FDA AdComm Gives Thumbs Up To Pfizer's RSV Vaccine Candidate For Elderly People

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of Pfizer Inc's PFE available data is adequate to support the safety and effectiveness of its respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF.
The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness.
The vaccine candidate is under FDA review to prevent acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 and older."
Related: Pfizer Touts Positive Data From Global Maternal Immunization Trial For Its Bivalent RSV Vaccine Candidate.
The VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including interim data from the pivotal Phase 3 RENOIR study demonstrating vaccine efficacy at 85.7%.
The Prescription Drug User Fee Act (PDUFA) goal date is in May 2023.
Last year, Pfizer acquired ReViral Ltd, a privately held, clinical-stage biopharmaceutical company focused on antiviral therapeutics for the respiratory syncytial virus (RSV), for $525 million, including upfront and development milestones.
If successful, Pfizer said annual revenue for these programs has the potential to reach or exceed $1.5 billion.
Price Action: PFE shares are up 0.12% at $40.62 on the last check Wednesday.