Adjuvanted RSVPreF3 Vaccine

Phase III data showed that adjuvanted RSVPreF3 reduced RSV-associated lower respiratory tract disease by 82.6% compared with placebo in adults aged 60 years and older. Clinical trials did not have enough power to reliably detect meaningful increases in very rare adverse outcomes. FDA approval was expanded in June 2024 to adults aged 50-59 years who are at increased risk for RSV-associated lower respiratory tract disease. The FDA first approved the vaccine in May 2023 for preventing RSV-associated lower respiratory tract disease in adults aged 60 years and older. Adjuvanted RSVPreF3 is a single-dose recombinant stabilized prefusion F protein vaccine that uses the AS01E adjuvant system.