Pfizer: FDA to Review Meningococcal Vaccine Candidate

 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine candidate (MenABCWY). 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.

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.1 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.

https://finance.yahoo.com/news/u-fda-accepts-review-biologics-114500292.html