The new crown vaccine developed in our country is all you care about here

: The research team laid out five technical routes such as inactivated vaccine, nucleic acid vaccine, recombinant protein vaccine, adenovirus vector vaccine and detoxifying influenza virus vector vaccine. At present, three vaccines have been approved for clinical trials . All types of vaccines have different processes, technical characteristics and requirements in preclinical studies, and vaccine entry into clinical trials requires the completion of pharmaceutical, effective and safety studies. The country for each link of vaccine research and development, there are corresponding technical regulations to follow, these regulations and technical requirements and WHO and other international standards are consistent . So far, the five technical directions of vaccines are generally progressing smoothly, the first batch of 9 tasks have completed most of the work of preclinical research, most of the research and development team in April can complete preclinical research, and gradually start clinical trials. It should be said that China's new crown vaccine research and development progress is currently in the international advanced ranks, will not be slower than foreignthe State Council Joint Prevention and Control Mechanism held a press conference on March 17 and April 14, respectively, at which authoritative experts answered China's independent research and development of the new crown virus vaccine related information. Is it safe to obtain a new coronavirus vaccine approved for clinical research? How long is it before the vaccine enters clinical study? Xinhua News Agency reporters will be based on the content of the press conference to organize and answer your concerns.

the new crown vaccine developed in China progress?Wu Yuanbin, Director of the Department of Social Development Science and Technology of the Ministry of Science and Technology: The scientific research team laid out five technical routes, such as inactivated vaccine, nucleic acid vaccine, recombinant protein vaccine, adenovirus vector vaccine and anti-virus influenza virus vector vaccine. At present, three vaccines have been approved for clinical trials, of which the adenovirus vector vaccine has been approved for clinical research, the first phase of clinical trial subjects was completed at the end of March, and on April 9 began to recruit Phase II clinical trial volunteers, the world's first new coronary vaccine species to start phase II clinical studies.On April 12, the State Drug Administration approved a new coronavirus inactivated vaccine jointly applied by the Wuhan Biological Products Research Institute of China and the Wuhan Virus Research Institute of the Chinese Academy of Sciences, and entered clinical trials. On the 13th, it approved the inactivated vaccine developed by Beijing Science and Technology Co., Ltd. to conduct clinical trials.

the development of china's new crown vaccine progress so fast?Wang Junzhi, academician of the Chinese Academy of Engineering: The vaccine itself is a special drug for healthy people, safety is the first. Therefore, in the emergency approval process, always adhere to respect for science, follow the law, to safety and effective as the fundamental policy, adhere to special operations, in the process of many research and development steps from series to in-line to in-line, research linkage, rolling submission of research and development materials, follow-up review. Under the premise that the standard is not lowered, the efficiency of research and development and the efficiency of the review are greatly improved through seamless interface.

the safety of vaccines approved for clinical trials be guaranteed?Wang Junzhi: Domestic and foreign vaccine market applications have strict laws and regulations and technical standards. The process, technical characteristics and requirements of all types of vaccines vary from preclinical to clinical trials, and pharmaceutical, effective and safety studies must be completed.In general, qualified vaccine samples must be produced before clinical trials can be conducted until they have been shown to be safe and effective in animal trials. For every aspect of vaccine research and development, the country has corresponding technical regulations to follow, these regulations and technical requirements and WHO and other international standards are consistent.

the new crown vaccine a few steps away from universal vaccination?Wang Junzhi: Generally speaking, the usual clinical trials are divided into three stages, that is, three stages of the goal and meaning is not the same, according to the design of research and development, the program is not the same, the time required is not the same.Phase I clinical trials focus on observing the safety of use, mainly through a small number of susceptible health volunteers as subjects to determine the human body's tolerance to different doses of the vaccine and understand its initial safety results, generally a relatively small number of people, are dozens or about 100 people, this is the first phase of clinical trials must do.Phase II clinical trials are designed to expand the sample size and target population in order to further confirm the initial effectiveness and safety of the vaccine in the population and to determine the immune procedure and dose, which must be completed in phase II clinical trials. The average subject is hundreds of people, and Phase II clinical trials are hundreds or more. It should be noted that Phase I and Phase II clinical trials are conducted by healthy volunteers and are relatively easy to raise, depending on the immunization procedures and different programs, which can take several months.Truly determine the effectiveness of the vaccine there are phase III clinical trials, phase III clinical needs a larger sample size, for the general infectious diseases, generally to observe an epidemic cycle to determine its protection rate of susceptible population, its size is several thousand, some even tens of thousands of people. The final results of phase III clinical trials are the scientific basis for vaccine approval. In general, you have to go through these three parts.

is China's vaccine research and development in the international level?Wang Junzhi: The successful research and development of vaccines is the key to the fundamental victory of mankind in the face of major infectious diseases, people at home and abroad look forward to, the central government attaches great importance to, thousands of scientists in related fields up and down the country go all out to promote China's vaccine research and development work to make positive progress, fully reflects our institutional advantages. 　　Up to now, the five technical directions of vaccines are generally progressing smoothly, the first nine tasks identified have completed most of the work of preclinical research (i.e., animal effectiveness, safety research), most of the research and development team in April can complete preclinical research, and gradually start clinical trials, some teams progress faster. It should be said that China's new crown vaccine research and development progress is currently in the international advanced ranks, will not be slower than abroad. (Source: China Women's Daily, Xinhua News Agency)