FDA

FDA OKs Arexvy for at-risk adults aged 18 to 49 years

March 17, 2026

On March 13, 2026, FDA expanded the approved age indication of Arexvy (Respiratory Syncytial Virus vaccine, [adjuvanted]) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. Arexvy was previously approved in the U.S. for the prevention of RSV-related LRTD in adults ≥60 of age, and adults aged 50 to 59 at increased risk for LRTD caused by RSV.

Arexvy is not for use in pregnant individuals.

Efficacy and safety

FDA’s decision was based on results from a phase 3b study (NCT06389487) showing an immune response that was non-inferior to that seen in adults aged 60 years and older. The safety profile aligned with the broader phase 3 program supporting initial U.S. approval, with the most frequently reported adverse events—including injection-site pain, fatigue, myalgia, headache, and arthralgia—occurring within four days after vaccination.

Source:

GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk. [News release]. 2026. https://www.gsk.com/en-gb/media/press-releases/gsk-s-rsv-vaccine-arexvy-approved-in-us-for-expanded-age-indication-in-adults-aged-18-49-years-at-increased-risk/

Arexvy (respiratory syncytial virus vaccine, adjuvanted) [package insert]. GSK. https://www.novartis.com/us-en/sites/novartis_us/files/cosentyx.pdf Revised March 2026. Accessed March 16, 2026.