Novartis announced Tuesday that European regulators approved Bexsero to protect individuals from 2 months of age and older against meningococcal serogroup B (MenB) disease. The company noted that the product, which it will make available as soon as possible, is the first vaccine cleared by the European Commission to prevent meningitis B.
The drugmaker indicated that following the approval, EU member states will evaluate Bexsero for potential inclusion into national immunisation programmes and, where relevant, reimbursement schemes. Novartis said it is already engaging with governments interested in the early adoption of the vaccine.
Bexsero gained the backing of the European Medicines Agency's Committee for Medicinal Products for Human Use in November last year. At the time, Novartis noted that the vaccine's tolerability profile and immunogenicity has been established through a clinical programme including data from Phase II/III trials involving almost 8000 infants, children, adolescents and adults.
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