GSK Shingrix new prefilled syringe presentation accepted for review by EMA

The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for physicians, pharmacists and other healthcare professionals who administer vaccinations. The current presentation of the vaccine consists of a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The new presentation has the same composition as the reconstituted vaccine and the submission is based on data demonstrating comparability between the two.

This European regulatory review follows the file acceptance by the US FDA on 8 January 2025 for the new prefilled syringe presentation. GSK is also investigating submission of this presentation to other markets. GSK’s shingles vaccine has been approved in the European Union for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults aged 50 years and older since 2018; and in adults 18 years and older at increased risk of HZ, since 2020. 

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. Following the rash, up to 30% of people experience PHN8, a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years. Shingles is also associated with significant healthcare and human cost, with 57% of people with shingles reported missing work for an average of 9.1 days.

Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. By age 50, VZV is present in most adults10 and in some may reactivate with advancing age. As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.