GSK’s RSV vaccine Arexvy receives positive CHMP opinion for all adults aged 18 and over

• Marketing authorization expected in February 2026
• Each year, an average of 158,000 adults are hospitalized for RSV-related illnesses in the EU.¹

GSK plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended extending the indication of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to all adults aged 18 years and over. The European Commission’s final decision is expected in February 2026. If approved, the expanded indication would make the vaccine available to all adults aged 18 and over.*

Arexvy was the first RSV vaccine approved in Europe for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older, and in people aged 50 to 59 years who are at increased risk of RSV disease.

Sanjay Gurunathan, Head of Vaccines and Infectious Diseases Research and Development at GSK, said:: “Today’s positive CHMP opinion is an important step towards providing more options to prevent severe RSV disease in adults in Europe. GSK is committed to increasing access to our vaccines in broader adult populations and we continue to drive innovation to make it easier for healthcare professionals to offer protection against severe RSV disease.”

RSV is a common contagious virus that affects the lungs and respiratory tract and affects approximately 64 million people of all ages worldwide each year.² RSV can exacerbate certain medical conditions and lead to severe illness leading to hospitalization or even death.^1,3,4

In the European Union, an average of 158,000 adults aged 18 and over are hospitalized each year due to RSV infection.¹ Compared to children, adults hospitalized for RSV are at higher risk of serious complications, require more expensive treatments, have a higher mortality rate, and their true numbers are likely underestimated due to lack of routine testing.^5,6,7,8

GSK continues to pursue expanded indications for its RSV vaccine in other geographies, including the United States and Japan.

About the GSK RSV vaccine

The adjuvanted respiratory syncytial virus vaccine contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01_E adjuvant.

The 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 vaccinated individuals.

The vaccine has been approved for the prevention of RSV-LRTD in people aged 60 and older in more than 65 countries. Additionally, it is approved for use in people ages 50 to 59 who are at increased risk due to certain underlying medical conditions in more than 55 countries, including the United States, Japan, and Europe.

Please refer to the Product Information (PI) for important information on dosage, administration and safety in Europe at this link: http://www.ema.europa.eu/medicines/human//EPAR/arexvy

GSK’s proprietary AS01 Adjuvant System, owned by GSK, contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, currently dba Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus Inc.

About RSV in adults

RSV is a common contagious virus that affects the lungs and respiratory tract and affects approximately 64 million people of all ages worldwide each year.² Adults may be at increased risk of RSV disease due to certain comorbidities, compromised immune status, or older age.⁴ RSV can worsen conditions such as COPD, asthma and chronic heart failure and can lead to serious consequences, such as pneumonia, hospitalization and death.⁴

About GSK

GSK is a global biopharmaceutical company dedicated to uniting science, technology and talent to together outpace disease. To learn more, visit www.gsk.com.

Caution Regarding Forward-Looking Statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this release, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. These factors include, but are not limited to, those described in the “Risk Factors” section of GSK’s 2024 Annual Report on Form 20-F and GSK’s 2025 Third Quarter Results.

Note

*The European Medicines Agency reviews medicines from European Union member states and the European Economic Area (EEA) countries Iceland, Norway and Liechtenstein.

References

1. Osei-Yeboah R, et al. Estimated number of hospitalizations associated with respiratory syncytial virus among adults in the European Union. J Infect Dis May 29, 2023;228(11):1539-1548. doi: 10.1093/infdis/jiad189
2. National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv. Accessed December 2025
3. Atamna A, et al. Morbidity and mortality of respiratory syncytial virus infection in hospitalized adults: comparison with seasonal influenza. Int J Infect Dis. February 2021; 103:489-493. doi: 10.1016/j.ijid.2020.11.185
4. Falsey, AR et al. Respiratory syncytial virus infection in the elderly and high-risk adults, in New Engl J Med 2005; 352: 1749-59. doi: 10.1056/NEJMoa043951
5. Niekler, P et al. Hospitalizations due to respiratory syncytial virus (RSV) infections in Germany: a national analysis of clinical data and direct costs (2010-2019). Infection. 2024 October;52(5):1715-1724. doi: 10.1007/s15010-023-02122-8
6. Gunen H, et al. Key challenges in understanding the burden of respiratory syncytial virus among older adults in Southeast Asia, the Middle East and North Africa: an expert’s perspective. Adv Ther. 2024 Nov;41(11):4312-4334. https://doi.org/10.1007/s12325-024-02954-2
7. Alfano, F., Bigoni, T., Caggiano, FP et al. Respiratory syncytial virus infection in the elderly: an update. Drugs Aged 41, 487-505 (2024). https://doi.org/10.1007/s40266-024-01118-9
8. Grace, M., Colosia, A., Wolowacz, S., Panozzo, C. and Ghaswalla, P. (2023). Economic burden of respiratory syncytial virus infection in adults: a systematic review of the literature. Journal of Medical Economics, 26(1), 742-759. https://doi.org/10.1080/13696998.2023.2213125