Pfizer’s BLA for Its RSV Vaccine Gets Priority Review
The FDA has granted a priority review to Pfizer’s Biologics License Application for its vaccine candidate RSVpreF for respiratory syncytial virus (RSV)-associated lower respiratory tract disease in individuals 60 years and older.
Currently surging across the U.S., RSV usually leads to mild and cold-like symptoms but can become serious in infants, older adults and people with chronic heart or lung disease. There is no approved vaccine.
In the U.S. alone, RSV infections typically account for up to 120,000 adult hospitalizations and up to 4,000 deaths each year.
RSVpreF received Breakthrough Therapy status in March. The FDA’s targeted decision date on the BLA is May 2023.