Shingrix Prefilled Syringe Accepted by EMA
GSK plc announced that the 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)
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.
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.
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