Japan clears prefilled syringe version of GSK's Shingrix

Japan's Ministry of Health, Labour and Welfare has cleared a new prefilled syringe version of GSK's Shingrix, the company's recombinant zoster vaccine, for shingles prevention, according to a 6-K filing dated September 10, 2026. GSK plc announced that Japan's Ministry of Health, Labour and Welfare approved a prefilled syringe presentation of Shingrix for the prevention of shingles.¹

Previously, the vaccine came as two vials, a dry lyophilised antigen and a liquid adjuvant, that had to be combined by hand before administration; the new prefilled version is ready to use, simplifying delivery for healthcare workers.¹

Shingrix has been available in Japan for several years under different age indications. The MHLW first approved it for adults 50 and older in 2018, then expanded the approval in 2023 to cover adults 18 and older who face elevated shingles risk.¹ The company also cited disease burden data: roughly 1.1 million people in Japan develop shingles annually, with risk rising with age and among those with weakened immune systems.¹

The rollout has already begun elsewhere. The prefilled syringe launched in the United States in February 2026 and is being introduced across Europe this year.¹ GSK said regulatory clearance for the new format rests on comparability testing rather than new clinical data: approvals were based on data showing technical comparability between the prefilled syringe and the original presentation, and the change does not alter the vaccine's indication or dosing.¹

GSK Head of Vaccines and Infectious Diseases Research and Development Sanjay Gurunathan commented on the disease's reach, saying "Shingles is a disease that 1 in 3 adults globally will develop in their lifetime."¹