First vaccine for meningitis B

by Gary Finnegan – EMA Highlights – The EMA has given the green light to a new vaccine for bacterial meningitis. Bexsero, by Novartis, provides broad coverage against the meningococcal group B infections and is intended for the immunisation of children aged two months and older.

The move was hailed by the public health community as it fills an unmet need in Europe where around 7,000 cases of invasive meningococcal disease are recorded each year.

Over 90% of cases of meningococcal meningitis and septicaemia are caused by five of the 13 meningococcal serogroups, specifically groups A, B, C, W135 and Y. In Europe, group B is the most prevalent meningococcal serogroup, with 3,406 to 4,819 cases reported annually between 2003 and 2007, according to a surveillance report published by the European Centre for Disease Control.

Vaccines have previously been authorised to protect against meningococcal disease caused by groups A, C, W135 and Y, but there had been no approved vaccine available 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. Despite the availability of medical treatment and effective antibiotics, 8% of European patients die and some 11-19% of survivors suffer life-long consequences, including permanent brain damage, learning disabilities and hearing loss.

There are currently some geographical regions within the EU with higher incidence rates, mainly in Belgium, Ireland, Spain and the United Kingdom.