GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk

GSK

13 March 2026 - GSK today announced that the US FDA has 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 caused by the respiratory syncytial virus.

The FDA’s decision was supported by data from a Phase 3b trial demonstrating a non-inferior immune response compared to adults aged 60 years and above.

Read GSK press release

Michael Wonder

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Michael Wonder

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Outcome , US , Vaccine , Registration