FDA Approves Second Meningitis B Vaccine

Novartis announced that the Food and Drug Administration (FDA) has granted accelerated approval of Bexsero (meningococcal group B vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningitis B in patients aged 10–25 years. Bexsero’s two-dose regimen offers a flexible dosing schedule which allows the first and second doses to be administered at least one month apart.

In Phase 2 and 3 clinical studies, Bexsero showed a protective immune response in adolescents and young adults after 2 doses. Post-vaccination, 62–88% of participants had antibodies in their blood that killed 3 different N. meningitidis serogroup B strains vs. 0–23% prior to vaccination. Novartis will continue its ongoing studies to confirm the efficacy of Bexsero against various serogroup B strains.

Bexsero is the second vaccine approved by the FDA in the past three months to prevent this disease. The agency approved the first meningococcal serogroup B vaccine in October 2014. Before these approvals, existing approved meningococcal vaccines in the U.S. covered only four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y and W.

Bexsero vaccine will be available as a suspension for intramuscular injection in 0.5mL single-dose pre-filled syringes in 1- and 10-count cartons.

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