- The FDA has granted Breakthrough Therapy Designation to Pfizer Inc's (NYSE: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.
