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Significant progress-China's efforts to combat coronavirus-the first inactivated vaccine injection on April 14

Home    行业前沿    Significant progress-China's efforts to combat coronavirus-the first inactivated vaccine injection on April 14

Significant progress-China's efforts to combat coronavirus-the first inactivated vaccine injection on April 14


On April 12, after the clinical trial of the new coronavirus inactivated vaccine (Vero cell) of Sinopharm Group s Wuhan Institute of Biological Products was approved, the first phase of clinical trial of the new coronavirus inactivated vaccine was also launched in Henan , This clinical study is "randomized, double-blind, placebo parallel controlled phase I / II clinical trial".


The researcher was the Henan Provincial Center for Disease Control and Prevention. After volunteers signed up and informed consent, after a number of tests, 32 volunteers finally entered the first phase of the clinical trial.


In the context of no specific treatment for new coronaviruses, the development of related vaccines has attracted much attention. Obtaining clinical trial approvals for the inactivated new coronavirus vaccine means that the protection of the vaccine is a step further from the public.


According to relevant sources of China Biotechnology, on April 12, a new class of new drugs, a new coronavirus inactivated vaccine, declared by Sinopharm Wuhan Bioproducts Research Institute of Sinopharm Group, has obtained a clinical trial license from the State Drug Administration. This is the world's first inactivated new coronavirus vaccine that has received clinical trial approval.


The clinical trials related to the vaccine were launched.


According to relevant national laws and regulations, it has been fully prepared for emergency use. China Biotech has the capacity to produce large-scale inactivated vaccines. It has declared that the clinical trial batch of the new crown vaccine will produce more than 50,000 doses, and its annual production capacity will exceed 100 million doses after mass production.


Previously, China Bio had developed a nucleic acid molecular detection kit for diagnosing the new coronavirus, as well as the plasma technical standards and clinical treatment plan of the convalescents during recovery.


In accordance with the requirements of the top level, in the next step, China Biotechnology will accelerate the establishment of an enterprise-based vaccine R & D and industrialization system that combines industry, education and research, accelerate the development of existing multiple technical route vaccines, and strive to promote vaccine clinical trials and early Listing for use.


As early as January 19, China Biotechnology has established a scientific research leadership team led by Yang Xiaoming, the chief scientist of the vaccine project of the "863" program of the Ministry of Science and Technology, arranging 1 billion R & D funds, and deploying three research institutes on two technical routes. Development of new crown vaccine.


First, the inactivated vaccine was jointly researched by the Wuhan Institute of Biological Products of China Biology and the Wuhan Institute of Virology, Chinese Academy of Sciences, and was developed in Wuhan. The Beijing Institute of Biological Products of China and the Institute of Viral Disease Control and Prevention of the Chinese Center for Disease Control and Prevention and China Food and Drug Administration The institute collaborates and cooperates in research and development in Beijing. Second, the genetic engineering vaccine was led by the Chinese Academy of Biotechnology.


On February 1, China Biotech, as the lead unit, was awarded the emergency project of the "2019-nCoV Inactivated Vaccine" project (Project No. 2020YFC0842100), a key special project of the National Key R & D Program of the Ministry of Science and Technology "Public Safety Risk Prevention and Emergency Technology Equipment".


The new coronavirus inactivated vaccine research team has been in research and development work since January, and the State Food and Drug Administration has organized experts in technical review and quality control to intervene early and participate in the whole process.


Up to now, China Bio has overcome key technologies for the production and quality control of a series of new crown vaccines such as vaccine strain screening, virus seed bank establishment, antibody preparation and identification, detection method establishment, production process research, compatibility and formulation screening, and the process technology route has been determined And product quality attributes, and carry out and complete the in vivo animal effectiveness and safety evaluation work.


It is reported that the inactivated vaccine refers to a vaccine prepared by physical or chemical treatment and other methods that make the virus lose its infectivity and replication, but retain the activity of the virus that can cause the human immune response. Inactivated vaccines are also the most effective vaccine development path for newly emerging sudden infectious diseases.


Compared with other types of vaccines (such as genetically engineered recombinant vaccines, adenovirus vector vaccines, attenuated influenza virus vector vaccines and nucleic acid vaccines), inactivated vaccines have advanced R & D technology, mature production technology, controllable quality standards, and good protection effects .


China Biotech has multiple mature inactivated vaccine R & D platforms, polio (a new class of drugs), hand, foot and mouth disease (a new class of drugs), forest encephalitis (a new class of drugs), hemorrhagic fever, etc. A variety of inactivated vaccines, with large-scale vaccine production experience and capabilities. The successful clinical trial approval will provide the possibility of large-scale production of the new inactivated vaccine.

2020-04-15 09:49