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LONDON - GlaxoSmithKline PLC (LSE/NYSE: NYSE:GSK) announced today that the European Medicines Agency (EMA) has begun reviewing a prefilled syringe form of Shingrix, GSK's vaccine for shingles prevention. This new syringe presentation is designed to simplify the administration process for healthcare providers by eliminating the need to mix a powder and liquid before injection.
The review by the EMA follows the U.S. Food and Drug Administration's (FDA) acceptance on January 8, 2025, of the same prefilled syringe for consideration. The vaccine, which has been available in the European Union since 2018 for individuals aged 50 and older and since 2020 for those 18 and older at increased risk of herpes zoster, is a non-live recombinant vaccine combining an antigen with an adjuvant system.
Shingrix is intended to protect against shingles, a painful rash caused by the reactivation of the varicella-zoster virus—the same virus responsible for chickenpox. It's estimated that up to one in three adults will develop shingles during their lifetime, with the risk increasing with age due to a natural decline in immune response.
The new syringe presentation contains the same components as the previously approved vaccine, and the application for review is supported by data demonstrating equivalence between the two. If approved by the EMA, this new option could streamline the vaccination process in clinical settings across Europe.
GSK is a global biopharma company focused on uniting science, technology, and talent to combat diseases. The company is also considering submitting the prefilled syringe presentation for approval in other markets as part of its ongoing efforts to enhance adult immunization.
Shingles can lead to severe complications, such as post-herpetic neuralgia, a long-lasting nerve pain that can persist for months or even years. The disease also has significant societal impacts, with many patients reporting missed workdays due to the condition.
The information in this article is based on a press release statement from GSK.
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