Source: China government website
The world's first!
On April 12
Novel coronavirus inactivated vaccine gets approval for clinical trial!
Relevant clinical trial has been started!
There is no specific treatment for novel coronavirus, so the development of vaccine has attracted much attention and expectation.A few days ago, in the novel coronavirus vaccine research and development of the blockbuster news - novel coronavirus inactivated vaccine received clinical trial approval!We are a big step closer to embracing vaccine protection.
On April 12, the novel coronavirus inactivated vaccine, a new type of drug declared by sinopulco wuhan institute of biological products, was approved for clinical trial by the state medical products administration.This is the first novel coronavirus inactivated vaccine in the world to obtain approval for clinical trials.
It is understood that clinical trials related to the vaccine have been launched simultaneously.According to relevant national laws and regulations, it has been fully prepared for emergency use.
Prior to this, sinopulmonary resuscitation (sinopulmonary resuscitation) was the first to develop a diagnostic novel coronavirus "searchlight" -- nucleic acid molecular detection kit, and the first to successfully launch the "ballast" -- plasma technical standard and clinical treatment plan for convalescent patients.Together with the new coronavirus inactivated vaccine, the "killer" developed in this novel coronavirus to prevent and control epidemics, a series of major scientific achievements have provided strong support for the realization of covid-19's goal of "diagnosable, treatable and preventable".
On February 1, sinopharm group China bio-biology, as the lead unit, won the emergency approval of the 2019-ncov inactivated vaccine project (project no. 2020YFC0842100), a key project of "public safety risk prevention and control and emergency technical equipment" in the national key research and development plan of the ministry of science and technology.
The strong leadership of the CPC Central Committee and the State Council and the Ministry of Science and Technology, ministry of industry, WeiJianWei, state food and drug administration and the support from the State-owned Assets Supervision and Administration Commission of the State Council, national medicine group China successively conquer vaccine strain screening, poison library building, antibody preparation and identification, detection method and production technology research, compatibility and formula screening and a series of new vaccine production and quality control of the key technologies, determine the technical route and the quality of the product attributes, and quickly carry out and complete the animal in vivo efficacy and safety evaluation work, achievements.The successful approval of the clinical trial will further lay the foundation for the "high-speed" launch of the novel coronavirus inactivated vaccine.
Inactivated vaccines
An inactivated vaccine is a vaccine made by physical or chemical treatment that makes the virus less infectious and replicating, but retains the activity of the virus to induce an immune response.
Inactivated vaccine is the most effective vaccine development route for emerging infectious diseases.
Compared with other types of vaccines (such as genetic engineering recombinant vaccine, adenovirus vector vaccine, attenuated influenza virus vector vaccine and nucleic acid vaccine), the inactivated vaccine has advanced research and development technology, mature production process, controllable quality standards and good protection effect.Sinopretics group China bio has the capacity to produce large-scale inactivated vaccine, and has declared the production of the clinical trial batch of the new crown vaccine to be more than 50,000 doses, and the output of each batch to be more than 3 million doses after the mass production, with an annual production capacity of more than 100 million doses.
Vaccines are crucial to controlling the outbreak.Since the outbreak of the epidemic, the scientific research team of the joint prevention and control mechanism of the state council has set up a special class for vaccine research and development, which has laid out 12 research and development tasks in accordance with the five technical routes of inactivated vaccine, recombinant protein vaccine, adenovirus vector vaccine, live attenuated influenza virus vector vaccine and nucleic acid vaccine, and is making steady progress.
Previously, the adenovirus vector vaccine of the academy of military sciences and the academy of military medicine has been approved for clinical trials, and is now in phase ii clinical trials.
The inactivated vaccine, which was approved to enter clinical trials this time, is a vaccine that kills pathogenic microorganisms but retains its immunogenicity. It has the advantages of mature production process, controllable quality standard and wide protection range, and can be used for mass vaccination. Moreover, there are international standards to judge the safety and efficacy of vaccines.
China's inactivated vaccine has a good research basis, inactivated hepatitis a vaccine, inactivated influenza (cleavage) vaccine, inactivated hand-foot-mouth disease vaccine, inactivated polio vaccine have been widely used.
In the epidemic prevention and control in the war, national medicine group China biological belongs to Beijing, Shanghai, wuhan, chengdu, lanzhou, changchun six institute of biological products and biotechnology research institute of China actively play a role of main body of scientific research, emphatically carried out will be coronavirus relevant diagnostic reagents, plasma treatment, will be taken coronavirus immunoglobulin, will be coronavirus inactivated vaccine, recombinant genetic engineering vaccine, monoclonal antibodies, the horse will be coronavirus researches such as serum.
Among them, the novel coronavirus nucleic acid molecular detection kit developed by sinopharmaceutical group China bioscience and biotechnology co.The plasma treatment technology for recovered patients was recommended by the joint prevention and control mechanism of the state council, and was included in the diagnosis and treatment program of the national health commission.As of April 7, a total of 2,169 pulps were collected nationwide, and 648 cases were treated clinically, with remarkable results.The treatment has been adopted in many countries.