2. Statement by Lead Counsel to the Inquiry

Mr Keith: My Lady, since the first preliminary hearing last September, the Inquiry has moved at pace. Since then, you have concluded the hearings in Module 2, the module examining the UK Government’s core political and administrative decision-making, and Modules 2A, 2B and 2C, the related modules in Scotland, Wales and Northern Ireland, and Module 2C, as you will recall only too well, finished just last Thursday.

I don’t propose, my Lady, to reintroduce the core participants – they were introduced at the last preliminary – or their legal representatives, given the number of core participants and the shortness of time, but there are 33 core participants in Module 4 and all are legally represented.

Written submissions have been received from 12 of the core participants, and we’re very grateful to all of them for the observations and insights which they have contributed, and I believe you’ll be hearing from nine advocates.

My Lady, may I start, please, with the issue of the timing of this module. On 10 January, you announced that the hearing had to be put back from this July to next January, some six months. The Inquiry acknowledges that the putting back of the hearing has caused frustration and distress, and we’re sorry for that. I want to emphasise, though, just how fast the Inquiry has been moving. You know that of course it opened on 21 July 2022, only five months following the end of the lifting of the Covid-19 restrictions on the UK population.

The first public hearing took place less than a year later, between June and July last year, and you’ve also conducted and concluded the hearings in 2, 2A, 2B and 2C, as I’ve said.

Each of those hearings was necessarily preceded by an extensive and complex process of obtaining potentially relevant documents from various government bodies and other entities and persons.

Those materials have, as you know, to be examined by the Inquiry team, and then documents, those that are deemed to be relevant, are disclosed to the core participants to assist them in their preparation for the hearings.

The preparation for each hearing is demanding and difficult for material providers and the Inquiry alike. It relies to a very great extent on the material providers and their ability to make that material available. So, for departments like the Department of Health and Social Care, this is an extremely onerous task.

We have attempted to reduce the overall length of the Inquiry by allowing only for relatively short periods of time between modular hearings. With the best will in the world, it proved not to be possible to hold 2A, 2B, 2C, Module 4 and then Module 3 in quick succession in the course of a single year. The impact on the material providers in Module 3 was just too great, on account of having to deal with the demands of Module 4 very fairly shortly before that module.

Rescheduling Module 4 to next January has enabled the material providers in Module 3 to give priority to the greater demands of that more complex and lengthier module in the autumn. The putting back of Module 4 by that six months is, I should say, relatively modest, it’s a relatively modest delay in the general scheme of the overall length of the Inquiry.

As for the suggestion which one core participant has advanced in their written submissions for this preliminary hearing to the effect that there has been a general delay across the hearings, that is absolutely not the case. Having only just concluded Modules 2A through to C, you are already in the foothills of one of the lengthiest and most complex modules, Module 3, healthcare, which starts in the autumn.

Finally on this point, may I just say that it is obvious that Module 4 has been put back until after Module 3, but who is to say that Module 4, vaccines, was required to be dealt with before healthcare? It is no more and no less important a module. But the extra time that we now have will allow us to be better prepared and will make for a more effective hearing.

Since last September, a great deal of progress in this module has in fact been made. We’ve sent Rule 9 requests to 95 additional individuals and organisations, and as at the date of the Counsel to the Inquiry note of earlier this month, Module 4 has sent out over 120 Rule 9 requests for witness statements and associated documents.

Details of those requests have been contained in the update notes provided by the Solicitor to the Inquiry in respect of this module. The core participants have an overview of the topics which have been covered and of the individuals and entities who have received Rule 9 requests, but they cover organisations such as the UKHSA, the Vaccine Taskforce and its officials, the Department for Science, Innovation and Technology, ministers, former Scottish cabinet secretaries, of course the former Chief Scientific Adviser, Sir Patrick Vallance, key figures within the Antivirals and Therapeutics Taskforce and its predecessor bodies, the MHRA, pharmaceutical companies, JCVI, NICE, the Department of Health and Social Care, and related health departments in the Welsh, Scottish and Irish administrations, as well as chief investigators and those leading the platform trials for new and re-purposed therapeutics.

So we have cast our net relatively wide.

We are very grateful to the recipients of those requests for the efforts they’ve made so far to comply with our demands. More than 80 draft statements have been received and these are either being reviewed with a view to giving the material providers feedback, or have been finalised but are awaiting final confirmation and/or signing.

We will of course be sending more Rule 9 requests out, and the ones in the next month or so are likely to include the former First Ministers of Scotland and Wales, the chief pharmaceutical officers in all four nations, senior responsible owners for vaccine deployment, as well as, of course, those individuals and entities who have been suggested to us by the core participants.

In the autumn, decisions will then have to be made as to whether there are follow-up Rule 9s and/or whether or not further new Rule 9 requests are required to be made.

Many thousands of documents and exhibits have been received already, not all of them, of course, relevant and disclosable. A significant amount of that documentation has already been disclosed.

May I also say something about the targeted approach to disclosure to which I made reference in the CTI note.

In the case of major government departments, it’s clear from the initial responses that many tens of thousands of documents were potentially responsive to our provisional outline of scope.

My Lady, the process of assessing such a large quantity of material would lead to an unconscionable delay in this Inquiry and its timetable, and would render impossible your stated determination to produce timely recommendations. So, with respect to some – and I emphasise only some – document providers, we have adopted a targeted approach by which, rather than simply asking for all documents relevant in the opinion of the material provider to particular broad themes or areas arising in Module 4, we’ve instead sought documentation specifically relating to key narrative events, core decisions and to the processes and systems concerning the development, procurement, approval, including the hugely important issue of safety, and delivery of vaccines and therapeutics.

My Lady, it would be an impossible task to seek and wade through the millions of pages of potentially responsive documents that relate to the production and deployment of vaccines in the United Kingdom. We applied a similar targeted approach in Module 2, and may I say, despite some initial misgivings on the part of core participants in Module 2, it is now, I think, generally recognised that the Inquiry secured absolutely everything that mattered for the purposes of that module.

Turning to scope, a large part of the written submissions that you have received address the issue of scope and whether or not the net cast by this module is sufficiently wide enough.

We’re very grateful to the CPs for the thought and energy that has gone into those submissions, and before I attempt to address some of them, which I can answer straightaway, may I make some preliminary observations.

As I’ve said, the Inquiry has neither the time nor the resources to address every issue related to vaccines and therapeutics, and the general public would not wish it to. Choices have to be made, and your conduct, if I may say so, of the five hearings that we have had so far suggests that the Inquiry can be trusted to seek, obtain and expose what really matters.

Module 4 must focus on matters of real importance. We cannot scrutinise every aspect of development or of delivery or deployment during the pandemic, or to examine issues with the same degree of specificity as forensic matters are examined in the course of single-event Inquiries.

But it is not correct to say, as some core participants have expressed in their submissions, that there will not be an examination of vaccine safety. On the contrary, the systems and processes which are the centre of this module’s focus are the backbone of the framework that existed for establishing and monitoring vaccine safety. We will be looking at critical aspects of vaccine safety: the nature and the efficacy of the regulatory regime for the approval of vaccines, the considerations that underpinned relevant decision-making, how risk/benefit assessments were undertaken and applied, and of course the operation of the post-approval monitoring system.

But what we cannot do is make precise determinations in relation to whether a specific vaccine is safe or determining matters of causation where death or injury has resulted from specific vaccines. Safety is a relative concept, and any determination, if it could be made, would serve no sensible purpose. Were we to engage in a process of expressing a determinative view on the safety of specific vaccines and on causation, we would be led into an enquiry into matters that would risk a breach of section 2.1 of the Inquiries Act which, as you know very well, provides an inquiry panel is not to rule on and has no power to determine any person’s civil or criminal liability. Indeed, as you know, litigation has already commenced in relation to one pharmaceutical company.

In any event, the exercise of pronouncing the last word on the efficacy and safety of specific vaccines may prove to serve little purpose. Who is to say whether past specific vaccines will be of any use in a future, perhaps a non-coronavirus, pandemic?

So what really matters is: what were the systems and decision-making processes for the development, procurement, approval, eligibility for and access to vaccines and therapeutics, and how can those systems and procedures be improved? Only with that approach will you have a sure foundation for the promulgation of recommendations for the future.

But I wish to assure core participants, and it’s been made plain from the CTI note and from the provisional outline, that we will be looking at, of course, preparedness and core decision-making, particularly in relation to the Vaccine Taskforce and the Antivirals and Therapeutics Taskforce.

We’ll be looking at the general impact of those decisions, especially on marginalised groups and communities. We’ll be looking at specific vaccine-related issues such as misinformation and disinformation, the reasons for vaccine hesitancy or lack of confidence, the steps taken to address vaccine hesitancy and lack of confidence. We’ll be looking at post-marketing surveillance, including the Yellow Card monitoring scheme and the UK Vaccine Damage Payment Scheme. Insofar as therapeutics are concerned, Module 4’s examination will include specifically the decision-making relating to the non-vaccine prophylactic Evusheld.

In our note, my Lady, we’ve made plain that whilst we will not be looking at matters such as costings or supply chains or manufacturing processes or intellectual property, we will be looking at, in an overall sense, the amount that the United Kingdom spent on vaccines, we’ll be looking at the approach to discounted rates and we’ll be looking at the general system for liability and indemnity arrangements.

In relation to issues of eligibility and priority for vaccination, we will examine the processes by which those were considered and decisions were reached, so of course we will necessarily be looking at how the balance was struck between relevant considerations such as vulnerability, age, likely contraindications, as well as diversity and ethnicity.

So may I respond to the submissions from the UK Covid Vaccine Adverse Reaction and Bereaved groups, who have stated that they’re deeply disappointed and concerned by what they perceive to be a suggested narrowing of the scope of Module 4, in particular in relation to vaccine safety.

They ask: how can the Inquiry assess regulation and safety without understanding and scrutinising the underlying data, the processes, scientific and medicinal, and are we looking at vaccine safety with a sufficient degree of specificity?

I want to assure them that we are. We will be examining what was and is in the public domain about vaccine safety. We’ll be looking at the regulatory processes concerning vaccine safety. We’ll be looking at the impact of the decisions on vaccine safety. And we will adduce whatever data is necessary to scrutinise those issues appropriately and proportionately.

May I then make a second point, a general point, concerning scope.

My Lady, as you’ve noted in the course of earlier preliminary hearings in other modules, the issues that will be explored at the hearing depend to a very large extent, of course, on the Rule 9 statements and the documents which are disclosed. As they are disclosed, the issues will become further distilled. That distillation will be reflected in the provisional list of issues and that will be made available in due course.

The core participants today have not yet seen the majority of the Rule 9 statements which will in due course be served, so the actual scope of Module 4 and the issues that will arise for scrutiny are not, of course, known to them yet through the Rule 9 material and the exhibits, but it will become clearer as they receive more and more of the documentation, and of course we remain open to suggestions that they may wish to make in due course.

My Lady, all that said, their submissions on scope have received the most careful consideration and you will, with your usual assurance that matters are kept under review, be continuing to look at those points.

Can I then turn to some of the many points which are raised specifically. I’m going to try to answer as many as I can in the time that I have, and to lay down what I hope are some general helpful markers.

Access to therapeutics. The Clinically Vulnerable Families group note the amendments to the provisional outline of scope and they ask whether we’ll be obtaining data relating to the number of people who received antivirals and comparing it against those who were eligible according to national eligibility criteria.

We do not intend to seek specific data or such specific data in the absence of a basis for believing that such data is reflective of a systems failure, but such data may well emerge in the course of the forensic process, and of course it’s open to CVF to ask appropriate witnesses about data underlying or underpinning their evidence.

Long Covid. FEMHO seek clarification on whether the investigation will cover the interrelationship between vaccines and Long Covid. My Lady, the Long Covid groups are not, as you know, core participants in Module 4, but they are in Module 3, and they made submissions on the link between Module 3 and Long Covid at the recent preliminary hearing in Module 3 in April.

Our approach in Module 4 is not to actively investigate the interrelationship between vaccines and Long Covid, not least because the way in which the issue has been framed in the submissions seems to us to be too broad. But I can say that the expert report on vaccine safety is likely to address the issue of vaccine effectiveness against Long Covid.

And casting, my Lady, your mind back to Module 2, you’ll recall that you received evidence from Professor Brightling and Dr Evans on Long Covid and on the impact of the pandemic on those who suffer from Long Covid. The issue has also been addressed in the expert evidence in Module 3, so in due course it’s open to you to admit that expert evidence if appropriate in Module 4.

Covid Bereaved Families for Justice Cymru repeat its request for reassurance that differences in approach to eligibility and prioritisation for vaccination in Wales will be properly considered. The short answer is: yes, it will, and you ruled on this in fact in the last preliminary hearing in September.

A number of the submissions relate to inequalities and barriers. In relation to eligibility and prioritisation, Covid Bereaved Families for Justice UK and Northern Ireland Covid Bereaved Families for Justice submit that it’s crucial that prioritisation of key workers and discrimination should be key areas of focus.

My Lady, the Inquiry does intend to focus on the processes which led to decisions on prioritisation, including whether they were discriminatory, and we are absolutely confident that the evidence which will be adduced will be sufficiently reflective of that issue and also any scientific considerations which underpin that particular theme.

FEMHO reiterate that the Inquiry must state its resolute commitment to placing inequalities at the forefront of its investigation. They wish us to explore whether institutional and structural racism played a part in the development, procurement and roll-out of vaccines. They ask us to look at all the Module 4 issues through what they describe as an inequality lens.

The British Medical Association wishes us to look at discrimination in the context of vaccine hesitancy, and the Traveller Movement submits that we should look at disadvantaged and discriminated against communities, again in the context of vaccine uptake.

My Lady, the issues around inequalities and barriers to uptake are being addressed in line with the ruling that you gave on this in September, and you made clear that Module 4 would be examining inequalities throughout its work.

The Inquiry has asked and will continue to ask recipients of Rule 9 requests about inequalities, barriers and discrimination.

We have also instructed two sets of experts (in the first part, Dr Kasstan-Dabush and Dr Chantler, respectively experts in health protection and vaccine roll-out at the London School of Hygiene and Tropical Medicine; and on the second part, Professor Heidi Larson, who is an expert anthropologist and director of the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine) to look at issues such as disparities in coverage, the causes of disparities, the reasons for barriers, the interplay between the vaccines roll-out and pre-existing inequalities and structural discrimination, and the causes of vaccine hesitancy.

We will also be asking them and the Rule 9 recipients about the extent to which those issues were foreseeable and what steps could have been taken to address them.

So, my Lady, we believe that all those areas are well covered by our requests of the Rule 9 recipients and also in the expert evidence that we intend to instruct and adduce.

We don’t consider, however, that any purpose would be served in formally identifying barriers to uptake as being a separate theme or specific purpose of this module. The issue will be thoroughly considered by the experts and explored in the evidence, and it will be so explored alongside the interrelated issues of pre-existing inequalities and disinformation. So it would be somewhat artificial and impractical, in our view, for barriers to uptake to be treated as a discrete issue, as requested by the Traveller Movement.

My Lady, turning to misinformation and disinformation, Scottish Covid Bereaved submit the Inquiry should consider the use of social media, in particular how protected or verified public health messages can be sent online, and what steps can be taken to gain the trust of those who may have concerns about receiving vaccines, particularly in light of the lack of regulation of the internet.

My Lady, that’s a sensible and proportionate request from the Scottish Covid Bereaved, and we agree. The Inquiry has in fact received already a draft witness statement from Meta, and we will be requesting witness statements from a number of internet providers, including X (previously Twitter), TikTok, YouTube and Google.

Turning to roll-out and delivery, we’ve received a number of submissions from the British Medical Association and the NPA. They have made a number of suggestions for areas concerning roll-out to be explored by the Inquiry, in particular to do with workforce planning and increased workload in the context of GPs and community pharmacists.

My Lady, we have requested evidence from government departments, the national health services, and senior individuals within all those organisations about roll-out and delivery, and we’ve specifically requested information concerning operational challenges and what systems were in place, in fact, to manage resources required during the roll-out of the vaccines.

Global vaccine inequity. The Covid Bereaved Families for Justice UK and the Northern Ireland Covid Bereaved Families for Justice group have made submissions that you should return, notwithstanding your ruling of September, to look at global vaccine inequality.

My Lady, in your ruling you noted that the issue of global vaccine inequality was potentially a vast topic and it would simply not be practical to examine it in detail in the course of Module 4. You also noted that the terms of reference of course oblige you to examine the comparative differences between England, Wales, Scotland and Northern Ireland. And so, my Lady, may I just repeat what you said in your ruling, which is that international comparisons will be appropriate only where they’re reasonable and where such comparisons are relevant. We simply cannot delve headlong into the issue of global vaccine inequality.

Vaccination as a condition of deployment (VCOD), the UK Covid Vaccine Adverse Reaction and Bereaved group express their gratitude for your ruling that this is something that we will be exploring, and they ask in particular whether we’ll be looking at whether employers have accepted responsibility for the subsequent ill health suffered by their staff.

FEMHO have also asked whether we will be examining whether VCOD was or would have been effective in limiting transmission.

My Lady, employer liability and responsibility is outside scope, but all VCOD and related issues are within scope, and you ruled on this following the preliminary hearing in September by noting that an important topic for Module 4 included whether VCOD was or would have been effective at limiting transmission and also what impact the VCOD policy may have had in exacerbating vaccine hesitancy.

My Lady, the reporting of vaccine injuries. The UK Covid Vaccine Adverse Reaction and Bereaved groups make a number of suggestions in relation to the obligation of Module 4 to look at post-approval monitoring, phase 4 trials by manufacturers, and whether or not those trials had sufficient sample size and diversity. We are looking at phase 4 trials, that is to say post-authorisation trials, at a high level, and we will be examining the obligations on pharmaceutical companies to conduct those trials.

Our expert witness, Professor Prieto-Alhambra, who is an expert pharmaco- and device epidemiologist at the University of Oxford, will be addressing those topics and we’ll also be asking relevant pharmaceutical companies about the phase 4 trials.

The same group also asks us whether we’ll be exploring if the government adequately planned for a clear diagnosis and care pathway for vaccine injured.

My Lady, the short answer is that the treatment of vaccine injured is not something that Module 4 is looking at. It would not only represent a massive expansion in our terms of reference, but treatment is very – only tangentially connected to the broader issue which lies at the heart of this module, which is the examination of the systems and processes for the development, manufacture, approval, safety and roll-out of vaccines and therapeutics .

We are looking at the Vaccine Damage Payment Scheme . We will be looking at household vaccination and vaccination in rural areas, which are issues raised by a number of core participants.

The UK Covid Vaccine Adverse Reaction and Bereaved groups also invite us to call experts on the psychological impact and treatment of what is known as vaccine-induced thrombocytopenia and thrombosis, VITT, and they ask whether we’ll call an expert who has collated the experiences of persons who have suffered from VITT.

My Lady, again, in relation to impact and treatment, Module 4 has to draw a line between examining the safety regulatory systems, that is to say the processes for identifying adverse effects, and specific treatment issues relating to vaccine injury, that is to say the care and treatment of those who have suffered.

We are, of course, looking at the Yellow Card scheme, but the issue of whether or not – or the degree to which there has been psychological trauma and how persons suffering from VITT have been treated is not something that we can possibly look at in the course of Module 4. It’s a huge topic and it simply doesn’t sit naturally within our scope.

But I emphasise for those representing that particular core participant group that it is quite possible to investigate the effectiveness of the system for side effect reporting without having to investigate or call evidence on what treatments were given to those who suffered from VITT and on whom that side effect reporting process reported.

The National Pharmacy Association raise issues concerning community pharmacies, and they’ve provided a very helpful and thorough statement which covers the position in each of the four nations. We will be asking, and we have asked in fact, Rule 9 recipients from NHS England, the DHSC, Scottish Health and Social Care Directorate and the Welsh Government about community pharmacies. Rule 9s have been sent to or will be sent to the chief pharmaceutical officers, and Dr Kasstan-Dabush and Dr Chantler will be addressing the issue of GP surgeries, primary care networks and community pharmacies in each of the four nations in their reports.

So, my Lady, doing the best I can in the time, and bearing in mind the complexity of some of the requests, that I hope is a helpful summary of the Inquiry’s current position on some of the many points raised in the written submissions, but I emphasise that, as you have said repeatedly, all these matters are gratefully received and they will of course be kept under review.

May I then turn to the issue of parliamentary privilege. The core participant group, the Migrant Primary Care Access Group, was good enough to give the Inquiry advance notice of the points that it wished to raise. We set out in the CTI note a detailed response to their arguments as we understood them to be, and then the MPCAG responded in their written submissions, which you have before you today.

In short, its first written submissions indicated that the group wanted to adduce in their own Rule 9 statement evidence of what its members had said to a select committee as well as adducing the select committee report itself.

What they wished to do was to adduce this evidence in order to make the forensic point that the government must thereafter be taken to have had direct knowledge of what they describe as inequality in healthcare and vaccine access amongst vulnerable migrants and asylum seekers, and of what identifiable barriers there were that existed which prevented access to vaccines and therapeutics for such people.

It basically wants to attribute to the government knowledge of what their position was by calling evidence as to what was put into the public domain before the select committee.

My Lady, we would gently question the forensic utility of such a course. The government’s knowledge at the time is likely to be no less apparent from its many policy and public statements on the matter.

Secondly, it is open to the MPCAG simply to ask government witnesses what they knew at the relevant time in relation to barriers and inequalities in relation to vulnerable migrants and asylum seekers.

And lastly, we would gently enquire as to what purpose would be served. Your primary aim, of course, is to look to the future and make recommendations as to how the system of vaccine and therapeutic roll-out can be better improved. Spending time focusing on what the government knew at a particular time in a particular place may not advance that cause hugely.

But in any event, my submission is that the adducing of such material is unlikely to amount to a breach of parliamentary privilege, even assuming in law that that privilege applies to this statutory tribunal. So there is, shortly, no need for you to rule on the underlying point of principle.

The purpose behind any intended reliance upon parliamentary records or material is key. What is not permitted is a challenge to the truth or worth or validity of what has been said or done in Parliament. So it’s not permissible to draw inferences from such material, to use it as evidence for or against disputed factual matters or to challenge the truth of a proposition. But in our view, simply adducing, mechanistically, evidence of what was said or concluded, merely to prove that the Government must be taken to be aware of it, it is no breach.

My Lady, they raise a second related point which requires your determination. They also ask whether the group may be permitted to file its Rule 9 witness statement in draft and for you to receive it de bene esse so that they can be enabled to review later the Home Office’s Rule 9 as well as any further follow-up questions that we may pose of the Home Office, and to do so in light of their own draft Rule 9. They want to re-edit or reformulate their own evidence in light of the evidence received from other material providers.

In my submission, the answer to their question, their request, has to be, I’m afraid, no. We cannot have a system in which material providers submit Rule 9s in draft and then revise them following cross-service of everybody else’s draft Rule 9s. It would result, in my respectful submission, in an endless forensic roundabout, and it would greatly lengthen the Rule 9 process, as well as being an additional burden on the legal team.

Shortly, it is for you to decide what, if anything, needs to be followed up in each Rule 9 and then for that Rule 9 to be finalised, signed and disclosed.

Turning, my Lady, to the issue of expert evidence. We have set out in the CTI note the detail of the experts who we propose to instruct. In relation to vaccine hesitancy, it’s Professor Dani Prieto-Alhambra, the professor of pharmaco- and device epidemiology at the Botnar Research Centre at University of Oxford. He will be dealing with issues of vaccine safety, regulation and monitoring, side effects, the Yellow Card reporting system, vaccine regulation and surveillance.

In relation to vaccine roll-out and vaccine hesitancy, the Inquiry’s instructed Dr Ben Kasstan-Dabush, the assistant professor of medical anthropology at the London School of Hygiene and Tropical Medicine and Dr Tracey Chantler, associate professor of public health evaluation at the LSHTM and co-director of its vaccine centre. They will cover vaccine coverage, disparities, the methods used to obtain data on vaccine coverage, disparities in coverage and the causes of disparities, the foreseeability of coverage issues, the interplay between roll-out and inequalities and structural discrimination, and of course, not least, the lessons that can be learnt.

In relation to vaccine hesitancy, or lack of confidence, as some prefer to call it, the Inquiry’s instructed Professor Heidi Larson, the professor of anthropology, risk and decision science, infectious disease epidemiology and dynamics, and director of the Vaccine Confidence Project, as I’ve said, at the London School of Hygiene and Tropical Medicine. She will be assisted by a number of other experts. They will deal with an overview of general trends in the United Kingdom and internationally in relation to vaccine hesitancy, hesitancy in relation to the specific Covid vaccines, differences between the four nations, common factual inaccuracies and misconceptions, the policy of vaccination as a condition of deployment and its impact on vaccine hesitancy, and also, as I’ve said, the issues of foreseeability and preventability.

Then there is the issue of therapeutics. The Inquiry believes that it has identified a suitable expert to deal with a report that seeks to cover all the topics relating to therapeutics, such as an explanation of what the non-vaccine prophylactics were, the different types of therapeutics, an overview of the pre-clinical trials, the clinical trials, the clinical trial phases, the emerging science in relation to therapeutics, and also, of course, the general impact of their use and roll-out.

So, my Lady, the expert evidence covers potentially a very broad scope, width, indeed.

A number of the core participants have set out further issues which they advance with a view to the Inquiry agreeing to include those issues in the current instructions for those experts.

Children. The Clinically Vulnerable Families have asked whether the expert evidence will cover vaccine roll-out, hesitancy, misinformation and therapeutics in the context of children.

My Lady, this is a difficult issue. It’s difficult because the issue of hesitancy applies to children to some extent in the same way as to adults, and therefore, to the extent that children are likely to have been influenced by parental choices, that is likely to be covered by our main expert evidence. But we will, in respect of roll-out, provide a summary of the way in which ages and dates and dosage intervals and so on were adapted and modified in the position of children, and we’ll also call expert evidence in relation to the system of vaccination in schools. And that, we hope, will address the majority of the points which have been raised in relation to children.

The clinically vulnerable, clinically extremely vulnerable, and severely immunosuppressed group, CVF, requests that the therapeutics expert addresses particular challenges faced by those groups. We are, of course, asking the therapeutics expert about the particular challenges faced by high-risk and clinically vulnerable groups.

The devolved administrations. We will be addressing differences through the expert evidence between the four nations.

In relation to inequalities, structural and institutional racism, the Covid Bereaved Families for Justice UK group and the Northern Ireland Covid Bereaved Families for Justice say they welcome your indication in the ruling following the last hearing that the question of whether an expert in these matters is needed would be kept under careful review, but they express their, again, concern as to the extent to which we will call specific expert evidence on structural and institutional racism.

My Lady, Dr Chantler and Dr Kasstan-Dabush will be looking at pre-existing inequalities and structural discrimination, so that is the short answer to the query, but also you will recall that experts were instructed in Module 2 to provide reports on structural inequalities in relation to ethnicity and race, gender, age, disability and LGBTQ+ identity. If in the course of preparing for Module 4 it becomes plain that there is a lacuna in relation to expert evidence on inequalities and structural discrimination, we have available that expert evidence to be re-adduced in the course of Module 4.

MPCAG requests that expert evidence be called on the specific issue of migrants in the United Kingdom in relation to the barriers and entrenched inequalities that they face. My Lady, it is open to that core participant group to summarise such evidence, which we know they have available, in their own Rule 9 statement, and of course they can propose questions to appropriate witnesses. In our view, however, it would not be proportionate in the course of a hearing of the length that it is to call experts specifically on the particular topic of vulnerable migrants.

The disabled persons organisation group seeks confirmation that Dr Kasstan-Dabush and Dr Chantler will address the issues of prioritisation and the timing of prioritisation for disabled people. Those experts will be addressing the processes involved in the roll-out and specifically how pre-existing inequalities impacted a number of groups, including disabled people.

They will similarly be looking at the barriers faced by marginalised or minority communities and that addresses the submissions made by the Traveller Movement core participant.

Finally, my Lady, on this topic, the UK Covid Vaccine Adverse Reaction and Bereaved groups return to the issue of the Vaccine Damage Payment Scheme, and they ask whether or not we would call particular witnesses in relation to the VDPS.

My Lady, we don’t presently intend to call an expert on the VDPS issue, our view and our submission is that you will be able to come to a view on the Vaccine Damage Payment Scheme, including whether it requires reform, from the factual evidence that you’ll receive through the Rule 9 process. We have Rule 9ed Professor Fairgrieve King’s Counsel. We’ve also sought and received a Rule 9 statement from Sarah Moore, who is the litigator at Leigh Day who represents a number of the bereaved and injured who have brought the litigation against AstraZeneca.

Covid Bereaved Families for Justice UK and the Northern Ireland group return to the issue of disclosure of both the letters of instruction and the draft reports.

My Lady, you’ve ruled on this in earlier modules. Subject, of course, as ever, to your ruling, we don’t intend to provide the letters of instruction, because of course we will be inviting comment on the draft final expert reports in due course, so providing the letter of instruction will not add anything.

My Lady, the next topic that I’m required to address is the number of additional submissions which have been made in relation to impact evidence.

My Lady, in brief, a number of the core participants state that they wish you to call a number of witnesses from their client groups who can give evidence about the consequences and impact of the pandemic and the government response in the particular context of vaccines and therapeutics.

So, my Lady, it’s the issue which you have addressed now on a number of occasions concerning the extent of relevancy of impact evidence.

You in fact ruled on this following the first preliminary hearing by saying that the evidence of the impact of the pandemic or the response may be admitted only where relevant to possible systemic failure, and of course in Module 4 our submission is that the accounts of individual sufferers, however insightful and terrible, are unlikely to be able to establish such failings, because they can only ever report upon their own individual experiences.

But in any event, we are, of course, going to be asking appropriate witnesses directly about the processes and systems concerning vaccines and therapeutics. That is what Module 4 is about. But in our note, my Lady, and I emphasise that we’ve made it absolutely plain, that just as was the case in Module 2, we will call impact evidence from representative witnesses on behalf of appropriate core participant groups, exactly as we did, I emphasise, at the beginning of Module 2.

The purpose of that evidence, therefore, is not to enquire into the impact on individuals but because those representative witnesses can talk about not only their own experiences but primarily the issues and the matters which were raised by those groups with the government. They can recount their dealings with the government in relation to vaccines and therapeutics, and they can summarise the body of material relating to the impact of vaccines. And that, in my respectful submission, is a far more effective and efficient way of adducing that evidence.

My Lady, turning finally to the issue of the timetable for the hearings.

Three weeks has been given to Module 4 in January. Taking account of the opening and closing submissions, and the impact film and the representative impact evidence, there will probably be only 10 or 11 days devoted solely to the calling of evidence. A number of the core participants invite you to consider whether you would allocate additional days or whether or not you would generally lengthen the length of Module 4. In my submission, the Inquiry must proceed at the pace that it is, and must proceed to devote those three weeks only to Module 4, because without such a rigorous timetable you will not be able to make the timely recommendations across all the modules to which you have committed yourself.

There is no more time available in the overall Inquiry timetable if you are to adhere to your stated determination to produce timely reports and recommendations, and I would remind the core participants that of course the hearing is only one part of the forensic iceberg. For the purposes of your report, and your recommendations, you will, as you have already done in relation to Module 1, consider all the documentary material and all the voluminous material which we have been provided with. So for those reasons, we believe that the length of time allowed for Module 4 will be sufficient.

Every Story Matters. Module 4 has agreed that there will be a report from Every Story Matters collating the data in relation to the experiences of vaccines and therapeutics. That report will be provided to the Inquiry team, we believe, in the late summer. Thereafter it will be finalised and we anticipate it will be shared with core participants in the late autumn.

UK Covid Vaccine Adverse Reaction and Bereaved group seek confirmation that their key lines of enquiry were included in the ESM process. They were.

In relation to the timetable and the preparation for public hearing, we will circulate a provisional list of witnesses along with a provisional list of issues in September, and of course the core participants will respond in the usual way.

The proposals for the Rule 10 process will be circulated in advance of the third and final preliminary hearing in October 2024, and there will, as with all the preceding modules, be an impact film.

My Lady, that further preliminary hearing will be here in October but the specific date will be provided in due course, and as I’ve averred to and as the material from the solicitor and counsel to this module has made plain, the public hearing will be between Tuesday, 14 and Thursday 30 January.

My Lady, those are all my submissions, and I hope they address the vast majority of the points raised in the quite extensive and complex written submissions from the core participants.

Lady Hallett: Thank you very much, Mr Keith.

May I just say in relation to a third preliminary hearing: if there’s going to be a third preliminary hearing it will be on a date to be announced in the autumn, but I’m only going to hold a third preliminary hearing if I consider it necessary, so people need to know there is a marker, because I only believe in holding hearings if I see a point to it.

Mr Keith: My Lady, yes.

Lady Hallett: Thank you.

Ms Munroe, you’re going to take us up to the break.