Pfizer receives FDA Priority Review for RSV jab

Dec. 8, 2022

Pfizer announced this week that the U.S. FDA has granted it Priority Review for its respiratory syncytial virus (RSV) vaccine candidate in older adults.

Pfizer’s PF-06928316 or RSVpreF — which received Breakthrough Therapy Designation in March 2022 — is a bivalent shot that protects against both RSV A and B. Its technology is based on the crystal structure of prefusion F, a vital form of the viral fusion protein (F) that RSV uses to attack human cells. 

With its recent Priority Review designation, the jab’s Prescription Drug User Fee Act (PDUFA) is now May 2023, shortening its BLA review period by four months. 

RSVpreF’s BLA was supported by results from the global, randomized, double-blind, placebo-controlled phase 3 clinical trial RENOIR (RSV vaccine Efficacy study in Older adults Immunized against RSV disease). The study, which enrolled approximately 37,000 participants, showed that the jab had of 85.7% efficacy in reducing the risk of severe lower respiratory tract illness (LRTI-RSV) defined by analysis of three or more RSV-associated symptoms. RSVpreF’ was also well tolerated among patients. 

The FDA’s recent decision comes just a month after GSK was also granted Priority Review for its RSV jab, which as a PDUFA date of May 3, 2023. Sanofi and AstraZeneca's jointly developed vaccine, nirsevimab, which is designed to protect infants from RSV, is already in the hands of regulators.