It is reported that the new coronavirus mRNA candidate vaccine (ARCoV) developed by the Institute of Military Medicine of the Academy of Military Sciences and local enterprises has been officially approved by the National Medical Products Administration on June 19. Clinical trial approval. This is the first mRNA vaccine approved for clinical trials in China.
Since the outbreak of the new coronavirus pneumonia, the Academy of Military Medical Sciences of the Academy of Military Sciences has deployed emergency scientific research to tackle key problems, and at the same time promoted the research and development of new coronavirus vaccines along multiple technical routes. The domestically produced COVID-19 mRNA vaccine is another high-tech vaccine variety successfully developed and approved for clinical trials by the hospital after the recombinant new coronavirus vaccine (adenovirus vector).
Research shows that this new coronavirus mRNA vaccine can not only induce high levels of neutralizing antibodies in mice and cynomolgus monkeys, but also induce protective T cell immune responses. Challenge experiments on cynomolgus monkeys show that vaccinated animals can tolerate high-titer new coronavirus challenge, effectively prevent virus replication and lung pathology progression, and show good protective effects.
mRNA vaccine is an emerging form of vaccine 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 specific immunity. response, thereby allowing the body to obtain immune protection. There are high technical thresholds for the development of mRNA vaccines. Currently, only a few varieties of mRNA vaccines developed in the United States and Germany have entered the clinical research stage. my country has never approved an mRNA vaccine to enter clinical trials before.
Researcher Qin Chengfeng, the project leader, said that the domestically produced COVID-19 mRNA vaccine has three major advantages: first, the vaccine antigen target selection is more precise, the neutralizing antibodies induced are highly specific, and the vaccine is safer; second, The core raw materials and equipment are all domestically produced, which can achieve rapid expansion of production capacity; third, it adopts a single-serve prefilled injection dosage form, which can be stored at room temperature for a week or 4°C for a long time. The cold chain cost is low, and large-scale vaccination of the population is easy to achieve. . At present, the new coronavirus mRNA vaccine has completed multiple batches of production in accordance with clinical trial requirements, and will officially launch Phase I clinical trials at Shulan (Hangzhou) Hospital in the near future.