Medical Net, May 9th, the reporter learned from the Press Center of the Chinese Academy of Medical Sciences that the Qinchuan team of the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences, Kexing Holding Biotechnology Co., Ltd., the Wang Xiangxi team of the Institute of Biophysics of the Chinese Academy of Sciences, and the Zhejiang Provincial Center for Disease Control and Prevention Zhang Yanjun's team, the China Food and Drug Control Institute, the Institute for Infectious Disease Control and Prevention of the Chinese Centers for Disease Control and Prevention and many other units have cooperated to publish the results of animal experiments on the new coronavirus vaccine in the internationally renowned academic journal Science. Studies have confirmed that the new coronavirus inactivated vaccine is safe and effective in the rhesus monkey model. This is the first publicly reported animal experimental study of the new coronavirus vaccine.

　　Qin Chuan, director of the Institute of Medical Laboratory Animals, Chinese Academy of Medical Sciences, Zhang Yanjun, researcher at the Institute of Microbiology, Zhejiang Provincial Center for Disease Control and Prevention, Yin Weidong, Kexing Holdings, Wang Xiangxi, researcher at the Institute of Biophysics, Chinese Academy of Sciences, Li Changgui, researcher at the China Institute for Food and Drug Control, and China Diseases Lu Jinxing, a researcher at the Institute for Infectious Disease Control and Prevention, Center for Prevention and Control, is the corresponding author. Gao Qiang from Kexing Holdings, Linlin Lin, Ph.D. from the Chinese Academy of Medical Sciences, Haiyan Mao, Ph.D. from Zhejiang Provincial Center for Disease Control and Prevention, Wang Lin from Kexing Holdings, Xu Kangwei, Ph.D. from China Institute for Food and Drug Control, and Yang Minnan, Ph.D. from the Institute of Biophysics, Chinese Academy of Sciences, are the joint articles of the paper. One author.

　　The COVID-19 pandemic caused by the new crown virus has brought an unprecedented crisis to people, posed a huge threat to human health and life, and brought catastrophic losses to the global economy. So far, there is no effective antiviral drug against the new coronavirus, so there is an urgent need for rapid development of an effective new coronavirus vaccine. The researchers isolated multiple new coronavirus strains from the bronchoalveolar lavage fluid of 11 hospitalized patients (including 5 ICU patients) infected with the new coronavirus, including 5 strains from China, 3 strains from Italy, and One strain each from Switzerland, Britain and Spain. These 11 strains are widely scattered on a phylogenetic tree constructed based on all available sequences, and to a certain extent represent the virus populations that are circulating.

　　The researchers selected the CN2 strain for vaccine preparation, developed a purified inactivated new coronavirus vaccine candidate, and conducted pilot production. The vaccine can induce the production of new coronavirus-specific neutralizing antibodies in mice, rats and non-human primates. These antibodies can effectively neutralize the selected other 10 strains (CN1, CN3-CN5 and OS1-OS6) representative of the new coronavirus strains, indicating that they may have potential for the widespread new coronavirus strains worldwide The neutralization ability. Subsequently, the researchers conducted a challenge experiment in rhesus monkeys immunized with the vaccine to evaluate the immunogenicity and protective effect of the vaccine. The researchers vaccinated rhesus monkeys with different doses of vaccines on days 0, 7, and 14. The results showed that S protein-specific IgG and neutralizing antibodies could be induced in the second week, and challenge was performed on the 22nd day after vaccination. The results showed that compared with the control group, the pathological changes in the lung tissue of the rhesus monkeys after the vaccine immunization were significantly reduced, and the viral load was also significantly reduced. On the 7th day after the infection of the high-dose rhesus monkeys, no virus was detected in the throat, anus, or lungs, and no enhancement of antibody dependence was observed to provide complete protection against the new coronavirus challenge. The researchers also verified the safety of the vaccine by observing clinical indicators and biochemical indexes, and found that none of the vaccinated rhesus monkeys found fever or weight loss, and their appetite and mental state remained normal. In terms of blood and biochemical analysis, the proportion of lymphocyte subsets and key cytokines of the vaccinated rhesus monkeys did not change significantly compared with the control group. The pathological evaluation of various organs and tissues including the lung, heart, spleen, liver, kidney and brain of the vaccinated rhesus monkey on day 29 showed that the vaccine did not cause significant pathological features. The above results indicate that The vaccine is safe in rhesus monkeys.

　　Based on the above research results, the National Medical Products Administration approved the vaccine to enter clinical studies on April 13, and the Phase I clinical study was officially launched in Suining County, Xuzhou City, Jiangsu Province on April 16. The first batch of volunteers have been successfully enrolled. And complete the first vaccination. (Reporter Tian Yating)