The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Pfizer’s investigational pentavalent meningococcal vaccine (MenABCWY) in individuals 10 through 25 years of age.

The BLA is supported by data from a randomized, active-controlled, observer-blinded trial (ClinicalTrials.gov Identifier: NCT04440163) which included 2341 healthy individuals 10 through 25 years of age. Participants were randomly assigned to receive either 2 doses of MenABCWY or licensed meningococcal vaccines (2 doses of Trumenba® plus 1 dose of Menveo®).

Findings showed that MenABCWY met the primary endpoint achieving noninferiority for all 5 serogroups (serogroups A, B, C, W and Y) compared with 2 doses of Trumenba and 1 dose of Menveo. Noninferiority was also demonstrated for serogroups A, C, W and Y with a single dose of MenABCWY compared with 1 dose of Menveo (secondary endpoint).

A Prescription Drug User Fee Act target date of October 2023 has been set for this application.

Annaliesa Anderson, PhD, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, said: “We believe our investigational MenABCWY vaccine, if approved and recommended, could help simplify the meningococcal vaccination schedule for adolescents and young adults, and in turn improve vaccination rates, and provide the broadest serogroup coverage of any meningococcal vaccine.”

Reference

US FDA accepts for review the Biologics License Application for Pfizer’s investigational pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents. News release. Pfizer Inc. Accessed December 28, 2022. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-review-biologics-license-application-pfizers.