• Ze-Jun Wang, Hua-Jun Zhang, Jia Lu, Kang-Wei Xu, Cheng Peng, Jing Guo, Xiao-Xiao Gao, Xin Wan, Wen-Hui Wang, Chao Shan, Su-Cai Zhang, Jie Wu, An-Na Yang, Yan Zhu, Ao Xiao, Lei Zhang, Lie Fu, Hao-Rui Si, Qian Cai, Xing-Lou Yang, Lei You, Yan-Ping Zhou, Jing Liu, De-Qing Pang, Wei-Ping Jin, Xiao-Yu Zhang, Sheng-Li Meng, Yun-Xia Sun, Ulrich Desselberger, Jun-Zhi Wang, Xin-Guo Li, Kai Duan, Chang-Gui Li, Miao Xu, Zheng-Li Shi, Zhi-Ming Yuan, Xiao-Ming Yang, and Shuo Shen.
• Wuhan Institute of Biological Products Co. Ltd., Wuhan, People's Republic of China.
• Emerg Microbes Infect. 2020 Dec 1; 9 (1): 2606-2618.

AbstractThe ongoing COVID-19 pandemic is causing huge impact on health, life, and global economy, which is characterized by rapid spreading of SARS-CoV-2, high number of confirmed cases and a fatality/case rate worldwide reported by WHO. The most effective intervention measure will be to develop safe and effective vaccines to protect the population from the disease and limit the spread of the virus. An inactivated, whole virus vaccine candidate of SARS-CoV-2 has been developed by Wuhan Institute of Biological Products and Wuhan Institute of Virology. The low toxicity, immunogenicity, and immune persistence were investigated in preclinical studies using seven different species of animals. The results showed that the vaccine candidate was well tolerated and stimulated high levels of specific IgG and neutralizing antibodies. Low or no toxicity in three species of animals was also demonstrated in preclinical study of the vaccine candidate. Biochemical analysis of structural proteins and purity analysis were performed. The inactivated, whole virion vaccine was characterized with safe double-inactivation, no use of DNases and high purity. Dosages, boosting times, adjuvants, and immunization schedules were shown to be important for stimulating a strong humoral immune response in animals tested. Preliminary observation in ongoing phase I and II clinical trials of the vaccine candidate in Wuzhi County, Henan Province, showed that the vaccine is well tolerant. The results were characterized by very low proportion and low degree of side effects, high levels of neutralizing antibodies, and seroconversion. These results consistent with the results obtained from preclinical data on the safety.

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