Pfizer Pentavalent Meningococcal Vaccine under USFDA review

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.

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 (IMD) globally. In the U.S., approximately 55 million adolescents and young adults are in the age range for meningococcal vaccination (11-23 years old), according to ACIP recommendations.

“The FDA’s acceptance of our application for the pentavalent meningococcal vaccine candidate is an essential step toward helping protect individuals and communities against the most common types of meningococcal disease,” said Annaliesa Anderson, Ph.D., Senior Vice President, and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “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. The pentavalent vaccine candidate was well-tolerated in clinical trials, with a safety profile consistent with currently licensed meningococcal vaccines.”

The regulatory submission is supported by previously announced positive 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 (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe.