Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a prefilled syringe presentation of Shingrix, GSK’s recombinant zoster vaccine (RZV), for the prevention of shingles (herpes zoster).
Until now, the vaccine was supplied in two vials – one containing the dry (lyophilised) antigen and the other containing the liquid adjuvant. The two components had to be combined manually before administration. The newly approved prefilled syringe is ready to use, making administration simpler and more convenient for healthcare professionals.
Shingrix is a non-live, recombinant sub-unit vaccine. It has been approved in Japan since 2018 for the prevention of herpes zoster in adults aged 50 years and older. In 2023, its approval was expanded to include adults aged 18 years and older who are at increased risk of herpes zoster.
An estimated 1.1 million people in Japan develop shingles each year. The risk increases with age and is also higher among people with weakened immune systems.
“Shingles is a disease that 1 in 3 adults globally will develop in their lifetime. It can have serious and long-lasting complications,” said Sanjay Gurunathan, GSK’s Head of Vaccines and Infectious Diseases Research and Development.
“GSK is pleased to support the healthcare community in Japan by making administration of our shingles vaccine easier,” he added.
GSK launched the Shingrix prefilled syringe in the US in February 2026 and plans to introduce it across Europe throughout the year. Regulatory approvals are based on data demonstrating technical comparability between the prefilled syringe and the existing presentation. The new presentation does not change the vaccine’s approved indication or dosing schedule.
Shingles occurs when the varicella-zoster virus (VZV), which causes chickenpox, reactivates in the body. More than 90% of adults are estimated to have dormant VZV in their nervous system, which can reactivate later in life. Besides advancing age, several chronic conditions, including cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease (COPD), asthma and diabetes, have been associated with an increased risk of shingles.
The condition typically causes a painful rash with blisters, often appearing on the chest, abdomen or face. One of the most common complications is post-herpetic neuralgia (PHN), a long-lasting nerve pain that can last for weeks or months and, in some cases, several years.
Shingrix contains the VZV glycoprotein E antigen along with the AS01B adjuvant system. The vaccine is designed to enhance immune responses, helping address the natural decline in immune responses associated with ageing. RZV is not indicated for the prevention of primary varicella infection, or chickenpox.
