Japan’s Ministry of Health, Labour and Welfare accepts Shingrix regulatory submission to prevent shingles in at-risk adults aged 18 years and older

GSK plc announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are at increased risk. This includes individuals with immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals.

Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine given intramuscularly in two doses, was initially approved in 2018 by the Japanese MHLW to prevent shingles in adults aged 50 years or older.

The MHLW regulatory submission is based on six clinical trials in patients aged 18 years and older who had undergone recent blood-forming cells (stem cell) transplantation, kidney transplant, or have blood cancer, solid tumour or HIV.

In Japan, adults aged 18 years and older who are immunocompromised or have chronic medical conditions have a higher incidence of shingles, including a higher risk of developing associated complications such as post-herpetic neuralgia (PHN), a severe intermittent or continuous long-term nerve pain that occurs in areas of skin previously affected by shingles. In a retrospective cohort study using data from Japanese adults aged 18 years and older, the risk of shingles was higher in women, irrespective of age and increased with age.