EC approval of Shingrix PFS

GSK PLC

07 January 2026

 

Issued: 7^th January 2026, London UK

GSK's Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved by the European Commission

·   Prefilled syringe offers healthcare professionals a convenient administration option

·   New presentation will begin rolling out across EU countries in 2026

·   Shingles affects approximately 1.7 million people in Europe each year,[1] with certain chronic conditions linked to a higher risk of shingles[2]^,[3]

 

GSK plc (LSE/NYSE: GSK) today announced the European Commission's (EC) approval of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) in a prefilled syringe. The current vaccine presentation comprises two vials, one with a lyophilised powder antigen and another with a liquid adjuvant. The lyophilised powder antigen requires reconstitution, where the suspension in the adjuvant vial is withdrawn and injected into the antigen vial. The new prefilled syringe simplifies the vaccine administration process for healthcare professionals by removing the need to undertake these steps prior to administration.

Tony Wood, Chief Scientific Officer, GSK, said: "This new presentation of Shingrix has been designed to improve ease of administration, helping healthcare professionals to provide protection against shingles. Shingles is a painful disease that can have serious and long-lasting complications. It affects millions of people each year in Europe, often imposing a greater burden on people living with common chronic diseases such as cardiovascular disease and diabetes. GSK is proud to support the healthcare community by making administration of its shingles vaccine easier."

This approval is based on data confirming technical comparability between the prefilled syringe and the existing vaccine presentation.[4] 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.² Globally, up to 1 in 3 adults will develop shingles in their lifetime.^{2,[5],[6],[7]} Over 90% of adults have the VZV dormant in their nervous system, waiting to reactivate.^{2,[8],[9],[10]} 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.^2,3

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face.⁸ Following the rash, up to 30% of people experience post-herpetic neuralgia (PHN),[11] a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years.²

About Shingrix (Recombinant Zoster Vaccine or RZV)

Shingrix 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.[12]^,[13] 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.

GSK's shingles vaccine has been approved in the European Union for the prevention of herpes zoster (HZ) and PHN in adults aged 50 years or older since 2018; and in adults 18 years or older at increased risk of HZ, since 2020.

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 www.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 Q3 Results for 2025.

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References

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[1] Pinchinat et al. Similar herpes zoster incidence across Europe: results from a systematic literature review. BMC Infect Dis. 2013;13:170.

[2] 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. 

[3] 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.

[4] GSK. Data on file.

[5] 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: November 2025.

[6] Lee C, et al. Lifetime risk of herpes zoster in the population of Beijing, China. Public Health Pract (Oxf). 2023;5:100356.

[7] Curran D, et al. Meta-Regression of Herpes Zoster Incidence Worldwide. Infect Dis Ther. 2022;11(1):389-403.

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

[9] 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.

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

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

[12] 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.

[13] 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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