China News Service, Beijing, June 25 (Li Chunzhuang Yingna) A China News Service reporter was informed on the 25th that the new coronavirus mRNA candidate vaccine (ARCoV) formed by the Research and Development of the Military Medical Research Institute of the Chinese Academy of Military Sciences and local enterprises It was officially approved by the National Drug Administration on June 19 for clinical trials. This is the first new crown mRNA vaccine approved for clinical trials in China.
Since the outbreak of New Coronary Pneumonia, the Institute of Military Medical Sciences of the Academy of Military Sciences has immediately deployed emergency scientific research and research, and has promoted the development of new crown vaccines on multiple technical routes. The domestic new crown mRNA vaccine is another high-tech vaccine variety that has been successfully approved for clinical trials following the recombinant new crown vaccine (adenovirus vector).
Studies have shown that this new crown mRNA vaccine can not only induce high levels of neutralizing antibodies in mice and cynomolgus monkeys, but also induce protective T cell immune responses. The cynomolgus monkey challenge experiment shows that the animals immunized with the vaccine can tolerate high-titer neocoronavirus attacks, effectively prevent virus replication and lung pathological progress, and show good protective effects.
The mRNA vaccine is a new vaccine form emerging in recent years. Its basic principle is to introduce the mRNA expressing the antigen target into the body through a specific delivery system, express the protein in the body and stimulate the body to produce a specific immunological response, so that the body gets immunity protection. There is a high technical threshold for the development of mRNA vaccines. At present, only a few mRNA vaccine varieties developed in the United States and Germany have entered the clinical research stage. China has never approved mRNA vaccines into clinical practice before.
Qin Chengfeng, the project leader and a researcher at the Academy of Military Medical Sciences of the Academy of Military Sciences, said that the domestic new crown mRNA vaccine has three major advantages: first, the selection of vaccine antigen targets is more precise, the specificity of induced neutralizing antibodies is high, and the vaccine is safer; second The core raw materials and equipment are all domestically produced, which can achieve rapid expansion of production capacity; the third is to use a single-served pre-filled dosage form, which can be stored at room temperature for one week or 4 degrees Celsius for long-term storage, the cold chain cost is low, and it is easy to achieve large-scale vaccination of the crowd .
It is reported that the new crown mRNA vaccine has completed multiple batches of production in accordance with the requirements of clinical trials, and will officially start a phase I clinical trial at Shulan (Hangzhou) Hospital. (Finish)