GSK’s Shingrix prefilled syringe has been approved in Japan for shingles prevention, simplifying vaccine preparation and administration for healthcare professionals.
Written By: Aasritha Thippavajjala, PharmD
Reviewed By: Pharmacally Editorial Team
GSK has secured Japanese regulatory approval for a prefilled syringe version of Shingrix, simplifying administration of the recombinant zoster vaccine for adults at risk of herpes zoster.
GSK’s prefilled syringe presentation of Shingrix has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the prevention of shingles, or herpes zoster (HZ). The new presentation replaces the existing two-vial format, in which healthcare professionals must manually combine a lyophilised antigen with a liquid adjuvant before administration.
The ready-to-use syringe eliminates that preparation step while maintaining the same indication and dosing regimen.
Shingles remains a major burden in Japan
About 1.1 million people develop shingles in Japan each year, with the risk rising substantially with age and in people with weakened immune systems. Shingles results from reactivation of varicella-zoster virus (VZV), which remains dormant in the nervous system after an earlier chickenpox infection.
More than 90% of adults carry latent VZV. Reactivation typically causes a painful blistering rash that can affect the chest, abdomen or face. One of the most important complications is post-herpetic neuralgia (PHN), a persistent nerve pain that can continue for months and, in some cases, years.
Several chronic conditions, including cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, asthma and diabetes, are also associated with increased shingles risk.
Shingrix uses recombinant antigen and AS01B adjuvant
Shingrix is a non-live recombinant subunit vaccine containing the VZV glycoprotein E antigen combined with GSK’s AS01B adjuvant system. The formulation is intended to generate a strong immune response in older adults, in whom immune responses to vaccination naturally decline.
MHLW first approved Shingrix in Japan in 2018 for adults aged 50 years and older. In 2023, the approval expanded to adults aged 18 years and older who are at increased risk of herpes zoster.
The vaccine is not indicated for prevention of primary varicella infection, or chickenpox, and its use should follow Japanese recommendations and the local product label.
Approval based on technical comparability
The Japanese approval rests on data demonstrating technical comparability between the prefilled syringe and the existing two-vial presentation. The regulatory change therefore concerns the vaccine’s presentation and administration rather than its clinical indication or dosing.
GSK Head of Vaccines and Infectious Diseases Research and Development Sanjay Gurunathan said the simpler presentation could help support healthcare professionals in Japan by making vaccine administration easier.
The prefilled syringe launched in the US in February 2026, while GSK is rolling out the presentation across Europe during 2026.
What comes next
The Japanese approval expands availability of a more convenient Shingrix administration format in a country with a substantial shingles burden. Because the presentation does not alter the approved indication or dosing schedule, its clinical significance lies primarily in simplifying preparation and administration for healthcare professionals.
For GSK, the rollout also extends the company’s global transition toward the prefilled syringe format, following its US launch and ongoing European introduction.
Reference
GSK’s Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved in Japan, GSK, 10 September 2026
About the Writer
Aasritha Thippavajjala (Linkedin) is a pharm D student and aspiring medical writer with medical writing, clinical training experience and a strong interest in clinical research and patient safety She has hands-on exposure to clinical pharmacy activities including medication profile assessment, clinical case review, identification of potential drug-related problems, ADR awareness, patient counselling, and clinical documentation. She has also gained experience in medical literature review, evidence synthesis, and scientific communication through her published review article on digital twin-based patient simulation and her poster presentation at the 74th Indian Pharmaceutical Congress. Certified in ICH Good Clinical Practice (E6(R3)) and Scientific Writing in Health Research, she is passionate about applying her clinical knowledge and research skills to medical writing ,clinical research and contributing to accurate, evidence-based healthcare.