New Crown Vaccine Research Progress Update National Drug 2 inactivated vaccines are included in the scope of emergency use

On October 20, the State Council joint defense control mechanism held a press conference, the Ministry of Foreign Affairs, the Ministry of Science and Technology, the Health And Wellness Commission, the Drug Administration and other relevant officials and experts to introduce the new crown vaccine.
New Crown Vaccine Research Progress - 4 vaccines entered Phase III clinical, 60,000 subjects did not appear serious adverse reactions Of the Ministry of Science and Technology, Deputy Director of the Department of Social Development Science and Technology Tian Baoguo introduced, a total of 13 new crown vaccines in China into clinical trials, including inactivated vaccines and adenovirus vector vaccine two technical routes a total of 4 vaccines into Phase III clinical trials.
four vaccines entering phase III clinical trials are progressing smoothly overall, with a total of about 60,000 subjects vaccinated so far and no reports of serious adverse reactions reported, initially showing good safety.
Tian Baoguo admitted that in China's new crown vaccine epidemic has been effectively controlled, does not have the conditions to carry out Phase III clinical trials, how to select the right region and suitable population and successfully organize the implementation of Phase III clinical trials, is currently the main problem facing the third phase of clinical trials, scientific research team will actively promote vaccine research and development in accordance with the law.
addition, so far, the national pharmaceutical group China Biological Research Institute of the domestic Phase I, II clinical trials have been vaccinated 4,064 people, the international Phase III clinical trials have been vaccinated more than 50,000 people.
, Chinese organisms have not received and observed serious adverse reactions, and the safety response has been good.
the vaccine is approved for market after safety and protection data are obtained in Phase III clinical trials.
, emergency use has already begun.
inactivated vaccines from China National Pharmaceutical Group were included in the scope of emergency use.
At present, China's biology has done a good job of mass production preparations, Beijing Institute of Biological Products, Wuhan Institute of Biological Products two new crown vaccine high-grade biosecurity workshop has been built, next year's production capacity will reach more than 1 billion doses, can ensure a safe and adequate vaccine supply.
The new crown vaccine to obtain sufficient clinical research data will be the first time to complete the approval of the National Drug Administration Drug Review Center chief reviewer Wang Tao introduced that the vaccine research and development is subject to a number of factors, of which Phase III clinical trials must be carried out in the affected areas, the progress of the rapid progress depends on the number of subjects, the speed of the participants into the group, the speed of infection in the subjects, as well as the results of the trial and other specific circumstances.
these are the factors that determine the progress of research and development, so there are still more interference factors.
he said applicants can submit a vaccine listing application once clinical trials have obtained enough clinical data to demonstrate that the vaccine is sufficiently protective and has an acceptable safety basis and stable commercial scale production quality.
People are concerned about when Phase III clinical trials end, in fact, vaccine research and development is subject to a number of factors, of which III clinical trials must be conducted in the affected areas, the progress of which depends on the number of subjects, the speed of the participants into the group, the speed of access to infected cases in the subjects, and the results of the trial and other specific circumstances.
these are the factors that determine the progress of research and development, so there are still more interference factors.
Once clinical trials have obtained sufficient clinical data to demonstrate that the vaccine is sufficiently protective and has an acceptable safety basis and stable commercial scale production quality, the applicant can submit a vaccine listing application.
the State Drug Administration will be in accordance with the law, special operations, in the first time to complete the technical review of the vaccine, to ensure safe and effective, controlled quality vaccine as soon as possible on the market.
Zhongwei, director of the Science and Technology Development Center of the National Health And Wellness Commission, said china's annual production capacity of the new crown vaccine is expected to reach 610 million doses by the end of this year, and will be effectively expanded on this basis next year.
The priority groups to get the new crown vaccine are high-risk groups and high-risk groups, said Zheng Zhongwei, director of the Science and Technology Development Center of the National Health And Wellness Commission, we have broadly divided the future vaccination population of the new crown virus into three categories: First, high-risk groups.
is the high-risk group.
is the general population.
The so-called high-risk population mainly refers to the first-line medical and epidemic prevention personnel, border, port staff, as well as because of work reasons must go to high-infection risk areas or national staff, as well as we have to ensure the basic operation of the city some staff.
high-risk groups mainly refer to the elderly, children, pregnant women and people with basic diseases.
such groups of people once infected with the new crown, the proportion of serious or critical cases is much higher than other groups of people.
regardless of the region, as long as it meets the characteristics of such populations, should be included in the priority vaccination considerations.
is it necessary to make urgent use of the new crown vaccine and to make the unlisted new crown vaccine available? Zheng Zhongwei said that in the process of dealing with overseas import pressure and domestic rebound pressure, we should pay attention to some of our people in the process of fighting the epidemic has always been a high-risk exposure.
e.g. medical and epidemic prevention personnel on the front lines of the epidemic, such as those at borders and ports, as well as those who have to go to high-risk countries or regions for assistance and work for work reasons, and public service security personnel who want to keep the city running, are at great risk of infection with the new crown outbreak."
emergency use of vaccines in such populations is therefore a very necessary means of protecting their lives and health.
the emergency use of China's new crown vaccine, it is on this basis in strict accordance with the People's Republic of China Vaccine Management Law, the People's Republic of China Drug Administration Law, in accordance with the corresponding procedures.
Emergency use of the start-up after layers of rigorous demonstration, review, but also to meet the relevant rules of the World Health Organization, after obtaining china's new crown vaccine emergency use approval, we and the World Health Organization representative office in China has been informed, has been their approval and support.
In the process of promoting the emergency use of the new crown vaccine, we carried out a very strict expert demonstration, our expert group leader is Zhong Nanshan academician, deputy group leader is Wang Junzhi academician, our expert group members also include a number of high-level, authoritative legal experts, ethics experts and clinical experts.
Through their argument, preferably the emergency use of vaccines, our emergency use of vaccines is strictly in accordance with the relevant provisions, all completed animal trials, clinical Phase I, Phase II trials, and Phase I, Phase II trials achieved very good safety indicators and immunogenicity indicators.
virus has mutated, and what is the impact of the virus mutation on the development of the new crown? Virus mutation is a scientific problem, scientific research team has been highly concerned about the problem of virus mutation, organized more than 30 scientific research institutions nationwide to carry out virus mutation tracking, research, timely analysis and research of virus mutation on vaccine research and development will have an impact.
, there are nearly 150,000 genome sequences of new coronavirus in global databases, covering 113 countries on six continents.
a comparative analysis of more than 80,000 high-quality viral genome sequences, the results show that the virus has little variation, is within the normal range of the accumulation of variation, and has no substantial impact on vaccine research and development.
is because: First, the current domestic and foreign vaccine research and development of antigen design, mainly for the new coronavirus S protein.
, by comparing and analyzing tens of thousands of new coronavirus genome sequences, it is found that the sequence of new coronavirus S protein is relatively stable.
is a mutation that occurs at individual bits of the existing S protein, which has little effect on the primary structure and immunogenicity.
trials have shown that the vaccine being tested can effectively medium and mutate the new coronavirus.
in the follow-up work, the scientific research team will closely track the virus mutation, timely research and judgment, for the vaccine research and development team to provide timely early warning and scientific reference.