The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for Pfizer’s bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF or PF-06928316, for the prevention of lower respiratory tract disease caused by RSV in adults 60 years of age and older.

The RSVpreF vaccine candidate consists of 2 prefusion F proteins selected to optimize protection against RSV A and B. The BLA is supported by data from the randomized, double-blind, placebo-controlled phase 3 RENOIR trial (ClinicalTrials.gov Identifier: NCT05035212) that evaluated the efficacy and safety of RSVpreF in approximately 37,000 adults 60 years of age and older. 

Patients were randomly assigned 1:1 to receive either a single dose of RSVpreF 120μg or placebo. The primary efficacy endpoint was the number of first RSV-associated lower respiratory tract illness (LRTI-RSV) episodes in the first RSV season.

Results from an interim analysis demonstrated that RSVpreF achieved a vaccine efficacy of 66.7% (96.66% CI, 28.8-85.8) for protection against LRTI-RSV defined by 2 or more symptoms, and a vaccine efficacy of 85.7% (96.66% CI, 32.0-98.7) for protection against LRTI-RSV defined by 3 or more symptoms. The vaccine was found to be well tolerated with no safety concerns.

A Prescription Drug User Fee Act goal date of May 2023 has been set for this application. The FDA previously granted Breakthrough Therapy designation to RSVpreF in older adults. 

“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,” said Annaliesa Anderson, PhD, SVP and Chief Scientific Officer, Vaccine Research & Development, Pfizer. 

The Company is also investigating RSVpreF for the prevention of RSV-associated lower respiratory tract illness in infants from birth up to 6 months of age by active immunization of pregnant women.

Reference

US 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. News release. Pfizer Inc. Accessed December 7, 2022. https://www.businesswire.com/news/home/20221206006147/en/U.S.-FDA-Accepts-for-Priority-Review-the-Biologics-License-Application-for-Pfizer%E2%80%99s-Respiratory-Syncytial-Virus-Vaccine-Candidate-for-the-Prevention-of-RSV-Disease-in-Older-Adults.