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GSK Says US FDA Expands Arexvy Vaccine Approval to At-Risk Adults Under 50
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GSK Says US FDA Expands Arexvy Vaccine Approval to At-Risk Adults Under 50
Mar 13, 2026 4:50 AM

07:23 AM EDT, 03/13/2026 (MT Newswires) -- GSK (GSK) said Friday the US Food and Drug Administration has expanded the approved indication of its Arexvy vaccine to include adults 18 to 49 years old who are at increased risk of lower respiratory tract disease caused by respiratory syncytial virus, or RSV.

The company said the expanded approval was supported by phase 3b trial data showing the vaccine generated an immune response comparable to that seen in adults 60 years and older.

Arexvy was previously approved in the US for use in adults aged 60 years and older, and for adults 50 to 59 years old at higher risk for RSV disease, GSK said.

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