GSK has announced a significant regulatory milestone in adult immunisation with the European Commission’s approval of a new prefilled syringe presentation for its widely used shingles vaccine, Shingrix. This updated format is designed to simplify the administration process for healthcare professionals by removing the need to mix components before injection — a step required in the current two-vial version. The approval paves the way for rollout across EU countries throughout 2026.
Shingrix, also known as the Recombinant Zoster Vaccine (RZV), has been authorised in the European Union for nearly a decade to prevent herpes zoster (shingles) and its painful complication, post-herpetic neuralgia (PHN), particularly in adults aged 50 years and older. Since 2020, the vaccine has also been approved for adults 18 and over who are at increased risk due to other health conditions.
The traditional Shingrix vaccine presentation consists of two separate vials — one containing a lyophilised (freeze-dried) antigen and another a liquid adjuvant — which must be combined immediately before use. This requirement adds time and complexity for healthcare providers. In contrast, the prefilled syringe comes ready to administer, offering a more convenient alternative that maintains the same vaccine composition, dosing and intended use as the original version.
Tony Wood, Chief Scientific Officer at GSK, emphasised the goal behind the new presentation: to make vaccination easier for clinicians and support broader protection against shingles, a disease that inflicts painful rashes and possible long-term nerve pain, especially in older and chronically ill populations. He highlighted that simplifying administration can help strengthen adult immunisation efforts.
Shingles is caused by the reactivation of the varicella-zoster virus (VZV) — the same virus responsible for chickenpox — which lies dormant in many people’s nervous systems and may reactivate later in life. Nearly 1 in 3 adults worldwide will develop shingles during their lifetime, with risk increasing with age and certain chronic health conditions.
The approval of the prefilled syringe did not change the vaccine’s indication or dosing, as regulatory assessment confirmed technical comparability with the original formulation. With this new option, healthcare systems across Europe can adopt a more efficient delivery method beginning next year, potentially improving patient experience and vaccination uptake.
