Transcript of Module 4 Preliminary Hearing on 13 September 2023

(10.30 am)

Lady Hallett: Good morning, everyone. Welcome to the first preliminary hearing for Module 4 of the Covid UK Inquiry, which will be focusing on vaccines and therapeutics.

Mr Richard Wald King’s Counsel will be explaining how the module is going to work. There will be inevitably some overlap with other modules, as I knew would be the case when I decided on the modular structure, but Mr Wald will explain how that’s going to work amongst other matters.

I have received a number of submissions from core participants as well as Counsel to the Inquiry, and I’m grateful to everybody who has produced them. I have read them all and obviously will listen carefully to any of those who wish to make oral submissions to supplement the written submissions.

Mr Wald.

1. Statement by Counsel to the Inquiry

Mr Wald: Thank you, my Lady.

This being the first preliminary hearing for Module 4, I will make, if I may, the following brief introductions. My Lady, you have kindly introduced me, and I won’t do that again, but I appear today at this hearing along with my learned friends Ms Williams, Ms Blower, Mr Mansell and Ms O’Kane, who are, with me, the counsel team for Module 4, the focus of which, as your Ladyship has indicated, will be vaccines and therapeutics.

Now, in accordance with the agenda for this first preliminary hearing, I will address you, my Lady, so far as this module is concerned, on the following areas.

First, the designation of core participants or CPs.

Second, the provisional outline of scope for Module 4.

Third, evidence gathering.

Fourth, disclosure to CPs.

Fifth, the listening exercise, Every Story Matters.

And finally, the dates for future hearings.

There will then be an opportunity for those who have been designated as CPs for this module to make submissions if they wish to do so, and I know that a number of them, ten in fact, do intend to do so.

These proceedings are, of course, being recorded and livestreamed to other locations. In making these arrangements, your Ladyship is fulfilling the obligation, pursuant to section 18 of the Inquiries Act of 2005, to take such steps as you consider reasonable to ensure that members of the public are able to attend or see and hear a simultaneous transmission of the proceedings. Livestreaming this hearing also allows the hearing to be followed by a greater number of people than would be able to be accommodated within the hearing room or any overspill rooms, and of course the fact that these hearings are recorded enables those who wish to, to review those recordings after the event.

In addition to the Inquiry’s counsel and solicitor teams, there are 20 CPs present in the hearing room today, with a further eight CPs in remote attendance. Four CPs are unable to attend today.

The lead legal representatives for CPs present in the room are, in no particular order, as follows:

Kate Stone, counsel for the Covid-19 Bereaved Families for Justice UK, Laura Shepherd, counsel for the Covid-19 Bereaved Families for Justice Cymru, Marie-Claire McDermott, counsel for the Northern Ireland Covid-19 Bereaved Families for Justice, Adam Wagner, counsel for the Clinically Vulnerable Families, Anna Morris KC, counsel for Covid Vaccine Adverse Reaction and Bereaved, comprising UK CV Family, Vaccine Injured and Bereaved UK and the Scottish Vaccine Injury Group.

Shamik Dutta, solicitor for Disabled Peoples’ Organisations, comprising Disability Rights UK, Disability Action Northern Ireland, Disability Wales and Inclusion Scotland.

Elaine Banton, counsel for the Federation of Ethnic Minority Healthcare Organisations.

Sonali Naik KC, counsel for the Migrant Primary Care Access Group.

Marc Willers KC, counsel for the Traveller Movement.

Brian Stanton, solicitor for the British Medical Association and National Pharmacy Association.

Lucy Plumpton, counsel for the Medicines and Healthcare products Regulatory Agency.

Claire Palmer, counsel for NHS England.

Kenneth McGuire, counsel for the Scottish Ministers.

Lucy McCann, Department for Science, Innovation and Technology.

Neil Block KC, counsel for His Majesty’s Treasury.

Peter Skelton KC, counsel for the Cabinet Office.

The lead legal representatives for the CPs attending remotely are, and again this is in no particular order, as follows.

Kevin McCaffery, counsel for the Scottish Covid Bereaved, Rachel Spearing, counsel for the UK Health Security Agency, Brian Donnelly, solicitor for the Public Health Agency (Northern Ireland), Julie Ellison, counsel for the Right Honourable Baroness Arlene Foster of Aghadrumsee and Paul Givan, Rhiannon Holtham, solicitor of the Public Health Wales, Richard Pugh KC, counsel for the Scottish Health Boards.

A full list of CPs in Module 4 and their recognised legal representatives has been published on the Inquiry website.

As is routine in public inquiries where there may from time to time be matters mentioned of a potentially sensitive nature, the broadcasting of the hearing will be conducted with a three-minute delay. This provides the opportunity for the feed to be paused if anything unexpected is aired which should not be. We do not expect this to arise over the course of today, but I mention it so that those who are following proceedings from further afield can understand the reasons for any such short delay.

My Lady, pursuant to Rule 5 of The Inquiry Rules, the following applicants, again in no particular order, were designated as CPs:

Covid-19 Bereaved Families for Justice UK, Covid-19 Bereaved Families for Justice Cymru, Scottish Covid Bereaved, Northern Ireland Covid-19 Bereaved Families for Justice, Clinically Vulnerable Families, Migrant Primary Care Access Group, Traveller Movement, Covid adverse reaction and bereaved, Disabled Peoples’ Organisations, Cabinet Office, Scottish Ministers, Welsh Government, the Right Honourable Baroness Arlene Foster of Aghadrumsee and Paul Givan. Department of Health and Social Care, Department for Science, Innovation and Technology, Secretary of State for Foreign, Commonwealth and Development Affairs, His Majesty’s Treasury, Medicines and Healthcare products Regulatory Agency, National Institute for Health and Care Excellence, Northern Ireland Department of Health, NHS England, Scottish Health Boards, Office of the Chief Medical Officer, UK Health Security Agency, Public Health Agency (Northern Ireland), Public Health Scotland, Public Health Wales, British Medical Association, National Pharmacy Association, Federation of Ethnic Minority Healthcare Organisations.

Finally, my Lady, for those who were either not granted CP status or for those who did not apply to be designated as CP, I wish to iterate that not being a CP in Module 4 in no way precludes any person, entity or group from applying for CP status in a later module, from bringing any matter to the attention of the Inquiry, from providing evidence and information, and from, where appropriate and relevant, giving evidence at a hearing, and finally, in the case of an individual affected by the pandemic, taking part in the Inquiry’s listening exercise, in relation to which I will return in a few moments.

Before I turn to the provisional scope of Module 4, it may assist to address you on where Module 4 sits in the overall framework of the UK Covid-19 Inquiry.

By way of background, therefore, on 12 May 2021 the then Prime Minister made a statement in the House of Commons in which he announced that there would be a public inquiry under the Inquiries Act of 2005. He stated that it would examine the UK’s preparedness for and response to the Covid-19 pandemic, and that it would learn lessons for the future. We are now, of course, engaged in that Inquiry.

Following your appointment as Chair, in December 2021, the draft terms of reference were consulted upon and were then published on 10 March 2022. That consultation included the devolved administrations. It also included your Ladyship’s recommendation to the Prime Minister that you would be able to publish interim reports so as to ensure that any urgent recommendations can be published and considered in a timely manner.

Furthermore, your Ladyship expressed the view that the Inquiry would gain greater public confidence if it was open to the accounts that many people, including those who have been bereaved, would wish to give.

You therefore suggested adding explicit acknowledgement of the need to hear about people’s experiences and that the Inquiry remit should consider any disparities in the impact of the pandemic.

A public consultation process on the Inquiry’s draft terms of reference was launched, and your Ladyship consulted widely across all four nations and spoke in particular to a number of bereaved families. In parallel, the Inquiry team met with representatives of more than 150 organisations, covering themes such as equality and diversity, healthcare, business, and education and young people among others.

In total, the Inquiry received over 20,000 responses to the consultation. An independent research consultancy was commissioned to analyse the responses and produce a comprehensive independent report on respondents’ views.

Following this, on 12 May 2022, your Ladyship recommended a number of significant changes to the draft terms of reference, which were subsequently accepted by the Prime Minister in full. The set-up date of the Inquiry was confirmed to be 28 June 2022, and on 21 July 2022 the Inquiry was formally opened. A fuller exposition of the background to the Inquiry has been provided to the CPs in a note by Counsel to the Inquiry, and for those following today’s proceedings who would like to know more about the background to the Inquiry that information is available in the video recording and the transcript to the Module 1 preliminary hearing which was held on 4 October of 2022.

Your Ladyship made the decision to conduct the Inquiry in modules, to be announced and opened in sequence. Those wishing to take a formal role in the Inquiry were invited to apply to become CPs within the meaning of Rule 5 of The Inquiry Rules 2006 for each module, rather than throughout the Inquiry as a whole.

Module 1, which concerns preparedness for the pandemic, was opened on 21 July 2022. The public hearings in Module 1 began on 13 June 2023 and concluded on 19 July 2023.

Module 2 concerns core political and administrative decision-making in relation to the pandemic, with Modules 2A, B and C addressing the strategic and overarching issues from the perspectives of Scotland, Wales and Northern Ireland respectively.

Module 2 was opened on 31 August 2022. The public hearings in Module 2 will commence in three weeks’ time, on 3 October 2023.

Module 3, which concerns the impact of the pandemic on healthcare systems, was opened on 8 November 2022. The public hearings in Module 3 are expected to begin in the autumn of 2024.

As mentioned, Module 4, this module, concerns vaccines and therapeutics. Modules 5 and 6 of the Inquiry concern government procurement and the care sector respectively. Later modules will address very broadly system and impact issues across the UK. The system modules will include testing and tracing and the government’s business and financial responses.

The impact modules will look at health inequalities and the impact of Covid-19 on education, children and young persons, and other public services, including frontline delivery of key workers. In due course the Inquiry will provide further detail about the order and provisional scope of those modules.

I now turn, my Lady, to address the scope of Module 4.

The emergence of Covid-19 in December 2019 fired a starting gun on a global race to develop an effective vaccine for that virus, with a view to saving as many lives as possible and preventing serious illness among the most vulnerable. The UK is viewed by many as having been a leader in that race. The first cases of Covid-19 in the UK were identified in January 2020. Less than a year later, on 2 December 2020, the Pfizer-BioNTech vaccine was approved for use in the UK.

Six days after that, Ms Margaret Keenan made history as she became the first person in the UK and the world to receive the Pfizer-BioNTech vaccination outside of a clinical trial.

Other vaccines followed, including the Oxford-AstraZeneca vaccine, which received approval on 30 December 2020 and the Moderna vaccine, approved on 8 January 2021.

Hospitals, GP surgeries, community groups, voluntary organisations and others worked together to deliver a vaccine roll-out which was unprecedented in its scale. At its peak, the roll-out saw over 970,000 vaccine doses administered in a single day. By 28 June 2022, over 149 million doses had been administered in the UK: 125 million in England, 7.4 million in Wales, 12.9 million in Scotland, and 3.9 million in Northern Ireland.

This equated to approximately 93% of the UK population aged 12 or older. Figures vary as to how many lives the vaccine has saved. One estimate is that, up to late September 2021, the roll-out of the initial two-dose regime had prevented approximately 261,000 hospitalisations and 127,000 deaths.

Module 4 of the Inquiry will focus on, among other things, the innovations that were introduced to rapidly develop, procure, manufacture and approve vaccines during the pandemic, including as part of the work of the Vaccine Taskforce.

We will also be scrutinising how the vaccines were delivered and, as part of that, roll-out procedures and public messaging. An important element of our work will involve asking why there was less uptake of vaccine among certain groups, including those from particular ethnic and other backgrounds. Were delivery processes adequately targeted at such groups? Was enough done to allay any concerns such groups had about the vaccine? Were broader barriers to vaccine uptake adequately addressed?

We will also be looking at the impact of misinformation and disinformation about the vaccines and the steps taken to address these.

Against this background of innovation and rapid deployment of the vaccine, it is right to note that certain individuals have experienced bereavement or illness following a vaccine, some of whom join us as CPs in this module. Accordingly, it is appropriate that a significant part of Module 4’s work will also involve examining issues relating to vaccine safety, including the steps taken by safety regulators prior to authorising the Covid-19 vaccine and the systems in place to monitor any side effects post authorisation.

We will be asking: what were the risks of taking a Covid-19 vaccine? How do those risks compare to the possible effects of contracting Covid-19? Where risks change with individual characteristics such as age, was the correct balance struck in terms of vaccination eligibility and priority decisions?

We will also be examining whether the government’s Vaccine Damage Payment Scheme is fit for purpose or requires reform in order to meet the needs of those who have suffered harm following a Covid-19 vaccination.

A further important aspect of Module 4’s investigation concerns therapeutics and in particular the way in which new therapeutics were developed and existing medicines repurposed to treat Covid-19 during the pandemic.

The RECOVERY Trial was its largest of several trials for testing therapeutic drugs in the UK. It has so far recruited 47,000 participants in the UK from 166 hospital sites. Other trials included the principal trial, with over 11,000 participants, the PANORAMIC trial with over 27,000 participants, and the REMAP-CAP trial with over 10,000 participants.

Such trials provided the evidence to ensure effective drugs were given to hundreds of thousands more NHS patients suffering from Covid-19. To take but one example, dexamethasone was the first therapeutic that was proved to reduce the risk of death from Covid-19. It is estimated that by March 2021 it has saved approximately 22,000 lives in the UK. In Module 4 we will be examining any obstacles that were encountered in relation to developing and repurposing therapeutics and asking how these can be avoided in the face of a future pandemic.

The Module 4 public hearing is expected to take place over four weeks in the summer of 2024. By virtue of the timescales, the Inquiry must maintain a tight focus on the key issues. The Inquiry team’s investigation in relation to Module 4 is already under way, with real progress having been made. We have started the process of gathering evidence and identifying areas for expert evidence, topics to which I will return in a few moments.

The documents setting out the provisional outline of scope for Module 4 states that this module will consider and make recommendations on a range of issues relating to the development of Covid-19 vaccines and the implementation of the vaccine roll-out programme in England, Wales, Scotland and Northern Ireland. Issues relating to the treatment of Covid-19 through both existing and new medications will be examined in parallel. There will be a focus on lessons learned and preparedness for the next pandemic.

Thematic issues relating to unequal vaccine uptake will be examined to include the identification of groups which were the subject of unequal uptake, potential causes of such unequal uptake, and the government response.

The module will address issues of recent public concern relating to vaccine safety and the current system for financial redress under the UK Vaccine Damage Payment Scheme.

In particular, this module will examine, first, the development, procurement, manufacture and approval of vaccines during the pandemic, including the effectiveness of UK-wide decision-making, in particular the role of the UK Vaccine Taskforce. What lessons can we learn from innovative practices that were successfully introduced during the pandemic for future pandemic preparedness?

Second, the development, trials and use of new therapeutics during the pandemic in addition to the use of existing medications.

Third, vaccine delivery in England, Wales, Scotland and Northern Ireland, including roll-out procedures such as arrangements on the ground and public messaging, Joint Committee on Vaccination and Immunisation recommendations on eligibility and prioritisation and decision taken by policymakers, the ethics of prioritisation decisions, and impact on particular groups such as those with comorbidities.

Fourth, barriers to vaccine uptake, including vaccine confidence and access issues, and the effectiveness, timeliness and adequacy of government planning for and response to inequalities relevant to vaccine uptake.

Vaccine safety issues including post-marketing surveillance, such as the Yellow Card monitoring and reporting system and a suggested correlation between Covid-19 vaccines and cardiovascular issues.

Sixth, whether any reforms to the UK Vaccine Damage Payment Scheme are necessary.

This scope is necessarily provisional. Although it introduces a wide range of topics, it is neither practical nor advisable to identify at this stage all the issues that will be addressed at the Module 4 public hearings.

There is close interplay between modules 3 and 4, a point that your Ladyship referred to in opening remarks, particularly when it comes to the topic of therapeutics. As you know, my Lady, Module 3 concerns the impact of the Covid-19 pandemic on healthcare systems in the four nations of the UK.

The provisional outline of scope for Module 3 explains that, amongst other things, Module 3 will be examining healthcare provision and treatment for patients with Covid-19, healthcare systems’ response to clinical trials and research during the pandemic, as well as decision-making about the nature of healthcare to be provided for patients with Covid-19. Module 3 will therefore examine the use of therapeutics in practice. That is, how therapeutics were used once effective treatments had been identified and approved.

Module 4, on the other hand, will focus on the preceding phases, the steps taken to enable the use of therapeutics. We will do this by examining the development and trial of new therapeutics and repurposed medications, as well as decisions around eligibility. It is important that this distinction is clear to CPs, as some of the submissions on scope concern the treatment of those with Covid-19, which is not a matter for Module 4.

A number of the CPs have made suggestions for matters that should be included in the provisional outline of scope. It is not practicable for me to address all of those today. All require and are receiving careful consideration. It may be that some suggestions accord with our own understanding of the scope or planned refinements of the scope.

There are, however, some specific matters relating to the scope that I would like to address today, and I turn to those now.

In their joint submissions, Covid-19 Bereaved Families for Justice UK and Northern Ireland Covid-19 Bereaved Families for Justice point to paragraph 1 of the Module 4 provisional outline of scope, a paragraph which I have read out a few moments ago. This concerns the development, procurement, manufacture and approval of vaccines. That paragraph concludes:

“What lessons can we learn from innovative practices that were successfully introduced during the pandemic for future pandemic preparedness?”

CBFFJ UK and Northern Ireland CBFFJ suggest that when considering lessons that can be learned for future pandemics, the Inquiry should not be limited to those practices that it considers were innovative or were successfully introduced. We agree, and can assure those bereaved groups that the Inquiry team does not read paragraph 1 in that limiting way. Module 4 will cast a critical eye over the entire development, procurement, manufacture and approval process in order to glean what did not go well and could be improved upon in the future.

Second, a number of CPs, including Covid-19 Bereaved Families for Justice Cymru, CBFFJ UK and Northern Ireland CBFFJ, stress the importance of Module 4 giving meaningful consideration to the processes adopted in Wales, Scotland and Northern Ireland, and the impact of the different decisions taken in those countries.

The Inquiry team firmly agrees and has already started the process of seeking evidence from those jurisdictions and will continue to do so. It is obviously important to understand the issues relevant to Module 4 as they apply in respect of each of the four nations. It will also enable the Inquiry to compare any contrasting approaches that were taken and thus draw out lessons for facing a future pandemic.

Third, in their submissions, Scottish Covid Bereaved helpfully set out a number of areas that the Inquiry may wish to explore during Module 4. These include how roll-out procedures affected uptake and the role played by social media in promoting misinformation about the Covid-19 vaccines. I can confirm that Module 4 does intend to explore those important issues, amongst others.

Fourth, Clinically Vulnerable Families, or CVF, raises a concern that there may be insufficient focus on therapeutics during Module 4, particularly as the provisional outline of scope largely concerns vaccines. I can reassure CVF in relation to that. Module 4 will be looking with care and in detail at the decision-making around the development of therapeutics for Covid-19. This is an important topic, we are particularly interested in whether therapeutic research and development was prioritised to a sufficient degree, particularly when compared with the large amount of work that was done on the rapid development of vaccines.

Fifth, CVF also raises the issue of the approval of the Covid-19 non-vaccine prophylactic Evusheld. I can confirm that Module 4 will be looking at the regulatory decision-making relating to Evusheld, including why a different approach seems to have been taken in respect of vaccines on the one hand and non-vaccine prophylactics on the other. The distinction is important, because vaccines are not suitable for everyone including the immunosuppressed.

Sixth, the submissions on behalf of Covid Vaccine Adverse Reaction and Bereaved highlight the importance of the safety approval process for the Covid-19 vaccines and asks whether any steps might have been overlooked due to the urgent need to roll out a vaccine. The Inquiry team agrees that this too is an important topic and we will be exploring whether the appropriate balance was struck between speed and safety in that process.

Seventh, a number of CPs including the Traveller Movement, Migrant Primary Care Access Group, and Disabled Peoples’ Organisations, have raised issues as to whether vaccine roll-out procedures were sufficiently tailored to meet the needs of those from particular backgrounds and communities, as well as those with specific needs. This will be a central issue in Module 4.

I turn now to the matters of evidence requests and a Rule 9 update.

The Inquiry has already issued or is about to issue formal requests for evidence pursuant to Rule 9 of The Inquiry Rules 2006 to a number of individuals and organisations which appear to it to have played a central or significant role in matters relevant to Module 4. These include:

• UK government departments such as the Department of Health and Social Care, the Department for Science, Innovation and Technology, the Department for Work and Pensions, the Treasury, and the Cabinet Office;

• Groups and organisations representing specific areas of interest within the scope of Module 4, including Covid bereaved groups, vaccine injured and bereaved groups, and those representing minority or marginalised communities and individuals;

• Key decision-makers in, and advisers to, the devolved governments in Wales, Scotland and Northern Ireland;

• Executive agencies and non-departmental public bodies, including the Medicines and Healthcare products Regulatory Agency, the UK Health Security Agency and National Institute for Health and Care Excellence;

• Key advisers and advisory groups such as the Chief Medical Officer and the Joint Committee on Vaccination and Immunisation;

• Central figures in the Vaccine Taskforce and the Antivirals and Therapeutics Taskforce;

• Pharmaceutical companies, researchers and academics, including those involved in the development of the Covid-19 vaccines and therapeutic trials.

A number of CPs, in their submissions for this hearing, have suggested particular lines of enquiry for the Module 4 investigation and suggestions of people to whom Rule 9 requests could be sent. These submissions have been and will be given careful consideration, as the Inquiry continues its investigation into vaccines and therapeutics.

As my Lady is aware, this Inquiry and the Scottish Covid-19 Inquiry are keen to avoid duplication between them, and so the Module 4 team is checking not only the requests made by other Inquiry modules within this Inquiry but also those made by the Scottish Inquiry. That process means inevitably that it takes a little more time to issue Rule 9 requests to Scottish bodies, but it is hoped that in the long run this approach will assist in minimising unnecessary repetition and thereby saving time and any wasted effort.

In that regard, I should add that on 23 February 2022 the Inquiry published a memorandum of understanding setting out how this Inquiry and the Scottish Covid-19 Inquiry intend to work effectively together, and I’m also aware that your Ladyship has met with the Chair of the Scottish Inquiry, Lord Brailsford, to discuss the constructive ways in which the two Inquiries can collaborate and cooperate.

In their submissions, CBFFJ UK and Northern Ireland CBFFJ and FEHMO reiterate requests they have made in previous modules that Rule 9 requests be disclosed to CPs. You may wish to rule on this issue as it applies to Module 4 in due course. However, you have ruled on this issue previously as part of Module 1 and decided that CPs will not be provided with copies of the Rule 9 requests made by the Inquiry. This was on the basis that disclosure to the CPs of the Rule 9 requests themselves, as opposed to the relevant documents and material generated by them, is neither required by the Rules nor generally established practice, established by past practice.

CBFFJ UK and Northern Ireland CBFFJ also reiterate a request that they have made in earlier modules that state and organisational CPs and material providers submit position statements. Again, you may wish to rule on this issue as it applies to Module 4 in due course. However, it is right to point out that you have ruled on this issue previously as part of Module 1 and decided against ordering the provision of position statements. This was on the basis, amongst other matters, that the Inquiry had already requested the Rule 9 recipients to provide a corporate statement setting out a narrative of relevant events and of the lessons learned and that these will serve a similar purpose to position statements.

Moving now to experts, Module 4 has already identified three areas where expert evidence is likely to be of assistance. At present, these include three broad issues.

First, vaccine safety, including the regulatory regime for vaccine authorisation and the benefits and risks of the Covid-19 vaccines.

Second, inequalities in vaccine coverage, including how these were or could have been addressed through roll-out processes and public messaging.

Third, hesitancy around vaccine uptake, including trends concerning misinformation and disinformation about the Covid-19 vaccines.

Other areas may be identified and explored as the Inquiry’s work continues. A number of CPs in their submissions have made suggestions about areas of potential expert evidence for Module 4 and these have been and will be given careful consideration.

The identities of instructed experts will be contained in the Solicitor to the Inquiry’s update notes. Once experts are instructed, these notes will also provide further details of the topics which the experts will address in their reports, thereby enabling CPs to comment on those matters.

So far as disclosure is concerned, in common with the approach taken in previous modules, Module 4 will adopt the following approach to disclosure: all CPs will receive all documents disclosed in Module 4, not just those documents relevant to them.

Disclosure will be subject to three things.

First, a relevance review so that only relevant documents are disclosed.

Secondly, a de-duplication exercise.

Third, redactions in accordance with the Inquiry’s redactions protocol.

A significant team of solicitors, barristers and paralegals is already in place to review for relevance the material that is received. Disclosure is likely to be in tranches made on a rolling basis. Disclosure will be made via the electronic data management and disclosure system known as Relativity.

Disclosure updates will be provided by the Module 4 solicitors team, informing CPs of the progress which has been made in obtaining relevant documents. We will of course also provide these at the next preliminary hearing.

The Inquiry is working to begin the process of disclosing materials to CPs as soon as possible. The process of disclosure to CPs is anticipated to begin in late autumn 2023. Each document provider is being asked to provide, amongst other matters, details of the key individuals who were involved in issues relevant to the Module 4 provisional outline of scope, the key meetings, and a summary of the categories of other material held and/or already provided to the Inquiry relating to that provisional outline of scope.

This information will allow the Inquiry to understand the nature of relevant material held by the document provider and make targeted requests for further material if necessary.

Where, as a result of the information provided, the Inquiry has any concerns about a provider’s processes for providing relevant documents, it will raise and pursue them. And of course, as documents are reviewed and gaps identified, further documents will be sought.

My Lady, you also have the power to compel the production of documents under section 21 of the Inquiries Act, and there are provisions in section 35 of the Inquiries Act which make it an offence during the course of an inquiry for a person to do anything to alter or distort a relevant document or prevent any relevant document being produced to the Inquiry or to intentionally destroy, suppress or conceal a relevant document.

Covid Vaccine Adverse Reaction and Bereaved raise the relevance to Module 4 of documents disclosed to other modules. The Inquiry legal team is reviewing documents disclosed to other modules for relevance to Module 4, and such documents will be disposed to Module 4 CPs as part of the Module 4 disclosure process.

I turn now to the listening exercise and Every Story Matters.

Every Story Matters is the name given to the Inquiry’s listening exercise. My Lady, the Inquiry’s terms of reference make clear that although the Inquiry will not investigate individual cases of harm or death in detail, listening to the accounts and experiences of the bereaved families and others who suffered hardship or loss will inform the Inquiry’s understanding of the impact of the pandemic and the response, and of the lessons to be learnt.

Every Story Matters is therefore the process by which the public can contribute to the Inquiry so that the Inquiry will be able to not just hear the voices of the people of the UK and to reflect upon their experiences, but also to incorporate the emerging themes into its work.

Everyone’s contribution through Every Story Matters will be collated, analysed and turned into themed reports which will be submitted into each relevant investigation. These will be anonymised, disclosed to the Inquiry CPs and used in evidence. The reports will identify trends and themes and include illustrative case studies which may demonstrate systemic failures.

Every Story Matters aims to obtain insights and information from anyone who wishes to contribute, that is from anyone who was impacted by the pandemic and wishes to share their experience. It has been designed so that anyone and everyone aged 18 and older in the UK can contribute if they wish to do so. For example, for Module 4 the Inquiry is particularly interested to hear from people who felt they were unable to access the vaccine and/or therapeutics in a timely manner, those who were hesitant about receiving Covid-19 vaccines, those who believe that they may have suffered damage as a result of a Covid-19 vaccine, and those who have positive experience connected with vaccines and therapeutics.

These experiences will be analysed and reviewed by the Inquiry’s research specialists based on key lines of enquiries, or, if my Lady will forgive yet another acronym, KLOEs, for Every Story Matters produced by the Inquiry team. The KLOEs are an important tool for setting out the way in which the Inquiry will gather and analyse experiences shared with Every Story Matters, in particular through the targeted research.

The Inquiry’s research specialists will conduct targeted qualitative research in relation to particular topics and particular groups of people based on the KLOEs. It is proposed in Module 4 that this research will focus on, among other things, listening to people from different communities and backgrounds where there was a relatively low uptake of Covid-19 vaccines.

The experiences shared with Every Story Matters will be collated into themed reports. The resulting reports, which will synthesise and amalgamate the individual accounts, will be aligned with and fed into Module 4 and the Inquiry’s later modules. They will be disclosed to CPs. The reports will be formally adduced in evidence so they can form part of the Inquiry’s written record.

In the coming weeks, the Inquiry legal team will work with its research specialists to identify research questions and priority audiences in relation to the following proposed KLOEs:

First, experiences receiving information on the Covid-19 vaccines, including the key sources of vaccine related information obtained by participants; the experiences of receiving useful information or mis or disinformation; the clarity, consistency and ease of understanding of public messaging; the quality, ie clarity, appropriateness, persuasiveness, sufficiency and timeliness of targeted messaging for specific groups; perceptions surrounding whether public messaging was sufficiently inclusive and culturally sensitive; experiences of whether public messaging appropriately communicated the benefits and risks of vaccines, including efficiency, safety and adverse effects; drivers of trust, mistrust in government public messaging; and views on how to improve public messaging.

Second, public trust in the safety of Covid-19 vaccines and the importance of being vaccinated, including: confidence - drivers and barriers to trust in safety of Covid-19 vaccines; complacency - perceptions of the purpose, value and necessity of Covid-19 vaccines; other drivers of vaccine hesitancy and unequal uptake, including how these differ for different groups and the causes of such disparities; how these factors affect vaccination decisions; and what reassurance people want to encourage them to be vaccinated and what could have been done to improve vaccine confidence and/or increase uptake.

Third, practicalities of vaccine roll-out including: convenience and barriers in relation to vaccine roll-out; experiences and particular barriers to accessing vaccines for those from vulnerable or marginalised groups; perceptions of whether there was fair and equitable vaccine distribution and access across different parts of the country and/or devolved nations; how accessibility and convenience factors affected vaccination decisions and uptake; and which government measures people felt encouraged their vaccination uptake and which measures people felt were counterproductive in that they increased or exacerbated hesitancy or otherwise discharged uptake.

Potential audience groups proposed for sampling in qualitative interviews include those categorised by: residency, in particular geographical locations with relatively low uptake of vaccines; ethnicity; socioeconomic circumstances, including level of education and homelessness; particular health concerns, such as amongst the immunosuppressed, pregnant and/or breastfeeding women, and/or those with fertility concerns.

It is unlikely that the targeted research will be able to cover all of the areas I have listed and CPs were invited to file written submissions making suggestions in relation to the KLOEs for targeted qualitative research, in particular on: whether there are any specific areas which I have listed that CPs consider to be of particular importance for targeted research; whether there are any further topics that CPs consider important for targeted research and why, including whether or not this evidence could otherwise be obtained through the Rule 9 process or by another method; and any views on the proposed target populations for the targeted research, either in relation to the above three topics or further proposed topics.

The Inquiry is grateful for the submissions it has received from CPs in relation to these matters. They will be reviewed in detail by the Inquiry team and will help inform work on the KLOEs. It is right to note that the ESM listening exercise, including its targeted research which focuses on specific groups, is but one of the Inquiry’s broader considerations of the experiences of groups and individuals impacted by matters falling within the scope of the provisional outline of scope for Module 4. The experiences of many more groups and individuals, from a large range of different communities and backgrounds, will be collected by means of the accounts offered to the Inquiry through its Rule 9 investigatory powers. And we will provide more information on the process of gathering and analysing information obtained through Every Story Matters shortly.

I turn now to the important issue of commemoration. My Lady, you have made clear your wish to recognise the very real and human suffering arising from the pandemic by ensuring that it is properly taken into account and reflected in the Inquiry’s work. As you know, the Inquiry is producing a series of impact films, the first of which was screened at the first Module 1 public hearing in June, and has used images and artwork to try to represent elements of the loss and suffering caused by the pandemic to the people of the UK.

Such was the scale of the tragedy, the grief and loss suffered by the bereaved and the lasting effect of the pandemic on the lives of so many millions of people, that no amount of commemorative activity could ever adequately reflect the depth of suffering experienced by so many.

However, the Inquiry remains committed to listening to the voices of those most impacted by the pandemic and to continuing to deliver commemorative activity that recognises the scale of this tragedy and the effect it had and continues to have on people’s lives.

There will be a new impact film played at the start of Module 4, and although it will not be themed specifically on the content of Module 4, there will be opportunities for individuals linked to Module 4 CPs to contribute interviews. Further information about these opportunities will be provided in due course. These films are a powerful means of reminding ourselves of the impact of the pandemic and, although they don’t constitute evidence, they do help to ground proceedings in the lived experience of those who have suffered hardship and loss.

My Lady, finally, moving on to directions and other matters, I now turn to address you on some specific points raised in the written submissions provided by CPs.

The joint submissions from CBFFJ UK and Northern Ireland CBFFJ express concern that the substantive hearing in Module 4 will take place before that of Module 3, because they had expected that the impact on healthcare systems would be examined after Module 2, which concerns core political and administrative decision-making.

Module 3 will of course still come after Module 2 chronologically, allowing relevant issues raised in Module 2 to be explored in the context of Module 3.

That the Module 4 evidence hearings will take place before those of Module 3 does not reflect a prioritisation of Module 4 over Module 3. Rather, it derives from the fact that time can be well spent hearing evidence about Module 4 while work continues in preparing for Module 3. The Inquiry is as keen as any CP group to hear evidence and draw appropriate lessons as quickly as possible, but investigations on this scale, particularly into matters as far-reaching as those which are the subject of this Inquiry, inevitably take time. If the investigations are not conducted in a thorough enough manner, then appropriate lessons cannot be learned. It is precisely because the Inquiry wanted to make recommendations as soon as possible that it has adopted a modular approach, allowing issues to be explored and relevant recommendations made on a rolling basis during the life of the Inquiry. The timing for the Module 3 and Module 4 hearings does not alter that fundamental approach.

The joint submissions from CBFFJ UK and Northern Ireland CBFFJ request that CPs be consulted on the sequencing of the modules. Timetabling hearings in this Inquiry is an extremely complex process, which involves a number of different factors, including your Ladyship’s other Inquiry commitments, the ability of material providers to provide evidence, the ability of the Inquiry to prepare the hearings and, of course, the importance of the issues in question. Timetabling involves your Ladyship’s making procedural judgments on the basis of your wide discretion and bearing in mind your obligations under section 17 of the Inquiries Act.

While the Inquiry will of course take into account any representations made about this, there is, in my submission, only a limited extent to which CPs can assist you with this, as it is inevitable that they cannot be sighted on all the complex issues involved.

What I can say is that if Module 4 were not to be heard next summer as planned, it would not be possible to substitute hearings in other modules within the time set aside for it, and that that part of the Inquiry programme would therefore be wasted and your report and recommendations relating to this module would be delayed.

Covid Vaccine Adverse Reaction and Bereaved ask that the Inquiry be mindful that its members are significantly health impacted and/or bereaved and will need support and appropriate accommodations from the Inquiry team to attend hearings and participate effectively. Specifically, Covid Vaccine Adverse Reaction and Bereaved request that significant dates be provided with at least a month’s notice. The points raised by Covid Vaccine Adverse Reaction and Bereaved also apply to some other CPs, and the Inquiry is keen to ensure that all CPs can participate as fully as possible in the process. I will provide an outline of the forthcoming hearing dates for Module 4 in just a short moment, and can say that the Inquiry team will endeavour to ensure CPs have as much notice as possible about specific dates in the investigation and any relevant deadlines for submissions.

My Lady, I know that once you have had an opportunity to consider the written submissions and those that are being made orally today, you will publish any appropriate directions in due course.

I turn now then, as I indicated that I would, to next dates for Module 4.

Turning then, a further two preliminary hearings for Module 4 will be held at Dorland House in Paddington and are currently scheduled for Thursday 8 February and 22 May of 2024.

The public hearing in Module 4 is expected to take place over the course of four weeks in July 2024. The hearing will be held here at Dorland House in Paddington.

My Lady, that concludes all of the matters upon which I wish to address you on behalf of Counsel to the Inquiry. A number of CPs wish to address you during the course of this hearing, and so, subject to any possible mid-morning break, can I invite you to hear from the first, Ms Stone on behalf of Covid-19 Bereaved Families for Justice UK.

Lady Hallett: Thank you very much indeed, Mr Wald.

Ms Stone, I think we can squeeze you in.

For those who are new to the hearings, I take a break usually after an hour and a quarter, for the benefit of everyone but particularly our wonderful stenographer.