COVID-19 Committee

Meeting date: Thursday, December 17, 2020

Official Report 682KB pdf

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Covid-19 Vaccination Programme

Good morning, and welcome to the 25th meeting in 2020 of the COVID-19 Committee. We have received apologies from the convener, Donald Cameron.

This morning, the committee will take evidence on the Covid-19 vaccination programme from Steve Hoare, director of quality, regulatory science and safety, Association of the British Pharmaceutical Industry; Professor Wei Shen Lim, chair, Covid-19 immunisation, Joint Committee on Vaccination and Immunisation; Professor Andrew Pollard, professor of paediatric infection and immunity, University of Oxford; and Dr Christian Schneider, Medicines and Healthcare Products Regulatory Agency. I welcome the witnesses to the meeting.

We have quite a large panel of witnesses, so we will move straight to questions. Committee members will have 10 minutes each to ask questions of the witnesses. I ask everyone to keep the questions and answers as concise as possible. If there is time for supplementary questions, I will indicate that once all members have had a chance to ask their questions.

I will ask the first question. Everyone wants to be a priority when it comes to getting a Covid vaccine. We have had a lot of discussion in Parliament about the policy around schools remaining open and whether teachers should be in the first phase of the vaccine roll-out. Do the witnesses believe that there is clinical justification for including teachers, and how practical would it be to do so, given that it is easier to find teachers all in the one place during the working week?

I will also ask a related question. We know that children under 16 are excluded from getting the vaccine at the moment. Do you have an update on the role of children in future clinical trials and the prospects of vaccinating children, particularly those with health conditions?

I will try to answer the question about the prioritisation of teachers. The current advice from the JCVI is that, for the initial wave or phase of the programme, we should prioritise protecting people who are at risk of dying from Covid-19 and protecting the national health service, which in turn saves lives.

The first phase of the programme is about trying to capture the vast majority of people who are at risk of serious and severe outcomes from Covid-19. That includes all people aged 50 and above, and people who are younger than that but who have underlying health conditions, down to the age of 16, which is the age at which there is authority to use the vaccine. That is where we stand at the moment. Teachers who are at risk from severe disease will obviously be captured in phase 1 of the programme.

The other point relates to teachers in schools who are younger than 50 but who are not at a very high risk of severe disease from Covid-19. Those teachers and other key workers across a range of occupations will be considered for vaccination, or an offer of vaccination, in the next phase of the programme.

It might be better for someone else to answer the question on including children in vaccine clinical trials.

Dr Schneider has his hand up, so I will come to him next.

Thank you. It is not unusual for there to be no children included in clinical trials for new medicines, including vaccines—unless the trial is for vaccine that is intended to be used in children, obviously. As already outlined, the vaccine is licensed for people aged 16 and above, which is based on the data on efficacy and safety.

Professor Pollard, can you add to that, please?

Thank you. I lead the clinical trials of the Oxford vaccine. We have always planned for trials involving children because, as members will know, some subgroups of children are at a slightly higher risk than others. There is a lot of interest in that, particularly from families.

As Wei Shen Lim said, there could come a point when, once the higher-risk groups have been vaccinated, it would become appropriate to think about some of the lower-risk groups. Therefore, our trials include a plan to start evaluating the vaccine in children. In fact, we hope that that will start very early in the new year. I know from colleagues who are working on the other vaccines—the Pfizer and Johnson & Johnson vaccines, for example—that they are planning trials in children to start extremely soon, for exactly those reasons.

However, I fully support the policy decisions that Wei Shen talked about, to start with the people who are at the highest risk of disease, such as healthcare workers, and those who are at a higher risk of severe disease, particularly the elderly and adults with other health conditions.

That is encouraging to hear. In my area, which was recently in the highest level of restrictions, children who had previously been shielding had been advised to stay at home and either be home schooled or do remote learning. I am thinking about young people with conditions such as cystic fibrosis. There was a real feeling of exclusion.

Beatrice Wishart has appeared on my screen. Do you want to add anything, Beatrice?

No.

In that case, I will move on.

I have been reading that women who are—[Inaudible.] Can the witnesses say a bit more on that, particularly on the breastfeeding issue? There is a concern that breastfeeding rates might drop. Will there be anything in clinical trials to address the issue of uptake by women who are planning a pregnancy, pregnant or breastfeeding? It would be helpful to hear about that. Professor Pollard wants to go first.

Those groups are initially excluded from the clinical trials because, obviously, things have moved very fast this year. Quite appropriately, regulators really want to establish safety and efficacy in healthier, younger adults first, before starting to target pregnant women, given the additional concerns that there might be for them, until we have established safety data.

However, now that we have reached that point with multiple vaccines, there are plans to start evaluations of vaccination in pregnant women. That is particularly important, not just here but in many countries around the world. An important target group will be healthcare workers, among whom there are a lot of women of childbearing age. Addressing that group will be an absolute priority in 2021.

There is a second question, which is sort of related. What about women who become pregnant after they have been vaccinated? We will have quite a lot of data on that group. Although participants in clinical trials usually try to avoid becoming pregnant, inevitably, in large trials, and as is happening with all these vaccines, many women become pregnant—in this case, following vaccination.

We already have a small amount of follow-up data on those women across all the different developers of the vaccines. However, to be able to assess safety, we really need to know the outcomes of those pregnancies. We need time for that, to follow up the babies after they have been born and so on. It is not something that we can get a quick answer to, but it is absolutely a focus of the work that is going on.

With regard to the vaccines that are being considered in the UK, I do not think that there is any scientific reason to be concerned about women receiving the vaccine when breastfeeding, because the vaccine is not likely to transmit anything to the woman that would be harmful to an infant if it got to them.

Those studies have not actively been pursued so far, but the issue is certainly being considered. Wei Shen Lim may want to comment on that from a policy perspective.

Thanks, Andy—I completely agree with everything that you have said, particularly on the absence of information on women who are breastfeeding that suggests any harm. What stance one takes depends on whether one is more or less permissive when interpreting that absence of information. We are trying to take an appropriate and reasonably cautious approach in terms of allowing people who are breastfeeding to receive the vaccine. The committee can be assured that, as far as we can tell, no concerns have been found so far.

The MHRA had a group that authorised the use of the vaccines in different groups of people, and it may be appropriate to ask the MHRA for its views about safety in relation to breastfeeding.

Thank you. I have just had a message that tells me that not everyone could hear my question—there might have been an issue with connectivity. The question was about women who are pregnant, planning a pregnancy or breastfeeding and the wider safety aspects around their inclusion in the vaccination programme at this point and in future clinical trials. Does Steve Hoare want to comment on that?

Yes. Thank you very much. Professor Pollard is quite correct that some women have become pregnant during the clinical trials. The sponsors of those clinical trials have agreed that they will follow up for at least two years after the first injection, so we should get some data. There is insufficient data to give the MHRA that confidence—I am sure that Dr Schneider would probably approve of that.

The wider question about whether pregnant women will be included in future clinical trials goes beyond the vaccine. As a trade body, the ABPI has convened a group of clinicians, academics and industry representatives to address the question of how we can include pregnant women more in clinical trials, regardless of whether they are vaccine, medicine or therapy trials. There may be some myths that we need to break down. Part of the purpose of that group, certainly over the next year, is to start to address those myths and work out how we can include pregnant women and encourage them to come forward for clinical trials—and how we can give clinical trial investigators the confidence that pregnant women can participate.

Thank you. The issue of confidence is important.

Dr Schneider, I come to you to wrap up on this line of questioning.

09:15  

I can confirm what has been said. Basically, there is no strict contraindication; it is more of a statement that there is no or limited data for the time being on pregnancy and breastfeeding. That is why, as a precautionary principle, vaccination is not recommended. I am sure that more individual recommendations will be possible for patients who are at high risk and so on, but of course we cannot cover those scenarios in a regulatory information sheet, such as we have published. The advice stands as it is, but that is not because of a particular concern; it is because of the absence of data for the time being.

Thank you. That is helpful.

My question is about uptake in different groups in society. There have been concerns that uptake in the black and minority ethnic community might be lower. How are you monitoring particularly vulnerable groups, such as the BME community, who already face massive health inequalities, and older people? A lot of this comes down to confidence in the vaccine, but there may be other factors. I am interested to know how you monitor and adjust the strategy on vaccination to take account of those factors.

I will start, and Andy Pollard can come in, too.

Uptake is extremely important; offering a vaccine is only the first step in the programme. The offer needs to be understood, accepted and received. Once the vaccine has been received, that is the end of the process, and—hopefully—protection starts. It is extremely important that we have a view of and monitor the whole process, including uptake by different groups.

The groups that one is perhaps most worried about include not just people from black, Asian and minority ethnic groups but groups who, for various reasons, have difficulty accessing or engaging with healthcare, such as homeless people. There are also those who live in the poorest, most deprived neighbourhoods in our society. Again, we know that those groups usually have greater difficulty in taking up vaccines. There is a range of communities in which clear monitoring, help and engagement are needed right now.

The JCVI’s advice is in two halves. The first half is about the offer of the vaccine to priority groups, but the second half, which is equally important and should not be overlooked, is about implementation. We stress that implementation needs to be locally tailored and locally appropriate. That involves engagement with community leaders and opinion leaders who can influence and promote vaccine uptake in local populations. That is extremely important, so thank you for raising the point.

I can only speak from the trial perspective. An absolute priority for us and, I know, for other developers has been to make sure that testing of vaccines is done across different ethnic and cultural groups. That is definitely challenging, because it depends on the make-up of the population around the trial sites in which we work and on the willingness of different groups to participate in clinical trials. For most developers, getting good representation from the communities that we are discussing has been more difficult than we might have anticipated, despite active efforts to engage with them.

However, we have representation in the United Kingdom trials, and we have also conducted trials in other countries that have much more diverse populations, such as Brazil and South Africa. Therefore, we have good representation of people from different backgrounds across our suite of trials.

I know that the same approach is taken in the trials that are under way in the United States, to ensure good diversity in the trial population. That has included extending the trials to give more time to specifically enrol the BAME communities, who did not participate as much in the first part of enrolment. The different strategies that developers use are really important to ensure good representation of the smaller populations that are sometimes harder to access in clinical research.

Another key question is when we will know whether the vaccines are effective in preventing the transmission of the virus. When can we get clarity on that? I am not sure who to direct that question to.

Steve Hoare has his hand up from the previous question, so we will come to him first. If others wish to respond, waving your hand is as good way as any to let me know.

I will answer both questions from the industry perspective.

On confidence in the vaccine, the industry’s duty is to listen to concerns and provide the data and assurances that are required. The ABPI has already launched the valuing vaccines campaign on social media to give some of the statistics and provide the context.

The answer to the question about transmissibility depends on some of the criteria in the clinical trials. I sit on the test and trace task force. In our most recent meeting, an NHS representative pointed out that there is an on-going study to consider post-vaccination and transmissibility, and that at least 40,000 people are involved in that. That data is being collected as we speak.

We certainly are keen to find out the vaccine’s impact on transmission rates and viral loading for those who are infected. It is a wait-and-see situation, but that study is on-going.

If the other witnesses do not want to come in on that point, I have a final question.

Professor Pollard has raised his hand.

I will add to that. It is clear that some data will come from the trials on transmissibility and whether vaccines can interrupt that. All the vaccines on which we have data have reduced the number of cases that are polymerase chain reaction—PCR—positive in our trials, so there will be an impact on transmission. If fewer people are PCR positive in the population, there will be less disease.

The critical point is about herd immunity, which is the level at which transmission has been reduced and a number of people are protected so that the virus can no longer transmit. That is a much bigger ask than being able to show some impact on the transmission of the virus. I expect that, once a decent number of people in the population are vaccinated, we will see less transmission. That will be really important in getting back to normal.

I am concerned that we do not focus entirely on herd immunity at the moment because, in order to get close to that, we might need 80 or 90 per cent of people to be vaccinated, and that is still a long way off. It is likely that we will continue to have some vulnerable people in the population who have not been or cannot be vaccinated, and we are still in a global community, in which there will be other countries with lower rates of vaccination. The virus is extremely good at transmitting.

Herd immunity would be a fantastic goal to reach, but it is a long way off. We should focus on protecting the vulnerable and having as many people in the population vaccinated as possible for direct protection. We will also get some impact on transmission, but we will not stop the virus completely in the first few months of next year.

On the question of how many doses there are, I see in Mr Hoare’s paper that the UK has pre-ordered 357 million doses. We do not have that many people in the UK—even if we divided that number by two. Why so many doses? Does that mean that Africa and India are losing out?

That is a very good question. The doses are not all ready to land on our doorstep tomorrow; that is a portfolio of procurements that the UK Government has carried out, and they will arrive as batches are scaled up and distributed and delivered. We are seeing the first batch of the Pfizer-BioNTech vaccine; as others come through and get approval, we will see them coming online. It is about spreading our bets on various horses in the race. If other vaccines come along that would have a benefit to a particular part of the population, they would probably be distributed accordingly.

As you said, that is a large number of doses, but they will not all arrive at the same time and, if it looks like a few of the horses that we put bets on are working, I believe that there is the right to defer or divert in some of the contracts. As you know, the UK Government has already committed some money to the global COVAX facility. If we reach what we need ahead of time, some of those vaccines could be diverted to the global solutions.

Would the contracts for the 357 million doses be legally binding?

I do not have that level of detail, but I understand that some clauses are available in order to divert, if necessary.

Fair enough. Thank you very much.

I have a question for Professor Lim. You have already spoken to Mark Ruskell about specific groups. Your paper mentions ensuring that

“inequalities are identified and addressed in implementation.”

Will you explain how that would happen? You suggest that we go through an age group. What are you suggesting about the other inequalities? Who would address them? How would they be addressed?

The implementation needs to be taken on by local teams working within health authorities and public health and local community workers. Implementation and local engagement should happen within each priority group; they are not prioritised separately. For instance, we want good vaccine uptake for all people who are more than 80 years old. If we know that certain groups within that priority group are less likely to receive information in the usual way or are more mistrustful of the usual information and the way that it is given, those groups will need more attention from local teams that understand those communities and are able to engage with them in a way that is meaningful and constructive, in order to enable those communities to have a high vaccine uptake. The prioritisation and the implementation are not two separate things—they go hand in hand.

I do not know whether that helps.

09:30  

That is very helpful. Thank you very much.

Anyone can come in on my final question. Do we have any idea about what the timescale will be to get the whole population of either Scotland or the UK vaccinated?

If no one is offering to answer that question, I will take that as meaning that we do not have any idea. Would a year be reasonable?

Rather than there being silence, I will give an answer.

It is difficult to give a timescale, as it depends on vaccine supply, the ability to deploy the vaccines, and how many vaccines are available. The more vaccines that pass through regulatory approvals, the more flexible the vaccine delivery can be. The Pfizer-BioNTech vaccine has very stringent cold-chain requirements, whereas the Oxford AstraZeneca vaccine, which we hope will gain regulatory approval, has much less stringent requirements. Having more types of vaccine will enable faster deployment of the vaccines. Putting an exact timescale on that now might be a hostage to fortune, so I suspect that nobody will be willing to say that we will have achieved X percentage by a certain date.

I think that Dr Schneider is going to give me a date.

I am afraid that I cannot give you a date, but I will build on that point.

The question is not easy to answer, because the picture is very complex. It depends on the authorisation, which is based on adequate data. The vaccines that we have been talking about, for which there are contractual agreements, are not all at the same stage of development, and we do not know whether they will succeed. Companies will have international contractual agreements, as well. We cannot always assume that the manufacturing process can be upscaled successfully and that there will be no problems with manufacturing. Therefore, it is difficult to say.

As was mentioned before, there is also the issue of people’s willingness to take up the vaccines. There are a lot of factors at play. In my opinion, it is difficult to give an exact date.

I expected that.

There have been huge efforts in the NHS to be prepared for vaccination. My sense is that, given that we have supply, the planning is extremely advanced to make sure that the doses can be put into people’s arms. As has been said, there needs to be regulatory approval first, and we have only one approved vaccine at this stage. Therefore, we have to wait for other approvals to come through.

There is also the manufacturing point that Dr Schneider mentioned. There are huge efforts to make tens of millions of doses of vaccine in the first quarter of next year, but we need just one batch to fail for there to be a big shortage for a period of time. In trying to make huge numbers of doses, it is not uncommon for some of the batches to go through an institutional biosafety committee and not pass the stringent standards that are quite rightly in place.

We cannot predict the future completely, but I have a sense that huge efforts are being made to make sure that the NHS is ready to deliver, and the supply chain work that is being done by the manufacturing people—although I am not one of them—is also in good shape at the moment.

Will Steve Hoare be brief, please?

Certainly. I echo those comments. The industry is playing its part, and we are working as fast as we can. However, we will go as slow as the science and the regulators require.

I am not sure who is best placed to answer this question. For how long does a vaccine remain viable when it has reached a local authority or health board area? Given the transport issues, that is of particular interest in remote and island areas, especially with regard to the Pfizer vaccine.

As the vaccine is developed, we are getting more and more stability data to give us an understanding of how long it remains viable in storage and in use. You are right to ask the question, as the Pfizer vaccine requires storage conditions that are not ideal. However, Pfizer has put in place thermal shippers to enable the vaccine to stay in the appropriate storage conditions for as long as possible. That period of time can be extended if there are no -70° freezers around.

The industry has committed its support, wherever possible, and the supply chain is in place to deliver the vaccine to hard-to-reach communities.

Can you give a timescale for the storage capability?

Please bear with me for a second while I find some details about the thermal shippers. The information that I have says:

“The shipper can maintain temperature for 10 days unopened which allows for transportation ... Once open, a vaccination center may use the ... shippers as a temporary storage solution to maintain the recommended storage conditions ... up to 30 days with re-icing every five days ... Once thawed, the vaccine vial can be stored for up to five days at refrigerated ... conditions.”

That is quite an extensive bit of support.

I have a question about the potential wastage of vaccine during the roll-out. I understand that consignments of the Pfizer vaccine are made up of 975 doses and, within that, vials are in packs of five. If, for example, 37 people are to be vaccinated, that would require packs totalling 40 doses, which would mean three spare vials that, potentially, might be wasted. Given that there is a tier system of vaccine delivery, should some flexibility be built in for a more pragmatic approach to be taken to fully utilise the—in my example—spare three vials for another group? Should we not be trying to vaccinate as many people as we possibly can?

That is an important and valid question. The problem is that the Pfizer vaccine is a fragile construct—the messenger ribonucleic acid, or mRNA, in the lipid nanoparticles is fragile—which is why it has to be frozen at -70°. The instructions that we have given are that the authorisation is based on data that support the fact that the vaccine will be stable within the conditions that we have given. However, once it is reconstituted, it is very fragile.

The problem is that, as much as pragmatism is desirable, it could lead to a situation in which it could no longer be guaranteed that the vaccine was efficacious or safe to use. That is inherent in the nature of the product rather than in the regulations that we have in place. It is based on the science of the product.

Steve Hoare?

I was going to direct the question to Dr Schneider. The MHRA has considered splitting the vaccine packs in order to do as Beatrice Wishart suggested.

Both Professor Lim and Professor Pollard have their hands up. Beatrice, are you content to hear more answers?

Yes, I am happy to hear more.

We do not want wastage, especially for these precious vaccines. The priority groupings at the moment allow for some latitude and we have advised that there should be common sense and flexibility operationally in the use of vaccines. We have not said that the priority groups are rigid and that everybody in one group has to be vaccinated because, as we know, vaccines will be offered and it might be that some groups do not want to take up the offer, in which case one has to move through the groups.

At a local level, I reassure you that at the moment the Pfizer-BioNTech vaccine is being deployed through mass vaccination sites, precisely to avoid high levels of wastage. For example, my trust has tried hard to invite people who are over 80 years of age to come for vaccination and, at the end of the day, if any vaccines are left and available, healthcare workers who are in the immediate vicinity are invited to have the vaccine. Because they are in a mass vaccination site that is a healthcare trust, they can turn up for vaccination within 10 or 15 minutes and we can make sure that no doses are wasted.

That makes sense.

One of the critical parts of our vaccine development has been our mission to make the vaccine not for profit and available in all corners of the world. An important part of that has been developing it so that it can run through the normal vaccine cold chain using fridge temperatures so that it can go to remote villages in Africa as well as islands in Scotland. That is an important part of how we have been thinking about the distribution.

There is a separate issue around wastage, which you brought up. One of the ways to approach mass vaccination, particularly at this time when there has been a shortage of pharmaceutical-grade glass to fill vials of vaccine, is that the manufacturing involves ten-dose vials, which comes back to the point that Professor Lim made that if you have a ten-dose vial but only five people turn up, once that vial has been opened for more than six hours it has to be thrown away, so careful logistics are required on the ground to make sure that once the vial is open those doses are not wasted. That can be particularly problematic in more remote areas, which tend to have higher wastage because it is harder to have a pool of people who can drop in at the end of the day to use the remaining doses.

That is very helpful. Finally, how many people would need to be vaccinated before it is safe to reduce any restrictions? Perhaps you cannot give an indication. Nobody wants to answer that one.

I will have a go at answering the question. It is generally estimated that if a vaccine was highly effective at blocking transmission—70, 80 or 90 per cent effective—given the transmissibility of this coronavirus one might need to vaccinate up to 70 or 80 per cent of the population. That is one estimate that has been given. That is the herd immunity that Professor Pollard described earlier on. Very high levels of vaccine uptake will be required to completely stop transmission of the virus through the population.

Professor Pollard, I will pick up on something that you said. You mentioned a shortage of pharmaceutical-grade glass. I have been aware of that issue; can you expand on that, and tell us how serious the issue is and what, to the best of your knowledge, is being done to address it?

It has been a problem globally throughout this year. More vaccines are being developed than have ever previously been made in one year, and the glass that is required to make the vials, and the filling capacity around the world, is being fully used up.

09:45  

There have been huge efforts this year to ensure that supply chains for different countries and different vaccines are properly established, and I think that we are in good shape in that respect. One of the ways in which that issue has been addressed has involved the use of multidose vials. If you put 10 doses in a vial, you need less glass, and you do not need so many hours of filling capacity, whereas if you had 10 times as many vials to fill, it would take you 10 times longer.

The systems have been put in place and there has been a whole year in which to do that. One of the ways that the industry has adapted to the situation is by trying to work out the most efficient process that could be put in place.

Thank you, that answer was helpful.

Are any of the witnesses aware of any testing that has taken place, or is scheduled to take place, with people who are addicted to drugs?

It is difficult to answer in a specific way the question about testing in individuals, as a population, who are addicted to drugs. What I can say is that the clinical trials, which are open to everyone, include people who take drugs and have addictions. That is a slightly different answer—they are included in the trials, but I cannot point to a specific analysis of a large number of people who are addicted to drugs.

That is simple—thank you.

I have a question for Professor Lim. The JCVI’s written submission says:

“Care home workers are therefore considered a very high priority for vaccination.”

This week, I have been contacted by multiple individuals in my constituency who work in care homes and have indicated that they will not be taking the vaccine. I am concerned about that because of the need to protect the residents of care homes as well as the individuals who work there and those in the wider community. Is there anything that could or should be done to encourage all care home workers to take the vaccination?

I agree that every effort should be made to encourage care home workers to take up the offer of the vaccine. It is important for them, as individuals who are potentially exposed more frequently not only to the virus, but to vulnerable people. If there is even a small chance that the vaccine will block transmission, taking the vaccine will also help them to protect other people. There is therefore a personal benefit and a healthcare, or social care, benefit overall.

It brings us back to the advice that local leaders need to understand why care home workers might be reluctant to take the vaccine. The reasons for that may differ in Scotland in comparison with somewhere in England, for instance, and understanding those issues will be helpful in encouraging uptake.

The vaccination programme is currently at a very early stage, so attitudes might change as more people get the vaccine, and as that is reported more widely in the local community. Nonetheless, I was concerned when I was approached by those care home workers because, as Professor Lim rightly identifies, people who stay in care homes are some of the most vulnerable in our communities.

It is worth noting that the annual flu vaccination offer has also been extended to care home workers this year, and that uptake rates differ between workers in hospital or primary health care and workers in care homes. I therefore do not think that any such reluctance relates specifically to the Covid vaccine—or so it appears. It might be more about the general concept of having a vaccine in order to protect oneself and the people that one is caring for. Some work might need to be done in order to improve uptake not just for Covid vaccines but for other vaccines that are equally important throughout the year.

Thank you. My next question is for Dr Schneider. Did Brexit have any influence on the ability of the MHRA to grant the temporary authorisation as quickly as it did?

There was a small crack on the line, so I will repeat the question to check that I understood it correctly. Was it about the impact of leaving the EU on our temporary authorisation for the Pfizer vaccine?

Yes; did Brexit have any influence on the ability of the MHRA to grant the temporary authorisation so quickly?

Thank you. The temporary authorisation was because of the realisation of a European law into UK law. That has enabled us to do it, as it would any other country. That will continue; such emergency situations can occur in the future, so it is enshrined in British legislation, and that will not change.

Obviously, if the European Medicines Agency authorises one of the vaccines this year, that will be directly applicable in the UK. Beyond 1 January, the MHRA has its own powers in law to issue a marketing authorisation.

Are there any concerns about the potential impact of Brexit on the vaccine supply chain? A few moments ago, you touched on the vials, but what about other aspects?

From an authorisation perspective, I would not have any concerns, because we have the power to issue a temporary authorisation, and we will have our own powers from 1 January. We have the resource in house for doing the assessment. Obviously, there are also questions about the supply that is coming into the country, but I cannot comment on those. In so far as we are a part of it, we have ensured that everything is in place so that there are no problems from the regulation perspective.

I have a final question, which is to any of the witnesses. When and how will we know whether the vaccine affords immunity in the longer term?

We are monitoring immunity all the time. Our trials have just reached the six-month point, and we are analysing those blood samples to see how long immunity lasts. We have some past experience with the Tamiflu vaccine, whereby we have seen the immune response last for well over a year after vaccination, but we have to take the scientific approach of doing the measurements and having a look.

Of course, no one can tell how long immunity lasts until time has gone by and, because of the nature of the pandemic, not enough time has gone by for us to answer the really important question about whether we are still going to see strong immune responses next winter, which is going to be really critical for all the vaccines and for the protection of populations. That needs following up over time.

A separate question is whether the immune responses that we see correlate with protection. We do not know that yet. Work has started among all the developers to ascertain whether the antibody levels that we are seeing in blood samples tell us that the person is protected. We can do work early in the new year to establish whether what we are seeing in the blood is a predictor of protection. If it is, we might well be able to say next winter whether we think that the population is still protected.

At the moment, are you anticipating that the vaccine will be an annual vaccine, similar to the flu vaccine, or is it too early to say?

We do not know yet. The flu vaccine is annual because the flu viruses change every year, so we need to redesign the vaccine each year to cope with the strains that are predicted to circulate. With this coronavirus, however, we do not yet know whether any of its mutations—some of which we have heard about in the news over the past few weeks—will affect the performance of vaccines. At this stage, there is no evidence that we should be concerned about that, but it is something that we absolutely must continue to monitor.

Good morning. This question is for Steve Hoare. What are the implications if the national regulators reach differing conclusions on vaccines that are seeking approval?

Are you asking about a possible difference of opinion between the MHRA and national regulators for other countries?

Correct.

The industry would take the advice of the regulator in the relevant country and act accordingly.

Would Dr Schneider like to comment?

It is an important question. The MHRA is working with other regulators across the globe; we have an informal information exchange. If a situation were to transpire where one regulator came to a different conclusion from that of another, we would have to look at the details of the different conclusion, in as much as it was applicable to the MHRA and the UK.

It really depends on the specific case. The likelihood of it happening is not high, but there is of course a possibility that it might happen. Many factors would play into it, but there are internationally recognised standards, and there have been clinical trial programmes, so I would be surprised if it did happen. As I have said, however, we are liaising with other regulators internationally.

If your organisation is confident in the safety of the vaccines when it grants approval, why have the regulations been amended to grant pharmaceutical companies immunity from civil liability?

That amendment was made because there was a provision that was unclear. To the extent that immunity—or there would be no indemnity—I am sorry: I am not a lawyer, and I am trying to find the right words. The indemnity would be waived for healthcare professionals and manufacturers, but the regulations did not explicitly mention pharmaceutical companies. The principle of equality, so to speak, was included, but the provisions do not exclude anyone from the normal liability in the case of breach of conditions or misconduct or any other items. It—[Inaudible.]—provisions.

I am sorry—I did not hear the last part of that.

My apologies. There was basically a gap in the provisions. They mentioned manufacturers and healthcare professionals but not pharmaceutical companies as such.

Okay—that is clear. Thank you.

Professor Pollard, are other companies likely to follow AstraZeneca’s lead and produce the vaccine on a not-for-profit basis?

I do not know the answer to that. My understanding is that Johnson & Johnson is taking that approach, but I am not really involved in that world of decision making, so I cannot fully answer the question. That may be more for the industry to address.

10:00  

Thank you, professor. Would Steve Hoare like to respond on that?

Many companies have committed to working on a not-for-profit basis, and the whole industry is committed to ensuring that the vaccine is made available according to an equitable and affordable process.

So, there is a possibility that that will happen. I understand from my own business background that there is a question of investment in research and development, so each case will presumably be considered individually.

Yes, and individual companies will make their own decisions. The ABPI cannot comment on that.

Good morning. My first question is probably for Steve Hoare. Constituents ask me: how come the vaccine has arrived so quickly, and how come the clinical trials have been completed so quickly? Can you offer an assurance to the public that the whole process of getting the vaccine approved has been correct and proper and so on, and that no corners have been cut in bringing the vaccine to the market?

It has been done on the back of quite a few things, including advancements in technology. There is the fact that the genetic sequence was unveiled and shared very early in the process. There was also our previous experience with similar viruses, in addition to the unprecedented collaboration between industry and other stakeholders, such as the MHRA; we were doing things in parallel, as opposed to sequentially, as is conventional.

Ultimately, the MHRA decides whether things have been done in the most appropriate fashion, to the highest standards of quality, safety and efficacy. The industry’s role is to present compelling evidence that that has been done. You can be assured that no corners have been cut.

We have learned some new ways of working. The MHRA started a process of rolling review six months ago, looking at the data as it was coming out, so it was much easier for it to take the final data and come to a decision in a short period of time. It has been a different way of working.

There are definitely some things that we can learn for future pandemics, and even some new ways of working that we can now claim as business as usual, which will have an impact on the speed of development of medicines. We will be able to get new medicines to patients even more quickly than was the case before.

That is very reassuring. It is a question that is posed quite often by constituents, so it was worth getting it on the record that everything has been done properly and no corners have been cut.

My next question is about the shielded group: those people who have underlying health conditions, no matter their age. Are they in the right place in the order of vaccination roll-out? We are correctly targeting our senior, most vulnerable citizens first, but are we giving younger people with underlying health conditions the proper priority in the order of vaccination roll-out?

Many people—particularly those with underlying health conditions—are asking that question, as you can imagine.

The unique character of Covid-19 is the very steep association of increasing age with a poor outcome, particularly the risk of dying. A lot of infections affect older people more, but coronavirus appears to hit older people particularly hard, and the association is not linear but exponential; it is like a wave that goes up very, very steeply.

When we have looked at models that consider the optimal way of delivering a vaccine to maximum benefit, in order to save the most lives, whether the outcome is to save lives or save lives measured by quality-adjusted life years—to take into account how many expected life years someone might have—in both those outcomes, we find that the optimal strategy is still to offer vaccination to older adults first. That is because of the incredibly steep association with age. That forms the basis and backbone of the recommendation and the priority groups.

We have looked and looked again at the risk of dying for the group of people who are clinically extremely vulnerable. As a group, they are at roughly the same level of risk as people who are aged around 70 or 75. That is why we have placed them alongside that group for the offer of vaccination.

That is very helpful. Dr Schneider, did you want to make a comment on that point?

It was not on that point; I wanted to make a point on the previous question of whether corners were cut. If you consider that sufficiently answered, I will not say any more.

Yes; thank you for that.

I have another question which I do not think that anyone has asked yet. If millions of people are being vaccinated, how do we manage the information technology and data management side of that? Where is the IT management of that taking place and who is doing it in order to properly record people coming to vaccination centres and being vaccinated and to make sure that they come back a few weeks or months later to do it again? I do not think that there is a role for our general practitioners’ surgeries in that process at the moment, so who is managing and delivering the IT side in order to make sure that it is done correctly? I do not know who might be able to answer that question. I will try Steve Hoare.

I do not think that I can answer to that level but the manufacturers and the MHRA carry out monitoring after vaccination. There is an on-going safety monitoring process and the MHRA has its yellow card scheme; I encourage everyone, once they have had the vaccination, to download the app for their phone and use it. There is also a process of providing information to patients every time they have that vaccination, to encourage them to report any effects.

The IT side of it around who has what comes down to the NHS and local government, which make up that part of the deployment team.

Okay; that is probably a question for our next panel, so I am happy with that answer.

Good morning. My first question is for Professor Pollard. The briefing tells us that the Pfizer vaccine employs a different technology from traditional vaccines, in that the production of the viral protein is stimulated in our cells, rather than in vats of cells. Can Professor Pollard explain to me, as a layperson, what that means and what the implications are?

Secondly, there is already one clear implication, which is that people who have allergies are being advised not to take the Pfizer vaccine. What is to happen to that set of people? I imagine that their number is consequential these days. Is there a vaccine in the pipeline for them?

First, I will explain the different technologies. Many different technologies have been used, and 50 different vaccines are currently in clinical development, so there is not really time to go through them all.

The RNA vaccines, which include the Pfizer vaccine, essentially deliver a small bit of genetic code that is the code for the spike protein of coronavirus. When the vaccine is given, our cells turn that genetic code into spike protein so that our immune system can then make a response. That works very powerfully, as we have seen in the studies on the immune response to the Pfizer vaccine. The Moderna vaccine, which is one of the other ones that the UK has bought, works in exactly the same way.

Some of the other vaccines, including ours and the Johnson & Johnson vaccine, which are viral vector vaccines, do something rather similar. The delivery mechanism for the genetic code is a common cold virus, but, in the end, all those vaccines are doing the same thing: they are converting a bit of genetic code into spike protein so that the immune system can make a response to it.

There is nothing magic about it. It is a new technology, but the way in which it ends up making the immune system respond is very similar to some of the other vaccines that are in development, as well as some of the licensed vaccines, such as the Ebola vaccines, which are licensed all across Europe.

I thank Professor Pollard for that answer; it is helpful to hear from the scientific experts. Perhaps my second question is even more pertinent. What about people who have allergies? When will they get the vaccine?

I have not been involved in the discussions about those cases but it might be that those individuals had an allergy to something specific in the vaccine, or they could even be allergic to something else that happens around vaccination, such as something that is in the syringes or the gloves that were used. I do not fully understand the nature of the allergy, and it is being investigated at the moment. While that is being looked into, it is a sensible precaution to pause vaccinations for that group, but that does not mean that we will not have it dealt with in the longer term or that people cannot be protected.

I thank Professor Pollard for that answer, which provides some reassurances.

I was pleased to hear Dr Schneider refer to the fact that the MHRA works with international bodies. However, will he assure us that that work extends to information sharing to avoid duplication, and that it is not just liaison?

Secondly, what is happening with regard to the least developed countries in the process? Perhaps Dr Schneider could share his views on that.

The information sharing is done on the basis of having a confidentiality agreement with other regulators; we have quite a number of such agreements in place. We have to explore how we can share information and also liaise with countries beyond the International Coalition of Medicines Regulatory Authorities, the US Food and Drug Administration, and the European Medicines Agency. That is a valid question and we are currently exploring it.

In response to your previous question about allergies, there were two cases of anaphylaxis, which is the highest grade of allergic reaction that someone can have. To my knowledge, any person who has a history of anaphylaxis to a vaccine, medicine or good should not receive the vaccine. If there is a history of severe or serious allergies, that should be discussed with the healthcare professional. It is not just about allergies; it is about severe allergies. However, again, we cannot exclude the fact that there has been an allergic reaction. We are looking into the mechanism and why it happened. It is not unexpected for such cases to occur when you expose many people within a short time.

I can assure the committee that we have a strong system for pharmacovigilance in the UK and that it works. We were able to act on the allergy cases and put out recommendations so that everything was kept in hand.

10:15  

Professor Lim, is the priority approach that the JCVI adopted reflected in the approach that other countries are taking internationally? Could you perhaps confirm the position in broad-brush terms?

Many other countries have adopted similar recommendations to the JCVI, which are to prioritise on age first of all and then to prioritise others who are vulnerable, to protect people from the severe effects of Covid-19.

That is helpful, because we get a lot of questions about priority—you have got a flavour of that this morning, Professor Lim. It is reasonable to suggest that the world is, by and large, taking that approach, which is based on clinical observation. I note that my time is just about up; I have one last question, for Mr Hoare.

I remember hearing an interview on the radio at the time that the Oxford vaccine information started to show a lot of promise. A young postgraduate student commented that she was really excited by that, because of the importance of the scientific community working together for a common good. She extrapolated that if we could maintain that momentum, we could see massive strides in, for example, vaccination against malaria. From an industry point of view, what concrete actions and reflections are now being taken forward to maintain that momentum to do something good for mankind?

It is a good question. It is exciting to have seen unprecedented levels of collaboration and co-operation between industry members, academia, the regulator and other stakeholders, as well as some real new science. We will learn a lot about new technologies and new ways of working from that collaboration. I would be surprised if we did not see knock-on effects on other diseases and approaches—not just malaria, but diseases in which antimicrobial resistance is a worry.

There could be ways of working to overcome barriers that we have come across in the past. It is absolutely right to be excited—it is an exciting time to be involved in science. I hope that one of the knock-on effects is that we see more people take an interest in science and in what we do, and that a whole new generation of students and pupils get involved in science, technology, engineering and mathematics—STEM—subjects.

I absolutely agree. We particularly need to see many more women in STEM. That is a really important point and must be one of the positives that we can take from the things that have happened over the past year, and will happen for a bit longer. The world will be watching and expecting more collaboration on the part of the scientific and pharmaceutical community.

My time is up. Thank you for your responses.

Mark Ruskell has indicated that he has a supplementary question, which we can squeeze in and, I hope, get a brief answer to.

It follows on nicely from the previous question. How does that collaboration take place on the ground and on what basis? Is it purely commercial? Are there other ways to share intellectual property and technology? In particular, is UK pharma fully bedded in to the World Health Organization’s Covid technology access pool and committed to it? Discussions have been had at board level about the financial bottom line. There is a chance for real global altruism here, so how do you work with those WHO initiatives?

A lot of the UK industry is made up of global companies, and we have already made that commitment. I previously mentioned the COVAX facility that the WHO set up. I am personally involved at the international level with the International Federation of Pharmaceutical Manufacturers and Associations, our sister trade association, and we are seeing co-operation right now around not just the vaccines but general new ways of working.

We have seen the regulators do the same thing: the MHRA is prevalent at the international level as well as the ICMRA—an international coalition of regulators, in which the MHRA is also quite prevalent. It is an exciting time, as was said previously.

There is a commitment from the industry to fair, equitable and affordable access to medicines.

There are no comments from other witnesses, so that brings our session to a close and concludes our consideration of this agenda item. I thank all the witnesses for their evidence and their time this morning. It has been helpful.

10:21 Meeting suspended.  

10:36 On resuming—