Researchers isolated novel coronavirus strains from bronchoalveolar lavage fluid from 11 patients diagnosed with novel coronavirus pneumonia in China, Italy, Switzerland, the United Kingdom, and Spain, and 11 samples containing novel coronavirus strains were widely distributed on a phylogenetic tree composed of all available gene sequences.
The researchers selected one of the strains and developed a purified and inactivated SARS-CoV-2 virus vaccine, PiCoVacc.
Genetic stability testing showed that PiCoVacc has excellent genetic stability without any S mutations that could potentially alter the NAb epitope.
To produce experimental-scale PiCoVacc for use in animal studies, the researchers propagated it in 50 liters of Vero cell cultures and inactivated it with beta-prolactone.
The team was then able to obtain a high purity formulation of PiCoVacc for use in the experiment, including through deep filtration, and was the first to publish animal results of the new coronavirus vaccine in Science.
Due to the rapid increase in new cases, coronavirus disease (COVID-19) in 2019 quickly gained global attention with the pathogen identified as SARS-CoV-2.
Due to the novel nature of the virus, there is currently no SARS-CoV-2 specific treatment or vaccine. Therefore, there is an urgent need to rapidly develop an effective vaccine against SARS-CoV-2.
On the 6th, the official website of Science magazine published the research article Rapid development of an inactivated vaccine for SARS-CoV-2 ("Rapid development of an inactivated vaccine for SARS-CoV-2 virus").
It is led by the Qinchuan team of the Institute of Medical Experimental Animals of the Chinese Academy of Medical Sciences, in collaboration with Zhang Grim team of the CDC of Zhejiang Province, Kexing Holdings Biotechnology Limited, Wang Xiangxi team of the Institute of Biophysics of the Chinese Academy of Sciences, China Food and Drug Testing and Research Institute, and the Institute for the Prevention and Control of Infectious Diseases of the China Center for Disease Control and Prevention.
This is the first publicly reported experimental animal study of a novel coronavirus vaccine. Previously, on April 19, a preview version of the paper was released on bioRxiv, the biological sciences preprint paper platform.
The research team obtained a purified and inactivated SARS-CoV-2 virus vaccine candidate called PiCoVacc through trial-scale production.
They found that PiCoVacc triggers an effective humoral immune response in non-human primates, providing complete protection against the SARS-CoV-2 virus strain that is currently raging worldwide.
Through systematic analysis of clinical signs, hematology, and biochemical indicators in rhesus monkeys, the researchers concluded that the vaccine is safe.
Therefore, the State Drug Administration has approved on April 13, 2020, the new coronavirus inactivation vaccine entered the clinical trial. The Phase I/II clinical study was officially launched on April 16 in Suining County, Xuzhou City, Jiangsu Province.
The article's correspondent authors include several top experts in infectious disease viruses, vaccine research.
However, the development of the vaccine, despite the high hopes, still needs time for a scientific process.
Several SARS-CoV-2 vaccines are being developed, such as DNA, RNA vaccines, recombinant subunit vaccines containing viral epitopes, adenovirus vector vaccines, and purified inactivated virus vaccines, according to the paper.
At present, three vaccines have been approved for clinical trials in China, and one of the adenovirus vector vaccines has entered phase II human clinical trials.
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