GSK announce EMA CHMP issued positive opinion for Shingrix in prefilled syringe

GSK (GSK) announced that the European Medicine Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has issued a positive opinion to support the approval of Shingrix in a prefilled syringe. Currently, the vaccine presentation consists of two vials, a lyophilised powder antigen and a liquid adjuvant, which are combined prior to administration. After approval by the European Commission, expected in December 2025, the new prefilled syringe will remove the need to reconstitute separate vials, simplifying the vaccine administration process for healthcare professionals. Tony Wood, Chief Scientific Officer, GSK, said: “At GSK, we are dedicated to driving innovation to continually enhance our world-class vaccines. The CHMP positive opinion on our new presentation of Shingrix reflects our commitment to supporting the healthcare community, making it easier for healthcare professionals to provide protection against shingles, a painful disease affecting well over a million people in Europe each year.”