China's first new crown mRNA vaccine approved to start clinical trials
Source: China News Network
The new coronavirus mRNA candidate vaccine (ARCoV), jointly researched and developed by the Academy of Military Medicine of the Chinese Academy of Military Sciences and local enterprises, has officially passed the clinical trial approval of the National Medical Products Administration. This is China's first COVID-19 vaccine approved for clinical trials.
Since the outbreak of the new crown pneumonia epidemic, the Academy of Military Medicine of the Academy of Military Sciences has immediately deployed emergency scientific research and promoted the development of multiple technical routes of new crown vaccines. The domestic new crown mRNA vaccine is another high-tech vaccine variety that the hospital has successfully developed and approved for clinical trials after the recombinant new crown vaccine (adenovirus vector).
Research shows 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 showed that the vaccine-immunized animals can tolerate high-titer new coronavirus attack, effectively prevent virus replication and lung pathological progress, and show good protective effects.
mRNA vaccine is an emerging form of vaccine in recent years. Its basic principle is to introduce mRNA expressing antigen targets into the body through a specific delivery system, express protein in the body and stimulate the body to produce a specific immunological response, thereby enabling the body to obtain 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 to enter clinical trials before.
Qin Chengfeng, project leader and researcher of the Academy of Military Medicine of the Academy of Military Sciences, said that the domestically produced COVID-19 vaccine has three advantages: First, the vaccine antigen target selection is more precise, the induced neutralizing antibody is highly specific, and the vaccine is safer; It is that the core raw materials and equipment are all domestically produced, which can realize rapid expansion of production capacity; the third is to use a single pre-filled injection form, which can be stored at room temperature for a week or for a long time at 4 degrees Celsius. The cold chain cost is low and it is easy to achieve mass inoculation .
It is reported that the new crown mRNA vaccine has been produced in multiple batches in accordance with the requirements of clinical trials, and the phase I clinical trial will be officially launched in Shulan (Hangzhou) Hospital.