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Positive CHMP opinion on Arexvy for all adults 18+
GSK plc announced that its respiratory syncytial virus (RSV) vaccine, Arexvy, has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to expand its indication to all adults aged 18 and older, with a final decision expected in February 2026. This potential expansion addresses the significant burden of RSV in the EU, where an average of 158,000 adults are hospitalized annually due to RSV-related illness. The company is also seeking expanded indications for Arexvy in the US and Japan. Disclaimer*
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 12 December 2025, London UK\n \nGSK's RSV vaccine, Arexvy, receives positive CHMP opinion for all adults 18 years and older\n \n· Marketing authorisation expected in February 2026\n· Every year an average of 158,000 adults are hospitalised with RSV-related illness in the EU[1]\n \n\n\nGSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to all adults aged 18 years and older. The European Commission's final decision is expected in February 2026. If approved, the expanded indication would make the vaccine available for all adults aged 18 years and older.*\n\nArexvy was the first RSV vaccine approved in Europe for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and in those aged 50-59 years who are at increased risk for RSV disease.\n\nSanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: \"Today's positive CHMP opinion is an important step towards bringing more options to prevent severe RSV disease for adults in Europe. GSK is dedicated to increasing access to our vaccines in broader adult populations and we continue to drive innovation to help make it easier for healthcare professionals to offer protection against severe RSV disease.\"\n\nRSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.[2] RSV can exacerbate certain medical conditions, and lead to severe illness resulting in hospitalisation and even death.1,[3],[4]\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 with 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 to be underestimated due to lack of routine testing.[5],[6],[7],[8]\n\nGSK is continuing 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, ...