GSK Announces FDA Review of Convenient Prefilled Syringe for Shingrix Shingles Vaccine

(IN BRIEF) GSK has announced that the FDA has accepted its application to review a prefilled syringe version of Shingrix, its shingles vaccine. This new version, expected to be available from January 2025, eliminates the need for reconstitution, offering a more convenient option for healthcare professionals. The prefilled syringe presentation will have the same composition as the reconstituted version, with data showing that both are comparable. Shingrix, which has been approved in the US since 2017 for adults 50 and over, continues to be an essential tool in preventing shingles, a painful condition caused by the varicella-zoster virus.

(PRESS RELEASE) LONDON, 10-Jan-2025 — /EuropaWire/ — GSK has announced that the US Food and Drug Administration (FDA) has accepted its application for the review of a new prefilled syringe version of its shingles vaccine, Shingrix (Recombinant Zoster Vaccine or RZV). This new presentation, expected to offer a more convenient administration option, eliminates the need for healthcare professionals to reconstitute the vaccine prior to use. Available from January 2025, the prefilled syringe presentation will help streamline the vaccination process for pharmacists, physicians, and other healthcare providers.

Currently, the vaccine comes as a lyophilised (powder) antigen and liquid adjuvant, which must be mixed before administration. The new prefilled syringe version will retain the same composition as the original reconstituted vaccine, and data has shown that both presentations are comparable in terms of efficacy and safety.

The approval process for this new presentation is a significant step in GSK’s ongoing efforts to improve accessibility to shingles prevention. Shingrix has been available in the US since 2017 for adults aged 50 and over, and since 2021 for those at increased risk due to immunodeficiency or immunosuppression. GSK continues to innovate and address the evolving needs of the healthcare community.

Shingles, caused by the reactivation of the varicella-zoster virus, is a painful condition affecting millions of Americans annually. The virus remains dormant in the body after a chickenpox infection, reactivating later in life when the immune system weakens. Shingrix, a non-live, recombinant subunit vaccine, is specifically designed to protect against shingles by enhancing the immune response in older adults.

GSK’s Shingrix vaccine combines glycoprotein E with an adjuvant system, AS01B, to overcome the age-related decline in immune response. It is approved for use in adults aged 50 and over, with further approvals in certain countries for individuals aged 18 and older who are at higher risk of developing shingles.

The FDA is expected to make a decision on the prefilled syringe presentation of Shingrix by June 2025.

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.3 An estimated one million people develop shingles annually in the US.3

Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.4 By age 50, VZV is present in most adults5 and may reactivate with advancing age.6 As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.6

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.7,8 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.

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 under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q3 Results for 2024.

References

GSK data on file 2024.
Shingrix prescribing information. SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), suspension for intramuscular injection. Last accessed: January 2025.
CDC. About Shingles (Herpes Zoster). Available at https://www.cdc.gov/shingles/about/index.html. Last accessed: January 2025.
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.
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.
Mueller, N.H., et al. Varicella zoster virus infection: clinical features, molecular pathogenesis of disease, and latency. Neurologic clinics. 2008;26(3):675–97.
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.
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.

Media Contact:

Tim Foley
Vice President, Global Corporate Media Relations
corporate.media@gsk.com
+44 (0)20 8047 5502

SOURCE: GlaxoSmithKline plc

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