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EC approval of Shingrix PFS
GSK plc announced that the European Commission has approved Shingrix, its Recombinant Zoster Vaccine, in a prefilled syringe presentation, which offers healthcare professionals a more convenient administration option and will begin rolling out across EU countries in 2026. This approval is based on data confirming technical comparability with the existing vaccine presentation and does not involve changes to indication or dosing. Shingles affects approximately 1.7 million people in Europe annually, with certain chronic conditions increasing the risk. Disclaimer*
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 7th January 2026, London UK\n \nGSK's Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved by the European Commission\n \n· Prefilled syringe offers healthcare professionals a convenient administration option\n· New presentation will begin rolling out across EU countries in 2026\n· Shingles affects approximately 1.7 million people in Europe each year,[1] with certain chronic conditions linked to a higher risk of shingles[2],[3]\n \n \n \n\nGSK plc (LSE/NYSE: GSK) today announced the European Commission's (EC) approval of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) in a prefilled syringe. The current vaccine presentation comprises two vials, one with a lyophilised powder antigen and another with a liquid adjuvant. The lyophilised powder antigen requires reconstitution, where the suspension in the adjuvant vial is withdrawn and injected into the antigen vial. The new prefilled syringe simplifies the vaccine administration process for healthcare professionals by removing the need to undertake these steps prior to administration.\n \nTony Wood, Chief Scientific Officer, GSK, said: \"This new presentation of Shingrix has been designed to improve ease of administration, helping healthcare professionals to provide protection against shingles. Shingles is a painful disease that can have serious and long-lasting complications. It affects millions of people each year in Europe, often imposing a greater burden on people living with common chronic diseases such as cardiovascular disease and diabetes. GSK is proud to support the healthcare community by making administration of its shingles vaccine easier.\"\n \nThis approval is based on data confirming technical comparability between the prefilled syringe and the existing vaccine presentation.[4] The new presentation does not involve a change in indication or dosing.\n \nAbout shingles\nShingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.2 Globally, up to 1 in 3 adults will develop shingles in their lifetime.2,[5],[6],[7] Over 90% of adults have the VZV dormant in their nervous system, waiting to reactivate.2,[8],[9],[10] In addition to advancing age, chronic conditions like cardiovascular disease, chronic kidney...