31 May 2023 - FDA’s decision is based on the data from the pivotal Phase 3 clinical trial in approximately 37,000 participants.
Pfizer announced today that the US FDA has approved Abrysvo (respiratory syncytial virus vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older.