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Mar 13, 2026 12:40 PM

FDA Broadens Access To GSK's Respiratory Syncytial Virus Shot For Younger High-Risk Adults

On Friday, the U.S. Food and Drug Administration (FDA) expanded the approved age indication for GSK plc’s (NYSE:GSK) respiratory syncytial virus vaccine, Arexvy.

The approval allows its use in adults aged 18 to 49 who face a higher risk of lower respiratory tract disease caused by RSV.

The vaccine was previously approved to prevent RSV-related lower respiratory tract disease in adults aged 60 and older, as well as those aged 50 to 59 who are at increased risk of complications.

The shot is not approved for use in pregnant individuals.

FDA Expands Access To RSV Protection

Sanjay Gurunathan, head of vaccines and infectious diseases research and development at GSK, said the broader age indication addresses an unmet medical need among younger adults with underlying health conditions.

He added that expanding eligibility for the vaccine could help protect people vulnerable to severe RSV disease while also easing pressure on ...