FDA Expands GSK’s Arexvy to High-Risk Adults 18–49, Completing Trio of RSV Vaccines for Younger At‑Risk Group

Overview

• GSK’s Arexvy won an FDA label expansion to cover non‑pregnant adults aged 18 to 49 who are at increased risk for RSV‑associated lower respiratory tract disease.
• With this decision, all three FDA‑approved RSV vaccines—Arexvy (GSK), Abrysvo (Pfizer) and mRESVIA (Moderna)—now include high‑risk adults under 50.
• The CDC and its Advisory Committee on Immunization Practices are still reviewing evidence and have not issued guidance for vaccinating the 18–49 high‑risk group.
• The FDA’s action was supported by a Phase IIIb non‑inferiority study (NCT06389487) showing immune responses in 18–49‑year‑olds comparable to those seen in adults 60 and older.
• Arexvy first launched in 2023 for adults 60+ and later expanded to 50–59, and GSK says it plans additional regulatory filings in other geographies as competition with Pfizer and Moderna intensifies.