REG - GSK PLC - GSK’s Shingrix Fully Liquid FDA approval

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RNS Number : 3829R  GSK PLC  17 July 2025

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 
(#_edn1)

 

 

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  (#_edn2)

 

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  (#_edn3) 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  (#_edn4)

 

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  (#_edn5) By age 50, VZV is present
in most adults 6  (#_edn6) and may reactivate with advancing age. 7  (#_edn7)
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,
AS01(B), 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  (#_edn8) (, 9  (#_edn9) ) 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
(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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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.

 

 

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References

 1  (#_ednref1) CDC. About Shingles (Herpes Zoster). Available at
https://www.cdc.gov/shingles/about/index.html
(https://www.cdc.gov/shingles/about/index.html) . Last accessed: May 2025.

 2  (#_ednref2) GSK. Data on file 2025.

 3  (#_ednref3) Shingrix prescribing information. SHINGRIX (Zoster Vaccine
Recombinant, Adjuvanted), suspension for intramuscular injection
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF)
. Last accessed: July 2025.

 4  (#_ednref4) CDC. Shingles Vaccine Recommendations. Available at Shingles
Vaccine Recommendations | Shingles (Herpes Zoster) | CDC
(https://www.cdc.gov/shingles/hcp/vaccine-considerations/index.html) . Last
accessed: July 2025.

 5  (#_ednref5) 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  (#_ednref6) 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  (#_ednref7) 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  (#_ednref8) 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  (#_ednref9) 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.

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