July 24, 2013

expert reaction to the JCVI interim position statement on meningitis B vaccination programme

The JCVI release an interim position statement on meningitis B vaccination programme saying they will not recommend the programme be introduced. 

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

 “This was indeed a very difficult decision for the JCVI to make, but close inspection of the JCVI interim position statement does emphasis that despite the extensive trials of this vaccine in 8000 infants, children, adolescents and adults, there appear – surprisingly – to be still many unanswered questions regarding Bexsero®.  These trials have shown that the vaccine is immunogenic, but the committee noted that the immunogenicity of Bexsero in the ‘new’ UK immunisation schedule has not been completely assessed. It is clear at this point in time that the numbers of cases of meningococcal disease in the UK appear to be falling, thankfully, but it is difficult to predict what the future incidence will be, given the cyclical nature of meningococcal disease. Based on this, one would argue that the only practical study to see if this vaccine really protects against disease is population-based immunisation. Indeed, this will still be a major consideration for other experimental MenB vaccines currently in clinical trials in the UK and elsewhere, for which predicted strain coverage is similar to Bexsero  (within confidence limits). Developing MenB vaccines continues to be a considerable challenge to scientists and clinicians and this interim decision highlights to me the need for increased support for basic vaccine research.

 “But for families who have lost loved ones to this disease and to the survivors who suffer life-long disabilities, the JCVI decision not to recommend Bexsero is moot. If Bexsero is introduced and efficacy predictions hold true, 60-80 individual lives will likely be saved this year. The opportunity has not been entirely lost and hopefully the decision does not set a precedent when other competitive MenB vaccines become available. However, in the continuing absence of an effective MenB vaccine for routine immunisation, we should all ensure that we reacquaint ourselves with the signs and symptoms of this devastating disease.”

 Professor Richard Moxon, Professor of Paediatrics, University of Oxford, who was involved in the production of the trialled vaccine, said:

 “The JCVI interim statement and its recommendation not to introduce Bexsero in the UK will evoke bitter disappointment among the advocates of this MenB vaccine.  The JCVI’s reasons – the lack of cost-effectiveness, uncertainties on its effectiveness to prevent disease and decrease person to person spread – are so similar to the unknowns surrounding the successful implementation of the MenC vaccine in the year 2000 that many will argue that there is blatant inconsistency.  The UK MenC campaign was hailed as a major public health triumph by the international community.  It is good that there is time for further dialogue and debate. As it stands, the JCVI’s statement runs the risk that this and other MenB vaccines could be shelved.”

Professor Adam Finn, Professor of Paediatrics, University of Bristol, said:

 “The JCVI decision not to advise introduction of the MenB vaccine contrasts with the decision 13 years ago to go ahead with MenC immunization, which turned out to be very effective. In both cases the illness targeted for prevention is very serious and sometimes fatal but very rare. Some key differences which may explain the very different advice being offered are that MenC disease was getting commoner at the time whereas MenB disease is currently getting rarer and that the MenC vaccine was of a similar design to existing meningitis vaccines whereas the new MenB vaccine is novel and so uncertainties around its likely effectiveness are greater. Other meningitis vaccines actually work largely by preventing circulation of the strains that cause disease and a key priority for those wishing to see this and other MenB vaccines developed and used will be to show clearly and convincingly that this can be achieved.”

Dr David Elliman, Immunisation Representative for Royal College of Paediatrics and Child Health, said:

 “This must have been a very difficult decision for the JCVI to make.  That they are not recommending the routine use of the new meningococcal B vaccine will be a disappointment to many people. The statement made by the JCVI today sets out the reasons for their decision.

 “Nobody doubts that meningococcal B disease can be catastrophic and that all reasonable means should be taken to prevent it. However, before introducing a new vaccine or drug, it is important to be sure that not only is it safe and effective, but bearing in mind the increasing financial pressures on the NHS, it also has to be cost effective. Money spent on the vaccine is money not spent on something else.  Unfortunately, evidence on these points is either lacking or conflicting.

 “It is important that the introduction of a new vaccine does not jeopardise our current immunisation programme. There is clear evidence that the vaccine is more likely to cause a high fever than other vaccines. While this may not seem important to a healthcare professional, it may dissuade some parents from bringing their children back for subsequent equally important vaccines. The only published peer reviewed study of the effect of giving paracetamol at the time of vaccination with other vaccines showed that the effect was to reduce the antibody responses to some of the other vaccines. It is not clear what this means in practice, but more work is needed, before one can recommend this as a way of reducing fever after vaccination.

 “No studies have been done to show, in practice, whether the vaccine protects against disease. Research has shown that the vaccine does result in high levels of antibodies and there is reason to believe these may result in protection. It is true that the meningococcal C vaccine was introduced on the basis of similar evidence, however, this is a different sort of vaccine and so estimating whether protection results from it is not so straightforward.

 “The only published study looking at cost effectiveness in England, suggested the vaccine may be cost effective, but only if the vaccine was priced very low. While the methods used for calculating cost effectiveness have been criticised, the principle of spending our money carefully and balancing it against other needs is well founded.

 “The JCVI statement is clearly a decision made for this point in time. It should be possible to fill some of these gaps in knowledge and then the decision should be reconsidered.”