GSK wins Japan nod for Shingrix prefilled syringe

Japan has approved GSK’s ready-to-use prefilled syringe presentation of Shingrix, aiming to simplify shingles vaccination for healthcare providers.

Rhea-AI Filing Summary

GSK plc (GSK) reports that Japan’s Ministry of Health, Labour and Welfare has approved a prefilled syringe presentation of Shingrix, its Recombinant Zoster Vaccine, for the prevention of shingles. This new ready-to-use format replaces the prior two-vial presentation and is intended to simplify and make administration more convenient for healthcare professionals.

Shingrix has been approved in Japan to prevent herpes zoster in adults aged 50 and older since 2018, and in adults aged 18 and older at increased risk since 2023. GSK states that the prefilled syringe presentation is already available in the US and is launching in Europe in 2026, with the Japanese approval based on data showing technical comparability to the existing formulation and no change in indication or dosing.

Key Figures

Shingles cases in Japan per year: Approximately 1.1 million people Global lifetime risk of shingles: 1 in 3 adults Adults with dormant VZV: Over 90% of adults +4 more

7 metrics

Shingles cases in Japan per year Approximately 1.1 million people Estimated annual incidence of shingles in Japan

Global lifetime risk of shingles 1 in 3 adults Proportion of adults globally expected to develop shingles in their lifetime

Adults with dormant VZV Over 90% of adults Adults estimated to carry varicella-zoster virus dormant in their nervous system

Post-herpetic neuralgia incidence Up to 30% of people People with shingles who may experience post-herpetic neuralgia after the rash

Japan approval age 50+ Adults 50 years and older Population approved for Shingrix in Japan since 2018

Japan approval at-risk adults Adults 18 years and older at increased risk Expanded Japanese approval granted in 2023 for higher-risk adults

US prefilled syringe launch date February 2026 Launch timing of Shingrix prefilled syringe presentation in the United States

Key Terms

Recombinant Zoster Vaccine, prefilled syringe, varicella-zoster virus, post-herpetic neuralgia, +1 more

5 terms

Recombinant Zoster Vaccine medical

"Shingrix (Recombinant Zoster Vaccine or RZV) is a non-live, recombinant sub-unit vaccine"

prefilled syringe medical

"has approved a prefilled syringe presentation of Shingrix for the prevention of shingles"

A prefilled syringe is a single-use, sterile syringe that comes already filled with a precise dose of a medication or vaccine, ready for immediate use like a pen already loaded with ink. For investors, they matter because they simplify administration, reduce dosing errors, and speed up care, which drives demand, can command higher margins, and ties into regulatory approvals, manufacturing capacity and supply-chain stability—factors that affect a health company's revenue and risks.

varicella-zoster virus medical

"Shingles is caused by the reactivation of the varicella-zoster virus (VZV)"

post-herpetic neuralgia medical

"up to 30% of people experience post-herpetic neuralgia (PHN), a long-lasting nerve pain"

adjuvant system medical

"combines an antigen, glycoprotein E, with an adjuvant system, AS01B"

FAQ

What did GSK (GSK) announce regarding Shingrix in Japan?

GSK announced that Japan’s Ministry of Health, Labour and Welfare approved a prefilled syringe presentation of Shingrix for the prevention of shingles, replacing the earlier two-vial format and providing a ready-to-use option for simpler administration by healthcare professionals.

Who can receive Shingrix in Japan according to GSK’s 6-K?

Shingrix is approved in Japan for adults 50 years and older since 2018, and for adults 18 years and older at increased risk of herpes zoster since 2023, in line with Japanese health authority approvals and official recommendations.

How common is shingles in Japan as cited by GSK (GSK)?

GSK cites data indicating that approximately 1.1 million people in Japan develop shingles each year, with risk increasing with age and among people with weakened immune systems.

Does the new Shingrix prefilled syringe change the dose or indication for GSK (GSK)?

No. GSK states that approval of the prefilled syringe is based on technical comparability to the existing presentation and that there is no change in indication or dosing for Shingrix in Japan.

Where else has GSK’s Shingrix prefilled syringe been introduced?

GSK reports that the Shingrix prefilled syringe launched in the US in February 2026 and is launching in Europe throughout 2026, with Japan now also approving this presentation.

What disease does Shingrix from GSK (GSK) target and how widespread is the virus?

Shingrix targets shingles, caused by reactivation of the varicella-zoster virus (VZV). GSK notes that over 90% of adults have VZV dormant in their nervous system, which can reactivate later in life as shingles.

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Available on EDGAR 09/10/2026 - 06:09 AM Accepted by SEC EDGAR 09/10/2026 - 06:09 AM Learn about SEC filing dates

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 September 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: 10 September 2026, London UK

GSK’s Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved in Japan

● Over one million people develop shingles in Japan each year [1],[2]

● New presentation offers convenient administration of GSK's shingles vaccine

GSK plc (LSE/NYSE: GSK) today announced Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster).

The vaccine previously came as two vials – a dry (lyophilised) antigen and a liquid adjuvant – which had to be combined manually before use. The new prefilled syringe is ready-to-use, making administration simpler and more convenient for healthcare professionals.

Shingrix (Recombinant Zoster Vaccine or RZV) is a non-live, recombinant sub-unit vaccine approved by the Japanese MHLW for the prevention of herpes zoster (HZ) in adults aged 50 years and older since 2018, and in adults aged 18 years and older at increased risk of HZ since 2023. Approximately 1.1 million people in Japan develop shingles each year,1,2 with risk increasing with age and among people with weakened immune systems.1,2

Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: “Shingles is a disease that 1 in 3 adults globally will develop in their lifetime. It can have serious and long-lasting complications. GSK is pleased to support the healthcare community in Japan by making administration of our shingles vaccine easier.”

GSK’s prefilled syringe launched in the US in February 2026 and is launching in Europe throughout this year. Approvals are based on data confirming technical comparability between the prefilled syringe and the existing vaccine presentation. The new presentation does not involve a change in indication or dosing.

About shingles

Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.[3] Over 90% of adults have the VZV dormant in their nervous system, waiting to reactivate.3,[4],[5],[6] 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.3,[7]

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face.5 Following the rash, up to 30% of people experience post-herpetic neuralgia (PHN),[8] a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years.3

About Shingrix (Recombinant Zoster Vaccine or RZV)

Shingrix (Recombinant Zoster Vaccine or RZV) 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.[9],[10] 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.

For product and important safety information, please consult the country relevant summary of product characteristics.

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.

GSK enquiries
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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 2025, and GSK’s Q2 Results for 2026.

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References

1 Adachi-Katayama, M., Kanda, N., Sasakura, S., Hatakeyama, S. Epidemiology of herpes zoster and postherpetic neuralgia in Japan: analysis of a large-scale claims database. BMC Infect Dis. 2026 Jan 10;26(1):287. doi: 10.1186/s12879-026-12534-0. [Last accessed: July 2026]

2 Statistics Bureau of Japan. (2024). Population estimates as of October 1, 2023. [Available from: https://www.stat.go.jp/data/jinsui/2023np/index.html Last Accessed: July 2026]

[3] Harpaz, R., et al. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008;57(Rr-5):1-30.

[4] 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.

[5] Mueller, N.H., et al. Varicella zoster virus infection: clinical features, molecular pathogenesis of disease, and latency. Neurologic clinics. 2008;26(3):675-97.

[6] Bricout, H., et al. Herpes zoster-associated mortality in Europe: a systematic review. BMC public health. 2015;15:466.

[7] 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.

[8] Kawai, K., et al. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ open. 2014;4(6).

[9] Cunningham, A.L., 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.

[10] 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.

GSK plc

(Registrant)

Date: September 10, 2026

By:/s/ VICTORIA WHYTE

--------------------------

Victoria Whyte

Authorised Signatory for and on

behalf of GSK plc