20
Examination of witness
Professor Sir Andrew Pollard.
Q159 The Chair: Welcome back to today’s meeting. This is the 14th oral evidence session as part of the committee’s inquiry into childhood vaccination rates in England. I thank Professor Sir Andrew Pollard for attending today. This session is open to the public and is being broadcast; it will subsequently be accessible on the parliamentary website. We will take a verbatim transcript of the evidence today; again, that will be published on the parliamentary website.
A few days after this session, our witness will be sent a copy of the transcript to check whether there are any inaccuracies in there. If there are, we would be most grateful if you could send them to us as soon as possible so that we can get everything up on the website. If, after this evidence session, you wish to clarify or amplify any points you made during your evidence, or you have anything additional that you want to say, you are very welcome to send us supplementary written evidence. We are grateful to you for the evidence that you have already sent us.
Here is the first question; it is a very general one. How safe and effective are the vaccines in the routine childhood vaccination schedule? What is the evidence on adverse events linked to vaccines in the routine childhood vaccination schedule? How does the safety of routine childhood vaccinations compare to that of other medicines or other vaccines, as well as for people who have not been vaccinated?
Professor Sir Andrew Pollard: Thank you very much. I am a professor of infection and immunity at the University of Oxford. I have been a paediatrician for 35 years and worked in infectious disease for most of that time, so I have seen the consequences of not being vaccinated. I have been the director of the Oxford Vaccine Group, which is a research institute in the University of Oxford, for the past 25 years. I also chaired the Joint Committee on Vaccination and Immunisation; I stepped down from that at the end of last year after 12 years in the role, advising the Government on vaccine policy for the NHS. I first started working on vaccines 40 years ago in my first studies as an undergraduate, when I was interested in the immune system.
I come on to the not-so-simple question—it was a rather complex question, in fact—that you asked. First, the right thing to do is frame what we mean by safety here because, when you talk about safety, it is very difficult to understand what you mean from the perspectives of the person who is talking about it and those who are hearing it. You often hear a statement like, “No medicines are completely safe”. In the case of vaccines, that is the right answer if you are a vaccine developer, because we collect data on tolerability and safety.
As most of us who have been vaccinated know, when you have a vaccine, some people have a sore arm or get a temperature. That is all recorded and is part of the safety database. So it is quite right to say that there are always some safety signals. Some people have a sore arm or feel a bit woozy for 24 hours after being vaccinated.
Let me frame that for an older adult receiving the pneumonia vaccine at the age of 65. Around 3% or 4% of such people may have a low-grade temperature. What is interesting is that, in those studies with a control group of people who did not get vaccinated, around half the number—1% to 2% instead of 3% to 4%—will also have a fever even if they have not been vaccinated. So you do have a signal: there is a bit of a temperature in some older adults who get vaccinated.
That would be a safety signal, but it is not a concern. Safety does not necessarily mean that it is a concern. We accept that because it is our immune system recognising a given vaccine so that it can start the preparation for being able to produce an immune response. It means that, if we ever get exposed to the pneumonia bug, we are ready to fight it. It is a natural part of the process, but it is considered part of the safety database, so it is quite right to say that it is not all safe.
Given to a baby, that same vaccine may lead to as much as 8% of babies having a bit of a temperature after they have been vaccinated. Again, though, that is self-limiting and usually stops in a day or so without any long-term consequences. Those are the sorts of thing we are talking about in terms of safety for most childhood vaccines.
In the clinical trials, we also collect what are called serious adverse events, which would include a broken leg. It would include someone having their appendix out because, in clinical trials, it is important to collect all safety events. It could be that something that happens normally in the population happens more commonly after a vaccine or a medicine is given, so you collect everything so that, at the end, you can analyse it to see whether there is an increased rate of that condition in the vaccinated group as compared to the non-vaccinated group.
In most clinical trials, we do not find any difference in the serious adverse events, but we report serious adverse events in the trial. There is a lot of misunderstanding around what that means, because it does not mean that they are caused by the vaccine. Clearly, if you get hit by a car, the vaccine has not caused that, but it would still be recorded in the data. That is the second bit of this.
There are some very rare serious adverse events. For example, we know that, with the Covid vaccines, there was a very rare condition of blood clots with one vaccine and heart inflammation with one of the others. There can be extremely rare ones, but you cannot pick those up in the clinical trials. They are so rare that they are not seen in that setting.
You asked about how that compares with what we see with medicines now. With medicines, we accept a lot more risk than we do with vaccines. Vaccines are given to a healthy population and healthy children. Whereas we will accept those tolerability issues that I talked about with medicines, we really do not accept any significant rate of anything serious with a childhood vaccine. However, if you have cancer and you have a treatment that might cure your cancer, you will accept quite a lot of risk associated with that treatment. We see that if you look at the clinical trials and the data we have from them, so vaccines are far safer than some drugs that we use, simply because we are giving them to a healthy population where we do not want to cause harm.
The Chair: Thank you very much. I have some little follow-ups to that presentation. It sounded to me as if you were saying that, if somebody has a bit of a temperature after receiving a vaccine, that is perfectly natural and the body responding positively to the immunity it is being given. Is that what you meant to say?
Professor Sir Andrew Pollard: Yes, absolutely. It is completely normal. What you want to do when you are vaccinating is to induce a response in the immune system, and that starts with a bit of it that we call the innate immune system, which is recognising that the vaccine is being given. Part of that is an inflammatory response, which might give you a temperature or a sore arm. It might give you a headache or make you feel a little unwell for 24 hours, but it is self-limiting and goes away after that period of time. It is just a normal response to being vaccinated, but I should say that not everyone gets that and, interestingly, you are less likely to get it when you are older.
The Chair: You also talked about comparing the percentage of people who have a particular effect against what there is in the normal population. I presume that relies upon having good-quality evidence about the base data. Can that be an issue sometimes?
Professor Sir Andrew Pollard: I was referring there to the clinical trial side, where you have very good data but, obviously, relatively small numbers. Most trials have only thousands of people when you get to the safety database before licence, not millions. For obvious reasons, there is just a cost in development, so that is what we are dealing with at that point. After licensure, data are collected by the regulators across the world, as well as by the companies marketing the product, to look at all adverse events that get reported. As you know, there are different systems—including our yellow-card system here—for that reporting.
For example, if people report high rates of a particular condition after vaccination, let us say multiple sclerosis, then it is really important to know whether that high rate is the same as you would see if someone had not been vaccinated. Now for a condition like that, we have really good data. There are of course huge numbers of multiple sclerosis cases identified every year in adults, so we can quite readily look at whether the rate observed in a trial—actually, not in a trial but after licensure—is similar to the rate you see in the general population. But if it is a rare condition, we very often do not have good data on it. We do not have data on how commonly it happens in the background, and what regulators tend to do there is to err on the side of caution. Where there is uncertainty, they will include that condition in the label, even though we are not really sure whether that condition is directly associated with the vaccine, but it means that people are alerted to that possibility.
The Chair: That pretty well answers my third question, which was why rare conditions are not picked up in the clinical trials. Is that simply because they are not big enough?
Professor Sir Andrew Pollard: Yes, it is just numbers. If something occurs in one in a million cases, no one can afford to run a trial of a million people. They may be in thousands or even tens of thousands of people—the Covid vaccines were in up to nearly 50,000 people—but it is unusual in a clinical trial for there to be more than about 100,000, and most are considerably less than that.
Q160 Baroness Wyld: That moves us neatly on. My question is about clinical trials, which you started to talk about. Could you talk to us in a bit more detail about how vaccines are tested for safety and efficacy in these trials, and licensed by the MHRA? You touched on some of your views on strengths and weaknesses, but if you could just set those out for us that would be very helpful.
As a follow-up question, some witnesses have told us that people in certain ethnic-minority groups have concerns about vaccine safety, on the basis that there is not as much evidence for safety and efficacy among these groups. Would you be able to comment on that for us, please?
Professor Sir Andrew Pollard: Yes. First, though, the process of clinical development starts in the laboratory with designing a vaccine. Once there is a design it is tested in animals, usually quite extensively, and the regulators require that animal data to then approve an application to start clinical trials. Those trials are done first in very small numbers of adults, usually tens of individuals, with a specific focus on safety. Obviously, as a developer you also look at the immune response because there is no point in proceeding if there is no immune response to a vaccine, but the main focus of phase 1 trials is on safety.
The next stage, if that all looks good and there is no safety issue in a few tens of people, is to move on to phase 2 trials. Those tend to have larger numbers and in the target population that you are aiming to eventually vaccinate. For example, if it is a vaccine for babies, the target population may be in age de-escalation, so you already have some adult data from phase 1 and then you work down, usually with sizes of studies in the hundreds, before you move into babies to see whether there are any concerning signals in that age group.
Moving on to the phase 3 clinical trials, which are usually in thousands of individuals, they have safety measurements but are also to see that the vaccine actually works. Does it protect individuals?
I have gone blank on the second bit of the question.
Baroness Wyld: The second bit is about certain ethnic-minority groups not having as much confidence in some of the evidence.
Professor Sir Andrew Pollard: You also asked about licensure. The MHRA has three different components that are reviewed for licensure. The animal studies are looked at closely by pre-clinical assessment; then there is a pharmaceutical assessor who looks at the way it has been manufactured and all the testing, to make sure that what is in the vial is what it says it should be and whether it is safe; then there is a review of all the clinical evidence that has been accumulated around the product. That is true for vaccines and drugs just the same.
The ethnic-minority component is an important question. Most of the vaccines that we use in the childhood schedule are used all over the world, across different ethnicities and with different databases and collating data. Certainly, if you were to look at most routine vaccinations, there are enormous databases of both safety and effectiveness across different ethnicities. I think the question is more about when new vaccines are introduced, and that depends a bit on where the development programmes have happened.
For example, in the Covid vaccine trials, one of the things that we decided to do for the Oxford University trial was to run them in the UK, but also in Africa and Latin America to try to get a wide range of ethnicities included, because we obviously have a much smaller proportion of people from ethnic minorities here. Even if you just reflect the national population, the numbers are by definition smaller.
There is a challenge, which is being actively worked on. Some ethnic minorities are less willing to take part in clinical trials, so that needs extra work, which I think is already happening nationally, but particularly by investigators to try to encourage people to take part.
Baroness Wyld: That was so comprehensive that I do not think I have any follow-ups, but perhaps colleagues will.
Professor Sir Andrew Pollard: I will just make one another point, which is that for most vaccines we do not see any differences in protection or immune responses between different ethnicities. We think that there are some differences, depending on where you live in the world, which are probably from environmental factors. Some vaccines actually give better immune responses in Africa than they do in the UK; for other vaccines, it is the other way around, but we do not think that is ethnically driven. It is more about the environment.
Baroness Wyld: I have one quick follow-up, unless I am stealing someone else’s question. Do you want to make a comment on the confidence point—that is, the fact that we have heard from different witnesses that certain groups feel less confidence? Regardless of what the evidence actually is, there is not necessarily that confidence.
Professor Sir Andrew Pollard: It is very rational for all of us to ask questions about our health when we go to have our child vaccinated, or have vaccines ourselves, and to want to understand what it is about. Often that questioning, which I would want to do if I was going to see my GP about something, is entirely appropriate. What we should be doing, as a literate, well-educated population, is to want to understand more. That is often called hesitancy and lack of confidence but, in my mind, it is quite an important part of that engagement with the health system.
When we look at the data about vaccine uptake and try to see where the obstacles are, the vast majority of that, in my view, is about access. It may be access to the immunisation services—we certainly see that, particularly in the more deprived communities—but it is also access to someone to get information from and have those health conversations with. As I say, it looks like lack of confidence, but I think it is just normal health behaviour and it is appropriate. There is an interesting question about how you might change that, which you addressed to some extent with the previous panel, but there is also a question about how you make sure the population, going forwards, is more confident in understanding what is there, so that there does not have to be so much engagement with the NHS around that question. For me, that is an educational question. We should be having school leavers leaving with a good understanding of science, how vaccines are used and their importance in protecting our children in the future. It is the wrong moment for a parent to make a decision when someone is coming at their baby with a needle; they should know before they go that it is the right thing to do.
The Chair: Now we move on to Baroness Nye’s question about the JCVI, which has made an interesting statement over the last few days.
Q161 Baroness Nye: It has, and this question leads on from the last part of Baroness Wyld’s question. It is about the JCVI and how it makes recommendations to the Government on changes to the routine vaccination schedule. We would be interested to know your views on the strengths and weaknesses of that.
The second part of my question is: in making recommendations about changes to the schedule, how does the JCVI take into account any potential impacts on public confidence and uptake? How are those risks to confidence managed?
Professor Sir Andrew Pollard: The process that the JCVI uses for a new vaccine is to look at, first of all, the safety and efficacy data from clinical trials. A full data package is collected from the published literature and the committee’s own analysis around any new vaccine. Usually in sub-committee, we also invite the company to come and present its data, which gives an opportunity to really grill them on things that are not in the public domain. But the main committee does not meet with industry; we do not want it to be influenced by that.
We also need to understand whether there is a need in the UK population. Epidemiological information, the rates of the disease, the burden on the health system and the mortality rate is all collated. The UK Health Security Agency gathers that together. If there is a good case of need and a vaccine available that meets those requirements, the final arbiter is cost effectiveness. That flows from the Treasury’s Green Book. It follows very similar guidelines to those that NICE uses and establishes what threshold of cost for a vaccine would make it cost effective. Obviously, that includes the administration costs as well as the purchase cost. Assuming that, with that analysis, we meet the Treasury’s guidance on cost effectiveness, we would then recommend to the Secretary of State that the vaccine be introduced.
I should say that that is separate from the other role of the JCVI, which is overseeing the whole programme as new data emerges. That data could be about safety. More often it is on efficacy, which might mean that we can withdraw some doses. A great example of that is the human papillomavirus vaccine for cervical cancer, introduced in 2008. We are looking at the data emerging from around the world. We started with three doses for adolescent girls and we now use—eventually, because of the new data emerging—only a single dose, which we give to girls and boys. We reduced the number of doses because we did not need more and there is no point in giving more if you do not need them.
There are other examples. Nearly 15 years ago, we had a number of baby deaths from whooping cough in the age group before they are vaccinated. At that point we introduced vaccination for the mother, because we were able to look at the data emerging and make recommendations about existing vaccines. Again, as long as it is cost effective to add an extra dose.
The last bit of the question is around—
Baroness Nye: The JCVI takes that decision, the Government accept it, and there is therefore a change in the schedule. Do you then get involved in telling the public and the people who are going to have it how it is going to be managed, to make sure they are confident enough? For instance, on the change to the MMRV, do you think enough was done to tell the public why it was being done and the reasons for it?
Professor Sir Andrew Pollard: The communication plan is developed by the UK Health Security Agency with the Department of Health and NHS England rather than the JCVI. Clearly, there is an awareness of the JCVI, and those issues are discussed, but that is not the expertise of the panel. The panel’s expertise is much more in the scientific assessment of the vaccines than that. But I completely accept that that is an absolutely key part of any change.
The Chair: We saw during the pandemic when there were various changes. Change sometimes undermines confidence. It is destabilising. When the programmes change, do you think that has an effect on the way people approach them?
Professor Sir Andrew Pollard: My experience of the childhood programme is that changes, when they happen, are quite difficult for the health service to adapt to, but the public are much more accepting of those changes. Practice nurses are very good at picking up the rationale and reasons for change. The recent big changes in the infant schedule have been driven largely by the withdrawal of one of the vaccines by the company, which meant that we had to rejig the schedule to fit that in, rather than it being a change because of any safety or efficacy issue. I do not think there is such a big problem with the public, because we have very good people on the front line in primary care explaining it to them.
You made a point about Covid, which is a really good point to make, because a lot of what we expect in the way that the debate is considered is much more like the political debate, which might be taken as an ideological standpoint. That is not what we do with science. We look at emerging evidence and change our mind as the evidence changes. That is not a failure; it is the right thing to do. We saw that very clearly in the pandemic. As new evidence emerged on which age groups should be vaccinated, there was a response. That gives me confidence as a scientist, but I can see how the communication of that to the public is something we need to do better.
Q162 Baroness Freeman of Steventon: You have very nicely led into my question about that communication. You mentioned that it is not the JCVI’s job to communicate, but it is the Government’s job to communicate about decisions about the vaccination schedule. Can you comment on how that communication works and how it could be improved, especially when decisions are made by the JCVI—for instance, its decision not to recommend meningococcal B vaccination for teenagers? How can that communication support public confidence?
Professor Sir Andrew Pollard: That is a very good question. One of the things we do not do very well in communication is doing enough of it. When you look at communication over many of the vaccine decisions, there is no government announcement about them; it is something that changes in the system over time. It seems to me that an opportunity to be on the front foot about what we are doing, why we are doing it and the potential health benefits is often missed.
If you were to frame childhood mortality over a few centuries, looking back to the 1700s, nearly half of all children died. Most of those deaths were from infectious diseases. That has changed dramatically. Now, about four in 100,000 children in this country will die in the first five years of life. That is an astonishing impact of public health. Vaccines have been a really important part of that. They are not the whole story—obviously, clean water and so on is also important—but that is a dramatic change that has happened.
With the vaccine story—most of the vaccines we use have been introduced over the last century—we do not have much of a story about the remarkable impact they have had and why, when we introduce a new one, we are also aiming for those enormous impacts.
The most recent maternal vaccine is the RSV vaccine. About 3% of babies will end up in hospital every year—some in intensive care—and we have an intervention that can completely stop that. The enormous impact that vaccination has is just not as well communicated and repeated as it should be. It needs joining-up more. It is great if a politician says something, but perhaps you need to have the right voices that are appropriate for the age group, usually younger adults, that is involved in vaccination. We may listen to media sources that are familiar to people over the age of 50 or 60—depending on the age of people in the room, maybe even higher—but people under 35 are certainly not listening to the same media sources. They also will respond much less favourably to one of us providing that information. We have to do a lot more with the parents of children today about connecting with the right media sources. Obviously, that is changing all the time as the type of media changes.
The Chair: It is a good-news story. The media are not interested in good-news stories.
Professor Sir Andrew Pollard: Yes, although you mentioned the meningococcal group B vaccine, and there was of course a government announcement just last week that that programme will be introduced this year. They say it will be a one-off campaign. When that vaccine was first launched, back in 2015, it was a great example of how things can be done. There was a political announcement and a joint press conference, which I did with the deputy chief medical officer at the time. We had very good communication. Obviously, the media was slightly different then, but it was a very widely read issue, because there had been so many cases of that awful disease that were very familiar to the public. That was disseminated well. But for most vaccine interventions you do not have politicians, scientists and boffins such as me all saying something, and indeed, you do not have parents and young people also speaking about the issues. We are missing some of the opportunity there.
Q163 Baroness Neuberger: You have said most of what I wanted to hear you say. We really need that. Can you take it a bit further? If you were completely in charge of government and absolutely everything, how would you do that?
Professor Sir Andrew Pollard: I think that is unlikely. Are you just talking about the communication part?
Baroness Neuberger: Just the communication. How would you take that forward?
Professor Sir Andrew Pollard: I do not know whether you have seen that there is a new report from the Royal Society on science and society, which nicely outlines where the public get their information about science from. We need to make sure we are properly engaged with that to understand how to communicate to people who are being vaccinated. As I said, the information is not just coming from people like me; it has to come from appropriate groups, whether that is particular communities or age groups, to make sure that it is communicated well.
Baroness Neuberger: We do not seem to hear from young parents.
Professor Sir Andrew Pollard: Or even younger doctors who are paediatricians.
Baroness Neuberger: Who might be parents too.
Professor Sir Andrew Pollard: Yes.
Q164 Baroness Wyld: I want to pick up on MMRV. Since the ‘V’ was added to chickenpox and to the MMR—which is a good thing; I wish my three children had been in time—have you picked up along the way a sense of any concern among parents that these vaccinations are all being given in one? Do you think that the workforce of people who are giving the vaccinations feel confident to be able to explain in terms that lay people like me can understand why it is safe and a good thing?
Professor Sir Andrew Pollard: I do not know the answer to that question. I have not discussed that specific question with practice nurses. But they are very familiar with that question about combination vaccines. I have a vaccine clinic, and I find that most parents who are referred by their GP to see us in the hospital are less concerned about the combination than about the number of needles. The great advantage of combination vaccines is that you use fewer needles. With regard to our immune system’s ability to make an immune response, these are pretty small viruses with a small number of proteins in them. MMRV, which is four different viruses, is much less of a burden on our immune system when it comes to the proteins we are exposed to, compared with if you had a strep sore throat. We are talking about tens of proteins with a vaccine and 4,500 to 5,000 proteins with strep sore throat. Our immune system does not care that it is a small number.
Baroness Wyld: That is quite a simple message to give to parents.
Professor Sir Andrew Pollard: Yes.
Q165 Baroness Neuberger: You have talked about how we communicate and deal with all that. How should we be more effective in communicating how we monitor the safety of vaccines? What we are trying to get at from you is: how do we tell the story differently? What about the yellow card? What about the fact that we have heard witnesses saying that people have lots of questions but they are not quite answered? How can we be more effective in this area?
Professor Sir Andrew Pollard: One of the difficulties is that vaccines are phenomenally safe. So, the “unsafe” question is really hard to answer, because you are talking about something that, if it is there at all, is extremely rare. The regulators always do a benefit/risk calculation. Going back to my point at the beginning, vaccines are given to a healthy population, so safety is absolutely paramount. The benefit/risk has to be calculated, particularly for rarer diseases, such as this awful meningitis, which is a very rare disease—it is dreadful, it kills teenagers and babies but is very rare. For most people being vaccinated, they are clearly protected against that disease, because we do not know whether they might get it. Most people will not, but we cannot take any risks with vaccines for the population. The MHRA, in its licensure, is assessing that benefit/risk, and it has to be near-to-zero risk and very high benefit for vaccines, because of that population.
After licensure, the Yellow Card system—another system used for monitoring—tries to pick up signals and allows the public or doctors to report anything that they think might be related to a vaccine. That is usually something that happens some time after vaccination. Of course, because stuff happens to all of us all the time, there will be lots of signals being picked up, which is not real. The Yellow Card system picks all that up, and then the regulator has to wade through that to see whether there is anything that is more common than you would expect in an unvaccinated population or by chance.
What was interesting in the Covid pandemic was that there were enormous numbers of Yellow Card reports, because stuff happens to us all the time and, of course, everyone had been recently vaccinated, so everything felt like it might have been related to that. If you developed cancer or had your first heart attack, all those things happen normally, but everyone had just been vaccinated. There is then the major question of how you sift through what might be a real signal versus what is just expected anyway.
Baroness Neuberger: Do you think you tell the story of that well enough?
Professor Sir Andrew Pollard: I do not think we tell a very good story about that. One of the other problems in the way that the MHRA collects the data is that it is listed as “adverse event reports”, which suggests that there is causality, just in the title of the document, whereas most of those are not. In those adverse event reports for vaccines given to older adults, you will see that there are lots of deaths. Sadly, we do not all live for ever. Death is a normal part of life, which happens in life after you have been vaccinated, but that does not mean that the deaths are caused by the vaccine. If you have an adverse event report, it is extremely difficult for the public to separate out what is real or not. We do not communicate that well.
Baroness Hodgson of Abinger: I can understand the difficulty of that. But is there also a difficulty in identifying that sometimes it may have caused the death? I wonder whether, in Covid, some deaths were overlooked for this reason.
Professor Sir Andrew Pollard: It is absolutely right that you have got to look very carefully at the safety data in the population. Where you have got historical evidence, for example, before the pandemic, of death rates and what you would expect at different ages, you can quite easily see what is expected. You can also do an analysis where you look within the population at different age groups. For example, in the weeks before the vaccines were given, you can look at the mortality rate versus the weeks after, so you can get an idea even within a relatively small timeframe of whether there is any temporal change in mortality rates. We do not see a signal for those. We know there are very rare events that have occurred, which are picked up exactly because it is possible in the way we have electronic data today to find those very rare events. We talked about the myocarditis—the heart inflammation—and the very rare blood clot issue. It was possible to pick that up because of the remarkable systems that we have now across Europe in the digital records, so you can see signals appear in real time.
Baroness Hodgson of Abinger: What would you call “very rare” as opposed to less rare? It is a communication issue. Trust from the public has been dented by a number of things. In the recent inquiry into the maternity units, for example, there you find in the report issued by Baroness Amos that there was huge cover-up. It does not help with public trust.
Professor Sir Andrew Pollard: That is why it is really important that vaccines are so highly regulated. This safety database is looked at independently by all these agencies. The MHRA does it here, but across Europe, the European Medicines Agency is doing the same process, collecting data from all across Europe. There are huge populations from which we are able to pick up the data.
Coming back to the point, one of the real questions we struggle with regarding the rarest conditions is what the normal rate in the population is. Regulations err on the side of caution in calling things out, even where there is uncertainty.
Baroness Neuberger: I just want to follow up on that, because it is really important about the failure of trust, which is a growing issue. Given that, during Covid, there were these rare but really quite serious adverse incidents, what should we be doing now to reassure the public that the way the regulation of vaccines is done and the way those adverse effects are monitored is pretty safe—as safe as is humanly possible? It is that, is it not? It is about reassuring the public that they can trust.
The Chair: To add to that, before you answer, can you just talk us through what happens when a genuine adverse effect that can be linked to the vaccine is identified?
Professor Sir Andrew Pollard: The first thing is that the signal has to be identified and then verified. There is data on those vaccines being collated in many different countries, because that may of course be needed for rare events, as they may be so rare that you cannot identify them in one country, particularly in many of the countries in Europe that have a much smaller population than ours. There is a process of identifying and trying to validate it around existing data, to see whether there is a signal.
As I say, that may be because of a temporal symptom—because there is a peak in something happening just after vaccination, then it is more clearly associated with vaccination, or if you have background data. That is the first step. Then there can be specific studies. The UK Health Security Agency does a number of studies looking into databases to try and compare safety signals in individuals who have been vaccinated and in those who have not. For example, there were some neurological rare events back in 2009 that were identified in Scandinavian countries with one of the pandemic flu vaccines. There was a study then done asking neurologists in this country to report all cases of a particular condition that was thought to be associated with the pandemic vaccine. Then there was a study done to try and identify it. It is not just relying on the regulator; there are also specific research studies in the NHS to try and identify conditions when they happen.
Baroness Hodgson of Abinger: Who pays for these studies? I think there is a suspicion sometimes. Companies clearly make vast amounts of money out of these vaccines and would probably have to pay vast damages if they were found to have damaged somebody. Are these studies actually truly independent?
Professor Sir Andrew Pollard: The studies done by the MHRA or by the UK Health Security Agency are independent. Pharmaceutical companies, as part of their commitments when they have a licensed product, are also usually asked to provide safety data. Of course, the advantage they have over a local or national government is that they have data accumulating from all over the world. They have to provide that to regulators as well, so that we have those two different sources. But most of these studies, either done by academies or the UK Health Security Agency, are funded through government sources or academic funding.
The Chair: So, they are not done by the pharmaceutical companies at all?
Professor Sir Andrew Pollard: They do studies, but they are not the primary ones we are talking about here, and they are required by the regulator to do some studies themselves and some reports into this system—but they are not the main ones I am talking about.
Q166 Baroness Cass: I think you have just pre-empted the question I was going to ask. How secure is the information from the largest populations like China and India?
Professor Sir Andrew Pollard: That is a very good question. Those very large populations may have very different data. I do not have a good window on Chinese data. Very often, they use their own vaccines rather than the ones we use. In India, they have slightly different reporting rules. They tend not to report safety events for quite as long as we do after vaccination. Again, they are mostly using Indian vaccines rather than western vaccines. Most children in the world are vaccinated using vaccines made in India, not ones made in Europe. Most of the data we have are from Europe, North America, Australia, South Africa, Latin America—countries that are using the same products.
Baroness Neuberger: To pick up on all of that, I am absolutely convinced by the scientific method that you need to validate something. But once you get a cluster of adverse events, and before that has been validated as causation, what then happens? That is when you sometimes get mistrust really growing.
Professor Sir Andrew Pollard: That is a really difficult area. Just to give one example—
Baroness Neuberger: Sorry to ask it.
Professor Sir Andrew Pollard: But is quite right, because the reason why it has to be validated is because it could be a very important signal, so you have got to be sure you are dealing with a signal. One of the problems is that if you have a cluster of cases that is then being reported, then everyone who develops some symptoms thinks they also have that condition, so you get a situation where you start to see lots of apparent events. This happened in Denmark after that cervical cancer vaccine was introduced. There was then a belief that there were lots of cases affecting teenage girls after vaccination, and the whole programme collapsed. There is a whole generation of girls who will now be at risk from cervical cancer. They have now rebuilt confidence there, but it is a real issue. If this happens, you can lose control of the narrative very quickly.
The Chair: When all this has been done and verified, and so on and so forth, is the response sometimes to identify a particular group of patients who should not receive this particular vaccine?
Professor Sir Andrew Pollard: It might be that, if there is a particular risk group. One good example of that, which you may not know anything about, is the chikungunya vaccine.
The Chair: You are right, I have never heard of it.
Professor Sir Andrew Pollard: Chikungunya is a disease you acquire from insects when travelling in some parts of the world. Sadly, it is also now transmitting in parts of southern Europe, so it may come here one day. The first vaccine licensed does appear in some older individuals and those with compromised immune systems to have some safety concerns around it, probably because it is a live viral vaccine and, if your immune system is not working properly, it may cause harm, but it does not seem to be harmful in healthy individuals. That was a signal that was picked up—it was only licensed a couple of years ago—so there are restrictions on the age groups who are vaccinated. That is just one example, as signals are picked up, of there being a response.
The Chair: Thank you. It is useful to know that that sort of thing sometimes happens and how it is responded to. Baroness Ritchie, I think your question is next.
Baroness Ritchie of Downpatrick: Is mine the last?
The Chair: There is one more after this. Yours is number 5.
Q167 Baroness Ritchie of Downpatrick: This question leads into all the things that you have already been referring to. How is vaccine technology likely to develop in the coming years? What work therefore will be done with the pharma companies in that respect? How could the childhood vaccination schedule change as a result? Will it be improved? Will accessibility be improved, or will the levels of take-up be improved?
Professor Sir Andrew Pollard: From a technological point of view, there was a real acceleration in the pandemic in some of the new technologies—things like the RNA vaccines that we used. They are an astonishing advance. Perhaps the most important thing with RNA is going to be the ability to respond rapidly to pandemics and outbreaks, because you can manufacture millions of doses in such a short period of time, which we cannot do with most old-fashioned technologies. I say old-fashioned; many of them are not that old-fashioned, but newer technologies have a huge advantage for speed.
I do not think much of that will have a huge—at least foreseeable—impact on the childhood programme. What we would most like for the childhood programme is to have fewer needles; it is the hardest bit for vaccination clinics. There is some work to try out devices that do not have needles—that might be a different way of administering vaccines. But there are real challenges, because you have to then disrupt a system which is working very well. It is always very hard to come in and develop a new product because, although you might have the same vaccine, it becomes a whole development programme for each of those vaccines if you have a new device that delivers it.
The other thing I think is really positive to say about childhood vaccination is that, in this country today, we vaccinate against almost all of the diseases that regularly kill children or bring them into hospital. Hilary is a paediatrician; she will know. Just going back through my career, what you see on the wards has transformed.
Baroness Cass: Totally.
Professor Sir Andrew Pollard: We do see children with infections all the time. But apart from this virus RSV, which has been the last big one, there is not any particular virus or bacterial infection that comes through the door in huge numbers because of the amazing programme we have, and it has just transformed what we do. Even going back to the early 1990s, when I started, there are lots of diseases I just do not see any more on the wards.
How are we going to change? There are a few bits that will change around the edges, and some additional things that we can prevent. But largely it is about, “How can we work out better ways of generating longer immunity with each dose, so that we do not have to have so many doses to protect children?”, and that deals with the needle burden. But we are not close to that at the moment.
Baroness Ritchie of Downpatrick: As a follow-up, what challenges therefore will there be in sustaining trust in vaccination as vaccine technology and the routine vaccination schedule evolve? How should those challenges, if they arise, be addressed?
Professor Sir Andrew Pollard: The main challenge as the schedule evolves with technology is probably a positive one: that if we have fewer needles and longer-term immunity generated by a dose of vaccines—if we could ever get there—that will bring a lot more confidence to the programme. It is really hard for parents to go back to face the needle again with their toddlers and then their pre-school children. That is really tough. It is much easier if we can get away with fewer doses. But we are not there yet to maintain the levels of protection we have; we cannot change that.
Baroness Ritchie of Downpatrick: What levels of preparation are currently being undertaken to prepare for the future and for changes in the potential vaccination programme?
Professor Sir Andrew Pollard: With the current programme, we have just been through a big change, which started at the beginning of this year. That was well prepared and it is now embedded in the system. I do not think we are envisaging major changes in the near future. We have to work on this issue of communication, building confidence in immunisation as we have it at the moment, rather than anticipating major changes at the moment.
Q168 Baroness Cass: You are right, Andrew; I remember the bad old days of wards with, particularly, ex-prems with whooping cough and being up all night with kids with meningitis. Anyway, you heard I was pretty mean with the last witnesses about giving me their top two recommendations to the Government to help us move this forward. Obviously, they were focused on delivery and a lot of what you have spoken to us about today is probably about trust, but what are your top two wishes for how we might improve trust, if that is probably the best thing to focus on?
Professor Sir Andrew Pollard: Can I say “uptake”, before we get to trust?
Baroness Cass: You can. Because there is only one of you, you can say as much as you like.
Professor Sir Andrew Pollard: For me, the key is uptake. We know the MMR figures, which I am absolutely terrified by. When you look at the data, there are some leafy parts of the country which have very good uptake. But in a way that makes it worse, because the headline figures of coverage for these vaccines hide the fact that there are pockets of abysmally low—and dangerously low—uptake, which is why we have had measles transmission.
When you look at all of the evidence, whether it is in the UK or elsewhere in Europe, or in even in low and middle-income countries, access is the number one issue. You cannot understand access centrally; you have to look at what is happening in the community. I will try to put some story around that. You are in community that has very large family sizes; there are a number of communities like that. Your GP surgery is two bus rides away, you are the mother—your husband is not taking part—and you have got five children. The new baby comes along. That baby will not get vaccinated. It is really difficult to do that. Then there are some communities where there is a lot of misinformation about vaccination, and that needs addressing in that community. You cannot do that centrally; you have got to understand the local community.
I certainly agree with Clare Gerada’s points that this should be community-led. We need the support to be perhaps an ICB or at a local level, but you need to have the GP surgery in that community to be empowered to raise what the issues are that need solving there locally. They will be different all over the country. It is very clear that it is related to inequality, but that is a bit of a get-out clause for a series of lots of different inequalities; it is not just a single one.
Baroness Cass: But again, the standard of primary care is very different around the country. The standard in Clare’s practice is probably very different from many others. There is significant disadvantage in access to good-quality primary care.
Professor Sir Andrew Pollard: Absolutely, and some of the systems that were there in the past, like the health visitors, were extremely good at mopping up the children who had not turned up to the GP surgery. But it needs to be properly resourced for that to happen. Understanding the local community is the key. Some of it is trust, because there are questions, in some communities, even of, “I am not going because I haven’t got enough money to pay for it”. If we have not dealt with that issue in the community, then no one is going to get vaccinated.
Baroness Cass: That is what I was doing as a community medical officer—running around trying to catch these kids. Are there any other recommendations that you would have then?
Professor Sir Andrew Pollard: That is the key one, around access. For me, the confidence is about, yes, there being lots of communication that we need to do. We need to do better in social media and in parent groups and so on. But this is about schools. We have got to have a vaccine-literate population leaving school that understands where vaccines play such an important part in the life of our society.
The Chair: Before we finish this session, we have three follow-ups from Baroness Hodgson, Baroness Neuberger and Baroness Freeman.
Q169 Baroness Hodgson of Abinger: Picking up on your point about how some primary care is very good and some is not, how important is the doctor-patient relationship, with the doctor knowing the patient and the patient knowing the doctor or health visitor, in all this?
Professor Sir Andrew Pollard: It probably helped in the way the system worked in the past. Having that close relationship helps with confidence and trust. Even today, the surveys that the UK Health Security Agency has done suggest that the most trusted person in immunisation is the GP. Most of the delivery and conversations happen with the practice nurse, not the GP, but the GP is the most trusted person. That suggests that it is an important relationship.
The question is whether we can get back to that world. I am not sure we can. We have an enormous population of older adults now and a lot more demand on GP services. It is important to project forwards what that looks like over the decades ahead. We have about 9 million people over 65 at the moment. That is set to more than double during this century. The NHS is not coping at the moment with the number of people we have. Most of the morbidity is in that age group. If you double that number, we need services that can cope with that. I cannot see that we will go back to that system where we will have GPs who know everyone in the way they used to.
Baroness Hodgson of Abinger: But on the other hand, they could deal with a patient much more quickly in a two-minute conversation on the phone if they know them, because they will not have to go through all the history.
Professor Sir Andrew Pollard: I agree; it would be great to be back in that world. I am a hospital doctor, so I should not really speak for primary care, but that is my assessment. Others may have a different view.
Q170 Baroness Neuberger: I rather agree. That is why I said to Clare in the previous session, “Let us assume that it will not go back to that system in the next 10 years”. I just cannot see the investment, given the change in population and population growth. That being the case, you mentioned schools, which I was going to raise. You want children leaving school vaccine-literate. What role can schools play? Most schools do not even monitor whether the kids are vaccinated or not, which I find quite extraordinary.
Professor Sir Andrew Pollard: I am sure that more could be done around that in schools. But there is lots of opportunity in primary and secondary school for interventions in the communication around the fact that they are being vaccinated in school, whether it is the flu vaccination in primary school or the various vaccines, including some of the meningitis vaccines, that are given in secondary school. When I go into schools, people—teenagers—are so interested in this topic. The science of vaccines and how the immune system works is fascinating.
Baroness Cass: You can teach so much on the back of teaching about vaccines; it is not a soft option. There is a lot of science. It is a PhD in itself, scaled down to a much younger person.
Professor Sir Andrew Pollard: Coming back to the questions you asked earlier, it is also about understanding benefit/risk ratios. I would love to be in a situation like we are with driving. We all wear seatbelts in our cars, I hope. Many of you will remember that when seatbelts came in there were a lot of people who were opposed to that idea. Now, when I get into my car, if someone does not put their seatbelt on, I do not drive off until they have. I would not even dream of doing it. In fact, the car will then beep at me to tell me that they do not have their seatbelt on. We need to be in a situation where we all feel that everyone should be vaccinated, because those diseases and microbes are out there threatening us all, today, if we do not maintain vaccination to keep them away. Every time vaccination drops anywhere in the world, these diseases come back, and they are devastating for our children.
The Chair: Perhaps we need a tobacco moment for vaccinations.
Q171 Baroness Freeman of Steventon: That perfectly feeds into my question, which is about those cost/benefit analyses, which is something that JCVI specialises in. You mentioned the costs and resources required for somebody with a family to get their youngest child to vaccination. On the other side, you have the costs and resources involved if somebody’s child is sick and people need to take time off work, and the effects on productivity. Can you talk about how you think we have that balance when you are making decisions in the JCVI? What gets taken into account and what does not? How could it be improved?
Professor Sir Andrew Pollard: That is a very good question. The way that cost effectiveness is done is that it looks only from the healthcare provider—so the NHS—perspective. It does not look at societal costs, so productivity and so on are not included in cost effectiveness.
Clearly, this is very important for the country. Chickenpox is a great example of that. We know that most children with chickenpox will be unwell for about five days, so parents take roughly that amount of time off work, on average. When you think that every child gets chickenpox, that is an enormous productivity loss—but that is not included in the calculation for the cost effectiveness of the vaccine. This is for the simple reason that, for most diseases, we just would not have the data to include those in the calculation, because there are so many different aspects on society that you would have to calculate for those. It is made a little bit simpler by only looking at it from the NHS perspective in calculating cost effectiveness, and that is following the Treasury Green Book’s rules.
Baroness Freeman of Steventon: Equally, it is not communicated in the communications around vaccines, that as a parent, if your child gets measles, you can expect this amount of time with them off school.
Professor Sir Andrew Pollard: Yes, that is right. It is about the child’s illness, and the cost for the GP and the health system of that illness is calculated.
Q172 Baroness Andrews: Professor Pollard, you were so heavily involved in Covid. In looking for recommendations, what is the most important lesson we might learn from what you learned in getting that whole programme up and delivered so brilliantly? Is there anything we can borrow? We have heard about the sense of urgency from other witnesses this afternoon.
Professor Sir Andrew Pollard: The communication bit is important. I was not involved in communicating for the JCVI or the Government, because I was involved in development, so I stepped away from that. But when you compare with other countries, we actually did quite well. Obviously, many issues have arisen as a result, and there was lots of misinformation, but the communication was actually pretty good, not least given that you are always dealing with uncertainty very early on. You do not know enough about the disease itself, let alone the development of the vaccine. Trying to make sure there was regular communication from Government actually worked quite well around the approach to managing the health crisis.
As a developer, because that was really my role then, the thing I found the most frightening was that every week, globally, about 10,000 people were dying. Anything that happened in the system that slowed down development meant another week had gone and another 10,000 were dead. For me, having the protocols and systems in place in the future that mean we can get to the point of having treatments and vaccines sooner is something we need to get right. I do not think we have still got to that point yet, but there is some advancement being made. That would be the bit I would pick up on, because it was just so devastating to be looking at that during that time.
Baroness Andrews: Do we need to invent anything or put anything new in place to make that happen? On mutation of viruses, for example, are we working hard on that sort of thing at the moment?
Professor Sir Andrew Pollard: There is quite a lot of work going on at the moment on some of the systems for how the regulators work and on how protocols are developed in advance. Some of that is happening.
There is also a lot of science that needs to happen. If it is another coronavirus, then we know what to do. But if it is one of the many other viruses out there, particularly an animal’s that jumps to humans, then for most of them we do not know what to do. Part of it is an investment in some of the science that underpins the decisions on how to make a vaccine.
The Chair: Thank you very much indeed. Professor Pollard, you have been very informative. We thank you very much indeed for taking all these very challenging questions. That closes this oral evidence session.
