GSK plc announced that the European Commission (EC) has approved a new prefilled syringe presentation of Shingrix, the company’s recombinant zoster vaccine (RZV), aimed at simplifying administration for healthcare professionals across the European Union.

Currently, Shingrix is supplied in a two-vial format consisting of a lyophilised antigen powder and a separate liquid adjuvant, which must be mixed prior to injection. The newly approved prefilled syringe eliminates the need for reconstitution, reducing preparation steps and streamlining the vaccination process.

Commenting on the approval, Tony Wood, chief scientific officer at GSK, said the new presentation is designed to make it easier for healthcare professionals to deliver protection against shingles. He noted that shingles is a painful condition that can lead to serious and long-lasting complications, particularly among older adults and individuals living with chronic diseases such as cardiovascular disease and diabetes.

The EC’s decision is supported by data demonstrating technical comparability between the prefilled syringe and the existing two-vial presentation. GSK confirmed that there is no change to the vaccine’s approved indication or dosing regimen.

Shingles is caused by reactivation of the varicella-zoster virus, which remains dormant in the nervous system of most adults following chickenpox infection. Globally, up to one in three adults will develop shingles during their lifetime, with risk increasing with age and in people with chronic conditions including cardiovascular disease, chronic kidney disease, respiratory disorders, asthma and diabetes.

The disease typically manifests as a painful rash with blisters on the chest, abdomen or face. Up to 30% of patients may develop post-herpetic neuralgia, a persistent nerve pain that can last for months and, in some cases, years.

Shingrix combines the glycoprotein E antigen with GSK’s AS01B adjuvant system and is designed to help address the age-related decline in immune response seen in older adults. The vaccine is not indicated for the prevention of primary varicella infection and should be used in line with official recommendations and local product labelling.

Shingrix has been approved in the European Union since 2018 for the prevention of herpes zoster and post-herpetic neuralgia in adults aged 50 years and older, and since 2020 for adults aged 18 years and above who are at increased risk of shingles.

GSK is a global biopharmaceutical company focused on using science, technology and talent to advance the prevention and treatment of disease worldwide.