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China takes the lead in opening the second clinical study of new crown vaccine

via:CnBeta     time:2020/4/15 10:01:18     readed:860

On the afternoon of April 14, The joint defense control mechanism of the State Council held a press conference, and Wu Yuanbin, director of the Department of Social Development Science and Technology of the Ministry of Science and Technology, and Wang Junzhi, academician of the Chinese Academy of Engineering, interpreted the issue of vaccines of public concern.

Secretary for Social Development Science and Technology, Ministry of Science and Technology

China is the first to launch the second clinical study of the new crown vaccine

At present, three vaccines in China have been approved for clinical trials. Among them, the adenovirus vector vaccine of academician Chen Wei's team was first approved for clinical studies. The first phase of clinical trials was completed at the end of March, and volunteers for the second phase of clinical trials were recruited on April 9. This is the world's first new crown vaccine variety to initiate phase II clinical research.

On April 12, the State Food and Drug Administration approved the new coronavirus inactivated vaccine jointly applied by Wuhan Institute of biological products of China and Wuhan Institute of viruses of Chinese Academy of Sciences to enter the clinical experiment. On April 13, it also approved the clinical experiment of the inactivated vaccine developed by Beijing Science and technology Xingzhong life Support Technology Co., Ltd. for two consecutive days.

Academician Wang Junzhi of the Chinese Academy of Engineering:

The research and development foundation of inactivated vaccine in China is good

The two newly approved vaccines are actually a technical route and belong to the new coronavirus inactivated vaccine.

Among the vaccines developed and listed in China, H1N1 influenza vaccine, hepatitis A vaccine, EV71 HFMD vaccine and polio vaccine are all inactivated vaccines. Our country has a good foundation in preparing inactivated vaccines.

At the beginning of the epidemic situation, the earliest isolated virus strain in China, at that time, the live virus had to be cultured on a large scale, through the joint defense and control mechanism, coordinated R & D units to use the relatively high level of biosafety protection P3 laboratory established in China, can cultivate a large number of live viruses, so that our R & D has the basic conditions.

Vaccine is a big step forward in application

Vaccine itself from the completion of preclinical research to clinical, this is a very significant progress, from the future application of a big step.

Generally, clinical trials are divided into three phases. The objectives and significance of the three phases are different. According to different R & D programs, the time required is different.

The first phase of clinical trial focuses on the safety of observation and use. It is mainly through a small number of susceptible healthy volunteers as subjects to determine the tolerance of human body to different doses of vaccine and understand its preliminary safety. Generally, the number of people is relatively small, which is about ten or one hundred.

The second phase clinical trial will further expand the sample size and target population, in order to further confirm the effectiveness and safety of the vaccine in the population, and determine the immune procedures and doses, which must be done in the second phase clinical trial. In general, there are hundreds or more subjects. It should be noted that phase I and phase II clinical trials are all aimed at healthy volunteers, which are relatively easy to recruit. According to different immunization procedures and different programs, it will take several months.

Three phases of clinical trials are needed to determine the effectiveness of the vaccine. For general infectious diseases, it is generally necessary to observe an epidemic cycle to determine its protection rate for susceptible population. Its scale is thousands of people, some even tens of thousands of people.

Generally, the scientific basis for the approval of the vaccine to market can be obtained only after the end of the third phase of clinical practice. Even in case of emergency, our evaluation criteria for the safety and effectiveness of the vaccine cannot be reduced. At present, the society pays great attention to vaccines, and we also look forward to seeing breakthrough and important progress in vaccine research and development in China as soon as possible, so that safe and effective vaccines can be put on the market as soon as possible.

Is vaccine approval really safe so fast?

Vaccine itself is a special medicine for healthy people, safety is the first, so in the process of emergency examination and approval, always adhere to respect for science, follow the law, take safety and effectiveness as the fundamental policy, adhere to special affairs special.

In this process, many R & D steps from series to parallel, research and review linkage, rolling submission of R & D materials, with the review with the review. Under the premise that the standard is not reduced, the efficiency of R & D and the efficiency of review are greatly improved by seamless connection, which is also the reason for the fast speed.

Does BCG novel coronavirus pneumonia prevent it?

It is a rumour abroad that "punch-in" can reduce the likelihood of new crown pneumonia. BCG vaccine is actually the vaccine of planned immunization for children, which is widely used in our country, and we do not see the exact research data to support this statement at present, so it is not known yet.

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