FDA accepts application for BLA for MenABCWY vaccine for meningococcal disease – Pfizer

Pfizer announced that the FDA accepted for review a Biologics License Application (BLA) for MenABCWY, its investigational pentavalent meningococcal vaccine candidate. Pfizer submitted MenABCWY for the prevention of meningococcal disease caused by the most common serogroups in individuals 10 through 25 years of age. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the pentavalent meningococcal vaccine application is in October 2023.

The regulatory submission is supported by previously announced positive results from a randomized, active-controlled and observer-blinded Phase III trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase III trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe.