REG - GSK PLC - Positive CHMP opinion on Arexvy for all adults 18+

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RNS Number : 2933L  GSK PLC  12 December 2025

Issued: 12 December 2025, London UK

 

GSK's RSV vaccine, Arexvy, receives positive CHMP opinion for all adults 18
years and older

 

·   Marketing authorisation expected in February 2026

·   Every year an average of 158,000 adults are hospitalised with
RSV-related illness in the EU 1  (#_edn1)

 

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

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 and
older, and in those aged 50-59 years who are at increased risk for RSV
disease.

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

RSV is a common contagious virus affecting the lungs and breathing passages
and impacts an estimated 64 million people of all ages globally every year. 2 
(#_edn2) RSV can exacerbate certain medical conditions, and lead to severe
illness resulting in hospitalisation and even death.(1, 3  (#_edn3) , 4 
(#_edn4) )

In the European Union, an average of 158,000 adults aged 18 and over are
hospitalised due to RSV infections each year.(1) Compared with children,
adults hospitalised for RSV are at a higher risk of severe complications,
require more costly treatments, have a higher fatality rate, and their true
number is likely to be underestimated due to lack of routine testing. 5 
(#_edn5) (, 6  (#_edn6) , 7  (#_edn7) , 8  (#_edn8) )

GSK is continuing to seek expanded indications for its RSV vaccine in other
geographies including the US and Japan.

 

About GSK's RSV vaccine

Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV
glycoprotein F stabilised 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
vaccinees.

 

The vaccine has been approved for the prevention of RSV-LRTD in individuals 60
years of age and older in more than 65 countries. In addition, it is approved
for use in individuals aged 50-59 who are at increased risk due to certain
underlying medical conditions in more than 55 countries, including the US,
Japan and Europe.

 

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

 

The GSK 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 affecting the lungs and breathing passages
and impacts an estimated 64 million people of all ages globally every year.(2)
Adults can be at increased risk for RSV disease due to certain comorbidities,
immune compromised status, or advanced age.(4) RSV can exacerbate conditions,
including COPD, asthma, and chronic heart failure and can lead to severe
outcomes, such as pneumonia, hospitalisation, and death.(4)

 

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at www.gsk.com
(https://www.gsk.com) .

 

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q3 Results for 2025.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

79 New Oxford Street

London

WC1A 1DG

 

 

Note:

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

 

References:

 1  (#_ednref1) Osei-Yeboah R, et al. Estimation of the Number of Respiratory
Syncytial Virus-Associated Hospitalizations in Adults in the European Union. J
Infect Dis 2023 May 29;228(11):1539-1548. doi: 10.1093/infdis/jiad189

 2  (#_ednref2) National Institute of Allergy and Infectious Diseases,
Respiratory Syncytial Virus (RSV). Available at:
https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv
(https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv)
. Accessed December 2025

 3  (#_ednref3) Atamna A, et al. Morbidity and mortality of respiratory
syncytial virus infection in hospitalized adults: Comparison with seasonal
influenza. Int J Infect Dis. 2021 Feb;103:489-493. doi:
10.1016/j.ijid.2020.11.185

 4  (#_ednref4) Falsey, AR et al. Respiratory syncytial virus infection in
elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59. doi:
10.1056/NEJMoa043951

 5  (#_ednref5) Niekler, P, et al. Hospitalizations due to respiratory
syncytial virus (RSV) infections in Germany: a nationwide clinical and direct
cost data analysis (2010-2019). Infection. 2024 Oct;52(5):1715-1724. doi:
10.1007/s15010-023-02122-8

 6  (#_ednref6) Günen H, et al. Key Challenges to Understanding the Burden of
Respiratory Syncytial Virus in Older Adults in Southeast Asia, the Middle
East, and North Africa: An Expert Perspective. Adv Ther. 2024
Nov;41(11):4312-4334. https://doi.org/10.1007/s12325-024-02954-2
(https://doi.org/10.1007/s12325-024-02954-2)

 7  (#_ednref7) Alfano, F., Bigoni, T., Caggiano, F.P. et al. Respiratory
Syncytial Virus Infection in Older Adults: An Update. Drugs Aging 41, 487-505
(2024). https://doi.org/10.1007/s40266-024-01118-9
(https://doi.org/10.1007/s40266-024-01118-9)

 8  (#_ednref8) Grace, M., Colosia, A., Wolowacz, S., Panozzo, C., &
Ghaswalla, P. (2023). Economic burden of respiratory syncytial virus infection
in adults: a systematic literature review. Journal of Medical
Economics, 26(1), 742-759. https://doi.org/10.1080/13696998.2023.2213125
(https://doi.org/10.1080/13696998.2023.2213125)

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