Pfizer: U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer’s Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV Disease in Older Adults

Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, as submitted for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

Priority Review designation by the FDA reduces the standard BLA review period by four months. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the RSVpreF application is in May 2023. This decision follows the FDA’s Breakthrough Therapy Designation of RSVpreF in older adults in March 2022.

“With no RSV vaccines currently available, older adults remain at-risk for RSV disease and potential severe outcomes, including serious respiratory symptoms, hospitalization, and in some cases, even death,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research & Development, Pfizer. “The FDA’s acceptance of the BLA for our RSV vaccine candidate is an important regulatory milestone in Pfizer’s efforts to help protect older adults against RSV and demonstrates additional progress toward what has been an elusive public health goal – reducing the overall burden associated with this infectious disease.”

The regulatory submission is supported by results of the Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease). RENOIR is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults 60 years of age and older. RENOIR has enrolled approximately 37,000 participants, randomized to receive RSVpreF 120 μg or placebo in a 1:1 ratio. In August 2022, Pfizer announced positive top-line results of an interim efficacy analysis for RENOIR.