6. Submissions on Behalf of Clinically Vulnerable Families by Mr Wagner

Mr Wagner: Thank you, and good afternoon. My name is Adam Wagner and I represent the Clinically Vulnerable Families, which I’ll refer to as CVF.

CVF, as you know, Chair, was founded in August 2020 and represents those who are clinically vulnerable, clinically extremely vulnerable and the severely immunosuppressed, as well as their households, from across all four nations.

The individuals CV represents are at a high risk of severe outcomes from the disease, such as a greater mortality, about 9.2 times more likely compared to those who are healthy, and long Covid, 5.4 times more likely compared to those who are healthy, than the greater population. In many cases they continue to shield to this day.

For many vulnerable individuals, the pandemic is by no means over, and indeed they still face as significant a risk, and, in some respects, a higher one, because of the removal of mitigation measures, from contracting Covid-19 as they did in early 2020.

CVF is keen to ensure that the Inquiry considers the full impact of the pandemic on the clinically vulnerable, the clinically extremely vulnerable, the shielded, and the severely immunosuppressed, their families and their households. Any planning for future pandemics and consideration of the effectiveness of public health services must include as a key consideration the impact on the clinically vulnerable.

I want to first address you, Chair, on working towards a safe hearing centre. As you know, CVF’s members include a large group of immunosuppressed and otherwise high-risk individuals, and it’s been our concern since the first preliminary hearing in Module 3, which was the first we attended, to ensure that the Inquiry centre is as safe as possible for immunosuppressed and high-risk people to attend and, therefore, play a full part in the Inquiry’s proceedings. The Inquiry has, of course, a legal duty under the Equality Act to make reasonable adjustments for disabled people, of whom many of CVF’s members are.

In this regard I want to thank the Inquiry team for its efforts to date. My lay clients, who sit to my left, report to me that the team have been responsive to requests and very much willing to listen, so that’s very much the good news, and really the umbrella point that I wanted to make.

Two bits of news which I will put under a “not bad news” heading, but perhaps the “work in progress” –

Lady Hallett: You frightened me last time, Mr Wagner.

Mr Wagner: I did, and I actually have the machine again here, I’ll come to that in a minute.

To be fair, it’s only when attending in person that the practical reality of the mitigation measures that have been put in place get tested, so we are very pleased to have the opportunity to attend today and give some feedback.

We say there is still more to do to make the hearings truly accessible, inclusive and safe for the immunosuppressed and high-risk people to attend in person. At the last hearing I attended, I showed you my client’s CO2 monitor, and according to the American Society of Heating, Refrigerating and Air-Conditioning Engineers, ASHRAE, the recommended CO2 levels in buildings should be no more than 1100 parts per million; the readings we have taken this morning using this monitor were, at points, between 1000 and 1100, so very close to the not safe line.

The Inquiry staff have helpfully provided a HEPA filter, which was part of the mitigation measures we proposed. However, it’s had to be turned to low because of the noise it was making. So that again is certainly something we can assist with and that we have been advising on, and we want to be able to continue working with the Inquiry team on that.

We have also pointed out, picking up on a similar point to what’s been made by my colleagues earlier, it would be extremely useful for a room to be available in the hearing centre for the immunosuppressed, the immune suppressed. To explain what this means in practice, without such a room, our lay clients are unable to eat and drink safely because they cannot remove their face masks.

We entirely appreciate that space is tight, however there is a prayer room, a support room and various core participant break-out rooms, and we would ask that consideration is given to making this reasonable adjustment in future.

A second point arising from CTI’s submissions this morning relates to scope. We note that the CTI clarified in his oral submissions that Module 4 will examine the development and trial of therapeutics, including decisions around eligibility, and Module 3 will examine the use of therapeutics in practice.

As you pointed out, Chair, earlier, it seems – it’s obvious there will be some overlap and I just wanted to explore that for a moment.

We ask that the Inquiry give some further consideration as to whether, in the context of therapeutics, it’s possible or desirable for Module 4 not to consider the use of therapeutics in practice, for these reasons:

For example, as I’ll set out in a moment, for many CVF members eligibility decisions had real world consequences, but we submit it’s only by considering those real world consequences – for example one group being made eligible but another not – that it’s possible to properly understand whether the eligibility decisions were taken appropriately.

It seems clear that, for example, the provision of antivirals to Covid-19 patients in hospital would naturally fit into Module 3. However, the provision of therapeutics and antivirals to vulnerable people in the community may not naturally fit into Module 3. It’s not in the scope of Module 3 or the provisional scope of Module 3 currently outlined. There is no mention of therapeutics or antivirals there, and certainly not in the community. Moreover, Rule 9 requests have already been sent out in Module 4, and we, for example, have already filed our Rule 9 statement in Module 3 and were not aware that the practical impact of therapeutics would be part of Module 3.

CVF are concerned that therapeutics, which is a hugely important issue for their members, and has received, we say, too little public attention, unlike vaccinations, which has received a huge amount of public attention, will fall through the cracks in the Inquiry. And it may well be this can be ironed out through a list of issues, but we do ask that additional consideration is given to that and the practical reality of the separation as soon as possible. And if helpful, we’d be happy to provide brief written submissions following this hearing as to what we consider the appropriate division to be. We do appreciate it’s not straightforward.

I will now briefly set out the five key areas of focus for CVF in Module 4, which I have quickly reformulated based on CTI’s clarification this morning.

First, eligibility for new therapeutics. CVF can assist the Inquiry regarding the narrow list of people who are eligible for antivirals. Many people who are vulnerable to severe Covid-19 did not and do not qualify for antivirals, for example diabetics, people with chronic obstructive pulmonary disease and older people. These people have sometimes inconsistently been pointed towards PANORAMIC or PRINCIPLE trials, which have now ended. CVF are very concerned about these trials, as they were using people with known vulnerabilities to a higher risk of more severe Covid-19 and only giving treatment to half. Some medications that were given were already proven not to be effective, for example ivermectin.

The second issue that we want to raise is Evusheld. This was another new therapeutic developed by AstraZeneca during the pandemic and it helps to reduce the chances of infection and severity of Covid-19 in people who have no immunological response to Covid-19 vaccination, especially the severely immunosuppressed.

The issue in the UK is that Evusheld was not subjected to the same rapid assessment and approval as vaccines or antivirals. Rather, it was subjected to NICE approval, the National Institute of Clinical Excellence.

CVF’s view is the lack of access to Evusheld in the UK has left severely immunosuppressed patients significantly unequal when compared to immune competent persons. Evusheld was not available at any time from the NHS, unlike in other OECD countries. Immunosuppressed people have not been given access to a prophylactic that would have given them the same protection as someone who is successfully immunised, and this has had substantial life-changing effects on CVF’s members’ lives. They have often been unable to partake in normal life in the way that successfully vaccinated persons can. Again, that underlines the point about separation between practical and eligibility decisions.

It’s affected many areas such as work, education and socialising, and it can even affect the basic needs such as buying foods, collecting medicines and attending medical appointments, and CVF can assist the Inquiry on these points, which only impacted upon the clinically vulnerable and their families and a large number of their membership.

The third key issue is, we say, prioritisation and eligibility criteria for vaccinations. CVF is concerned about the prioritisation and eligibility criteria throughout the pandemic. There is evidence of inequality of access between geographical areas for adults, children and their families. CVF have case studies of the challenges people faced accessing vaccinations, either being turned away despite eligibility or the lack of access in terms of availability.

The fourth issue is barriers to vaccine uptake by the clinically vulnerable. Some CVF members have had to travel significant distances to vaccination centres. Many members have found that centres are unsafe for the clinically vulnerable, with some members even contracting Covid-19 as a consequence of going to get their vaccination.

We note that the Disabled People’s Organisations in their written submissions also highlighted important issues around physical access to vaccinations. CVF are concerned that some patients who are eligible for vaccination have not taken them up and remain concerned about the risks. In addition, vaccine-damaged patients are concerned about further damage. The communication on vaccination is, we say, often confusing; people do not understand their eligibility.

The fifth issue, many clinically vulnerable adults live in households with children, some of whom were also clinically vulnerable. For them, speedy and safe vaccination was paramount. There were multiple issues affecting children’s vaccination in the UK, including slowness of distribution in schools. The delay led to many more children contracting Covid-19. CVF are concerned that there was an apparent policy to encourage infection and delay vaccination.

For children five years and under, despite there being a vaccine that has been used globally, it’s still not available in the UK at the time of submitting our written submissions. Some CVF members have gone abroad to access vaccination for their vulnerable children. There is clear inequality for the very youngest vulnerable children, or vulnerable families with very young children. There are other issues to be discussed further, such as the lack of support for people with allergies to vaccinations or people who are vaccine hesitant.

Finally, I’ll make some brief submissions on the written documents with which we were provided prior to this hearing.

First, provisional outline of scope. CVF appreciates this is very much a provisional list and is likely to be supplemented in due course by a list of issues. However, one point we wish to highlight is that it appears that a significant proportion of the focus to date in this module has been on vaccinations rather than therapeutics, evidenced by the fact that only one of the six topics identified in the provisional scope relates to therapeutics, and that, as I’ll submit, none of the key lines of enquiry for the listening exercise relate to therapeutics.

We submit that both topics, vaccinations and therapeutics, are of equal importance, and we appreciate Mr Wald KC’s clarification earlier that this will be the case. But we do worry that because of the very, very high focus in the public mind on vaccinations during the pandemic, there is an attendant disproportionate focus on vaccinations in this Inquiry. From a public health perspective, both therapeutics, antiviral and vaccinations, are hugely important. CVF have set out some provisional points made in relation to therapeutics which have been of central importance to the clinically vulnerable from the moment they were developed.

On the key lines of enquiry, we have set out in a bit of detail some potential amendments to the key lines of enquiry, and I make the point again that generally – our overall point is that there is no reference to the development and use of therapeutics in key lines of enquiry. And this is such an important element of Module 4, it really does need to be included there.

It may be the lack of reference to therapeutics in the key lines of enquiries connected to the point that you made earlier about overlap, but this does need to be considered.

There should also, we say, be consideration of children and/or parents of vulnerable children and/or families who are immunosuppressed living in the same household as clinically vulnerable children, clinically vulnerable people who have vaccine priority status but who are not immunosuppressed, the effect of Covid-19 vaccines on other childhood vaccinations, the vaccination of clinically vulnerable under 5s, the fact that healthy under 5s were not offered vaccination despite all other children and young people over 5 finally being offered them, the fact that those with sensory or learning disabilities should be included in the research. And we’ve suggested a couple of amendments which are in the written submissions directly, and it’s probably easier if you consider those rather than me reading them out.

Finally, in relation to paragraph 66 of CTI’s note, we definitely support the indication me that some evidence regarding individual deaths and circumstances may well be relevant where it relates to possible systemic failings. The note refers to the potential to hear from clinically vulnerable individuals. CVF would be happy to assist in providing potential case studies and individuals to the Inquiry team. We ask that the Inquiry team get in touch with CVF, as we have access to potentially thousands of relevant stories and individuals.

Thank you again for granting CVF core participant status. We look forward to working with you, Chair, and your team in the coming months.

Lady Hallett: Thank you very much indeed, Mr Wagner. Just one question: you mentioned your monitor which is beginning to, as I say, instill fear in me these days. You mentioned American guidance. With no disrespect to the organisation that provided it, I’m sure it’s very worthy, but is there guidance in the United Kingdom?

Mr Wagner: Yes, there is some guidance and we can provide that to the Inquiry in very short order. I was provided with a helpful note from, I think it was, Unison. There is some HSE guidance which mentions a figure of 1500, but we say that that doesn’t apply for clinically vulnerable people and it also doesn’t take into account Covid-19 in particular. But we would be very happy to provide all of that –

Lady Hallett: It’s just that the team, when they’re obviously trying to make what adjustments are necessary, would welcome the fullest information.

Mr Wagner: Yes. And I should point out there is an Inquiry CO2 monitor behind me, and interestingly it shows a much lower reading than our CO2 monitor. The important point is that the readings have to be taken in the right place, which is around where all the people are essentially. It’s not straightforward at all and it’s not, I don’t think, an exact science, but we would be very happy to work with you and your team.

Lady Hallett: Thank you very much, Mr Wagner.

Right, Ms Morris KC.