Introducing a new group B meningococcus vaccine

The introduction of a new vaccine is highly complex, particularly a new category of vaccine with no biological precedent. The new group B meningococcus vaccine Bexsero (4CMenB),1 developed using a genomic based reverse vaccinology approach,2 is a case in point. When a vaccine is targeted against a relatively common disease, the company usually sponsors a large randomised controlled trial to show that the vaccine works. Group B meningococcal infection is sufficiently rare, however, that such a trial is not feasible.

In most countries, advice on vaccines and immunisation programmes is given to governments by independent committees. This advice includes data on vaccine effectiveness, the likelihood that the vaccine will confer herd immunity (protect some unimmunised people by reducing carriage or spread of disease), safety, and cost effectiveness. In the United Kingdom, the Joint Committee on Vaccination and Immunisation (JCVI) has such a role. In the UK,3 and in Australia, Canada, the United States, and many European countries, the government is not permitted in law to fund an immunisation programme unless the immunisation advisory committee says it is cost effective.

Different countries allow different assumptions in the modelling, so they do not always reach the same decision. The process usefully distances …