or curing the condition. |
| Medicines and Healthcare products Regulatory Agency | An executive agency of the Department of Health and Social Care. It regulates medicines, medical devices and blood components used in transfusions in the UK. It decides whether to approve new medicines such as vaccines. |
| Messenger ribonucleic acid (mRNA) | Cellular genetic material that corresponds to an equivalent DNA sequence. It carries ‘ready-to-read’ instructions used by cellular machinery (ribosomes) to produce proteins. |
| Middle East respiratory syndrome (MERS) | A serious illness caused by the Middle East respiratory virus (MERS-CoV), a coronavirus first identified in 2012 in Saudi Arabia. Largely zoological (camel-to-human transmission); limited human-to-human transmission has been noted. |
| Molnupiravir | Oral antiviral drug developed for the treatment of Covid-19 through preventing viral replication. It reduces the risk of hospitalisation or death for at-risk non-hospitalised adults with mild to moderate Covid-19 by 50%. |
| Monoclonal antibodies | Biological therapies synthesised in a laboratory. They mimic natural antibodies by recognising a specific target protein on the surface of a cell and then flagging these cells for killing, or by binding directly to the virus and stopping the virus from attaching to a human cell. Antibodies can be designed by using genetic sequences of interest from the virus. The main target of SARS-CoV-2 monoclonal antibodies is the spike protein on the surface of the virus, to block viral entry into cells. |
| mRNA vaccine | Vaccines containing mRNA to produce a pathogen’s antigen, which can be directly produced by the human body. This strategy is used in the Pfizer/BioNTech and Moderna vaccines, which both use mRNA instructions to produce the SARS-CoV-2 spike protein. |
| Myocarditis | An inflammatory disorder affecting the heart. |
| National Institute for Health and Care Excellence (NICE) | An executive non-departmental public body sponsored by the Department of Health and Social Care. Its role is to improve patient outcomes by producing national guidance and advice, and quality standards that set out what high-quality and cost- effective care should look like. |
| National Institute for Health and Care Research (NIHR) | One of the UK’s major funders of health and care research, which invests in pandemic preparedness research, clinical research infrastructure and ‘hibernated’ research projects. |
| New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) | An expert scientific committee of the Department of Health and Social Care which advises the Chief Medical Officer and, through them, the government. It provides scientific risk assessment and mitigation advice on the threat posed by new and emerging respiratory viruses and on options for their management. |
| NHS | The term used to refer collectively to the publicly funded healthcare systems in England, Scotland and Wales, comprising NHS England, NHS Scotland and the NHS in Wales (also known as ‘NHS Wales’). The publicly funded healthcare system in Northern Ireland is Health and Social Care (Northern Ireland). |
| NHS England | An executive non-departmental public body, sponsored by the Department of Health and Social Care, that leads and oversees the NHS in England. It is responsible for the operation of the NHS in England and for implementing healthcare strategy developed by the Department of Health and Social Care. |
| NHS in Wales (NHS Wales) | The NHS in Wales is made up of local health boards, trusts (including Public Health Wales) and special health authorities (Health Education and Improvement Wales and Digital Health and Care Wales). The local health boards are responsible for planning, securing and delivering all healthcare services for the benefit of their resident population in a specific geographical area. The term ‘NHS Wales’ is commonly used to refer collectively to local health boards, trusts and special health authorities in Wales, though there is no central legal entity with this name. |
| NHS Scotland | The publicly funded healthcare system in Scotland, made up of geographical health boards and non-geographical special boards, and supported by NHS National Services Scotland (known from 1 April 2026 as Public Services Delivery Scotland) and Healthcare Improvement Scotland. |
| Northern Ireland Executive | The Northern Ireland Executive is the administrative branch of the Northern Ireland Assembly, the devolved legislature for Northern Ireland. It is responsible for matters including enterprise, trade and investment, agriculture and rural development, education, health, policing and justice, environment and regional development. |
| Office for National Statistics | The UK’s largest independent producer of official statistics and the recognised national statistical institute of the UK. |
| Omicron variant | A variant of SARS-CoV-2 which emerged in the autumn of 2021, causing a wave of infections that peaked in the UK on 4 January 2022. |
| Outbreak | The occurrence of cases of disease in excess of what would normally be expected in a defined community, geographical area or season. |
| Pandemic | An epidemic occurring worldwide, or over a very wide area, crossing international boundaries and usually affecting a large number of people. |
| Pathogens | Infectious organisms, such as viruses, bacteria or parasites, that can produce a disease. |
| Paxlovid | A small-molecule antiviral medicine used to treat Covid-19 in adults. It is used in patients who do not require supplemental oxygen and are at increased risk of the disease becoming severe. Paxlovid contains two active substances, nirmatrelvir and ritonavir, in two different tablets. |
| Pericarditis | The inflammation of the pericardial sac, which surrounds the heart to limit its movement and protect it from injury or infection. |
| Permanent Secretary | A senior civil servant responsible for the day-to-day running of a government department. In the UK government and in Northern Ireland there is a Permanent Secretary for each government department. There is a single Permanent Secretary for each of the Scottish and Welsh Governments. |
| Pharmaceuticals | A medicinal product defined as (a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or (b) any substance or combination of substances that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis. |
| Pharmacovigilance | Detecting, collecting and monitoring data about adverse events that may be linked to a medicine (such as a new drug or vaccine) so that appropriate action can be taken. In the UK, the Yellow Card scheme collects reports of adverse drug reactions. |
| Phase 1 clinical trials | Initial safety trials involving a small group of healthy participants (about 5 to 10 people) to assess whether the medicinal product is safe in humans and the appropriate dosage. |
| Phase 2 clinical trials | Trials conducted in slightly larger numbers of people than Phase 1 trials (in the range of 20 to 50) that involve the clinical response being studied in patients who have the disease the drug is aimed at treating. |
| Phase 3 clinical trials | Larger trials than Phases 1 and 2, with many hundreds or thousands of trial participants, in order to gain statistically robust evidence about efficacy and to collect further safety data. Phase 3 trials are used to provide the primary evidence on clinical safety and efficacy for authorisation of a medicine. |
| Placebo | A substance or treatment that should have no clinical effect. This is given to control groups so that the effects of an intervention can be distinguished from improvements that occur just from the placebo effect. |
| Platelets | Blood cells that stop bleeding following an injury through the formation of blood clots. |
| Platform Adaptive trial of NOvel antiviRals for eArly treatMent of COVID-19 In the Community (PANORAMIC) | A trial that rapidly evaluated several novel antiviral treatments selected by the Antivirals Taskforce that could potentially help clinically vulnerable people with Covid-19 recover sooner and prevent the need for hospital admission. PANORAMIC followed the design of its precursor, the PRINCIPLE trial, which instead evaluated the efficacy of repurposed existing therapeutics. |
| Platform Randomised Trial of Interventions against COVID-19 in Older People (PRINCIPLE) trial | A study that evaluated potential treatments for Covid-19 in the community setting. It aimed to identify existing, available medicines that could help people recover faster and reduce the need for hospitalisation. The trial was a forerunner to the PANORAMIC trial, which evaluated potential novel treatments rather than those which were repurposed. |
| Primary care | A patient’s ongoing first point of contact in a healthcare system, focused on comprehensive care including the diagnosis and treatment of common diseases and illnesses, managing long-term conditions, care coordination and preventative care. |
| Prime Minister of the UK | The leader of the UK government, ultimately responsible for the policy and decisions of the government. |
| Priority groups | Groups of people identified by the Joint Committee on Vaccination and Immunisation who are given a vaccine before it is available for the general population. |
| Prophylaxis | A drug taken to prevent (rather than treat) a disease. |
| Public health | The science and art of preventing disease, prolonging life and promoting health through organised efforts of society. |
| Public Health Agency (Northern Ireland) | Established under the Health and Social Care (Reform) Act (Northern Ireland) 2009. Responsible for the improvement of health and social wellbeing, reducing health inequalities in Northern Ireland, health protection and service development. |
| Public Health Emergency of International Concern | A formal designation declared by the World Health Organization, giving a special status to an emergency caused by an infectious disease outbreak. The International Health Regulations specify that it is a serious, sudden, unusual or unexpected outbreak, which carries implications for public health beyond the affected state’s national border, and which may require immediate international action. |
| Public Health England | An executive agency of the Department of Health and Social Care responsible for all aspects of public health, replaced by the UK Health Security Agency and the Office for Health Improvement and Disparities in October 2021. |
| Public Health Scotland | Scotland’s national public health body, working to prevent disease, prolong healthy life and promote health and wellbeing. Preceded prior to 1 April 2020 by Health Protection Scotland. |
| Public Health Wales | An NHS trust which aims to protect and improve health and wellbeing and reduce health inequalities in Wales. |
| Randomised controlled trial | An experiment where participants are randomly placed into a control group or an intervention group. Cluster randomised controlled trials involve random assignment to the control or intervention at a group level (such as assigning whole schools, hospitals or local councils). They are considered a particularly robust study type, as the randomisation reduces the likelihood of bias from extraneous variables. As experiments, they can demonstrate causation. |
| Randomised Evaluation of Covid-19 Therapy (RECOVERY) trial | An international clinical trial that aimed to identify treatments that may be beneficial for people hospitalised with suspected or confirmed Covid-19. The initial RECOVERY trial was known as the Covid-19: multi-arm, multi-stage adaptive platform clinical trial (CoV-MAMS). It was jointly funded by the Medical Research Council and the National Institute for Health Research and was designed to rapidly evaluate potential treatments for Covid-19 among hospitalised patients. |
| Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) | An international trial established after the 2009 influenza pandemic, with sites in the UK, which pivoted to Covid-19 research. REMAP-CAP used an adaptive study design to rapidly evaluate treatments within critically ill patients, rather than patients in community settings, who were instead targeted by the PRINCIPLE and PANORAMIC trials. |
| Relative risk | Statistics that compare two absolute risks to give an indication of how much a selected factor increases or decreases the risk. |
| Remdesivir | Antiviral drug used to treat hospitalised patients with Covid-19. It can reduce the time to recover for some patients. |
| Risk | The possibility of a harmful event. In the context of civil emergency preparedness and resilience, an event, person or object that could cause loss of life or injury, damage to infrastructure, social and economic disruption or environmental degradation. |
| Ronapreve | Drug based on a combination of two monoclonal antibodies (casirivimab and imdevimab). It is used to treat or prevent acute Covid-19 infection. |
| Safety signal | Information on a new or known adverse event that may be caused by a medical product and requires further investigation. |
| Scientific Advisory Group for Emergencies (SAGE) | An advisory group convened to provide independent scientific advice to support decision-making in COBR in the event of a national emergency. |
| Scottish Government | The devolved administration for Scotland. |
| Secretary of State | A Cabinet minister in charge of a government department. |
| Senior responsible officer | A leader who is accountable for ensuring that a programme or project meets its objectives, delivers the projected outcomes and realises the required benefits. |
| Severe acute respiratory syndrome (SARS) | A serious disease caused by the coronavirus SARS-CoV-1. |
| Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) | The coronavirus that causes the disease known as Covid-19. |
| Side effects | A secondary, unwanted effect that occurs during use of a drug or vaccine, such as pain at the injection site of a vaccine. |
| Stabilisers | Ingredients to extend the shelf life of a vaccine. |
| Swine flu | A relatively mild influenza pandemic, which began in 2009. |
| Symptomatic | Showing symptoms following an infection. |
| Therapeutics | Drugs used to treat rather than prevent a disease. |
| Thrombocytopenia | Low levels of platelets. This is an extremely rare side effect of some SARS-CoV-2 vaccines. |
| Thrombosis | Formation of blood clots that stop blood circulation in blood vessels. It can create serious damage and death. Thrombosis is an extremely rare side effect of some SARS-CoV-2 vaccines. |
| Tocilizumab | Anti-inflammatory drug used to treat rheumatoid arthritis. Research to date shows that it can reduce the risk of death in severe Covid-19 cases. |
| Transmission | The process by which a pathogen, such as a virus, spreads from one infected person to another. |
| Transverse myelitis | Rare neurological disorder caused by inflammation of the spinal cord. This inflammation can damage the insulating material, called myelin, that covers nerve cell fibres. |
| UK government | The central government for the UK, headed by the Prime Minister. The UK government is responsible for non-devolved policy matters across the UK. (The Scottish Government, Welsh Government and Northern Ireland Executive are separate from the UK government and are responsible for devolved policy matters, such as health and social care, in their respective nations.) |
| UK Health Security Agency (UKHSA) | An executive agency, established in April 2021 and sponsored by the Department of Health and Social Care, responsible for public health protection and infectious disease capability. |
| UK Vaccine Network | A network of industry, academia and relevant funding bodies, which advises the Department of Health and Social Care on research and development investment relating to infectious diseases with the potential to cause an epidemic in low and middle-income countries. |
| Vaccination | Protecting individuals from a disease by administering a vaccine. |
| Vaccine | Vaccines train the immune system to recognise a pathogen and to produce antibodies to defend the body from it at the next encounter. |
| Vaccine candidate | New vaccine under development. |
| Vaccine coverage | Proportion of the population that has received a vaccine. |
| Vaccine Taskforce | Established in April 2020 to drive forward the development and production of a coronavirus vaccine as quickly as possible, bringing together government, academia and industry. Closed in October 2022. Its vaccine supply responsibilities have moved to the UK Health Security Agency and its work in onshoring vaccine manufacture now sits within the Office for Life Sciences. |
| Vaccine uptake | Accepting a vaccine when it is offered by public health authorities. |
| Variant | As a virus replicates, it can accumulate mutations. A version of the virus with these mutations is called a ‘variant’. Mutations may facilitate transmission or impact the effectiveness of vaccines, treatments or immunity resulting from previous infection. Notable Covid-19 variants during the pandemic included Alpha, Delta and Omicron. |
| Virology | The scientific and medical discipline concerned with understanding the biology of viruses and viral diseases, and their treatment and prevention. |
| Virus | A parasitic infectious agent which replicates only inside the cells of an organism. |
| Wellcome | A charitable foundation funding research, leading policy and advocacy campaigns, and building global partnerships (formerly the Wellcome Trust). |
| Welsh Government | The devolved administration for Wales. |
| World Health Organization | A specialised agency of the United Nations responsible for international public health. |
| Zika | Can refer to the Zika virus or the disease it causes. A mosquito-borne virus that causes a very mild illness for most infected people, but if a pregnant woman has the disease it can lead to serious brain defects in an unborn baby. |
Appendix 3: List of recommendations
Chapter 3: Securing supplies
Recommendation 1: Establish a pharmaceutical expert advisory panel
The UK government should establish a standing pharmaceutical expert advisory panel, in consultation with the Department of Health and Social Care and the Department for Science, Innovation and Technology.
The panel should include ministers, civil servants and representatives from industry and academia, and be led by an independent Chair with experience of working in a relevant industry.
The panel’s role should be to:
- oversee the UK’s preparedness to develop, procure and manufacture pharmaceuticals (vaccines and therapeutics) in the event of a pandemic or health emergency, assisting with cross-government strategy development;
- ensure that the UK government and devolved administrations, their agencies, industry and academia are aligned around shared goals in developing vaccines and therapeutics for pandemic diseases;
- oversee strong links between government and the pharmaceutical industry;
- advise the UK government on how to incentivise pharmaceutical companies to invest in manufacturing facilities and research in the UK; and
- advise the UK government on its research investments, with a view to ensuring a diverse portfolio of pharmaceutical research in the UK.
During a pandemic, the panel should form the basis of specialist taskforces, which would be responsible for securing and developing medical interventions and leading on their procurement on behalf of the four nations of the UK. They should have sufficient autonomy, delegation and direct access to senior ministers, similar to that which worked well in the Covid-19 pandemic.
Chapter 6: Disparities in vaccine uptake
Recommendation 2: Formalise work with communities about vaccine equity strategies
The UK government, Scottish Government, Welsh Government and Northern Ireland Executive should maintain networks with local communities to produce targeted vaccination strategies and communications.
To achieve this:
- The Scottish Government, Welsh Government and Northern Ireland Executive should establish local community networks, mirroring the approach being taken by the UK Health Security Agency.
- All four governments should work with their network to identify specific and measurable actions to improve vaccine uptake and reduce inequalities and consult with these networks on communications campaigns and delivery approaches.
- All four governments should publish a report annually on progress against these actions.
Recommendation 3: Improve monitoring and evaluation of vaccine uptake and delivery
Each of the four UK public health or health security agencies should work together to:
- maintain accurate, UK-wide insight into the state of vaccine uptake and hesitancy; and
- understand the measures proven to be effective in increasing uptake across the four nations of the UK.
There should be collaboration and some standardisation in the agreed approach across the four nations for monitoring and publishing routine vaccine uptake and vaccine confidence levels in order to better understand regional variations and patterns. Each nation should set and regularly review its minimum acceptable standards of vaccine uptake, which would trigger targeted uptake campaigns if not reached.
The effectiveness of vaccine uptake campaigns should be evaluated against clear, standardised measures. This includes retrospective analysis of the Covid-19 uptake campaigns, as well as evaluation of routine vaccination uptake campaigns.
Chapter 7: Post-authorisation safety and surveillance systems
Recommendation 4: Proportionate access to linked healthcare records for use in the assessment of safety signals
The UK government and devolved administrations should work together, with their respective health delivery services, to facilitate and coordinate regulatory bodies’ access to healthcare records in order to make the post-authorisation safety monitoring of new vaccines and therapeutics more efficient.
In particular, the Medicines and Healthcare products Regulatory Agency should be granted specific and proportionate access to comprehensive and comparable data from across the four nations of the UK, including linked primary and secondary healthcare data records. This should include data on vaccines and therapeutics administration. This improved linkage must be accompanied by strong safeguards for patient confidentiality, which the Information Commissioner’s Office should work with the four governments to ensure.
Chapter 8: The Vaccine Damage Payment Scheme
Recommendation 5: Reform the Vaccine Damage Payment Scheme
The UK government must reform the Vaccine Damage Payment Scheme as soon as possible. The reform should include as a minimum:
- increasing the £120,000 payment, at least in line with inflation to date;
- subsequently applying annual increases in line with inflation;
- introducing multiple levels of payment, commensurate with the degree of injury suffered; and
- any transitional arrangements necessary to provide for fairness between applicants to the existing scheme and applicants to the revised scheme.