Pfizer submitted a marketing application for pentavalent meningococcal vaccine to the US FDA
Pfizer submitted a Biologics License Application (BLA) for MenABCWY, a pentavalent meningococcal vaccine candidate, to the U.S. Food and Drug Administration (FDA) for the prevention of meningococcal disease, the most common serogroup in people aged 10 to 25 years. FDA expects to make a decision in October 2023. Pfizer said its pentavalent meningococcal vaccine MenABCWY, like its own group B meningococcal vaccine Trumenba and GlaxoSmithKline’s meningococcal vaccine Menveo, met the primary and secondary goals of the phase III trial in healthy people aged 10-25 years. Pfizer said Wednesday that if approved, the vaccine would help simplify the meningococcal vaccination schedule and provide the broadest meningococcal seropopulation coverage.