my country's first new crown mRNA vaccine
Approved to initiate clinical trials
The new coronavirus mRNA candidate vaccine (ARCoV) developed by the Military Medical Research Institute of the Academy of Military Sciences and local enterprises was officially approved by the National Drug Administration on June 19th. This is the first mRNA vaccine approved for clinical trials in China.
Since the outbreak of the New Coronary Pneumonia epidemic, the Academy of Military Medical Sciences of the Academy of Military Sciences has immediately deployed emergency scientific research, and at the same time 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 reorganization of a new coronavirus 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. my country has never approved mRNA vaccines into clinical practice.
Researcher Qin Chengfeng, the project leader, 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 safety of the vaccine is better; second, all the core materials and equipment are realized With the localization, the production capacity can be rapidly enlarged. The third is to use a single-serving pre-filled dosage form, which can be stored at room temperature for a week or 4 ℃ for long-term storage, the cold chain cost is low, and it is easy to achieve mass vaccination. At present, the new crown mRNA vaccine has completed multiple batches of production in accordance with the requirements of clinical trials, and will soon officially launch a phase I clinical trial at Shulan (Hangzhou) Hospital.
Author: Shaolong Fei Sun Wei Ran Zhangzhen