GSK submits shingles vaccine application in Japan for over 18s
Pharma giant GlaxoSmithKline on Tuesday said it had submitted a regulatory application Japan's Ministry of Health, Labour and Welfare (MHLW) for its Shingrix shingles vaccine for adults aged 18 years and older who are at increased risk.
This includes individuals with immunodeficiency or immunosuppression caused by known disease or therapy, GSK said.
Shingrix, a vaccine given intramuscularly in two doses, was initially approved in 2018 by the MHLW to prevent shingles in adults aged 50 years or older, GSK said.
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.