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 July 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: 17 July 2025, London UK
US FDA approves
GSK's Shingrix in a prefilled syringe
presentation
● Prefilled
syringe presentation offers a convenient administration option to
healthcare professionals
● An estimated one million
people develop shingles in the US each year[1]
GSK plc (LSE/NYSE: GSK) today announced that the US Food and
Drug Administration (FDA) has approved a prefilled syringe
presentation of Shingrix (GSK's
Recombinant Zoster Vaccine or RZV) for the prevention of shingles
(herpes zoster). The
new prefilled syringe removes the need to reconstitute separate
vials prior to administration, simplifying
the vaccine administration process for healthcare
professionals.
The existing vaccine presentation consists of two vials, a
lyophilised (powder) antigen and a liquid adjuvant, which
healthcare professionals combine prior to administering. The
approval of the new presentation is based on data demonstrating
technical comparability between the new and existing vaccine
presentation.
[2]
Brigid Groves, Vice President of Professional Affairs, American
Pharmacists Association, said: "The
prefilled syringe presentation of GSK's shingles vaccine is good
news, providing a convenient method of administration. The FDA
approval is a positive step toward driving prevention of this
painful disease, and as a practicing pharmacist I welcome the
availability of this new presentation."
Consistent with the existing indications
for Shingrix,
the prefilled syringe presentation is licenced in the US for
immunisation of adults aged 50 years and older, as well as those
aged 18 years and older who are or will be at increased risk of
shingles due to immunodeficiency or immunosuppression caused by
known disease or therapy.[3] The
US Centers for Disease Control and Prevention (CDC) recommends two
doses of GSK's shingles vaccine to prevent shingles and related
complications in adults aged
50 years or over, and two
doses for adults aged
19 years or over who
are or will be immunodeficient or
immunosuppressed.[4]
Tony Wood, Chief Scientific Officer, GSK, said: "At
GSK, we are committed to advancing scientific innovation and
delivering practical solutions that address the needs of the
healthcare community. This new presentation
of Shingrix was
developed to streamline the vaccination process, supporting
healthcare professionals to provide protection against shingles, a
disease that 1 in 3 US adults will develop in their
lifetime."
The prefilled syringe presentation of GSK's shingles vaccine is
also undergoing regulatory review by the European Medicines Agency
(EMA), with filing acceptance received in January 2025, marking
another important regulatory milestone. In addition to GSK
exploring submission of this presentation to other markets, this
highlights GSK's commitment to providing solutions to help increase
adult immunisation rates.
About shingles
Shingles is a painful, blistering rash that can last for weeks.
Approximately 99% of US adults over 50 years old have the virus
that causes shingles inside their body, although not everyone will
develop shingles.1 An
estimated one million people develop shingles annually in the
US.1
Shingles is caused by the reactivation of the varicella-zoster
virus (VZV), the same virus that causes
chickenpox.[5] By
age 50, VZV is present in most adults[6] and
may reactivate with advancing age.[7] As
people age, the strength of the immune system response to infection
wanes, increasing the risk of developing
shingles.7
About Shingrix (Recombinant Zoster Vaccine or
RZV)
Shingrix (GSK's
Recombinant Zoster Vaccine or RZV) is a non-live, recombinant
subunit vaccine indicated for the prevention of shingles in adults
50 and over. It 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.[8],[9] RZV
is not indicated to prevent primary varicella infection
(chickenpox). In several countries, RZV is also approved for adults
aged 18 years or over at increased risk for shingles. The use of
RZV should be in accordance with official recommendations and local
product label.
The following information is based on the US Prescribing
Information (PI) for Shingrix.
Please refer to the US PI at this link: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF
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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Investor
Relations:
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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 Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
[1] CDC.
About Shingles (Herpes Zoster). Available at https://www.cdc.gov/shingles/about/index.html.
Last accessed: May 2025.
[2] GSK.
Data on file 2025.
[3] Shingrix
prescribing information. SHINGRIX
(Zoster Vaccine Recombinant, Adjuvanted), suspension for
intramuscular injection. Last accessed: July
2025.
[4] CDC.
Shingles Vaccine Recommendations. Available at Shingles
Vaccine Recommendations | Shingles (Herpes Zoster) |
CDC. Last
accessed: July 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] 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.
[7] Mueller,
N.H., et al. Varicella zoster virus infection: clinical features,
molecular pathogenesis of disease, and latency. Neurologic clinics.
2008;26(3):675-97.
[8] 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.
[9] 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.
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: July
17, 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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