Adjuvanted RSVPreF3 Vaccine

How it works

Benefits

Background

Evidence quality

Highlighted claims

• Adjuvanted RSVPreF3 is a single-dose recombinant stabilized prefusion F protein vaccine that uses the AS01E adjuvant system. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
• The FDA first approved the vaccine in May 2023 for preventing RSV-associated lower respiratory tract disease in adults aged 60 years and older. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
• 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. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
• 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. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
• Clinical trials did not have enough power to reliably detect meaningful increases in very rare adverse outcomes. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study