GSK plc has received approval from Japan’s Ministry of Health, Labour and Welfare for its prefilled syringe version of Shingrix, a recombinant sub-unit shingles vaccine combining glycoprotein E antigen with the AS01B adjuvant system. The change eliminates the need for healthcare providers to manually combine two vials, making administration more convenient without altering the vaccine’s approved indications or dosing regimen. Approval was based on technical comparability data between the new and existing presentation formats.
Shingles affects approximately 1.1 million people annually in Japan, with 1 in 3 adults globally expected to develop the condition at some point in their lifetime. The varicella-zoster virus, dormant in the nervous system for over 90% of adults, triggers shingles, and up to 30% of patients experience post-herpetic neuralgia—a chronic nerve pain lasting weeks, months, or occasionally years. The vaccine remains contraindicated for preventing primary varicella infection.
GSK’s Sanjay Gurunathan, Head of Vaccines and Infectious Diseases Research and Development, noted that Shingrix is a significant health burden, emphasizing GSK’s commitment to improving vaccine accessibility. The prefilled syringe launched in the U.S. in February 2026 and is set to enter the European market throughout 2026. Approvals in Japan follow prior approvals in 2018 for adults aged 50+, and in 2023 for those aged 18+ at increased risk of shingles.
This development aligns with broader efforts to streamline vaccine administration while preserving clinical safety and efficacy standards.
