Pfizer announces FDA acceptance of BLA for MenABCWY in adolescents

Pfizer announced that the U.S. Food and Drug Administration accepted for review a Biologics License Application for 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 goal date for a decision by the FDA on the pentavalent meningococcal vaccine application is in October 2023. Pfizer’s MenABCWY vaccine candidate combines the components of two vaccines into one, helping protect against the meningococcal serogroups that cause the majority of invasive meningococcal disease globally. In the U.S., approximately 55 million adolescents and young adults are in the age range for meningococcal vaccination, according to ACIP recommendations. The regulatory submission is supported by previously announced results from a randomized, active-controlled and observer-blinded Phase 3 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 3 trial evaluated more than 2,400 patients from the U.S. and Europe.