Policy & News

Domestic mRNA rabies vaccine first clinical acceptance, the new crown after the vaccine R & D targeting these areas

2023-06-13

On June 10, information on the official website of the Centre for Drug Evaluation (CDE) of the State Drug Administration showed that the application for clinical trial of human rabies mRNA vaccine of Livanda Biologicals, a subsidiary of domestic private vaccine maker Aimee Vaccines, has been accepted. This signifies that the first rabies mRNA vaccine declared for clinical use in China is expected to enter the clinic soon.

 

 

Advantages of mRNA rabies vaccines over traditional human rabies vaccines include: higher immunogenicity; fewer doses (two or three) required to achieve immunity than traditional vaccines (four or five doses), with simpler dosing regimens; easier to produce as it does not involve complex cell culture processes; fewer impurities from raw materials, making it easier to purify; and greater consistency of quality between batches; Can reduce the risk of injecting inactivated viruses or foreign cells into the body, providing a higher level of safety.

According to the research paper published in Virology Journal in November last year, animal experiments show that the company's research mRNA rabies vaccine can obtain immune protection against rabies virus after two doses of inoculation, and can effectively induce antibody production and stimulate cellular immune response, with the highest immunoprotection efficacy observed at 14-day intervals of dosing; three months after infection with the vaccine The survival rate was 100 per cent after 3 months of infection with the vaccine.

Rabies remains a serious threat to public health, but the disease can be prevented by appropriate vaccination. Globally, nearly 30 million people are currently vaccinated against rabies each year after being bitten by an animal, and vaccination as soon as possible after exposure to the rabies virus remains effective in preventing the onset of symptoms. However, once clinical symptoms appear, the disease is almost 100 per cent fatal.

China has the largest rabies vaccine market in the world, and rabies vaccine is a large vaccine species in China, which is different from Europe and the United States, where rabies vaccine is not a priority species for development.

Currently, several domestic pharmaceutical companies are developing mRNA rabies vaccines. For example, Genting Xinyao announced at the end of last year that its newly developed mRNA rabies vaccine programme had reached proof-of-concept milestones in preclinical studies such as immunogenicity, and that, in head-to-head immunogenicity comparative tests with marketed inactivated rabies vaccines, mice vaccinated with two injections of the mRNA rabies vaccine rapidly produced more highly potent serum-neutralising antibodies at significantly higher titres than the sera of mice immunised with four doses of inactivated rabies vaccine.

In addition, Kangtai Bio is also cooperating with Jiachen Xihai to lay out mRNA rabies vaccine; the mRNA rabies vaccine developed by Kanghua Bio in cooperation with Xinran Bochuang has completed the development of small trial process at the end of last year.

New Crown has brought mRNA vaccines to the public eye, and mRNA platform technology is becoming the next high point of competition among vaccine manufacturers. In addition to rabies vaccine, influenza vaccine, Ebola vaccine, human respiratory syncytial virus (RSV) vaccine, etc. are also mRNA technology is very potential development direction, the domestic enterprises, including China Biologicals, Shiyao Group, Watson Biologicals and other companies will be the focus of the mRNA platform for strategic layout.

After Xin Guan, there have been a number of mRNA products declared for clinical use, with Jiachen Xihai, Abbot Biotech, and S Microbial declaring IL-12 mRNA, and Xinhe Biotech declaring the first neoantigen mRNA vaccine for tumours.

 

Source: First Financial Phoenix Information

 


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