Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Wednesday that the European Commission has approved a prefilled syringe presentation of its shingles vaccine Shingrix, providing a simplified administration option for healthcare professionals across the European Union.
The approval covers a new presentation that removes the need for reconstitution of the lyophilised antigen and liquid adjuvant currently supplied in two vials, with no change to indication or dosing. The decision was supported by data confirming technical comparability with the existing presentation.
GSK said rollout of the prefilled syringe will begin across EU countries in 2026. Shingles affects around 1.7 million people in Europe each year, with higher risk linked to advancing age and chronic conditions including cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, asthma and diabetes.
Shingrix has been approved in the European Union since 2018 for prevention of herpes zoster and post-herpetic neuralgia in adults aged 50 and over, and since 2020 in adults aged 18 and over at increased risk.
Mabtech partners with Sai Life Sciences to expand access to EYRA multiplex immunology platform
Elaris FlexCo signs global licence agreement with Valneva
Sino Biological launches 2026-2027 Northern Hemisphere influenza vaccine strain antigens
Centivax Inc doses first healthy volunteers in Centi-Flu 01 Phase 1A clinical trial
Delonix Bioworks gets IND clearance for DX-104 in China
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
European Commission approves GSK's Arexvy for adults aged 18 and over