GSK announced that the European Commission (EC) has approved a new prefilled syringe presentation for Shingrix (Recombinant Zoster Vaccine, Adjuvanted; RZV), a key advancement designed to streamline vaccine administration. Previously, Shingrix required reconstitution by mixing a lyophilised powder antigen vial with a liquid adjuvant suspension. The new ready-to-use prefilled syringe eliminates this step, offering healthcare professionals a more convenient option without altering the vaccine’s composition, efficacy, safety profile, indication, or two-dose regimen.
The approval follows submission of data confirming technical comparability between the prefilled syringe and the current presentation. Shingrix remains indicated in the European Union for the prevention of herpes zoster (shingles) and post-herpetic neuralgia (PHN) in adults aged 50 years and older, as well as adults 18 years and older at increased risk of shingles due to immunodeficiency or immunosuppression.
Tony Wood, Chief Scientific Officer at GSK, commented: “This new presentation of Shingrix has been designed to improve ease of administration, helping healthcare professionals to provide protection against shingles. Shingles is a painful disease that can have serious and long-lasting complications. It affects millions of people each year in Europe, often imposing a greater burden on people living with common chronic diseases such as cardiovascular disease and diabetes. GSK is proud to support the healthcare community by making administration of its shingles vaccine easier.”
Shingles, caused by reactivation of the varicella-zoster virus, impacts approximately 1.7 million people annually in Europe. Up to one in three adults may develop it in their lifetime, with risk increasing with age and conditions like cardiovascular disease, chronic kidney disease, COPD, asthma, and diabetes. Symptoms include a painful rash with blisters, and up to 30% of cases lead to PHN, a debilitating long-term nerve pain. The prefilled syringe presentation is expected to begin rolling out across EU countries in 2026, potentially facilitating higher vaccination rates by reducing administrative burden. Shingrix, combining glycoprotein E antigen with the AS01B adjuvant system, helps address age-related immune decline and is administered according to official recommendations.
