Posted by Michael Wonder on 24 Mar 2022
Pfizer granted FDA breakthrough therapy designation for respiratory syncytial virus vaccine candidate for the prevention of RSV in older adults
24 March 2022 - Pfizer today announced that its respiratory syncytial virus vaccine candidate, PF-06928316 or RSVpreF, received breakthrough therapy designation from the U.S. FDA for the prevention of lower respiratory tract disease caused by the respiratory syncytial virus in individuals 60 years of age or older.
The FDA decision is primarily informed by the positive results of a proof of concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age.
