EMA recommends marketing authorization for Bexsero (mening B – Novartis)

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the granting of a marketing authorisation for Bexsero, a new Novartis vaccine intended 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 European Union (EU) for bacterial meningitis caused by Neisseria meningitidis group B…In Europe, group B is the most prevalent meningococcal serogroup, with 3,406-4,819 cases reported annually between 2003 and 2007, according to a surveillance report published by the European Centre for Disease Prevention and Control….There are currently some geographical regions within the EU with higher incidence rates, mainly in Belgium, Ireland, Spain and the United Kingdom…The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group-B strains in different geographical areas should be considered when vaccinating. Vaccination with Bexsero should be in accordance with official recommendations applicable in the Member States. The CHMP’s opinion on Bexsero will now be sent to the European Commission for the granting of a marketing authorisation.