Pfizer Submits BLA to U.S. FDA for Pentavalent Meningococcal Vaccine MenABCWY

Gelonghui December 28th丨According to market news, Pfizer has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its pentavalent meningococcal vaccine candidate MenABCWY, intended to prevent meningococcal disease caused by the most common serogroups in individuals aged 10 to 25. The FDA is expected to make a decision by October 2023. Pfizer stated that its pentavalent meningococcal vaccine MenABCWY, similar to its own Group B meningococcal vaccine Trumenba and GlaxoSmithKline's meningococcal vaccine Menveo, met both primary and secondary endpoints in Phase III trials conducted among healthy individuals aged 10-25. Pfizer said on Wednesday that if the vaccine is approved, it would help streamline the meningococcal vaccination schedule and provide the broadest coverage of meningococcal serogroups.