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European Commission approves Arexvy for adults 18+
GSK plc announced that its RSV vaccine, Arexvy, has received European Commission approval for expanded use in all adults aged 18 and older, a significant market expansion as an average of 158,000 adults in the EU are hospitalised with RSV annually. This approval follows previous authorisations for older adults and those at increased risk, and GSK is seeking similar expanded indications in the US and Japan. Disclaimer*
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 26 January 2026, London UK\n \nGSK's RSV vaccine, Arexvy, receives European approval for expanded use in all adults 18 years and older\n \n· In the EU, an average of 158,000 adults are hospitalised with RSV-related illness every year[1]\n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, has been approved by the European Commission* (EC) for use in adults aged 18 years and older. Arexvy was the first RSV vaccine authorised in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV. It was previously approved in adults aged 60 years and above, as well as in those aged 50 to 59 years who are at increased risk for RSV disease. Today's updated indication now enables European countries to make the vaccine available to all adults aged 18 years and older.\n \nSanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: \"This approval helps protect all adults aged 18 and older in Europe against RSV, a potentially serious respiratory infection that can lead to significant illness, hospitalisation and even death, particularly for those with certain underlying health conditions. GSK is proud to expand prevention options against RSV across Europe.\"\n\nIn the European Union, an average of 158,000 adults aged 18 and over are hospitalised due to RSV infections each year.1 Compared to children, adults hospitalised for RSV are at a higher risk of severe complications, require more costly treatments, have a higher fatality rate, and their true number is likely underestimated due to lack of routine testing.[2],[3],[4],[5]\n\nGSK continues to seek expanded indications for its RSV vaccine in other geographies including the US and Japan.\n \nAbout GSK's RSV vaccine\nRespiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK's proprietary AS01E adjuvant.\n \nThe use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.\n \nThe vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of a...