REG - GSK PLC - European Commission approves Arexvy for adults 18+

GSKAnnouncement

Today 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260126:nRSZ3209Qa&default-theme=true

RNS Number : 3209Q  GSK PLC  26 January 2026

Issued: 26 January 2026, London UK

 

GSK's RSV vaccine, Arexvy, receives European approval for expanded use in all
adults 18 years and older

 

·   In the EU, an average of 158,000 adults are hospitalised with
RSV-related illness every year 1 

 

 

GSK plc (LSE/NYSE: GSK) today announced that its adjuvanted recombinant
respiratory syncytial virus (RSV) vaccine, Arexvy, has been approved by the
European Commission* (EC) for use in adults aged 18 years and older. Arexvy
was the first RSV vaccine authorised in the European Economic Area for the
prevention of lower respiratory tract disease (LRTD) caused by RSV. It was
previously approved in adults aged 60 years and above, as well as in those
aged 50 to 59 years who are at increased risk for RSV disease. Today's updated
indication now enables European countries to make the vaccine available to all
adults aged 18 years and older.

 

Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and
Development, said: "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, hospitalisation and even death, particularly for
those with certain underlying health conditions. GSK is proud to expand
prevention options against RSV across Europe."

In the European Union, an average of 158,000 adults aged 18 and over are
hospitalised due to RSV infections each year.(1) Compared to 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 underestimated due to lack of routine testing. 2 (, 3 , 4 , 5 )

GSK continues 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 for RSV disease
due to certain underlying medical conditions in more than 60 countries,
including the US and Japan.

 

Please refer to the Product Information (PI) for important dosage,
administration and safety information in Europe via 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 contains STIMULON QS-21 adjuvant
licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc.
STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.

 

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. 6 
Adults can be at increased risk for RSV disease due to certain chronic
conditions, immune compromised status or advanced age. 7  RSV can exacerbate
certain chronic conditions, including COPD, asthma and chronic heart failure,
and can lead to severe outcomes such as pneumonia, hospitalisation and
death.(7)

 

 

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) .

 

 GSK enquiries
 Media:               Tim Foley          +44 (0) 20 8047 5502  (London)
                      Simon Moore        +44 (0) 20 8047 5502  (London)
                      Alison Hunt        +1 540 742 3391       (Washington DC)

 Investor Relations:  Constantin Fest    +44 (0) 7831 826 525  (London)
                      James Dodwell      +44 (0) 20 8047 2406  (London)
                      Mick Readey        +44 (0) 7990 339 653  (London)
                      Steph Mountifield  +44 (0) 7796 707 505  (London)
                      Sam Piper          +44 (0) 7824 525 779  (London)
                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 3126       (Philadelphia)

 

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 Commission approves medicines for European Union member states
and for the European Economic Area (EEA) countries Iceland, Norway and
Liechtenstein.

 

 

References:

 1  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;228(11):1539-1548.

 2  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;52(5):1715-1724.

 3  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;41(11):4312-4334.

 4  Alfano F, et al. Respiratory Syncytial Virus Infection in Older Adults: An
Update. Drugs Aging. 2014;41:487-505.

 5  Grace M, et al. Economic burden of respiratory syncytial virus infection
in adults: a systematic literature review. J Med Econ. 2023;26(1):742-759.

 6  National Institute of Allergy and Infectious Diseases, Respiratory
Syncytial Virus (RSV). Available at:
https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv.
Last accessed January 2026.

 7  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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCKZGZMMKFGVZZ



            Copyright 2019 Regulatory News Service, all rights reserved