The U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of Pfizer Inc.'s (PFE) respiratory syncytial virus or RSV vaccine for older adults.
The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness of RSV bivalent vaccine candidate PF-06928316 or RSVpreF, Pfizer said in a statement on Tuesday.
The vaccine candidate is currently under FDA review for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 years of age and older.
The FDA decision is expected by the Prescription Drug User Fee Act (PDUFA) goal date in May 2023.
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