GSK PLC on Tuesday announced it has submitted a regulatory application for Shingrix, a shingles vaccine, to the Japanese Ministry Health, Labour & Welfare.
The new submission for adults aged 18 and older aims to expand the number of people who can be protected against shingles, including those with immunodeficiency or immunosuppression, GSK explained. Shingrix was approved by the Japanese MHLW in 2018 to prevent shingles in adults aged 50 and over.
The expanded regulatory application was based on six clinical trials in patients aged 18 and over who had recently undergone blood-forming cells transplantation, kidney transplant, have blood cancer, solid tumour, or HIV.
Shingles is caused by the reactivation of the varicella-zoster virus - the same virus that causes chickenpox. Age-related decline of the immune system allows the virus to resurface. Those with suppressed or compromised immune systems are also at an increased risk.
The European Commission and the UK approved the vaccine in 2020 for the prevention of shingles and post-herpetic neuralgia in adults aged 18 and older.
An extended indication of the vaccine was also recently approved in the US to include adults at increased risk of shingles due to immunodeficiency or immunosuppression.
Shares in the London-based pharmaceutical company were up 0.7% at 1,776.00 pence on Tuesday morning in London.
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