Breakthrough Designation for Pfizer RSV Vaccine Candidate

FDA has granted breakthrough designation for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate to prevent lower respiratory tract disease caused by RSV in individuals age 60 and older. The company says the designation was 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 RSVpreF in a human viral challenge model in healthy adults 18 to 50 years old.

Pfizer announced in 9/2021 the opening of the RENOIR Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults age 60 and older. That study is continuing, it says.

Earlier, FDA granted breakthrough designation to RSVpreF for preventing RSV-associated lower respiratory tract disease in infants from birth to 6 months in age by active immunization of pregnant women.