In September 2023, the Institute of Medical Biology, Chinese Academy of Medical Sciences (Institute of Biology, Chinese Academy of Medical Sciences) independently developed the bivalent inactivated vaccine of enterovirus 71 Coxsackievirus A16 (human diploid cell) and obtained the "Drug Clinical Trial Approval Notice" (acceptance number CXSL2300415) issued by the National Medical Products Administration. The target audience for this vaccine is the population aged 6 months to 5 years old.

The Drug Safety Evaluation Research Center of Shandong Xinbo Pharmaceutical Research Co., Ltd. (hereinafter referred to as Shandong Xinbo) has undertaken preclinical safety studies on the bivalent inactivated vaccine of enterovirus 71 Coxsackievirus A16 (human diploid cells), demonstrating its good immunogenicity and safety, which has helped it obtain clinical trial approval.

Hand, foot and mouth disease (HFMD) is a common infectious disease in children caused by enterovirus (EV) infection, which is more common in children under 5 years old. The main features are fever and papules or blisters on the hands, feet, mouth, and other areas. Most children recover on their own within about a week, while a few may suffer from serious neurological diseases such as neurogenic pulmonary edema, aseptic meningitis, encephalitis, and delayed paralysis caused by neurological infections. The prognosis is poor and the mortality rate is high.

Hand, foot, and mouth disease is the most reported infectious disease in China, which seriously endangers children's health and has become a serious public health problem. Among them, Enterovirus 71 (EV71) is the main pathogen causing severe and fatal cases of hand, foot and mouth disease. In addition to EV71, the main pathogens also include Coxsackievirus A16. Therefore, it is extremely necessary to use vaccines targeting two or more pathogenic antigens (at least EV71/CA16) to control the occurrence of hand, foot, and mouth disease in children.

According to the national epidemic situation of legally recognized infectious diseases released by the National Bureau of Disease Control and Prevention, the number of reported cases of hand, foot and mouth disease increased rapidly in June and July this year. The prevention and treatment of hand, foot, and mouth disease still face enormous challenges. The development of a bivalent inactivated vaccine against enterovirus 71 Coxsackievirus A16 will provide a new tool for preventing hand, foot, and mouth disease!