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expert reaction to MenB vaccine for meningitis B, following the public petition calling for all children in the UK to be given the vaccine

A public petition to give the meningitis B vaccine to children up to the age of 11 has gathered more than 575,000 signatures, which means the matter will be debated in parliament. Since September 2015 the MenB vaccine has available on the NHS for children under the age of one, but if parents want older children to receive the vaccine they must pay privately.

 

Dr David Elliman, community paediatrician, said:

“The death of any child is a tragedy that we should do all we reasonably can to avoid.

“My understanding is that the JCVI looked at this vaccine very carefully and found that in the dose regimen recommended, the vaccine would only just be cost effective, if it was purchased at a very low price – well below the market price. I do not know what price was agreed, as unlike in USA, where the price paid for vaccines by the public services is readily available, it is not so here.

“Something like a half of cases of MenB are in children under 2 years old and, unlike for MenC, there is only a very small peak in adolescence.

“We have a limited budget in the health service and so we have to spend very carefully and look at what gets the best return for the money available. To increase the cover to include all children up to 11 years old would increase the initial spending enormously and there would not be the vaccine or probably the people to do it.

“If we took money away from Trident or bombing the hell out of people in the Middle East, or increased taxes, we would have more resources available, but then we would still need to consider what best to spend it on. I would suggest that good housing and the relief of poverty, might have a greater effect.”

 

Prof. Richard Moxon, Emeritus Professor of Paediatrics, University of Oxford, said:

“Should Bexsero be offered to older children? This is a very complex issue. There are inevitably cost issues associated with provision of vaccines. Bexsero was licensed in 2013 by the EMA without formal clinical trials on its efficacy. This is because meningococcal infection is a rare, howbeit devastating, disease and the classical double blind placebo controlled efficacy trial was utterly impractical. Its introduction into the UK routine immunisation programme in the autumn of 2015 provided not only an opportunity to prevent cases of MenB disease, but the first opportunity to do a population- based study of its effectiveness. Estimates of its protective potential, in the absence of a formal clinical trial, were based on laboratory evidence using a  bacterial killing assay to determine whether sera from immunised humans (infants, toddlers, adolescents etc) was able to kill meningococci “in the test tube”. Inevitably, there are many uncertainties as to how effective in protecting against invasive meningococcal disease the vaccine will prove to be.  The laboratory estimates for the UK predict around 73% efficacy. Time alone will tell how well the predicted protection will play out in “real life” against the experience gained after several years of using the vaccine.  So, there are important uncertainties including a lack of evidence as to whether or not Bexsero could provide community protection through herd immunity.

“The highest incidence of MenB and other forms of meningococcal meningitis is in children less than 1 year old. There was a very heated debate on the cost effectiveness of Bexsero prior to the JCVI recommending its use and the government agreeing to implement the vaccine for in the UK infant routine immunisation programme. As with all public health interventions, costs have to be assessed in relation to other programmes.  Broadening the MenB programme beyond infants to include toddlers, older children, adolescents and perhaps even adults needs careful evaluation. I understand too that the manufacturer of Bexsero, GSK, is currently struggling to provide sufficient vaccine; their manufacturing facilities are not unlimited and Bexsero is a complex vaccine involving recombinant proteins and membrane vesicles. Quality of product is hugely important (safety) and these associated manufacturing and regulatory constraints are non-trivial.

“Of course, even one case of MenB or MenC is one too many. The tragedy of the two cases that have attracted recent notoriety is testimony to the importance of prevention of a terrible disease.  In the case of the baby with MenC, who thankfully survived, I have not found out whether the MenC vaccine was given although clearly all infants are routinely offered the MenC vaccine at aged 3 months with boosters. Clearly, the child with MenB would not have been immunised unless the vaccine had been administered privately.  Given outside of the U.K. Immunisation programme, the vaccine costs in the region of £600 for the 3 injections.

“Is the Bexsero vaccine unusual?  From a number of points of view, the answer is yes.  Unlike all the other meningococcal vaccines, A, C, W and Y that are based on the sugar coating or capsular polysaccharide, the B strain cannot be prevented using this strategy for technical reasons, including concerns about the safety of using B polysaccharide-based vaccines.  Bexsero was developed to get around the problem of using the B polysaccharide and instead uses proteins, 3 recombinant (genetically engineered) and a mix of proteins obtained by extracting membrane blebs from the surface of meningococci; a complex vaccine.  One of the striking features of Bexsero is that the identification of the 3 recombinant proteins was achieved through genomics.  The complete sequence of a Men B strain (originally isolated from a case of meningitis in the infamous Stroud meningococcal B outbreak in the UK in the early 1980s) was used to identify the potentially protective antigens that are in Bexsero. This project was initiated in my laboratory in Oxford in 1995 and became the Chiron-TIGR- Oxford collaboration. Under the brilliant execution of Rino Rappuoli and Mariagrazia Pizza at Chiron, then Novartis, this pioneering vaccine research programme realised Bexsero. It is the first vaccine to be licensed that was based on microbial genomics.”

 

Dr Myron Christodoulides, Reader in Molecular Bacteriology / Microbiology, University of Southampton, said:

“The new MenB vaccine, called Bexsero, represents that first vaccine of its kind to be used in humans, in which the protective components were selected by a computer-based predictive screen of the genetic profile of the meningococcus B bacterium. The process is called ‘genome-based reverse-vaccinology’ and it is an extremely powerful technology that is increasingly being used to develop vaccines against bugs like MenB, which have resisted other methods of vaccine development.

“The three important protective proteins from the bug are then mixed with the MeNZB vaccine from New Zealand, which was used to control an outbreak of MenB infection in New Zealand that was caused by a single bug. The significant advantage of including the three protective components is that they were chosen on the basis of providing immunity against all MenB bacteria that can cause disease. This combination is the basis of the Bexsero vaccine, which has undergone exhaustive research in the laboratory and in clinical trials to demonstrate that these chosen bug components can stimulate protective responses in humans.

“Bexsero was approved for routine vaccination of infants in the United Kingdom and entered the infant immunization schedule from September, 2015. The incidence of meningococcal infection is highest in infants and children under one year of age, hence the decision to vaccinate this most at-risk group initially.

“As a parent myself, the most important advice I would give is to make sure that we recognise the signs and symptoms of meningitis. I would urge all parents who are worried to check the websites for the meningitis charities, MeningitisNow (https://www.meningitisnow.org/) and the Meningitis Research Foundation (http://www.meningitis.org/), who both offer ‘life-saving information’.  If parents spot any of the signs or symptoms, prompt actions – i.e. emergency doctor/A&E visits – save lives. And we shouldn’t restrict this advice to infants and young children; teenagers and young adults going to university also need to be aware.

“The decision to vaccinate infants with the MenB Bexsero vaccine in the first instance is because they are the highest at-risk group for meningitis.”

 

Dr Helen Bedford, Senior Lecturer in Children’s Health, Institute of Child Health, UCL, said:

“The UK was the first country in the world to introduce MenB vaccine into the routine vaccination schedule. In deciding which children to offer vaccines to, you need to see which age group are most at risk of the disease. For MenB, it is children in the first year and this is why the vaccine is being offered to children at 2 and 4 months (with a booster at 12 months).

“There is no question that MenB disease, which can present as meningitis (inflammation of the lining of the brain) and/or septicaemia (blood poisoning), is a devastating disease and rightly feared by parents and health professionals alike, so we are lucky that there is a safe and effective vaccine to offer infants. However, decisions about which age group is offered any vaccine are based on the best scientific evidence about which age group will benefit most, and this includes issues of cost. For MenB disease an additional factor is that there has been a reduction in the number of cases in recent years, without any vaccination programme. The age vaccines are offered differs for different causes of meningitis.”

 

Comments from Scientific Advisory Panel members of the Meningitis Research Foundation – please note the following four scientists have not been asked by the SMC for declarations of interest so none are supplied:

Dr Shamez Ladhani, Paediatric Infectious Disease Consultant, St George’s University of London, and Scientific Advisory Panel member of the Meningitis Research Foundation, said:

“The UK is the first country to introduce a national and publicly funded infant MenB immunisation programme in the world. This is a new vaccine and we need to gather as much information as possible from the current programme to make informed decisions about how best to protect those who are most at risk. We are targeting the age group most at risk and every year, another birth cohort will be protected by this vaccine. By next year, all 1 year-olds and many 2 year olds will also be protected against this devastating illness.”

 

Prof Paul Heath, Professor of Paediatric Infectious Diseases, St George’s University of London, and Scientific Advisory Panel member of the Meningitis Research Foundation, said:

“It is really important that high quality research continues to be funded in order to address the remaining questions. The UK is the first country in the world to introduce this new vaccine and has first targeted those who are at highest risk. We need to gather the evidence in order to see whether this strategy needs to be extended to protect more children.”

 

Prof James Stuart, visiting Professor at the University of Bristol and WHO advisor, and Scientific Advisory Panel member of the Meningitis Research Foundation, said:

“It is important to emphasise that the UK is the first country to introduce MenB vaccination, that babies who are at highest risk are being offered vaccine  and that we need to know how well the vaccine is working. So it may not be the time yet to widen the programme.”

 

Prof Nigel Klein, Professor of Infection and Immunity, Great Ormond St Hospital and UCL, and Scientific Advisory Panel member of the Meningitis Research Foundation, said:

“It has been fantastic how research funded by charities such as MRF has improved the way we manage children with meningitis and septicaemia. This includes helping parents to recognise this condition and seeking medical help as well as encouraging the introduction of effective vaccines to prevent all forms of this disease.  We are delighted that the new MenB vaccine has now been introduced and we all hope will be successful. However as yet we really don’t know how effective it will be and if there are going to be any problems and this is a major area of ongoing research supported by the MRF. If successful, we would strongly recommend extending the vaccine programme to cover all vulnerable people.”

 

Declared interests

Dr David Elliman: None.

Prof. Richard Moxon: “I have been deeply involved in the R and D of the MenB vaccine (Bexsero) and have over the years I have been on the Scientific Advisory Boards of Chiron, Novartis and now GSK.  The MenB project was started in 1997 as a collaboration between Chiron Vaccines, TIGR (The Institute for Genome Research, USA and my laboratory at the University of Oxford.”

Dr Myron Christodoulides: “Myron Christodoulides (MC) is currently the chair of the scientific and medical advisory panel of MeningitisNow. He has received honoraria from Novartis Pharmaceuticals for expert opinion and all honoraria were paid into his employer, The University of Southampton, accounts for research use only. MC is a named inventor on patents held by the University of Southampton and has received research funding from GlaxoSmithKline to develop new MenB vaccines. No other competing interests or declarations.”

Dr Helen Bedford:

  • paid employment or self-employment – no.
  • grant funding – 1. Funded by PHE for a study of parents’ knowledge and views about meningitis and MenB vaccine (2014-15). 2. Collaborator on a grant proposal to Meningitis Research for funding for a study to look at side effects of menB vaccine (awaiting a decision re funding).
  • voluntary appointments – no.
  • memberships – no.
  • decision-making positions – no.
  • other financial interest – none.”

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