UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of December 2025
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
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]
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] RSV
can exacerbate certain medical conditions, and lead to severe
illness resulting in hospitalisation and even
death.1,[3],[4]
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],[6],[7],[8]
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 AS01E 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
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.
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GSK enquiries
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Media:
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Simon
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Alison
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(Washington
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Investor
Relations:
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Constantin
Fest
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+44 (0)
7831 826525
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(London)
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James
Dodwell
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McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 3126
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(Philadelphia)
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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] 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] 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. 2021 Feb;103:489-493. doi:
10.1016/j.ijid.2020.11.185
[4] 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] 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] 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
[7] 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
[8] 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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: December
12, 2025
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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