GSK’s Shingles Vaccine Shingrix Moves Closer to More Convenient Administration

GSK plc, the global pharmaceutical company, has announced that its European Medicines Agency (EMA) has accepted for review a regulatory application for a prefilled syringe version of Shingrix, a groundbreaking recombinant zoster vaccine designed to prevent shingles and post-herpetic neuralgia (PHN) in adults.

Prefilled Syringe Offers Convenience to Healthcare Professionals

The new prefilled syringe eliminates the need for healthcare providers to mix separate powder and liquid components before administering Shingrix. This change streamlines the vaccination process, making it more efficient and less prone to errors.

The current Shingrix presentation includes a powdered antigen and a liquid adjuvant, which need to be combined just before use. The new prefilled syringe ensures the vaccine has already been reconstituted, offering a streamlined solution that maintains the same effectiveness.

Positive Reviews in Europe and the U.S.

The EMA review follows the United States Food and Drug Administration’s (FDA) acceptance of the prefilled syringe application on January 8, 2025. GSK is also exploring submission in other global markets.

Shingrix, known for its robust efficacy, gained approval in the European Union for adults 50 and older in 2018. In 2020, the vaccine received additional approval for adults 18 years and older who are at a higher risk of shingles.

Understanding Shingles

Shingles is a painful rash typically characterized by fluid-filled blisters that appear on one side of the body or face. It is caused by the reactivation of the varicella-zoster virus (VZV), which is also responsible for chickenpox.

The pain from shingles can persist long after the rash disappears, affecting quality of life in up to 30% of those affected. Post-herpetic neuralgia, a complication of shingles, can last for weeks, months, or even years.

Shingles is not just a minor inconvenience; it can lead to significant healthcare costs and lost workdays. Studies suggest that 57% of shingles patients miss work, with an average of 9.1 days off.

About Shingrix (Recombinant Zoster Vaccine or RZV)

Shingrix is a recombinant zoster vaccine developed to provide robust protection against shingles and its complications.

For more detailed information on dosage, administration, and safety, healthcare professionals can refer to the Product Information available on the European Medicines Agency’s (EMA) website: https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix.

About GSK

GSK is committed to advancing medical research and healthcare solutions. With a global presence, GSK works to improve health outcomes worldwide, focusing on innovative treatments and preventive measures.

To learn more about GSK and its initiatives, visit gsk.com.

Important Forward-Looking Statements

GSK cautions investors that forward-looking statements, including those in this announcement, are subject to risks and uncertainties that could affect the actual results. Such risks are detailed in GSK’s filings with the U.S. Securities and Exchange Commission.

References

1. 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.
2. 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 2024.
3. Lee C, et al. Lifetime risk of herpes zoster in the population of Beijing, China. Public Health Pract (Oxf). 2023;5:100356.
4. Curran D, et al. Meta-Regression of Herpes Zoster Incidence Worldwide. Infect Dis Ther. 2022;11(1):389-403.
5. GSK data on file 2024.
6. Shingrix EU product information. https://www.ema.europa.eu/en/documents/product-information/shingrix-epar-product-information_en.pdf Last accessed: November 2024.
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. Kawai, K., et al. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ open. 2014;4(6).
9. Rampakakis E, Stutz M, Kawai K, Tsai TF, Cheong HJ, Dhitavat J, et al. Association between work time loss and quality of life in patients with Herpes Zoster: a pooled analysis of the MASTER studies. Health and Quality of Life Outcomes. 2017;15(1).
10. 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.
11. 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.
12. 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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