Childhood Vaccinations Committee

Monday 22nd June 2026

(began 3 months, 1 week ago)

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14:14
14:14
None Portrait Speaker 2
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Yes. So first of all, thank you for having the opportunity to participate in this in this session. Um, my name is Roberta Pastore. I'm a medical doctor by training and I work in the Who in the World Health Organization Regional Office for Europe. And I work in the immunization unit as a team lead for immunization program strengthening. So to reply to your question, um, I will refer mostly to the trends in the European region, uh, which are more familiar with, but the trends are similar globally.

Um, so we take as a, as a starting point to monitor the trends. The 2019 year, because it's the year before the Covid pandemic that brought a lot of disruption in immunization programs worldwide. And in most of the countries, uh, there was a evidence of a backsliding in immunization coverage for several, vaccines. And, um, in the European region, we can see that the recovery from this backsliding that was observed in 2020, 2021, um, has really not happened homogeneously across the countries in the region.

And, uh. As a whole, it includes 53 countries and we have registered a recovery in mostly a third, a full recovery, mostly a third of the countries. If we take only the high income countries, we can see a similar trends to the middle income countries, but less acute. I will focus on the high income countries now because they are more comparable to to England and probably, uh, more interesting, uh, for the scope of, of this session. Um, so I'll just consult some, some data.

So, uh, overall, if we compare the coverage level in 2019 with the coverage level in 2024, uh, we can see that 22 countries, uh, over 36 high income countries in the region, uh, had a decline in coverage. And if we compare, uh, just the most recent trend between 2023 and 2024, we can see that there was a slight, uh, further decline in 15 of these 36 high income countries. And this is, uh, using as a tracer, let's say, of vaccination coverage, the coverage for diphtheria, tetanus, and pertussis containing vaccine, the third dose, which is used globally as a tracer of vaccination.

Uh, but this trend is actually not, uh, the same. If we look at vaccines such as HPV. So the vaccine against, uh, um, human papillomavirus, um, for this type of vaccine that is usually administered during adolescence. So we actually see, a different trend with a number of countries registered an increase in vaccination. And this is because probably the starting point for the coverage of this vaccine was much lower than for traditional childhood vaccines. Maybe I'll stop here, but please let me know if you want more details.
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None Portrait Speaker 1
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Uh, actually, checking the vaccination records at the school, at the entry school, the school entry, sorry, uh, is, is a recommendation from W.H.O., especially when it comes to, for example, control of strategies to, to achieve measles elimination. That is one of the recommended strategies because it has, it is actually a very effective strategy, uh, for, um, understanding who has not been vaccinated and have an opportunity for catching up vaccination and, um, in majority of countries, uh, in, in the European region, do, um, checks of vaccination records, uh, at the school entry in kindergarten or in school or both.

So this is a very common practice. What changes is whether, um, the vaccine records are only checked. And then if vaccination is missing, uh, parents will say are referred to vaccination services or if vaccination can be, uh, directly provided from health school services. So that is something that makes a difference in terms of, uh, how much of the immunization gap can be filled through this strategy. So nudging parents in general is a, is a strategy that proved to be useful. But the impact of this strategy is also linked to then how easy it is to get access to vaccination.

And so there are studies conducted, uh, on, um, how to best leverage, um, the, the check of vaccination records in the schools for sure in the kindergartens also, but also in any contact that parents might have for children with the health sector. So there are guidelines, for example, on the so-called missed opportunities, uh, when vaccination records could be checked if a child is in contact with a, with a health system or sectors that, um, care about the, um, the well-being of the child overall.
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None Portrait Speaker 1
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What we suggest to all countries is actually to um to follow. We have um, published, uh, some guidelines on how to investigate and address inequities in immunization and inequities. Doesn't mean that is a, an intentional inequity. It's just as some people might not be vaccinated. And what we recommend is actually to use a structure, uh, phased approach, uh, to allow, first of all, to identify if there are immunity gaps and have an understanding from the available data and available information on where the immunity gaps may be and who might be affected by them.

And then based on that, have some targeted investigation to understand the underlying, um, reasons for not being vaccinated because they can be very context specific and very population specific. And based on that, uh, really tailored, um, strategies that are informed by evidences and not by general opinion that really try to understand what can work in every context, based on, on the available evidences. And then, uh, implement, um, an assessment and evaluation of the, the strategies to understand if they worked or not and if they worked, understand if they can be expanded maybe to other contexts or further strengthened.

And if they didn't understand why they didn't. Uh, so this is a structured approach that can really help in, uh, devising. Uh, strategies that are locally relevant and can be, uh, locally impactful. Uh, this of course requires resources. So, uh, resources to have this type of tailored intervention should be allocated in terms of human resources and financial resources. But this is what we suggest, uh, and recommend to all the countries to, to follow a structured approach that can really, um, have a, be based on an understanding of the real reasons for undervaccination in specific populations or specific locations.
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None Portrait Speaker 3
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Doctor Pastore. Thank you very much indeed. You've given us a lot of information today based on your international experience. We're very grateful. And as you mentioned, there are a number of things that you're going to refer us to. And our Secretariat team will will follow those up. I'm very grateful to you. That is now the end of the session. Back to today's meeting. This is the 16th oral evidence session as part of the committee's inquiry into childhood vaccination rates in England.

Thank you very much to Professor Wei Shen Lim and Professor Shareen Doak for attending today to give us evidence. The session is open to the public and its broadcast live and will subsequently be accessible via the parliamentary website. A verbatim transcript will be taken of the evidence and it will be published on the parliamentary website. In order to get it absolutely correct. A few days after this session, our witnesses will be sent a copy of the transcript to check for accuracy, and it would be very helpful if you could both advise us of any corrections as quickly as possible after today.

If after this evidence session, you'd wish to clarify or amplify any points you make during your evidence or have any additional points that you would like to send us, you're very welcome to submit supplementary written evidence after today's session, so I'm going to ask the first question, which is this how safe and effective are the vaccines in the routine childhood vaccination schedule in England?What is the evidence on links between routine childhood vaccinations and any adverse events?How does the safety of routine childhood vaccinations compare to other medicines and other vaccines, and actually to people who have not been vaccinated?Shall we go to you, Professor Doak, first?
15:15
None Portrait Speaker 5
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Thank you very much. And thank you, chair and and members of the committee for the opportunity to provide evidence today. Um, so my name is Shireen Doak and I am a deputy director in Benefit Risk Evaluation, which sits within the safety and surveillance function of the MHRA, which is the Medicines and Healthcare Products Regulatory Agency. Um, just by way of background to the MHRA, we are responsible for ensuring that all vaccines used in the UK meet robust standards of safety, quality and effectiveness, and that includes vaccines, um, that form part of the routine childhood immunisation schedule.

Um, we regulate vaccines across the whole life cycle. And that goes from providing pre-clinical scientific advice during development phases of vaccines through to providing regulatory approval to clinical trials for new vaccines in the UK. Um, we also undertake rigorous assessment of safety, quality and effectiveness for vaccines as part of that licensing process. Um, prior to those licensed products actually reaching market. We will also test vaccine batches, um, independent of the manufacturer to ensure that they meet, um, the quality that's necessary.

And then finally, we will provide, um, continuous safety monitoring of vaccines even once they're in use through schemes such as a yellow card reporting. So to your question about how safe and effective vaccines are, um, I would say routine childhood vaccines that are used within our immunisation schedule are absolutely safe and effective. All vaccines in the UK must meet very strict standards that are set by the MHRA. Um, to give you a flavour of that, there are several vaccines um that offer protection against a range of infectious diseases with about 11 brands available.

These have been used globally for many years, ranging between 5 to 26 years depending upon the brand, with millions to to hundreds of millions of doses given, which means that they do have very strong and well established safety records in place. Um, we could comfortably say that the childhood vaccines are among the most extensively studied and closely monitored medical products that are used in children, and they do remain the most effective way in terms of protecting children from, from serious and potentially life threatening illnesses. And our role is very much central, um, in terms of ensuring that the vaccines are safe and effective, as well as assuring, um, their high standards, um, with all medicines, vaccines can cause some side effects, but, but most of those side effects are mild and short lived.

So for example, um, pain or redness at the site of injection and fever, elevated temperature and some body aches. But it's, that's to be expected as well because vaccines work by introducing a safe or a weakened part of a virus or a bacterium, which can't cause the disease itself, but helps the immune system to learn how to recognize and fight. Um, those infectious agents. And then as the body builds that protection, that's when people may experience some of those mild side effects, which should usually go away within a few days.

Um, they are normal signs that the immune system system is responding as it should do. Um, serious side effects can occur, but they are rare. And we continuously monitor for them. And the risks are very well characterised by ourselves at the MHRA. And we include that in information that's given to um both healthcare professionals as well as patients and caregivers. Um and we very carefully take those risks into account as we're continuously assessing the overall benefit versus risk of, of vaccination.

Um, what I would say is, is that childhood vaccines are probably among the most closely monitored medical products in use because ultimately they are administered to, to healthy children and therefore, the regulatory standards that we have in place for safety are, are particularly high. But nonetheless, for those vaccines that are in use, um, currently within the childhood programme, we have extensive safety records extending over over several decades. And as I've mentioned. Of, of, of administered doses worldwide. So we are really quite clear that the overall benefit of, of the routine childhood vaccination outweighs the, the known or potential risks, um, of, of um side effects for the vast majority of, of children.
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None Portrait Speaker 6
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Thank you very much. Um, first of all, just to say that, um, my name is Michelle Lim. I am a consultant chest physician in Nottingham. Uh, and my other role is as chair of Jcvi, the Joint Committee on Vaccination and Immunisation. As regards your question on safety and efficacy, I guess I want to just start by saying that healthy people in general do not take medicines. However, healthy people do take or receive vaccines in order to remain healthy.

And that means that any, uh, criteria or threshold of safety that's applied to medicines and vaccines would be very stringently applied to vaccines, in particular, because it is given to healthy people to keep them healthy. And so the public and clinician tolerance of safety is such that we would expect the highest standards applied by MHRA and every other regulator. I think that's the baseline starting point. Um, the other bits that may be helpful in framing the question of vaccine safety is how we use the word safety.

Uh, often, uh, we put safety together with tolerability and report them as one. And what I mean is something that doc mentioned just now, uh, when somebody is jabbed with a needle into the skin, you would expect some pain. And both the administrator and the person receiving the needle jab would expect some pain. And that is a natural response. Vaccines create natural responses like pain and swelling. And although we describe those as safety, uh, indicators, actually they are natural responses.

They are not necessarily unsafe. And most people would not say having a bit of pain when they have a needle jab meant that the vaccine was unsafe. That compares to other adverse events or reactions, which may indeed represent a safety signal. So something untoward, unexpected that is not a natural response. An example might be during the Covid pandemic, uh, we had a report of very unusual or very rare occurrences of myocarditis that is inflammation of the heart muscle, because potentially of the vaccine.

That would be considered a true safety signal. And in that situation, whether something is acceptably safe or not is read in the context of the disease, as has been just mentioned. So a comparison, for instance, for Covid 19 was made and the incidence of this rare complication as a result of the disease itself. Uh, sa Covid 19 infection was about four times higher than the effect if you had the vaccine. So even though there was a safety signal identified related to the vaccine, the same problem was arising because of the disease at a higher rate.

And so one would say that therefore, the benefit and risk in that situation was such that one might describe the vaccine as acceptably safe in the context of how it's being used. Uh, and I think those are important in terms of thinking about tolerability and safety. And then you mention, um, efficacy, uh, just, uh, not too long ago, I think two years ago, uh, W.H.O. celebrated 50 years of the expanded, uh, immunization program. And to celebrate the 50 years of childhood vaccines being, uh, supplied to the global world.

Uh, an estimate was done regarding how many lives were saved. And the estimate was that of all the improvements in childhood mortality over 50 years, 40% of that improvement was down to vaccinations. Uh, the estimate in terms of numbers was 150 million. Children's lives were probably saved. Each life saved represented, I think, 66 healthy life years. And therefore in total, 50 years of childhood immunization across the world saved over 10 billion healthy life years. That is the efficacy of these childhood vaccines across the world.

And they are the same vaccines that we use in the UK and many other countries have been proven time and time again, not just to be safe and tolerable and acceptable, but also to be highly efficacious in saving millions of of children. And I think that also needs to be put in context.
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None Portrait Speaker 6
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Decide if a vaccine should be implemented in the UK, for instance, there are broadly three categories that we need to consider. The first is the burden of the disease and in particular the age spectrum if it's relevant. The second is the vaccine product itself. How tolerable, safe and effective the vaccine or efficacious the vaccine might be. And, um, the third, which is very important part of what Jcvi does is the cost effectiveness of the vaccine for the UK or for England.

Uh, so, um, if we think about, um, say the meningitis B vaccine, because that's in the news quite a lot, uh, the meningitis B vaccine was introduced into the UK childhood schedule in 2015. And that was given, uh, or offered at eight and 16 weeks with a booster later on in life. And the reason for choosing eight and 16 weeks. Uh, well, one of the reasons is because meningitis B affects children where there's a peak in incidence. So we want to give the vaccine before the peak incidence of disease occurs.

There would be less point in giving the vaccine later on in life if that's after the peak of maximum incidence. So that's one of the reasons, how a vaccine age is determined is when is the peak of infection, and can we prevent the most number of cases, because that would also help with the cost effectiveness. You prevent the most number of cases. Now obviously, if we want to give a vaccine at a certain time to prevent disease happening later on, we need to know that it works.

If given to younger infants and at what dose schedule. So in the case of the meningitis B vaccine, um, although the initial trials were using three doses, there were also other trials that showed two doses to start with were good enough with an eight week gap between them. Hence we started with eight weeks, followed by 16 weeks for the second dose. Uh, the reason for bringing up the meningitis B vaccine infant programme is because there has been a later development, as you know, in that we've moved the second dose from 16 weeks down to 12 weeks.

And the reason for that move, um, is because having introduced the meningitis B programme, it was found that the peak of incidence of meningitis B disease in infants had moved from 5 to 6 months down to 1 to 3 months. So because of the vaccine programme, the peak incidence of disease had moved and therefore there was a desire to introduce the second dose before that peak. So rather than waiting to 16 weeks, bring the second dose to 12 weeks in order to capture the now new peak of disease in infants, in order to help with the scientific decision for that move, a clinical trial was performed in the UK, specifically testing what happens if we move the second dose earlier by reducing the dose interval between the two doses, we lose uh vaccine efficacy because, as some of you may remember, there are some data to suggest that if you have a wider dose interval, uh, one might get a better immune response.

So the question was, can we lower or reduce the dose interval and still get a good immune response?The second question was, if we move that second dose, will we have more adverse or tolerability problems?And then the third question is if we move the dose interval, we might also want at the same time to move the pneumococcal vaccine, which is being given at eight weeks, up to 16 weeks. So a little jiggling around of the programme to avoid too many needles at any one point, because giving too many needles to any person, any one point, uh, reduces the acceptability of the programme.

So we want to reduce the needle jabs at any visit. Uh, the, the trial was conducted in the UK, and the trial showed that it was not only safe, but, uh, useful to move the dose down from a second dose from 1816 to 8 weeks. Um, and actually there was greater acceptability in terms of tolerance. And so that was a bonus. And there was no degradation in the immune response. So you'll find now that the meningitis B programme has indeed changed since it was first introduced and changed because of good surveillance.

That tells us when the peak of disease is and good clinical trial scientific data to tell us that we can do this safely and on good scientific grounds. Um, so I think those are just some of the examples of how one decides on a vaccine programme and how that then impacts on the schedule. This is all of these things put together really.
15:32
None Portrait Speaker 3
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Thank you for that example of Post-introduction monitoring and response. That was very helpful. Baroness Hodgson, thank you both very much. Um, I'm really interested in what what you've had to say. Um it's no doubt that vaccinations overall are of great benefit. I've got kind of three bits to my question. The first one is how do you test batches for safety monitoring. Um the second one is around the childhood vaccines, 23 doses by 18 months.

Seems to me a very heavy load. And I think when people talk about benefit versus risk, that always worries me because when you're the 1 in 1,000,000 that the risk goes wrong. You know, it's very, very devastating. And I notice Professor Duke emphasized that they're given to healthy children. So when would you consider a child not healthy and not suitable for the vaccine?Are they screened for that?How does that happen?And the third bit of my question is, you know, there's obviously, um, a trust element to this.

And when I hear Professor Lim talk about the Covid vaccines, that does concern me. I mean, the heart inflammation, I haven't got the right medical words. I'm not medical. I don't remember hearing about that at the time when people were being vaccinated. And I mean, I think people need to know the risk and, you know, might not have chosen to have the vaccine and get this, uh, infection. I understand what you're saying about it's much worse if you'd had the actual Covid, but people might decide to completely isolate themselves and avoid the vaccine.

And it's just the whole thing about information, how much information is out there. And if things went terribly wrong, would you ever tell us or would it all be squirreled away?Who would like to go first on that very challenging question?
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None Portrait Speaker 5
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I'm, I'm happy to to jump in first, because there's probably quite a number of areas that that fall to the MHRA there as well. And, um, I'm, I'll work through those questions one at a time. Hopefully I capture them all. Um, just in terms of the first part of the question about the batch testing. So, um, all licensed vaccines are subject to, to independent control testing before they can be used in patients. This is a legal requirement. Um, and it does apply to, to every vaccine batch that's used in the UK childhood immunisation programme.

So, so we at the MHRA have got a statutory responsibility for testing and quality assurance. And that's delivered by our control testing team, which sits within the um biological laboratories at the MHRA. Um so what happens there is that we perform independent quality and safety checks on every batch of vaccine. And that's separate from the manufacturers. And this is really a piece of work that is critical in terms of maintaining trust, because it's that independent, um, evaluation of, of those vaccines before they go into use.

And the process includes review of, of the manufacturer's data as well as targeted laboratory testing of key parameters such as the vaccine's potency, how well they work, um, their identity and the, and their purity and, and this whole testing programme operates under really robust, um, assurance frameworks. So. That's the first part of the question that the second part in terms of the benefit risk evaluation, um, this is something that we, we do on a daily basis for, for every medicine, um, but maybe it would be helpful if I just explain what's involved in that, because it might help to, to set the scene a little bit.

Um, much of that benefit risk evaluation happens both before licensing as well as afterwards. So before licensing, we will collect a whole range of data. It will be data from um non-clinical studies that are conducted in laboratories. The data that's generated through the clinical trials. And we will very carefully look at all of that information in order to understand all safety aspects, um, that are known at that particular point in time, as well as, um, how well that medication or the vaccine is working.

So, you know, ensuring that it provides the protective effects that, that it should, um, the clinical trials are designed that they are quite broad, they'll involved thousands up to tens of thousands of patients to help us to understand how different individuals will respond as well. Um, once a vaccine is authorised, it doesn't stop there in terms of measuring that benefit risk because we have ongoing safety monitoring where we are continuously gathering information from a wide range of sources, including yellow card reports, to understand if there are any, um, issues that we maybe need to, to, to take into consideration and to evaluate.

And we'll draw data from a wide range of sources. So yellow card reports I've mentioned, but we'll have access to clinical databases. Um, data from our partners in both the NHS and the UK Health Security Agency as well as um international information through contacts with other regulators as well. And so what we'll do is we'll gather all of that information. Um, and we need to, to, to sift through it then because we have to distinguish between, um, real signals from, from background noise, if you like, because many health events would happen in the population anyway.

And so we have very experienced scientific and clinical assessors that will undertake robust statistical analyses and evaluate the strengths and the patterns of the associations between, um, the vaccination and any health effects that that may be seen, um, to work out whether or not it's a real effect or if it is background noise. Um, within that. That because of the breadth of data we're collating and collecting, we will have information on individuals with wide ranging, um, health backgrounds as well as demographic backgrounds as well. Um, and that's all taken into consideration when we're weighing up that, that benefit risk evaluation as, as we call it, um, if we do identify any issues that we need to raise awareness about, we are very, very proactive about that.

It's, we have to be transparent with understanding with, with providing an understanding of exactly what we understand and know and, and those things that we maybe need to gather more information on as well. So we will issue communications when we identify, um, any new things that we need to inform people about through a wide range of different sources. And the idea is that we target both healthcare professionals as well as parents and the carers and patients themselves, so that they are able to make informed decisions about the vaccines available.

And those communications will take, um, a number of different forms so that we will reach as wide a net workers as possible. And that might be through, um, updates, updated product information, press releases. We'll also use partners to amplify our messaging as well as social media. So, so we do have very robust monitoring systems in place that allow us to identify meaningful, um, safety signals despite high and quite noisy data volumes that we, we do receive in order to inform, um, our regulatory approach.

Um, I'm hoping I've answered most of your questions there.
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None Portrait Speaker 5
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Essentially, within the clinical trials phase in particular, um, they are. Healthy children that would be included within that. And, and the clinical trials that are approved by the MHRA are done. So under stringent conditions as well to ensure that patients um. Are, are well protected through that programme of work too. There will be some cases where specific groups, for example, are not advised to receive a particular vaccine. And that's also something that we would look at very carefully.

And often it is identified during those clinical trials phases. And it's reflected very early on in the the licence and the product information to where that might be the case. And, and perhaps one example might be, um, for individuals that have got, for example, a suppressed immune system because of a pre-existing condition that they may have, it might be that they are, um, suggested as, as, as shouldn't receive a vaccine. Um. Typically it's a clinical trials phase that we would identify that occasionally something may be observed through wider rollout, through our post-market surveillance.

And in those cases we would identify a signal rapidly through that process of post-market surveillance that I've just described by reviewing the data from multiple sources. And should we see anything where we need to, to update the information or provide additional guidance in terms of, um, whether or not individual groups should or should not be advised to receive a vaccine. We can we can provide that information, um, quite rapidly as needed through our updated communications.
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None Portrait Speaker 3
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Professor Lim.
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None Portrait Speaker 7
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Uh.
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None Portrait Speaker 6
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Um, now, in terms of how frequently we review cost effectiveness, um, wanting to one, one thing to state, um, is that the cost effectiveness models at the start of any immunisation programme are fairly rigorous. They take months to put together and they're not done on the back of one spreadsheet. Uh, they take into account, uh, vaccine uptake or coverage, and they are usually modelled based on either observed data. If there are such observed data or expected estimates, and there will be a range of different sensitivity analyses, as it's called, it's a cover different estimates, uh, assumptions.

So those are all integral to the models at the start. We often have two models which are independent by two academic groups. These are non-industry funded academic groups. Um industry may themselves. Shall I say commission models. Um and those may be published independently, but they are not part of the Jcvi process for evaluation. How frequently these models are updated, whether it depends on the vaccine programme and whether the product changes in costs and so on.

So there are a number of features that would, uh, warrant a change or an update in the model. Uh, as an example, the flu vaccination programme. Um, I can't remember when the first model was done, but we're really looking at the model again, uh, later this year. We've relooked at the Covid 19 vaccination model because the epidemiology of Covid 19 has been changing ever since 2020, and it's required an update to the model. So it does depend on which programme we're talking about and how the disease has changed over time.

Um, do we uh, are all. Uh, studies funded by industry or are they sometimes funded by academics?So the answer is both. Uh, there are studies that are funded by industry and probably, uh, Professor Doe can say more about those because they fall more in the remit of MHRA. Uh, but there are also many independent studies that are funded by academic groups or public health bodies.
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None Portrait Speaker 5
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Yes, I'm quite happy to to to jump in there as well. Um, well Professor Lim has just outlined is, is quite right that the funding for clinical trials comes from a number of different sources. Um industry, uh, funding. Grant funding efforts as well, uh, where they may be academic, um, in origin, for example, uh, at the MHRA, we don't get engaged or involved with the funding side of the clinical trials. Um, and, and perhaps also just to, to highlight, um, that, that we have a very stringent conflicts of interest policy in place as well.

So that covers conflicts of interest, um, not only for our staff, but also for those external experts that we have on our advisory committees that support some of the evaluation work that we undertake. Um, we can't hold direct financial interests in the industries that the MHRA regulates. And, and we are very open about declaring um, any relevant interests on appointment or when they may arise, um, on a regular basis as well, so that we can either discuss or mitigate, mitigate against that. We obviously do receive data from industry because that is part of our process.

Um, the, the companies that are undertaking the clinical trials and that will ultimately hold the licence are legally required to carry out. Um, and provide us with, with safety data continuously. And this is in part because it's their responsibility to, to oversee the safety of, of their, um, their medicine, but they also have access and are able to draw on very large global data sets because they've got direct linkage into, um, the, the, the worldwide, different um, avenues in which their medicines are being used. So that's actually a strength as well for us because it means that we can access information across multiple countries, um, quite readily and quickly, but it's probably important to also stress that we don't rely on that data alone.

We are an independent regulator. And so we do draw on a wide range of other sources. That includes data coming from within the health care systems, but also academic studies and international partners and other regulators globally who are using the same products as us.
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None Portrait Speaker 5
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Yes. Thank you for that question. All vaccines are subject to a very rigorous MHRA led process of development. The clinical trials testing as well as subsequent regulatory review, um with regard to the clinical trials themselves, they are specifically designed to assess safety, the immune response and effectiveness. And they will typically involve thousands to tens of thousands of participants before a vaccine is authorised. And so the trial design, um, is, is overseen by ourselves to ensure that it provides the data and the information that we need to be assured of, of those things.

Um, each trial would be um, considered. Independently with regards to its own um outcomes or expected outcomes as well. So it can be quite a complex process and those trials will go through several different phases. So an initial trial may be much smaller. And then depending on the outcome of that it will then grow in size to cover cover wider groups. Um authorisation is only granted where the MHRA would determine that those, those benefits um are, are, are clearly outweigh any potential side effects.

And it is based on the totality of evidence at that given time. Um. However that there are limitations to clinical trials, even large ones. So for example, they may not detect very rare adverse events because for those, you actually need to have. Hundreds of thousands to even millions in some cases of individuals. Um, that would be vaccinated. And they're obviously limited in terms of scale. Um, they may not also fully represent the diversity of our wider population and all population groups, particularly, for A wider population and all population groups, particularly, for example, those perhaps that have got a rare medical condition.

And the other limitation is that trials are typically conducted over a finite period of time, which does limit detection of longer term effects. But these are all limitations that that we are very of. Um, and so we mitigate against this through that robust post-authorisation safety system that we have in place. That's an essential part of our, of our vaccine safety assessment. Um, that includes our yellow card reporting scheme as well as, um, clinical, um, data analyses that, as I mentioned, we work closely with partners in the NHS and the UK, HSA to help in terms of identifying any emerging risks that may arise in a larger and more diverse population.

So it's that ongoing monitoring that really provides, um, the additional safeguards with review to um, improvements. Uh, I'd say that vaccine regulation and safety monitoring, particularly with ourselves at the MHRA, we see as a continually evolving system because we always strive to, to respond and take into consideration advances in science and in data analyses, as well as public health need, and to introduce those into our processes in as timely a manner as possible. Um, so one example for, uh, instance, this year we had new clinical trials, regulations that came into force with a view to, to streamlining approvals processes to, to make them more flexible, to incorporate innovative trial designs with a view to helping accelerate patient access to safe treatments, but at the same time, maintaining those robust standards of safety, transparency and oversight that are really central to, to our, our function.

Um, but I'd say an area for improvement and, and one that's very much on our radar is, is how to increase participation from more diverse populations in clinical trials generally, um, with regards to our, um, surveillance model, we do have a very robust surveillance process in place, but there's always opportunities for further strengthening oversight and ensure and assurance. Um, so one of those areas is by us continuing to enhance our international collaboration, because that's really quite important in detecting and evaluating some of those rarer events more rapidly by having access to, to, to, um, broader and larger data sets.

And, and another area, um, of improvements that we're looking at as well is an ambition to move away from, from more passive safety monitoring to, to a more fully integrated data enabled system so that we have what we're calling an always on surveillance approach. And, and the way to do that is by improving the integration of, of healthcare with vaccination data. It's enriching the data that we have, um, ready access to. And so advances in data science and also things such as the electronic health record may really help us to improve our ability to identify rarer safety signals.

Assess outcomes in specific populations, for example, to allow us to effectively, um, monitor in near real time. So those sorts of system wide improvements would, would be helpful to, to provide us with linked high quality data that um, would enable us to, to really identify some of those risks earlier and act faster where possible to, to protect.
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None Portrait Speaker 7
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To to. maybe help.
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None Portrait Speaker 7
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Uh.
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None Portrait Speaker 6
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Uh, say those in the UK. Uh, they have relationships with their patients and with the communities around them. Uh, and they will generally invite people to participate in a trial. And this could be done, uh, depending on who they want to include in the trial. It could be done by radio, by, by newspaper, by all sorts of different means. Um, and if somebody is interested, then obviously they're given the correct information and, um, the most robust trials are those that are randomised.

So the participants would be, uh, voluntarily agreeing to be included in one or the other arm of a trial if it was a two arm trial, uh, and nobody would, uh, pre-select which arm they entered into would be done at random. Um, so the hope is that by having a open process that invites as many people as possible, one gets a representative, uh, response. And so the participants in the trial would be representative of the community, uh, that was invited to participate in the trial. Uh, and this is the bit where Professor Duke has mentioned where one of the improvements we want to make, generally not just vaccine trials, but in any trial, uh, is to increase the participation from the whole of the population across all communities and neighborhoods.

Uh, because unfortunately, it's while some communities may say we want to see more people, uh, represented at trial, but if they don't volunteer or understand how to volunteer or have access to the process of participating, then obviously they will be underrepresented as a neighborhood or a community. And that's an effort that needs to be made. Um, in terms of communication, even at the clinical trial stage.
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None Portrait Speaker 3
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Thank you.
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None Portrait Speaker 8
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Could.
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None Portrait Speaker 7
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Um, the.
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None Portrait Speaker 7
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Um.
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None Portrait Speaker 7
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Would.
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None Portrait Speaker 12
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Yes. I'll.
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None Portrait Speaker 6
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I'll make a make a start and we might need to supplement this later on. Um, so perhaps um I started the example of PCV 20 because that may help answer some of the other things anyway. So PCV 20, uh, PCV sorry, is the pneumococcal conjugate vaccine, uh, covering 20 different serotypes or serogroups of Pneumococcus. And there are about 100 Serogroups of Pneumococcus that cause disease. This covers 20 um, and this was approved by MHRA, you say two years ago in 2024.

Um it has been used in some other countries in the infant programmes, um in the UK. Uh, we um have been looking at PCV 20 and how it might be used in the UK programme. And in fact in two days time we have a pneumococcal subcommittee to review PCV 20 use in the UK immunisation programme. Um part of um the process of working out whether to use a new product or not, uh, involves those three points that I mentioned before, which is the burden, uh, what the vaccine is like and the cost effectiveness in the case of pneumococcal vaccines.

This is particularly difficult. As you know, we have a pneumococcal vaccine programmes for infants and also one for adults. Um, the nature of pneumococcal disease is that um the pneumococcus is carried in the back of throats of children. And it is then transmitted or spread and can cause disease in adults. It means that if we give a vaccine to children where the vaccine is able to block or reduce carriage of the pneumococcus in the throats of children, it can have a protective effect, which is called herd protection.

In adults. Um, and so if we, uh, removed all of the carriage in children, we would have a reduction in disease in adults. And that would then impact on the adult vaccine programme. One of the difficulties in Pcv20 is that the amount of carriage reduction in children might be different compared to its previous product, which is the one we're using currently. Pcv13, uh, and those differences in how much it affects carriage will impact on how much adult disease may or may not be protected.

And in turn, how that affects the adult programme. Uh, so this interaction between the children and the adult makes the modelling, uh, extremely difficult. So it's the modelling process that has taken quite a long time. Uh, before we can come up with something that says whether this is cost effective or not, uh, bearing in mind that there are in this particular field, many new products that are being, uh, rolled through the regulation process over the next 2 or 3 years. Um, so it is this process that is taking time, uh, and making the recommendation difficult.

Ask me, what are the weaknesses of the process and the strengths?The strength is, is it's highly robust. It is based on scientific data and not on opinion generally. Um, and, um, it does take into account very seriously the modelling and the cost effectiveness because that's, uh, what we are tasked to do. Uh, the weakness is that, uh, the modelling capability and modelling resource can be quite restricted. Sometimes these models take many, many months to build and to run.

Just changing 1 or 2 assumptions in the model can take weeks for the output to be read. So having enough capacity, uh, and resource to run the models, uh, is important, particularly as we have more and more vaccines coming down the line. We have more and more models that need to be run, and there is a certain limit to the modelling capacity in the UK. Um. The other question, um I think one of the questions was then about um the. One off menb offer that was just announced, um a couple of a few days ago.
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None Portrait Speaker 11
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And Professor Duke.
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None Portrait Speaker 5
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I'm quite happy to make a start. Yeah, I think that um communications is, is, is really quite key in terms of um improving uptake. And it really does rely on a, on a system wide approach as well, I would say, because each of our agencies do all um release communications and certainly from the MHRA perspective, we do publish quite a wide range of information, including um patient facing information, the, the product information that goes alongside um, the vaccinations themselves. We'll release safety updates, um, and we have also started to try and be a little bit more proactive in terms of how we communicate and have taken steps to release vaccine, um, fact sheets, which we have put up on, um, the gov UK website.

And within that whole process of, of generating the vaccine, the vaccine fact sheet, sorry, we worked very closely with our partners, particularly UK HSA, to make sure that the messaging that we were including, um, was cohesive and connected. We were saying the same things because UK, HSA, NHS, they do all have information sources available on their various public um platforms as well. So that effort of working together to make sure that our messaging was consistent, um, was, was really quite important. And within those fact sheets, we also included information on how to report potential side effects through the yellow card scheme as well, so that we could really link link up, um, awareness around that.

So there was a series of fact sheets. We had a general one on vaccines plus, um, a series of, of others that came out on specific vaccinations too. And certainly looking ahead, we're planning to, to build on this further so that we can have that closer collaboration with partners across the wider health system to really ensure that that consistent messaging and, and, and the release of trusted evidence based messaging, which I think is quite important, um, reaches both, both patients, um, as, as well as healthcare professionals to, to support their discussions as well.
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None Portrait Speaker 6
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Uh, yes. Thank you. Um, importance of communications cannot be underestimated. Um. Usually um changes in advice. Uh, occur because of important changes in science or epidemiology. Uh, and this was true for Covid. Uh, as for any other situation, the difference in the pandemic was the pace of change. So as scientific information, uh, increases, um, it may well be that scientific or medical decisions need to change and they need to be communicated.

Um, unfortunately, um. The communication regarding why some advice changes over time may not always come across to all sectors of the community, such that it is well understood that the changes occurred because evidence has changed, not because the same evidence has suddenly been looked at with the left hand. And who didn't know what the right hand was doing. Uh, and it's making that clarity, uh, better understood, which is, I think, one of the challenges with communication. Um, you might come on to, uh, how to improve, uh, uptake later on.

Um, uptake and communication are both highly dependent on understanding of what local communities and neighborhoods are thinking. And so part of communication is being able to listen and hear what people are concerned about and listening, how to communicate because different people, uh, listen in different ways. And it's trying to get all those points right. Uh, which is difficult, particularly in a pandemic. And I, I would say that when anything changes rapidly, there is always the chance that something will be dropped in that listening process.

And therefore the communication process.
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None Portrait Speaker 9
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Thank you.
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None Portrait Speaker 6
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Thank you. So I want to raise two things. But before I do just want to mention that, uh, in October 2023, Jcvi noted the, uh, decreasing coverage of childhood immunisation and Jcvi commissioned the four nations to form a forum and to identify, investigate ways and means of, uh, both understanding why, uh, deployment was being reduced and what factors could be taken into account. Uh, that report was published with the Jcvi October 20th five minutes. Uh, and I think the report has been submitted to the committee for review.

Um, so just want to mention that to you and the two things I want to raise are probably the report first. Um, it's access, which has been repeatedly identified as the most important factor. Uh, it's difficult for somebody who has got many children, uh, to find the time, take time off work, uh, take the child, organise childcare, and then have the vaccine and deal with the crying child afterwards. That takes a huge amount of effort. Um, and if we can improve access to vaccination and support for vaccination, uh, that makes the biggest difference based on the reports that have been coming out, that is so important.

Um, part of improving access is to be able to offer vaccination at any and every appointment where this is available. So opportunistic, uh, identification of vaccine opportunities. Um, earlier you heard from, um, W.H.O., um, and there was mention about school based catch up programmes. Again, that is a very useful time to check on vaccination schedules and to be able not just to check, but also to offer catch up vaccines. This requires the school programmes to be adequately resourced, adequately funded, so that they can offer catch ups.

These things where we can reduce the barriers to access to vaccinations will be so important. School vaccination programmes are less subject to, um, socio economic, uh, biases, uh, because people enter school and they're offered a vaccine that's less about having to travel two miles or two buses or two hours to get to a vaccine clinic. Uh, the second point is education. Um, as you've heard, I think time and time again, uh, nurses and doctors are the most trusted voices in comes to advice. Um, what would be good would be for every health professional, nurse, midwife, physio, social worker, medical student, it doesn't really matter everybody to be a reasonably trained in vaccination and be comfortable to discuss vaccination with everybody else.

It shouldn't be left just to the practitioners who does vaccines. Everybody can have a share in supporting vaccination. It's a public health programme, and it should be for the public to understand. And the education can be in schools, in universities, uh, antenatal clinics, so that the mum understands why she would be mum. She needs a vaccine. And then later on why her child might need a vaccine. Uh, all of these are really important. So I would stress education, um, early education for all health professionals as the next step, uh, in any, uh.
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None Portrait Speaker 3
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No. Who knows.
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This debate has concluded
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