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GSK plc (LSE/NYSE:GSK) announced Tuesday that the China National Medical Products Administration has approved Shingrix, its recombinant zoster vaccine, for the prevention of shingles in adults aged 18 and over who are at increased risk due to immunodeficiency or immunosuppression. The approval makes Shingrix the first vaccine authorized for this specific population in China, according to a press release statement and the company’s SEC filing.
Shingrix was previously approved in China for adults aged 50 and above. The expanded indication now includes adults 18 and older whose immune systems are compromised by disease or therapy. GSK cited data indicating that approximately six million cases of shingles occur annually in China, with immunodeficient or immunosuppressed patients facing higher risk compared to the general population.
The approval was supported by six clinical trials involving adults aged 18 and over who had undergone stem cell or kidney transplants, or who have blood cancer, solid tumors, or HIV. No other shingles vaccine is currently approved for immunocompromised adults in China.
Sanjay Gurunathan, Senior Vice President of Vaccines and Infectious Diseases R&D at GSK, stated, “This approval marks a critical milestone in expanding access to GSK’s RZV for those at a higher risk of what can be a disrupting and devastating disease.”
Shingles, caused by reactivation of the varicella zoster virus, can lead to complications such as post-herpetic neuralgia, a type of nerve pain that may persist for months or years. Shingrix is a non-live, recombinant subunit vaccine that combines an antigen, glycoprotein E, with an adjuvant system and is not indicated for the prevention of primary varicella infection (chickenpox).
GSK is traded on the London Stock Exchange and the New York Stock Exchange under the ticker LSE:GSK and NYSE:GSK. All information is based on a press release statement and the company’s SEC filing.
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