GSK's Shingrix New Prefilled Syringe Receives Positive CHMP Opinion


2025-10-21SEC Filing 6-K (0001654954-25-011999)

GSK plc announced that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the approval of Shingrix in a prefilled syringe. This new presentation will simplify the vaccine administration process for healthcare professionals by removing the need to reconstitute separate vials. The marketing authorization in the EU is expected in December 2025. Shingrix, GSK's Recombinant Zoster Vaccine, is designed to prevent herpes zoster and post-herpetic neuralgia in adults aged 50 years or older. The positive CHMP opinion is based on data confirming technical comparability between the prefilled syringe and the existing vaccine presentation. Shingles affects approximately 1.7 million people in Europe each year.


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