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 January 2026
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: 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 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 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
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.
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GSK enquiries
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Media:
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Tim
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Simon
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Alison
Hunt
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+1 540 742 3391
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(Washington
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Investor
Relations:
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Constantin
Fest
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+44 (0)
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(London)
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James
Dodwell
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+44 (0)
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(London)
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Mick
Readey
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+44 (0)
7990 339 653
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(London)
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Steph
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+44 (0)
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Sam
Piper
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(London)
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Jeff
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 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.
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: January
26, 2026
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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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