Report by : Gan Yung Chyan
/ KUCINTA SETIA
Image : A rhesus monkey after vaccination. Courtesy of TBS.
On 6 May 2020, Science magazine's official website published the "safe and effective" experiment results in the research article by the Qin Chuan team led by the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences, together with the Zhang Yanjun team of the Zhejiang Provincial Center for Disease Control, Kexing Holdings Biotechnology Co., Ltd., and the Wang Xiangxi team of the Institute of Biophysics, Chinese Academy of Sciences.
The research article entitled "Rapid development of an inactivated vaccine for SARS-CoV-2" is the first publicly reported result of an experimental study of a SARS-CoV-2 vaccine on animals. Prior to 19 April 2020, a preview version of the paper was published on bioRxiv, the preprint paper platform for Biological Sciences.
The researchers isolated SARS-CoV-2 strains from the bronchoalveolar lavage fluids of 11 patients diagnosed with covid in China, Italy, Switzerland, the United Kingdom, Spain, etc. 11 samples containing the SARS-CoV-2 strains were widely distributed in all available gene sequences on the phylogenetic tree. They selected one of the strains and developed the a purified inactivated SARS-CoV-2 virus vaccine PiCoVacc.
The genetic stability test showed that PiCoVacc has excellent genetic stability, and there is no S mutation that may potentially change the NAb epitope.
To produce the pilot-scale PiCoVacc for animal research, the researchers propagated it in a 50-liter Vero cell culture and inactivated it with β-propiolactone. After that, through deep filtration and other means, the research team obtained a high-purity PiCoVacc preparation for the experiment. The Qin Chuan team of researchers are the first to publish the animal experiment results of the SARS-CoV-2 vaccine.
The research team obtained a purified and inactivated SARS-CoV-2 virus candidate vaccine named PiCoVacc through trial-scale production. They found that PiCoVacc can elicit an effective humoral immune response in non-human primates, providing complete protection for the SARS-CoV-2 strain currently raging globally. Through systematic analysis of the clinical signs, hematology, and biochemical indicators of rhesus monkeys, the researchers believe that the vaccine is safe.
Therefore, on 13 April 2020, the State Drug Administration approved the SARS-CoV-2 inactivated vaccine developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd. ("Kexing Zhongwei"), a subsidiary of Kexing Holding Biotechnology Co., Ltd. and entered the clinical study. The Phase I / II clinical study was officially launched on 16 April 2020 in Suining County, Xuzhou City, Jiangsu Province.
However, despite the high expectations for vaccine research and development, it still takes time for scientific processes. The research article said that there are currently a variety of SARS-CoV-2 vaccines under development, such as DNA, RNA vaccines, recombinant subunit vaccines containing viral epitopes, adenovirus vector vaccines and purified inactivated virus vaccines. Currently, three vaccines have been approved for clinical trials in China, and one adenovirus vector vaccine has entered Phase II human clinical trials.
StayGate's Notes:
The corresponding writers of the research article in Science include many top experts in the field of infectious disease virus and vaccine research, including Qin Chuan, director of the Institute of Microbiology of the Zhejiang Provincial Center for Disease Control and Prevention, who was responsible for animal model research projects during the SARS outbreak in 2003. Yan Jun, General Manager of the Novel Coronavirus Inactivated Vaccine Project of Kexing Holdings Biotechnology Co., Ltd. Yin Weidong, Researcher Wang Xiangxi, Institute of Biophysics, Chinese Academy of Sciences, Researcher Li Changgui, China Academy of Food and Drug Control, and Researcher Lu Jinxing, Institute of Infectious Disease Control and Prevention, Chinese Center for Disease Control and Prevention.
Ref : Rapid development of an inactivated vaccine for SARS-CoV-2, Science, https://science.sciencemag.org/content/early/2020/05/05/science.abc1932?
/ KUCINTA SETIA
Image : A rhesus monkey after vaccination. Courtesy of TBS.
On 6 May 2020, Science magazine's official website published the "safe and effective" experiment results in the research article by the Qin Chuan team led by the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences, together with the Zhang Yanjun team of the Zhejiang Provincial Center for Disease Control, Kexing Holdings Biotechnology Co., Ltd., and the Wang Xiangxi team of the Institute of Biophysics, Chinese Academy of Sciences.
The research article entitled "Rapid development of an inactivated vaccine for SARS-CoV-2" is the first publicly reported result of an experimental study of a SARS-CoV-2 vaccine on animals. Prior to 19 April 2020, a preview version of the paper was published on bioRxiv, the preprint paper platform for Biological Sciences.
The researchers isolated SARS-CoV-2 strains from the bronchoalveolar lavage fluids of 11 patients diagnosed with covid in China, Italy, Switzerland, the United Kingdom, Spain, etc. 11 samples containing the SARS-CoV-2 strains were widely distributed in all available gene sequences on the phylogenetic tree. They selected one of the strains and developed the a purified inactivated SARS-CoV-2 virus vaccine PiCoVacc.
The genetic stability test showed that PiCoVacc has excellent genetic stability, and there is no S mutation that may potentially change the NAb epitope.
To produce the pilot-scale PiCoVacc for animal research, the researchers propagated it in a 50-liter Vero cell culture and inactivated it with β-propiolactone. After that, through deep filtration and other means, the research team obtained a high-purity PiCoVacc preparation for the experiment. The Qin Chuan team of researchers are the first to publish the animal experiment results of the SARS-CoV-2 vaccine.
The research team obtained a purified and inactivated SARS-CoV-2 virus candidate vaccine named PiCoVacc through trial-scale production. They found that PiCoVacc can elicit an effective humoral immune response in non-human primates, providing complete protection for the SARS-CoV-2 strain currently raging globally. Through systematic analysis of the clinical signs, hematology, and biochemical indicators of rhesus monkeys, the researchers believe that the vaccine is safe.
Therefore, on 13 April 2020, the State Drug Administration approved the SARS-CoV-2 inactivated vaccine developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd. ("Kexing Zhongwei"), a subsidiary of Kexing Holding Biotechnology Co., Ltd. and entered the clinical study. The Phase I / II clinical study was officially launched on 16 April 2020 in Suining County, Xuzhou City, Jiangsu Province.
However, despite the high expectations for vaccine research and development, it still takes time for scientific processes. The research article said that there are currently a variety of SARS-CoV-2 vaccines under development, such as DNA, RNA vaccines, recombinant subunit vaccines containing viral epitopes, adenovirus vector vaccines and purified inactivated virus vaccines. Currently, three vaccines have been approved for clinical trials in China, and one adenovirus vector vaccine has entered Phase II human clinical trials.
StayGate's Notes:
The corresponding writers of the research article in Science include many top experts in the field of infectious disease virus and vaccine research, including Qin Chuan, director of the Institute of Microbiology of the Zhejiang Provincial Center for Disease Control and Prevention, who was responsible for animal model research projects during the SARS outbreak in 2003. Yan Jun, General Manager of the Novel Coronavirus Inactivated Vaccine Project of Kexing Holdings Biotechnology Co., Ltd. Yin Weidong, Researcher Wang Xiangxi, Institute of Biophysics, Chinese Academy of Sciences, Researcher Li Changgui, China Academy of Food and Drug Control, and Researcher Lu Jinxing, Institute of Infectious Disease Control and Prevention, Chinese Center for Disease Control and Prevention.
Ref : Rapid development of an inactivated vaccine for SARS-CoV-2, Science, https://science.sciencemag.org/content/early/2020/05/05/science.abc1932?
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