Brisith drug major GSK plc (GSK.L) announced Tuesday that Japan's Ministry of Health, Labour and Welfare or MHLW accepts Shingrix (Zoster Vaccine Recombinant, Adjuvanted) regulatory submission to prevent shingles in at-risk adults aged 18 years and older. Shingrix is already approved in Japan for adults aged 50 years and above.
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.
The targeted treatment group also 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.
Shingles, also known as herpes zoster, is caused by a reactivation of the varicella-zoster virus or VZV - the same virus that causes chickenpox - which lays dormant in the body after the initial infection.
Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine given intramuscularly in two doses, was initially approved in 2018 by the MHLW to prevent shingles in adults aged 50 years or older.
Shingrix combines an antigen, glycoprotein E, and an adjuvant system, AS01B, to generate a VZV-specific immune response that can help overcome the decline in VZV immunity as people age.
The recombinant shingles vaccine is not indicated to prevent primary varicella infection (chickenpox).
The European Commission and the UK approved Shingrix in 2020 to prevent shingles and PHN in adults aged 18 or older at increased risk of shingles. In July 2021, the US Food and Drug Administration approved the vaccine to prevent shingles in adults aged 18 years or older at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.
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