June 24, according to official public number of military academy of Sciences, by military academy of Sciences military medical research institute and local enterprises jointly research, develop the novel coronavirusmRNA candidate vaccine (ARCoV) has been on June 19 officially approved by the State Administration of medical Products clinical trial.
This is the first mRNA vaccine approved for clinical trials in China.
After the novel Coronavirus vaccine (adenovirus vector), the novel novel coronavirus vaccine developed by the hospital was successfully approved for clinical trial.
The study showed that the new corona mRNA vaccine not only induced high levels of neutralizing antibodies in mice and cyclamate monkeys, but also induced protective T cell immune responses.
The novel coronavirus attack can be tolerated by vaccine-immunized animals, and the novel coronavirus attack can effectively prevent virus replication and pulmonary disease progression, showing good protective effect.
MRNA vaccine is a new form of vaccine in recent years. Its basic principle is to introduce the mRNA expressing antigen target into the body through a specific delivery system, express proteins in the body and stimulate the body to produce specific immunological response, so that the body can obtain immune protection.
The research and development of mRNA vaccine has a high technical threshold. At present, only a few mRNA vaccine varieties developed in the United States and Germany have entered the clinical research stage, and the mRNA vaccine has never been approved for clinical application in China.
Qin Chengfeng, the project leader, said that the domestic NCOVID-19 mRNA vaccine has the following advantages: first, the selection of vaccine antigen target is more accurate, the induced neutralization antibody is more specific, and the vaccine is safer.
Second, all the core raw materials and equipment have been localized, and the production capacity can be rapidly enlarged.
Third, the single-dose pre-filling needle dosage form can be stored at room temperature for a week or for a long time at 4℃, with low cold chain cost and easy mass vaccination.
At present, multiple batches of the mRNA vaccine have been produced according to the requirements of clinical trials, and phase I clinical trials will be officially launched in Shulan (Hangzhou) Hospital in the near future.