BEIJING: GSK plc (LSE/NYSE: GSK) said Tuesday that China’s National Medical Products Administration has approved Shingrix, its recombinant zoster vaccine (RZV), for use in adults aged 18 and older who are at increased risk of shingles due to immunodeficiency or immunosuppression caused by disease or therapy.
The approval marks the first shingles vaccine authorized in China for immunocompromised adults under 50, a population previously unserved by existing immunization options. Shingles affects an estimated six million people annually in China, with immunosuppressed individuals facing heightened risk and more severe complications.
“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,” said Sanjay Gurunathan, GSK’s senior vice president of vaccines and infectious diseases R&D. “We continue to drive innovation that helps protect vulnerable patient groups and shift healthcare systems toward prevention.”
Shingrix is a non-live, recombinant subunit vaccine that combines glycoprotein E with the AS01B adjuvant system. It is already approved in multiple countries for adults aged 50 and older, and for those 18+ at increased risk. The China approval was supported by six clinical trials involving patients with HIV, blood cancers, solid tumors, and recent stem cell or kidney transplants.
Shingles, caused by reactivation of the varicella zoster virus, typically presents as a painful rash and can lead to post-herpetic neuralgia (PHN), a nerve pain that may persist for months or years. PHN occurs in up to 30% of shingles cases and significantly impacts quality of life, including sleep and daily functioning.
GSK said the expanded indication will help protect China’s most vulnerable patients and aligns with its strategy to prioritize disease prevention through global regulatory partnerships.