On January 26, 2026, GSK announced that the European Commission approved the RSV vaccine Arexvy for adults aged 18 and older. Previously, the vaccine was approved for people aged 60 and older and for those aged 50 to 59 at increased risk, according to GSK. The new indication allows European countries to make Arexvy available to all adults. According to GSK, an average of 158,000 adults aged 18 and older are hospitalized annually in the European Union with RSV infections.
RSV is a widespread, contagious virus that affects the lungs and airways and reportedly affects an estimated 64 million people of all ages worldwide annually, according to GSK. Adults with certain chronic conditions, weakened immune systems, or advanced age may be at increased risk, according to GSK. RSV can worsen COPD, asthma, and chronic heart failure and can lead to pneumonia, hospitalization, and death. Arexvy contains a stabilized RSV glycoprotein F in the prefusion conformation, combined with GSK's proprietary adjuvant AS01E, according to GSK. The company states it was the first RSV vaccine approved in the European Economic Area for lower respiratory tract disease.
How the Expansion Came About
GSK requested the change in approval status from the European Medicines Agency on May 29, 2025. The CHMP issued its recommendation on December 11, 2025. The basis was the open-label Phase 3b study 222253 (RSV OA=ADJ-025), which examined noninferiority of immune response and safety in adults aged 18 to 49 years at increased RSV risk compared to those aged 60 and older, according to the EMA assessment report. The noninferiority criteria were met, according to the EMA. This allows efficacy in adults aged 18 to 59 to be inferred from the results in adults aged 60 and older. Among other factors, people with immunosuppression or unstable chronic conditions were excluded from participation, according to the study registry ClinicalTrials.gov. According to scientific advice quoted in the assessment report, approval for younger adults could be based on such immunobridging and safety data if efficacy had previously been demonstrated in the pivotal study in persons aged 60 and older by a prespecified criterion. In the earlier expansion to ages 50 to 59 at risk, GSK had used the same principle with study RSV OA=ADJ-018.
What the Efficacy Study in Older Adults Shows
Efficacy data for adults aged 60 and older come from the randomized, placebo-controlled, observer-blinded Phase 3 study AReSVi-006 conducted in 17 countries across Africa, Asia, Oceania, Europe, and North America. According to the European product information, 24,960 participants aged 60 and older were randomized 1:1 to receive one dose of Arexvy (12,466) or placebo (12,494). Before the second season, vaccinated participants received a second dose or placebo. Median follow-up lasted 30.6 months. According to GSK, the cumulative efficacy of a single dose after three seasons was 62.9 percent against lower respiratory tract disease and 67.9 percent against severe disease, as CIDRAP reported on October 9, 2024. In the third season, efficacy was still 48 percent against lower respiratory tract disease. According to the European product information, a second dose 12 months after the first provided no additional benefit. According to the US prescribing information, at a median follow-up of 12.2 months, 110 of 12,469 vaccinated and 114 of 12,503 placebo recipients died, each 0.9 percent, with no indication of a connection to the vaccine. Clinical studies were conducted by GSK or on its behalf, according to the EMA assessment report.
Recommendations in Germany
Germany's Standing Committee on Vaccination (STIKO) recommends a single RSV vaccination for all adults aged 75 and older as well as for certain risk groups aged 60 to 74.
According to the European product information, Arexvy is not recommended during pregnancy.