(Fighting against New Coronary Pneumonia) The new coronavirus vaccine developed in China is the first to enter Phase II clinical trials globally
China News Agency, Beijing, April 14 (Reporter Li Chun) A recombinant adenovirus vector recombinant crest virus vaccine developed by the academician Chen Wei team of the Institute of Bioengineering, Academy of Military Medical Sciences, Chinese Academy of Military Sciences . Wu Yuanbin, director of the Department of Social Development Science and Technology of the Ministry of Science and Technology of China, pointed out on the 14th that this is the world's first new crown vaccine variety to initiate Phase II clinical research.
Three new coronavirus vaccines have been approved for clinical trials in China, and the vaccine developed by Chen Wei's team is the first to be approved. At the press conference of the Joint Defense and Joint Control Mechanism of the State Council on the 14th, Wu Yuanbin said that the vaccine has begun recruiting volunteers for the second phase of clinical trials on April 9. According to the official website of the World Health Organization, this is the only new coronavirus vaccine currently in Phase II clinical trials in the world.
According to Chinese official media reports, compared with the first phase, the second phase of the clinical trial of adenovirus vector recombinant new coronavirus vaccine has opened the upper limit of the age, allowing some older volunteers over 60 years old to join it. An 84-year-old Wuhan man who completed the vaccination became the oldest volunteer in the current phase II clinical trial.
Relevant reports said that on January 26, Chen Wei led his team to the front line in Wuhan to fight with the Beijing rear scientific research base to carry out vaccine research and development. The 108 volunteers who completed the first phase of clinical trials of the vaccine on March 27th have all completed concentrated medical observation and are in good health. In the second phase of the clinical trial, 500 volunteers will be recruited and a placebo control group will be introduced to further evaluate the immunogenicity and safety of the vaccine. As of 17:00 on April 13, 273 volunteers have been vaccinated.
At the same news conference on the 14th, Wang Junzhi, academician of the Chinese Academy of Engineering, said that clinical trials of vaccines are usually divided into three stages. The first phase of the clinical trial focused on the safety of use, mainly through a small number of susceptible healthy volunteers as subjects, to determine the degree of tolerance of the human body to different doses of vaccines, and to understand the preliminary safety results. The number of test subjects is relatively small, generally around tens or a hundred.
The second phase of the clinical trial should expand the sample size and target population, further confirm the preliminary effectiveness and safety results of the vaccine in the population, and determine the immunization procedure and immunization dose. The subject is usually hundreds of people.
The phase III clinical trial requires a larger sample size. For general infectious diseases, an epidemic cycle should be observed to determine the protection rate of the vaccine for susceptible people. The scale of the subjects is thousands or even tens of thousands. The scientific basis for the approval of the vaccine for marketing can only be obtained after the final phase III clinical trial.
Wu Yuanbin also pointed out that the research and development of vaccines is based on the basic premise of science, safety and effectiveness. Although it is an emergency project, the scientific and procedural nature is still emphasized in the research and development process. The adenovirus vector recombinant new coronavirus vaccine that has already started the second phase of clinical trials will also undergo a third phase of clinical trials. Based on the results of the clinical trials, it is finally determined whether to use it. (Finish)