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Original title: The Joint Prevention and Control Mechanism of the State Council presents the situation of the new corona vaccine. Annual production capacity is expected to reach 610 million doses by the end of the year
Staff perform impurity test on samples of inactivated novel coronavirus vaccine, information image from Xinhua News Agency
On October 20, the Joint Prevention and Control Mechanism of the State Council held a press conference to present the new corona vaccine. Wang Tao, chief reviewer of the Drug Evaluation Center of the National Medical Products Administration, noted that there are two tasks that must be completed prior to inclusion: one is to approve the effectiveness of the phase III clinical trial vaccine; the other is to complete the verification of the commercial scale production process and establish a Controlled quality standards demonstrate that the vaccines to be marketed have acceptable safety, clear efficacy and quality control.
Once clinical trials can obtain sufficient clinical research data to demonstrate that the vaccine has sufficient protective efficacy, an acceptable safety basis, and stable production quality on a commercial scale, the applicant can submit a marketing application for the vaccine. . The State Food and Drug Administration will complete the technical review of vaccines for the first time in accordance with laws and regulations, with special tasks, to ensure that safe, effective and controllable vaccines are on the market as soon as possible.
Progress
No serious adverse reactions were reported in the phase III clinical trial of the vaccine.
Tian Baoguo, deputy director of the Department of Science and Technology for Social Development of the Ministry of Science and Technology, stated at a press conference on the Joint Prevention and Control Mechanism of the State Council that the 4 new vaccines against the coronavirus from China that have entered phase III clinical trials have received a total of approximately 60,000 subjects so far. He received reports of serious adverse reactions.
The results of phase III clinical trials are an internationally recognized indicator of efficacy to verify the protection of vaccines. Tian Baoguo introduced that any type of vaccine, whether in the clinical trial stage or the large-scale post-marketing use stage, can have adverse reactions. The new coronavirus vaccine currently entering phase III clinical trials has basically mild adverse reactions, such as local pain, redness and swelling at the injection site, as well as transient low-grade fever and fever.
Liu Jingzhen, chairman of Sinopharm Group, said that two inactivated vaccines, the Beijing Institute of Biological Products and the Wuhan Institute of Biological Products, affiliated with Sinopharm Sinopharm, are currently in phase III clinical trials in 10 countries, including the United Arab Emirates, and more than 50,000 people have been inoculated. So far, no reports of serious adverse reactions have been received or observed.
Gao Qiang, general manager of Beijing Kexing Zhongwei Biotechnology Co., Ltd., said that the company’s partners in Brazil, Indonesia, and Turkey have established a comprehensive adverse reaction monitoring system in accordance with the requirements of the management regulations of quality (GCP) of internationally accepted drug clinical trials. So far, some mild adverse reactions have been found, but all partners have not reported serious vaccine-related adverse reactions.
Dispel doubts
The virus mutation did not have a substantial impact on the development of the vaccine
Does the mutation of the new coronavirus have an impact on the development of vaccines? Tian Baoguo said that follow-up studies have shown that the new coronavirus mutation has not had a substantial impact on the development of the vaccine.
Tian Baoguo said that the scientific research team has always paid great attention to the virus mutation problem and has organized more than 30 scientific research institutions across the country to carry out follow-up research on the virus mutation. Currently, there are about 150,000 new coronavirus genome sequences in the global database, which covers more than 100 countries and regions on six continents. Comparative analysis of more than 80,000 high-quality viral genome sequences shows that the virus does not have much variation, which is an accumulation of variation within the normal range, and has not had a substantial impact on vaccine development.
Tian Baoguo explained that, first of all, the antigen design of vaccine research and development at home and abroad is mainly for the protein S of the new coronavirus. Through comparison and analysis of tens of thousands of new coronavirus genome sequences, the sequence of the novel coronavirus protein S is found to be relatively stable.
Second, mutations in individual sites of the existing protein S have little effect on antigen structure and immunogenicity. Tests have shown that the vaccine under test can effectively neutralize the new mutated coronavirus.
Tian Baoguo said that in the follow-up work, the scientific research team will closely monitor the virus mutation, conduct timely investigations and trials, and provide timely warnings and scientific references for the vaccine research and development team.
Capacity
Expected by the end of the year
Annual production capacity reaches 610 million doses next year, production capacity will exceed 1 billion doses
Zheng Zhongwei, Head of the Vaccine R&D Team of the Research Team of the Joint Prevention and Control Mechanism of the State Council and Director of the Science and Technology Development Center of the National Health Commission, said that for the purpose of this year, China’s annual vaccine production capacity will reach 610 million doses. Expand effectively on this basis to effectively ensure the demand for China’s new crown vaccine in China and other countries in the world.
Liu Jingzhen, chairman and secretary of the Sinopharm Group Party Committee, said that China National Biotechnology Co., Ltd. is ready for large-scale production. The two new P3 corona vaccine production plants of the Beijing Institute of Biological Products and the Wuhan Institute of Biological Products have been built, and the production capacity will reach 1 billion next year. You can ensure a safe and sufficient supply of vaccines.
Prices
New Crown Vaccine Prices
It must be within the acceptable range of the public.
Zheng Zhongwei, vaccine research team leader of the State Council Joint Prevention and Control Mechanism Research Team and director of the Center for Medical Science and Technology Development of the National Health and Health Commission, said the price of China’s new crown vaccine must adhere to the price of the main body of the company first, but must adhere to several basic principles. One is the principle of public product attributes. As an attribute of a public product, its price should not be based on supply and demand, but on cost. The second is to carry out the pricing of the new corona vaccine in accordance with the will and demand of the public for a new corona vaccine. Therefore, the price of the new Chinese crown vaccine should be within the acceptable range for the public.
Warranty
4 Important Steps to Strengthen Vaccine Quality Supervision
How to guarantee the quality and safety of the new corona vaccine? In response to a question from Chengdu Commercial Daily-Red Star News reporter, Wang Tao, chief reviewer for the Center for Drug Evaluation of the State Food and Drug Administration, said that the State Food and Drug Administration attaches great importance to its market production and quality supervision work, and will do its best to realize the potential internally without lowering inspection standards. Reduce inspection and approval time, and issue production licenses to eligible companies in a timely manner. Currently, the four vaccine manufacturers that have been approved to enter Phase III clinical trials have passed the production license inspection and all have obtained drug production licenses in accordance with the law. For subsequent production licenses and drug GMP inspections of new crown vaccine manufacturers, the company will continue to provide guidance and hand-over in accordance with the company’s request, conducting on-site inspections in a timely manner and issuing licenses. production for qualified products.
Regarding the supervision of the quality of vaccines, the State Administration of Food and Drug Administration has continuously strengthened the new supervision of the quality of vaccines of the crown in accordance with the “Law of the Administration of Vaccines of the People’s Republic of China “and the” Law on the Administration of Medicines of the People’s Republic of China “and other relevant laws and regulations. First, for companies that have obtained production licenses, local provincial drug regulatory authorities should increase their daily supervision and inspection, and immediately deploy trained personnel, dispatch inspectors to the factory, and urge and guide companies to implement accountability. main of product quality; second, actively organize the country. The Vaccine Inspection Center initiates random inspections and controls at the relevant manufacturing companies; third, it organizes the National Center for Drug Evaluation to cooperate with the National Health Commission to monitor suspected abnormal vaccines (AEFI); fourth, it supervises the companies and all circulation and use units to capture the vaccine. Trace and carry out the work in strict accordance with the regulations on the circulation and use of vaccines. Through these measures, supervise companies to effectively fulfill their primary responsibility for quality and safety, carry out production and quality control in strict accordance with approved production processes and quality standards, and organize the production in strict accordance with the “Pharmaceutical production quality management regulation” to ensure quality and safety.
Yan Yucheng, Reporter for Chengdu Commercial Daily-Red Star News
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