GSK plc announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of a new prefilled syringe version of its shingles vaccine, Shingrix (Recombinant Zoster Vaccine, RZV).
The new format, expected to receive European Commission approval in December 2025, will simplify vaccine administration by eliminating the need to mix two separate vials — currently a lyophilised antigen powder and a liquid adjuvant — before use.
Tony Wood, GSK’s Chief Scientific Officer, said the development reflects the company’s commitment to innovation and supporting healthcare professionals. “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,” he said.
Shingrix has been approved in the European Union since 2018 for the prevention of herpes zoster (shingles) and post-herpetic neuralgia (PHN) in adults aged 50 and older, and since 2020 for adults 18 and over at increased risk of shingles. The vaccine is designed to boost immune response in individuals with declining or compromised immunity.
The CHMP’s positive opinion is based on data confirming that the prefilled syringe maintains technical and immunological comparability with the existing two-vial presentation.
If approved, the new format will make Shingrix administration more efficient and user-friendly for healthcare providers across Europe, supporting wider access to protection against shingles — a painful disease that affects more than a million people in Europe each year.