EMA recommends approval of first vaccine for meningitis B

Vaccine to provide broad coverage against meningococcal group B infections

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Bexsero.

Bexsero is new vaccine for the immunisation of individuals over two months of age against invasive meningococcal disease caused by Neisseria meningitidis group B.

There is currently no authorised vaccine available in the EU for bacterial meningitis caused by this group of bacteria.

Each year, approximately 1.2 million cases of invasive meningococcal disease are recorded worldwide, of which 7,000 occur in Europe. More than 90% of cases of meningococcal meningitis and septicaemia are caused by five of the 13 meningococcal serogroups. In Europe, group B is the most prevalent, with 3,406–4,819 cases reported annually between 2003 and 2007, according to a surveillance report published by the European Centre for Disease Control.

Authorised vaccines against meningococcal disease caused by groups A, C, W135 and Y are available, but there is currently no authorised vaccine that provides broad coverage against group B meningococcal disease.

The disease mainly affects infants and young children, but could occur also in older children and young adults.

‘In spite of the availability of medical treatment and effective antibiotics, 8% of European patients die and 11–19% suffer life-long consequences, including permanent brain damage, learning disabilities and hearing loss,’ said EMA. There are higher incidences in Belgium, Ireland, Spain and the UK than in other EU countries.

The CHMP’s opinion on Bexsero will now be sent to the European Commission for the adoption of a marketing authorisation.

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