GSK’s Arexvy Vaccine Positive aspects Constructive CHMP Opinion for Adults 18 and Up

• Advertising authorisation anticipated in February 2026
• Yearly a mean of 158,000 adults are hospitalised with RSV-related sickness within the EU¹ 

GSK plc (LSE/NYSE: GSK) right this moment introduced that the European Medicines Company’s (EMA) Committee for Medicinal Merchandise for Human Use (CHMP) has beneficial increasing the indication of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to all adults aged 18 years and older. The European Fee’s last choice is predicted in February 2026. If accredited, the expanded indication would make the vaccine obtainable for all adults aged 18 years and older.* 

Arexvy was the primary RSV vaccine accredited in Europe for the prevention of decrease respiratory tract illness (LRTD) brought on by RSV in adults aged 60 and older, and in these aged 50-59 years who’re at elevated danger for RSV illness. 

Sanjay Gurunathan, GSK Head of Vaccines and Infectious Ailments Analysis and Improvement, stated: “At present’s constructive CHMP opinion is a vital step in the direction of bringing extra choices to forestall extreme RSV illness for adults in Europe. GSK is devoted to growing entry to our vaccines in broader grownup populations and we proceed to drive innovation to assist make it simpler for healthcare professionals to supply safety towards extreme RSV illness.”

RSV is a standard contagious virus affecting the lungs and respiratory passages and impacts an estimated 64 million individuals of all ages globally yearly.² RSV can exacerbate sure medical situations, and result in extreme sickness leading to hospitalisation and even loss of life.^1,3,4

Within the European Union, a mean of 158,000 adults aged 18 and over are hospitalised as a consequence of RSV infections every year.¹ In contrast with youngsters, adults hospitalised for RSV are at a better danger of extreme problems, require extra expensive therapies, have a better fatality fee, and their true quantity is more likely to be underestimated as a consequence of lack of routine testing.^5,6,7,8

GSK is continuous to hunt expanded indications for its RSV vaccine in different geographies together with the US and Japan.

About GSK’s RSV vaccine

Respiratory Syncytial Virus Vaccine, Adjuvanted, incorporates recombinant RSV glycoprotein F stabilised within the prefusion conformation (RSVPreF3). This antigen is mixed with GSK’s proprietary AS01_E adjuvant. 

The usage of this vaccine ought to be in accordance with official suggestions. As with all vaccine, a protecting immune response will not be elicited in all vaccinees. 

The vaccine has been accredited for the prevention of RSV-LRTD in people 60 years of age and older in additional than 65 international locations. As well as, it’s accredited to be used in people aged 50-59 who’re at elevated danger as a consequence of sure underlying medical situations in additional than 55 international locations, together with the US, Japan and Europe. 

Please check with the Product Data (PI) for essential dosage, administration, and security data in Europe at this hyperlink: http://www.ema.europa.eu/medicines/human//EPAR/arexvy  

The GSK proprietary AS01 adjuvant system, owned by GSK, incorporates STIMULON QS-21 adjuvant licensed from Antigenics Inc, at present dba Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus Inc.

About RSV in adults

RSV is a standard contagious virus affecting the lungs and respiratory passages and impacts an estimated 64 million individuals of all ages globally yearly.² Adults might be at elevated danger for RSV illness as a consequence of sure comorbidities, immune compromised standing, or superior age.⁴ RSV can exacerbate situations, together with COPD, bronchial asthma, and continual coronary heart failure and may result in extreme outcomes, corresponding to pneumonia, hospitalisation, and loss of life.⁴

About GSK

GSK is a world biopharma firm with a function to unite science, know-how, and expertise to get forward of illness collectively. Discover out extra at www.gsk.com.

Cautionary assertion concerning forward-looking statements

GSK cautions traders that any forward-looking statements or projections made by GSK, together with these made on this announcement, are topic to dangers and uncertainties which will trigger precise outcomes to vary materially from these projected. Such components embody, however should not restricted to, these described within the “Threat Components” part in GSK’s Annual Report on Kind 20-F for 2024, and GSK’s Q3 Outcomes for 2025.

Notice

*The European Medicines Company opinions medicines for European Union member states and for the European Financial Space (EEA) international locations Iceland, Norway and Liechtenstein.

References

1. Osei-Yeboah R, et al. Estimation of the Variety of Respiratory Syncytial Virus–Related Hospitalizations in Adults within the European Union. J Infect Dis 2023 Could 29;228(11):1539–1548. doi: 10.1093/infdis/jiad189
2. Nationwide Institute of Allergy and Infectious Ailments, Respiratory Syncytial Virus (RSV). Out there 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 an infection in hospitalized adults: Comparability with seasonal influenza. Int J Infect Dis. 2021 Feb;103:489-493. doi: 10.1016/j.ijid.2020.11.185
4. Falsey, AR et al. Respiratory syncytial virus an infection in aged and high-risk adults, in New Engl J Med 2005; 352:1749-59. doi: 10.1056/NEJMoa043951
5. Niekler, P, et al. Hospitalizations as a consequence of respiratory syncytial virus (RSV) infections in Germany: a nationwide scientific and direct price knowledge evaluation (2010-2019). An infection. 2024 Oct;52(5):1715-1724. doi: 10.1007/s15010-023-02122-8
6. Günen H, et al. Key Challenges to Understanding the Burden of Respiratory Syncytial Virus in Older Adults in Southeast Asia, the Center East, and North Africa: An Skilled Perspective. Adv Ther. 2024 Nov;41(11):4312-4334. https://doi.org/10.1007/s12325-024-02954-2
7. Alfano, F., Bigoni, T., Caggiano, F.P. et al. Respiratory Syncytial Virus An infection in Older Adults: An Replace. Medication Growing older 41, 487–505 (2024). https://doi.org/10.1007/s40266-024-01118-9
8. Grace, M., Colosia, A., Wolowacz, S., Panozzo, C., & Ghaswalla, P. (2023). Financial burden of respiratory syncytial virus an infection in adults: a scientific literature evaluate. Journal of Medical Economics, 26(1), 742–759. https://doi.org/10.1080/13696998.2023.2213125