China's first monkeypox vaccine approved for clinical trials, aiding global pandemic prevention and control.

The MVA-based monkeypox attenuated live vaccine developed by China Biologic Products Shanghai Institute has been approved for clinical trials. The vaccine is based on the replication-defective vaccinia virus MVA strain, and its safety and efficacy have been validated. It employs a mature cell factory process, ensuring reliable quality. Preclinical studies show that the vaccine provides good immune protection in non-human primate models. The global monkeypox outbreak is severe, with over 100,000 confirmed cases and 226 deaths in 121 countries. China has reported 2,567 cases. A new variant, Ib, originating in Africa, is more virulent and has spread to Europe and Southeast Asia. Vaccination is crucial for prevention and control, and multiple countries have already approved monkeypox vaccines for market. China Biologic Products will continue to advance clinical research to expedite the vaccine's market availability and meet domestic epidemic prevention and control needs.