Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) said the European Commission has approved expanded use of its respiratory syncytial virus vaccine, Arexvy, for adults aged 18 years and older. Decision broadens the vaccine's indication from previous approvals covering adults aged 60 and above and those aged 50 to 59 at increased risk, enabling EU countries to make Arexvy available to all adults from 18.
Arexvy was the first RSV vaccine authorised in the European Economic Area for prevention of lower respiratory tract disease caused by RSV. Approval addresses a significant disease burden, with an average of 158,000 adults aged 18 and over hospitalised with RSV-related illness each year in the European Union.
GSK said adults hospitalised with RSV face higher risks of severe complications, increased treatment costs and higher fatality rates compared with children, with overall case numbers likely underestimated due to limited routine testing. The company continues to pursue expanded RSV vaccine indications in other markets, including the United States and Japan.
Arexvy contains recombinant RSV glycoprotein F stabilised in the prefusion conformation combined with GSK's proprietary AS01E adjuvant. The vaccine is approved in more than 65 countries for adults aged 60 and over and in more than 60 countries for adults aged 50 to 59 at increased risk due to underlying conditions.
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European Commission approves GSK's Arexvy for adults aged 18 and over