Pfizer's RSV Vaccine Candidate Receives FDA Breakthrough Therapy Tag For Prevention of RSV In Older Adults

The FDA has granted Breakthrough Therapy Designation to Pfizer Inc's PFE respiratory syncytial virus (RSV) vaccine candidate (PF-06928316 or RSVpreF) to prevent lower respiratory tract disease caused by RSV in 60 years of age or older.
The positive results primarily inform the FDA decision of Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg vaccine in a human viral challenge model in healthy adults 18 to 50 years of age.
In September 2021, Pfizer initiated a RENOIR Phase 3 trial evaluating the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults ages 60 years or older. This study remains ongoing.
Earlier this month, the FDA granted the Breakthrough Therapy tag to Pfizer's RSV vaccine candidate to prevent RSV-associated lower respiratory tract illness in infants up to six months of age by active immunization of pregnant women.
Price Action: PFE shares are up 0.13% at $52.26 during the premarket session on the last check Thursday.