India Pharma Outlook Team | Friday, 24 October 2025
GSK plc revealed that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a green signal to the approval of a new prefilled syringe presentation for Shingrix, GSK’s recombinant zoster vaccine (RZV).
The change is intended to make the vaccine administration easier for healthcare professionals without the need for reconstitution of the currently used two-vial format of lyophilised antigen and liquid adjuvant.
The prefilled syringe will make vaccination more comfortable and safer after the European Commission green light, which is anticipated in December 2025. Consequently, efficiency will be raised, and the chances of making errors in the preparation will be reduced.
Tony Wood, Chief Scientific Officer, GSK stated: “The CHMP positive opinion reflects our commitment to supporting healthcare professionals and improving access to protection against shingles, a painful disease affecting over a million Europeans annually.”
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The use of Shingrix has been allowed within the European Union since 2018 for people aged 50 years and above and since 2020 for high-risk patients of herpes zoster (HZ) aged 18 years and above. The vaccine is the method of choice to achieve this as it will power the immune response of the aging or immune compromised adults.
The CHMP’s positive opinion is mostly based on the data that show the technical comparison of the prefilled syringe with the existing presentation. For I nstance, shingles is an illness that results from reactivation of the varicella-zoster virus (VZV) and affects about one-third of adults worldwide.
Most of the time, the disease is accompanied by painful skin eruption, and exactly in 30% of the patients, post-herpetic neuralgia (PHN) may develop, which is a chronic nerve pain lasting weeks to months.
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