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 October 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: 21 October 2025, London UK
GSK's Shingrix new prefilled syringe presentation receives
positive CHMP opinion
● Prefilled syringe offers a convenient ready-to-use
administration option to healthcare
professionals
●
Marketing
authorisation in EU expected in December 2025
●
Shingles affects
approximately 1.7 million people in Europe each
year[1]
GSK plc (LSE/NYSE: GSK) today announced that the European Medicine
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) has issued a positive opinion to support the approval
of Shingrix (GSK's
Recombinant Zoster Vaccine or RZV) in a prefilled syringe.
Currently, the vaccine presentation consists of two vials, a
lyophilised powder antigen and a liquid adjuvant, which are
combined prior to administration. After approval by
the European Commission, expected in December 2025, the new
prefilled syringe will remove the need to reconstitute separate
vials, simplifying the vaccine administration process for
healthcare professionals.
Tony Wood, Chief Scientific Officer, GSK, said: "At
GSK, we are dedicated to driving innovation to continually enhance
our world-class vaccines. The CHMP positive opinion on our
new presentation
of Shingrix reflects
our commitment to supporting the healthcare
community, making it
easier for healthcare professionals to provide protection against
shingles, a painful disease affecting well over a million people in
Europe each year."
GSK's shingles vaccine has been approved in the European Union for
the prevention of herpes zoster (HZ) and post-herpetic neuralgia
(PHN) in adults aged 50 years or older since 2018; and in adults 18
years or older at increased risk of HZ, since 2020. GSK's RZV is
specifically designed to enhance the varicella-zoster virus
(VZV)-specific immune response of a declining or compromised immune
system.
[2],[3] This
positive CHMP opinion is based on data confirming technical
comparability between the prefilled syringe and the existing
vaccine presentation.[4]
About shingles
Shingles is caused by the reactivation of the varicella-zoster
virus (VZV), the same virus that causes
chickenpox.[5] Globally,
up to 1 in 3 adults will develop shingles in their
lifetime.5,[6],[7],[8] Over
90% of adults have the varicella-zoster virus (VZV) dormant in
their nervous system, waiting to reactivate.6,[9],[10],[11] In
addition to advancing age, chronic conditions like cardiovascular
disease, chronic kidney disease, chronic obstructive pulmonary
disease, asthma, and diabetes are all linked to higher risk of
shingles.5,[12]
Shingles typically presents as a rash, with painful blisters across
the chest, abdomen or face.9 Following
the rash, up to 30% of people experience PHN,[13] a
long-lasting nerve pain that can last weeks or months and can
occasionally persist for several years.5 Shingles
is also associated with significant healthcare and human cost, with
one in three patients with shingles taking an average of 12.5 days
of sick leave and patients with PHN taking sick leave for an
average of two months.[14]
About Shingrix (Recombinant Zoster Vaccine or
RZV)
Shingrix combines
an antigen, glycoprotein E, with an adjuvant system,
AS01B,
and may help overcome the natural age-related decline in responses
to immunisation that contributes to the challenge of protecting
adults aged 50 and over from shingles.2,3 RZV
is not indicated to prevent primary varicella infection
(chickenpox). The use of RZV should be in accordance with official
recommendations and local product label.
Please refer to the Product Information (PI) for important dosage,
administration, and safety information in Europe available at this
link:
https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix
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 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 Q2 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
[1] Pinchinat
et al. Similar herpes zoster incidence across Europe: results from
a systematic literature review. BMC Infect Dis.
2013;13:170.
[2] Cunningham,
AL, et al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults
70 Years of Age or Older. New England Journal of Medicine.
2016;375(11):1019-32.
[3] The
GSK proprietary AS01 adjuvant system contains QS-21 Stimulon®
adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of
Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.
[4] GSK.
Data on file 2025.
[5] Harpaz
R, et al. Advisory Committee on Immunization Practices (ACIP),
Centers for Disease Control and Prevention (CDC). Prevention of
herpes zoster: recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR Recomm Rep.
2008;57(RR-5):1-30.
[6] Australian
Institute of Health and Welfare. Shingles in Australia. Available
at: https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx.
Last Accessed: October 2025.
[7] Lee
C, et al. Lifetime risk of herpes zoster in the population of
Beijing, China. Public Health Pract (Oxf).
2023;5:100356.
[8] Curran
D, et al. Meta-Regression of Herpes Zoster Incidence Worldwide.
Infect Dis Ther. 2022;11(1):389-403.
[9] Mueller,
N.H., et al. Varicella zoster virus infection: clinical features,
molecular pathogenesis of disease, and latency. Neurologic clinics.
2008;26(3):675-97.
[10] Johnson,
R.W., et al. Herpes zoster epidemiology, management, and disease
and economic burden in Europe: a multidisciplinary
perspective. Therapeutic
advances in vaccines.
2015;3(4):109-20.
[11] Bricout,
H., et al. Herpes zoster-associated mortality in Europe: a
systematic review. BMC public health.
2015;15:466.
[12] Steinmann
et al. Risk factors for herpes zoster infections: a systematic
review and meta-analysis unveiling common trends and heterogeneity
patterns. Infection. 2024;52(3):1009-1026. doi:
10.1007/s15010-023-02156-y. REF-224255
[13] Kawai,
K., et al. Systematic review of incidence and complications of
herpes zoster: towards a global perspective. BMJ open.
2014;4(6).
[14] Ultsch
B, Koster I, Reinhold T, et al. Epidemiology
and cost of herpes zoster and postherpetic neuralgia in Germany.
Eur J Health Econ. 2013;14(6):1015-26.
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: October
21, 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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