Meningitis B Vaccine

Philippa Whitford Excerpts

Monday 25th April 2016 Westminster Hall

[Geoffrey Clifton-Brown]

I could not agree more. That is why the CEMIPP group study should look at not only the medical costs but the educational costs, the cost of carers and so on. There are considerable costs to the public purse. We tend, under our democratic system, to be quite short-termist in our view of such matters. I am involved at the moment in work on drugs for cystic fibrosis, to which exactly the same issues apply. After the considerable cost at the outset, there is a lifelong benefit to babies from getting such drugs. If we are going to carry out a cost-benefit analysis for the meningitisusb B vaccination, that is what we should consider.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I agree with the vast majority of what the hon. Gentleman says. In actual fact, it was not possible to trial Bexsero in humans because this is such a rare condition, and therefore we do not yet know whether the immunity will be for life.

[Geoffrey Clifton-Brown]

I am extremely grateful to the hon. Lady. The benefit of these debates is that we always have a professional on hand who can give us the last word on the subject. My sister is a GP and would no doubt have given me that same advice.

I am grateful for the chance to speak in this debate. This is a tragic disease with tragic consequences. I urge the Minister to go further, and faster in rolling out a good, safe vaccine that will give immunity to a larger section of the population.

--- Later in debate ---

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I apologise to the Chamber for being late; that was due to the health statement earlier. I, too, begin by paying tribute to the families who attended the combined Petitions and Health Committees last month. Their bravery in going through their experience again was incredible, and it was obviously very moving for us to listen to.

Funnily enough, this is World Immunisation Week, so the debate could not have been timed any better. Just think of the lethal diseases and conditions that we have tackled across the world because of immunisation. The hon. Member for Totnes (Dr Wollaston) referred to polio; we have not beaten that yet, but we are on the way.

Meningitis is an inflammation of the meninges, the covering of the brain, and that can happen with other diseases, not just meningitis B or any of the meningococcal diseases, but they are the most serious; they are the ones that result in the biggest harm. There is A, B, C, W and Y. When I was a younger doctor, which was a wee while ago, meningitis C was the big concern. It was very common in teenagers as well as in children, and there was always a big peak when people went off to university, but in 1999 the vaccine for that was introduced. It was given to those right up to the age of 18, and 90% of those cases are now prevented, which is a real transformation.

That leaves meningitis B, which is the most lethal type and affects people very quickly. We have heard that from the families and from hon. Members in the debate. There are not many conditions whereby someone will go from being slightly off-colour to either death or permanent disability in less than 12 hours. Having worked in a paediatric hospital and dealt with children with meningitis, I can tell hon. Members that for a doctor, it is terrifying. As was talked about in the Committee, it is not that doctors think, “Och, no, it won’t be that; I’ll ignore it.” It is simply that it is so hard to pick out that child. When they are a little bit hingy, as we would say in Scotland—a little bit off—it is not obvious, but there are signs that people should be looking for.

As the hon. Member for Faversham and Mid Kent (Helen Whately) said, do not wait for the rash. I was delighted to see in the Meningitis Now advice that that is written in big red letters: “Don’t wait for a rash”. Do not wait for the rash if the child is quiet, not reacting normally and very feverish. As a doctor, what I would say is of real concern is cold hands and feet. If a child has a fever, yet has cold hands and feet, that to me is a sign of septicaemia—a sign that the blood supply to the extremities is beginning to shut down. That should be a warning sign long before we get to the rash. Reading the testimony produced by the families and the petitions group is absolutely heartbreaking. In case after case, the first warning sign that the parents or the medical professionals recognised was that horrible rash.

It is important that we take account of the long-term disability. One in 10 of these children will not survive. One in three of them will be left with a severe disability. That includes brain damage, cognitive and sensory impairment and, as we have heard, limb amputation. That is horrific to think of in little children. I can tell hon. Members as a doctor that this impinges on doctors as well. If someone has seen a child and not spotted meningitis, or seen a child and watched them just slip through their fingers, that is absolutely horrific. Meningitis moves so fast that vaccination has always been the holy grail. We now have it, but we probably have not rolled it out widely enough, because of the cost-benefit analysis.

I will echo the hon. Member for Totnes: there is no question but that the decision should not be made in this House. It is not a political decision; it must be made in the cold light of evidence of benefit, but that is not just cost-benefit; it is also risk-benefit. We spend a lot of our time being lobbied by constituents who are against vaccination. Think of the saga we have been through with the measles, mumps and rubella vaccine in the last decade, and here we are with a movie reigniting all of that.

There was no trial with Bexsero, so we are still gathering the data through this year. I am talking about the efficacy, safety, side effects and, crucially, as I mentioned earlier, whether people have permanent protection. We do not know that yet, but questions on those points have to be answered, so it is crucial that the body responsible is the JCVI . On my reading, the key problem has been in the discounting. Of course if people invest money in any treatment, they want a quick return. That is what the City of London would look for as well. But we are talking about preventing things—preventing damage that will be with someone for their whole life. A child’s life is written off, before they are 28, as really not having any additional value in being saved. A discounting of 3.5% means that that value is gone at that age, even though we have perhaps saved 70 years of life. In particular, if the child never got ill in the first place, we would have saved a disabled life; we would have saved a life of suffering, and the cost to society and the family of looking after a child who perhaps faces incredible disabilities and suffering.

Every year, that life is discounted at 3.5% until we reach zero, yet we accept that public health measures, such as smoking cessation, take a long time to give us a return. Having seen the results of people smoking, I am not quite ready to say that we should give up on those public health measures. We need people to stop smoking as that will save us money in the long term. However, we should be using the same rate, because if we were discounting at 1.5% a year, the catch-up up to the age of five would have been considered cost-effective. It is not that the rate should not be down to the JCVI, or that it should not be based on proper medical evidence. The issue is the tool that was given by the National Institute for Health and Care Excellence, based on the Treasury figure of 3.5%, although appraisal committees can consider anything between zero and 6%. The key thing is to ask for that evidence to be looked at—specifically the long-term costs of major disability—and to look at the impact on the decisions of using that lower discount rate.

The other thing mentioned was a study of adolescents. In meningitis C, we were particularly after the adolescents. Babies do not carry meningococcal meningitis; teenagers do. When we vaccinate little children, it is for the individual protection of that child. The protection that is given by teenagers is herd immunity. When they stop carrying it, babies will catch it less. We do not know whether that will happen with Bexsero as it is such a different vaccine. As the hon. Member for Totnes mentioned, the whole structure is totally different. Normally, we are looking at the sugars on the surface of bacteria. Bexsero was done through genomics—identifying protein to create antigens and antibodies. It is so expensive because it has been done in a totally different and novel way.

We need to do a study on adolescents. There seem to have been a couple of years of talking about doing it, yet we have not even started or laid out the terms and parameters. It is really important that we answer the questions with evidence, not just by thinking that we would quite like to splash the vaccine around. The case for extending the catch-up to five years is stronger as half the cases will happen before the age of two and the majority will happen before the age of five. The cost burden for a child who requires 24/7 care for their entire life—particularly when they are older and their parents are no longer looking after them—including the burden on their family, friends and society, is enormous. I find it hard to believe that it would not be cost-effective to prevent that.

For me, as a doctor, vaccination is almost the only way. The one thing I do not recognise in the cost-effectiveness balance is the talk about peace of mind. As we explored with families in Committee hearings, peace of mind caused some of the problem, because some parents thought, “My child is vaccinated against meningitis.” We cannot cast that up. A simple change in the discounting method and the inclusion of long-term social care costs are the most important things.

Even if we roll the vaccination out, we must remember that there are other types of meningitis, and that there is more than one strain of meningitis B. We need to get that great little Meningitis Now card out to families and parents as widely as possible, but we also need to get this message to doctors: do not wait for the rash. Look at the child, listen to the parents, and, as I said earlier, think about cold hands and feet. We have the potential to stop the damage of this absolutely horrific disease, and I hope that we take the issue back to the JCVI.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Health (Jane Ellison)]

I thank all hon. Members who have spoken in this important debate. As others did, I start by offering my condolences to the family of Faye Burdett, whose tragic death sparked such interest in the e-petition that led to this debate, and to all the other parents. Their powerful testimony on their personal family tragedies has led us and their Members of Parliament here today, and they have helped to stimulate interest in the petition, which has huge support, with more than 820,000 signatures. The petition goes right to the heart of the concern that parents and the public have about meningitis.

I have listened to the many hon. Members who have spoken this afternoon and, like everyone in the Chamber, I have been moved by the stories we have heard of how both meningitis and septicaemia have affected families and, in some cases, have tragically changed their lives forever. As has been made clear, meningococcal meningitis—the infection and inflammation of the lining of the brain—and meningococcal septicaemia, or blood poisoning, which for simplicity I will refer to as meningitis, are very serious infections that can be severely disabling and even fatal, as has been movingly and, in some cases, starkly demonstrated by hon. Members today. It is right that we should have robust arrangements in place to protect against this disease. In fact, we are the only country in the world with a vaccination programme for all the major causes of meningitis, and it is clear from the strength of feeling today that hon. Members fully support the meningitis and other world-class vaccination programmes that we have in place to protect individuals, particularly children, and the community as a whole by vaccinating against preventable diseases.

For 35 years successive Governments have based decisions on vaccination programmes on independent expert advice from the Joint Committee on Vaccination and Immunisation, and it will help to answer one or two points that have been raised if I clarify the JCVI’s legal basis. Since 1 April 2009, the Health Protection (Vaccination) Regulations 2009 have placed a duty on the Secretary of State for Health in England

“to ensure, so far as is reasonably practicable, that the recommendation of the JCVI is implemented”

where certain conditions are met, including that the recommendation is

“in response to a question referred to the JCVI by the Secretary of State”

and that it is

“based on an assessment which demonstrates cost-effectiveness”.

That is the basis on which the JCVI was constructed and under which it operates.

At the recommendation of the JCVI, as the House knows, we introduced in September 2015 a men B programme, using the vaccine Bexsero, for babies born on or after 1 July 2015. The babies receive a dose of vaccine at two months, with a further dose at four months and a booster at 12 months. To ensure that we have protected as many infants born in 2015 as possible from men B before the usual winter peak in cases, we also offered the vaccine to babies born in May and June 2015 as part of a one-off catch-up programme, which was possible because the vaccinations could take place when the babies were due to attend their routine immunisation appointments at three and four months.

By May 2016, all infants under one will have become eligible for the men B vaccine, and by May 2017 all children under two will have become eligible for vaccination, which clarifies the points made by my hon. Friends the Members for Erewash (Maggie Throup) and, in particular, for The Cotswolds (Geoffrey Clifton-Brown). Obviously, much of today’s debate has focused on extending the men B vaccination programme, and hon. Members and those who signed the e-petition want us to go further, which I absolutely understand. The term “meningitis” strikes fear into the heart of any parent. Public Health England surveys parental attitudes, and its surveys regularly show that meningitis is the disease that parents fear the most. When we hear sad stories and see utterly heart-breaking pictures of children such as Faye, of course it adds to parents’ fear and worry. They want what is best for their children, which includes protecting them from meningitis if there is a means available to do so.

The Government feel the same, which is why we became the first country in the world to introduce a programme using Bexsero. However, although meningitis is a much-feared disease, it is now much rarer, thanks in large part to the success of this country’s immunisation programmes. Cases are currently at their lowest numbers in more than two decades. To give the House an example drawn on by the hon. Member for Central Ayrshire (Dr Whitford), who spoke for the Scottish National party, cases of meningitis C have dropped from a peak of around 900 in 1998-99 to about 30 cases in 2014-15. Very few children will get meningitis, and thankfully, deaths are uncommon, although no less tragic.

The hon. Member for Central Ayrshire also mentioned teenagers. As I have enough time, I will draw the House’s attention to the men ACWY programme that we have introduced. Men W is the strain of meningitis that has increased; cases have been increasing since 2009. There were about 50 cases in 2012-13, about 100 in 2013-14 and around 180 in 2014-15. We rapidly introduced a vaccination programme this year as part of an emergency response to control the national outbreak of group W meningococcal disease. Provisional data show men ACWY vaccine uptake at around 34% in the urgent catch-up cohort aged 17 to 18 in 2014-15. I say that to enlist the help of hon. Members when we try to increase awareness of the men W campaign again this year. We need any help that can be given in publicising it. As I remarked with one colleague before the debate, it is considerably harder to get teenagers to the GP than small infants. It is an important campaign involving a very dangerous strain of meningitis that we must continue to bear down on.

However, the petition is about men B. It calls for the men B programme to be extended to children up to 11 years, although several hon. Members have suggested that up to five years may be a compromise. I fully understand why parents and the public want the extension, but as we have begun to explore in this debate, it is not a simple matter; I hope that hon. Members agree. Some of the reasons for that have been teased out, and I will say a little more about them.

Any Government must make the best use of the resources that they have to ensure that they deliver the maximum health benefit to the population. The greatest burden of meningitis B falls on the under-ones, who have therefore been our focus, on expert advice. As we have heard, such judgments are based on NICE’s rules on cost-effectiveness, which have helped successive generations of Ministers to make difficult decisions that are none the less fair and justifiable and reflect, as the Chair of the Health Committee said, the many challenges across our healthcare system.

I have spoken in detail to Professor Andy Pollard, the chair of the JCVI, to understand what process the committee went through when considering the men B vaccination and to be assured that the committee’s recommendation is robust. I have been reassured that the programme we have is the right one, targeting the group of children at highest risk of disease and death. Professor Pollard confirmed that a catch-up programme for one to four-year-olds would not be cost-effective at a realistic vaccine price. Also, the disease is so rare in those aged five to 11 that a programme for that age group would not be cost-effective, and the JCVI could not recommend it.

[Dr Whitford]

Is it not the case that the JCVI did a cost-effectiveness analysis using a 1.5% discount, which is the same as in public health, and at that level a catch-up programme for one to five-year-olds would be cost-effective?

[Jane Ellison]

I am coming to that point, but I thank the hon. Lady for her intervention.

As it stands, on the evidence and advice that I have received, I cannot support extending the men B vaccination programme to older children, but I emphasise that the JCVI keeps under review the evidence relating to all vaccination programmes, and I know that it will consider all the points made in this important debate. If the committee’s advice changes, I will consider it as a priority. The JCVI also keeps the eligibility criteria under review. I wrote to the chair on 17 March this year, following the evidence session with parents, asking the committee to review the cost-effectiveness evidence for one to two-year-olds, which Professor Pollard mentioned in his evidence to the committees. I await formal advice on that. Again, if the JCVI’s advice changes, I will consider it as a priority.

Many of the contributions made by hon. Members in this debate have queried whether the cost-effectiveness methodology used by our experts is right for immunisation programmes. The shadow Minister drew out that point, as did others, including my hon. Friend the Member for Bath (Ben Howlett), who led the debate on behalf of the committees. As some hon. Members said, an independent expert group—the Chair of the Health Committee gave it its full title, but I will call it CEMIPP for ease—is considering the cost-effectiveness methodology for immunisation generally. It includes factors such as peace of mind, cost of long-term social care for surviving children and how prevention is taken into account, all of which have been mentioned in this debate, as well as the issue of discounting.

The CEMIPP review is considering whether current discount rates are appropriate for vaccination in general, and it will report in the summer. I will consider any recommendations on that, although obviously I cannot pre-empt decisions in this debate. As I indicated to the Chair of the Health Committee when she made her contribution, I look forward to receiving the report in the summer. I have committed to publishing the report, and I do so again. If it is of interest, I will also provide the Petitions and Health Committees with a written briefing summarising the report and the Government’s proposed next steps when we get it.

Several hon. Members have expressed concern about whether the research requested by JCVI into whether a men B vaccination programme for adolescents would be cost-effective will take place and how long it might take. I can confirm that a preliminary study of the meningococcal strains carried by teenagers is now under way and will report in February 2017. It will inform a larger study of the effect of men B vaccination in that group. As the Chair of the Health Committee said, it is about exactly how the impact of the larger group would bed down on the impact of the disease in smaller children. I commit to the House to commission the second, wider study following on from the preliminary study now under way on strains.

I recognise that Members have concerns—again, the hon. Member for Central Ayrshire mentioned this issue—about how long the research is taking. I have had extensive discussions about that, because like hon. Members, I want quick answers. However, things are sometimes difficult to weigh in the balance. Robust scientific studies on which long-lasting and important decisions can be taken take time. My scientific advisers have told me that this is a particularly complex study, and that a previous study had inconclusive findings. We want to get this one right and ensure that we have a definitive answer. I am hopeful that this study could start in December 2017. The House has my complete assurance that we will always go with as much speed as we can while maintaining important robustness, so that we reach answers on which evidence-based policies can be made.

Much has been made about the importance of raising awareness and ensuring quick treatment. As many have said, no matter what the nature of the vaccination programme, there will still be cases, and we need to bear that in mind. Many Members have spoken of the reassurance that vaccinations offer and how they set minds at rest; it came out particularly in some of the evidence sessions. Although it is important that it reassures parents, I take this opportunity to underline and stress that vaccination is not a silver bullet. Even with a vaccination programme up to the age of 11, there would still be men B cases in under-11s, as we think that the vaccine covers only about three quarters of all men B strains and no vaccine is 100% effective.

A number of people have made the point, including the hon. Member for Central Ayrshire in an earlier intervention, about understanding the impact of the programme. No other country has introduced a free vaccination programme.

There is as yet no evidence regarding the real-world effectiveness of Bexsero in preventing meningococcal disease in a population—that is different from the safety issue—because, as has been said, incidence is too low for clinical trials to provide a reliable measure of effectiveness.

In response to points made by my hon. Friend the Member for The Cotswolds, I will say that we should have some indication later in 2016 of how effective the vaccine has been. However, establishing an accurate measure of how effective the vaccine is, how long the protection lasts and what proportion of strains it will prevent will take many years of detailed observation by Public Health England, and that clearly will feed into the ongoing review and the important decision-making process that we have. It is worth making that point.