FDA expands approved age indication for GSK RSV vaccine in higher risk adults

13th Mar 2026 10:36

(Sharecast News) - The US Food and Drug Administration has expanded the approved age indication of GSK's respiratory syncytial virus vaccine, Arexvy, to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV.

GSK noted on Friday that the vaccine was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50-59 at increased risk for LRTD caused by RSV. It is not for use in pregnant women.

Sanjay Gurunathan, GSK head of vaccines and infectious diseases research and development, said: "This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system.

"We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations."

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