EU regulators expand GSK’s Arexvy indication to all adults 18+, boosting RSV prevention efforts and addressing the growing adult hospitalisation burden.
Written By: Pharmacally Medical News Desk
The European Commission (EC) has approved GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for use in adults aged 18 years and older, significantly expanding access to RSV prevention across the European Economic Area. This updated indication makes Arexvy available to all adults, beyond its earlier approvals limited to adults aged 60+ and high-risk individuals aged 50–59. The decision allows European countries to broaden vaccination strategies against RSV, a respiratory infection that can lead to serious illness, hospitalization, and death.
RSV is often under-recognized as a severe adult respiratory disease, yet its impact across Europe is substantial. In the EU, an estimated 158,000 adults aged 18 years and older are hospitalised every year due to RSV-related illness. Adults admitted with RSV infections face higher risks of severe complications compared with children, often requiring intensive or costly treatment. Experts also note that the true burden may be underestimated because RSV testing is not routinely performed in many healthcare settings.
GSK emphasized that this expanded approval is an important step in protecting adults across Europe from RSV, especially those with underlying medical conditions. Sanjay Gurunathan, Head of Vaccines and Infectious Diseases R&D at GSK, stated that broader access helps reduce the risk of severe outcomes such as hospitalisation and death, which can occur particularly in vulnerable populations.
About Arexvy
Arexvy is an adjuvanted recombinant vaccine that contains the RSV fusion (F) glycoprotein stabilized in its prefusion form (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant, designed to enhance immune response, especially in populations with weaker immunity. As with all vaccines, immune protection may not occur in every individual, and its use should follow official national immunisation recommendations.
Global Status of Arexvy
Arexvy is already approved in more than 65 countries for adults aged 60 years and older. It also holds approval in over 60 countries for adults aged 50–59 at increased risk due to chronic medical conditions, including in the United States and Japan. GSK has announced that it continues to pursue broader indications in additional global markets.
Arexvy is part of a growing landscape of adult RSV prevention options. Pfizer’s Abrysvo (bivalent RSV prefusion F vaccine) is also authorised for older adults and maternal immunisation in several regions, while Moderna’s mRNA-based RSV vaccine mRESVIA has recently entered the adult RSV vaccine space.
Why RSV Prevention Matters in Adults
RSV is a highly contagious respiratory virus that affects an estimated 64 million people globally each year. While often associated with infants, RSV also poses serious risks to adults, particularly those with chronic lung or heart conditions, weakened immune systems, or older age. RSV infections can worsen diseases such as COPD, asthma, and heart failure, and may lead to pneumonia, hospitalisation, and fatal outcomes. The expanded availability of Arexvy represents an important public health tool to reduce this burden in EU region.
Reference
GSK’s RSV vaccine, Arexvy, receives European approval for expanded use in all adults 18 years and older, 26 January 2026, https://www.gsk.com/en-gb/media/press-releases/gsk-s-rsv-vaccine-arexvy-receives-european-approval-for-expanded-use-in-all-adults-18-years-and-older/