13th Mar 2026 11:02
(Alliance News) - GSK PLC on Friday said its respiratory syncytial virus vaccine, Arexvy, has gained an age indication expansion from the US Food & Drug Administration.
The London-based pharmaceutical firm said the vaccine has been approved for use in adults aged 18 to 49, who are at increased risk for lower respiratory tract disease caused by RSV.
GSK said its vaccine previously had approval in the US for the prevention of RSV-related lower respiratory tract disease in adults aged 60 and older. It added that it was also approved for use in adults aged 50 to 59 at increased risk of lower respiratory tract disease from RSV.
In the US, is is estimated that 21 million adults below 50 possess at least one risk factor for severe RSV infection, noted GSK. Further, the company reported that the annual RSV burden among US adults between 18 and 49 is around 17,000 hospitalisations and 277,000 emergency department admissions.
GSK noted that the FDA's decision was supported by phase 3b trial data that demonstrated a "non-inferior immune response" compared to adults aged 60 years and above.
The company added that is continuing to advance regulatory submissions for its RSV vaccine across several geographies.
Shares in GSK were up 0.7% at 2,045.00 pence on Friday morning in London.
"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," said Sanjay Gurunathan, GSK head of Vaccines and Infectious Diseases Research and Development.
"We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations."
By Christopher Ward, Alliance News reporter
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