GSK’s Arexvy Gains EU Approval for Adults Aged 18 Years and Older

GSK’s adjuvanted recombinant respiratory syncytial virus (RSV) vaccine Arexvy has received European Commission approval for an expanded indication covering all adults aged 18 years and older in the European Union (EU) and European Economic Area. Previously authorized for adults aged 60 years and above and for adults aged 50–59 years with increased risk of severe disease, this broader label now allows vaccination across the adult population (1).

According to GSK, an estimated 158,000 adults aged 18 years and over are hospitalized annually in the EU due to RSV-related illness, and adults face a higher risk of severe complications and costly treatments compared with pediatric cases (1,2). The company anticipates it will offer expanded RSV prevention options to public health systems and clinicians across Europe while continuing to pursue further regulatory expansions globally, including in the United States and Japan.

“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, hospitalization, and even death, particularly for those with certain underlying health conditions,” said Sanjay Gurunathan, head of Vaccines and Infectious Diseases Research and Development, GSK, in a company press release. “GSK is proud to expand prevention options against RSV across Europe.”

How is FDA’s priority review shaping broader adult use of Arexvy?

In the US, GSK made significant regulatory progress toward expanding Arexvy’s indication when FDA accepted a supplemental biologics license application (sBLA) in July 2025 to extend Arexvy use to adults aged 18–49 years at increased risk of RSV disease (3). That submission was supported by Phase IIIb immunogenicity and safety data demonstrating a consistent immune response and acceptable tolerability relative to the vaccine’s established use in older adults. A regulatory decision is expected in the first half of 2026 (3).

The July decision builds on earlier actions by FDA, which granted priority review designation for an expanded indication in adults aged 50–59 years at increased risk for lower respiratory tract disease caused by RSV (4). That expanded indication was approved in 2024, making Arexvy the first RSV vaccine for this age cohort in the US, based on evidence from a large Phase III clinical trial showing non-inferior immune responses compared to the original older adult population (5).

These regulatory moves underscore ongoing efforts by GSK to broaden RSV vaccine access across adult age groups in major markets. In addition to European and US submissions, similar applications have been accepted in Japan for adults aged 18–49 years at increased risk of severe RSV disease (1).

What are the clinical and market implications?

Expanding Arexvy’s label in the EU to all adults aged 18 years and older and FDA’s ongoing review of broader US indications signal a strategic shift wherein RSV prevention is evolving from a targeted older age group intervention to a potential population-level vaccine strategy, aligning with similar moves from other RSV vaccine developers (1).

For biopharmaceutical and vaccine manufacturers, these regulatory developments reflect a broader trend in adult immunization strategy and underscore the role of RSV vaccines in public health paradigms beyond traditional pediatric immunization frameworks (6).

References

1. GSK. GSK’s RSV Vaccine, Arexvy, Receives European Approval for Expanded Use in All Adults 18 Years and Older. Press Release. Jan. 26, 2026.
2. Osei-Yeboah, R.; Spreeuwenberg, P.; Del Riccio, M.; et al. Estimation of the Number of Respiratory Syncytial Virus-Associated Hospitalizations in Adults in the European Union. J. Infect. Dis. 2023, 228 (11), 1539–1548. DOI: 10.1093/infdis/jiad189
3. GSK. US FDA Accepts Application to Review Expanded Use of GSK’s RSV Vaccine, Arexvy, for Adults 18-49 at Increased Risk. Press Release. July 14, 2025.
4. GSK. GSK’s RSV Vaccine, Arexvy, Accepted Under Priority Review in US for the Prevention of RSV Disease in Adults Aged 50–59 at Increased Risk. Press Release. Feb. 6, 2024.
5. GSK. US FDA Approves Expanded Age Indication for GSK’s AREXVY, the First Respiratory Syncytial Virus (RSV) Vaccine for Adults Aged 50–59 at Increased Risk. Press Release. June 7, 2024.
6. See, K. C. Vaccination for Respiratory Syncytial Virus: A Narrative Review and Primer for Clinicians. Vaccines (Basel) 2023, 11 (12), 1809. DOI: 10.3390/vaccines11121809