GSK plc (LSE/NYSE: GSK) has announced that the European Medicines Agency (EMA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster).
· If approved, the new presentation will offer a convenient administration option to healthcare professionals
· Globally, up to 1 in 3 adults will develop shingles in their lifetime[1],[2],[3],[4]
· Over 25 million people in Europe have received GSK’s shingles vaccine since 2018[5]
The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for physicians, pharmacists and other healthcare professionals who administer vaccinations. The current presentation of the vaccine consists of a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The new presentation has the same composition as the reconstituted vaccine and the submission is based on data demonstrating comparability between the two.5
This European regulatory review follows the file acceptance by the US FDA on 8 January 2025 for the new prefilled syringe presentation, continuing GSK’s commitment to providing solutions to increasing adult immunisation. GSK is also investigating submission of this presentation to other markets. GSK’s shingles vaccine has been approved in the European Union for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults aged 50 years and older since 2018; and in adults 18 years and older at increased risk of HZ, since 2020.[6]
[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.
