FDA expands GSK's AREXVY vaccine approval to adults 18-49 at risk
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GSK’s RSV Vaccine, AREXVY, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased Risk
March 13, 2026 11:44 AM EDTIn the US, an estimated 21 million adults under 50 have at least one risk factor for severe RSV infection1*
PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (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 (LRTD) caused by RSV. AREXVY was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and... More
