GSK Shingrix prefilled syringe approved in Japan
- Japan’s Ministry of Health, Labour and Welfare approved a prefilled syringe presentation of Shingrix for herpes zoster prevention.
- The new syringe replaces the prior two-vial format (lyophilised antigen + liquid adjuvant) and is ready-to-use for healthcare professionals.
- Shingrix has been approved in Japan since 2018 for adults 50+ and since 2023 for adults 18+ at increased risk of herpes zoster.
- GSK launched the prefilled syringe in the US in February 2026 and is rolling it out across Europe during the current year; approval based on technical comparability and no change to indication or dosing.
Regulatory approval
Japan’s Ministry of Health, Labour and Welfare has approved a prefilled syringe presentation of Shingrix (recombinant zoster vaccine, RZV) for the prevention of shingles (herpes zoster).
Presentation change and rollout
The prefilled syringe is ready-to-use and replaces the previous two-vial presentation that required manual reconstitution of a lyophilised antigen and a liquid adjuvant. GSK launched the prefilled syringe in the US in February 2026 and is introducing it across Europe during the current year. Approvals were granted on data confirming technical comparability to the existing presentation; there is no change to indication or dosing.
Indications and disease burden
RZV is a non-live recombinant subunit vaccine authorised in Japan since 2018 for adults aged 50 years and older and since 2023 for adults 18 years and older at increased risk of herpes zoster. Approximately 1.1 million people in Japan develop shingles each year, with risk rising with age and in people with weakened immune systems.
Vaccine composition and limits
Shingrix combines the glycoprotein E antigen with the AS01B adjuvant system. It is not indicated to prevent primary varicella (chickenpox) and should be used per local recommendations and the product label.
Source: GSK
