GSK plc has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a prefilled syringe presentation of Shingrix (Recombinant Zoster Vaccine, RZV) for the prevention of shingles (herpes zoster). The announcement was made on September 10, 2026.
The newly approved presentation is designed to simplify vaccine administration for healthcare professionals. The existing Shingrix presentation consists of two vials, one containing a lyophilised antigen and the other a liquid adjuvant which need to be combined before administration. The prefilled syringe is ready to use, eliminating these preparation steps.
Shingrix is a non-live, recombinant subunit vaccine that combines glycoprotein E antigen with the AS01B adjuvant system. In Japan, the vaccine has been approved since 2018 for the prevention of herpes zoster in adults aged 50 years and older. Its indication was expanded in 2023 to include adults aged 18 years and older who are at increased risk of shingles.
GSK stated that approximately 1.1 million people develop shingles in Japan each year, with the risk increasing with age and among people with weakened immune systems. Shingles results from reactivation of the varicella-zoster virus, which also causes chickenpox, and can lead to complications including long-lasting post-herpetic neuralgia.
The approval of the Japanese prefilled syringe presentation was supported by data demonstrating technical comparability between the new presentation and the existing vaccine presentation. GSK noted that the new presentation does not change the indication or dosing of Shingrix.
The prefilled syringe presentation was launched in the United States in February 2026 and is being introduced across Europe during 2026, following regulatory approvals in those markets.
