The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to RSVpreF (PF-06928316), a respiratory syncytial virus (RSV) vaccine candidate, 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 designation was based on positive topline results from a global, double-blind, placebo-controlled, proof-of-concept phase 2b study (ClinicalTrials.gov Identifier: NCT04785612), which evaluated the efficacy, safety, and immunogenicity of a single dose of RSVpreF 120mcg in healthy adults 18 to 50  years of age using a human viral challenge model.

The Company is currently investigating RSVpreF in adults 60 years of age and older in the randomized, double-blind, placebo-controlled phase 3 RENOIR trial (ClinicalTrials.gov Identifier: NCT05035212), which was initiated in September 2021.

“Today’s decision is a significant step forward in our efforts to help protect vulnerable populations, particularly older adults, against certain potentially serious respiratory illnesses, including RSV,” said Kathrin U. Jansen, PhD, SVP and Head of Vaccine Research & Development at Pfizer Inc. “The clinical and economic burden of RSV represents a critical need, and we look forward to our ongoing dialogue with the FDA to accelerate the development of our RSV vaccine candidate.”

In March 2022, the FDA also granted Breakthrough Therapy designation to 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

Pfizer granted FDA Breakthrough Therapy designation for respiratory syncytial virus vaccine candidate for the prevention of RSV in older adults. News release. Pfizer Inc. Accessed March 24, 2022. https://www.businesswire.com/news/home/20220323005984/en/Pfizer-Granted-FDA-Breakthrough-Therapy-Designation-for-Respiratory-Syncytial-Virus-Vaccine-Candidate-for-the-Prevention-of-RSV-in-Older-Adults