China News Service, May 15th, Zeng Yixin, deputy director of the National Health and Health Commission, gave an introduction on the development of a new coronary pneumonia vaccine on the 15th. He said that there is already a recombinant adenovirus vector vaccine and four inactivated vaccines, which have successively obtained national medicines. The bureau approved the launch of the combined phase I and II clinical trials. During the clinical trials of these projects, no reports of major adverse reactions have been received. According to the plan, if all goes well, these projects will complete the second phase of clinical trials in July this year.
Data map: Researchers conduct new coronavirus vaccine research and development experiments. Photo by Tang Yanjun
The State Council Information Office held a press conference on the 15th to introduce the normal prevention and control of the new coronary pneumonia epidemic. Regarding the progress of vaccine research and development that the public is more concerned about, Zeng Yixin said that since the outbreak, a scientific research team led by the Ministry of Science and Technology has been established under the joint defense and joint control mechanism. Organize and coordinate services for all units to promote vaccine research and development. At present, the overall progress is very smooth, to a large extent thanks to the advantages of the system, can fully integrate all aspects of resources, and fully coordinate the advantages of all aspects.
Zeng Yixin introduced that medical institutions have cases, and they can obtain viruses from the cases. There can be good cooperation between medical institutions and scientific research institutions, as well as scientific research institutions and enterprises. Every step of the vaccine process has to undergo strict identification and strict verification by the Food and Drug Administration, the Central Procuratorate, and the Drug Evaluation Center, so it is very important to cooperate with government departments. It also includes the Ministry of Science and Technology. The Ministry of Science and Technology gives timely project support and financial guarantees. These are important reasons why vaccine work can make relatively good progress.
Zeng Yixin revealed that there is currently a recombinant adenovirus vector vaccine and four inactivated vaccines, which have been approved by the State Food and Drug Administration successively to carry out phase I and phase II combined clinical trials. This is also an innovation in the emergency approval of the Food and Drug Administration. Approval of the first phase of the enterprise and the second phase of the trial to proceed simultaneously. Up to now, a total of 2575 volunteers have been vaccinated in various projects.
One phase of the clinical trial has cumulatively completed the vaccination of 539 volunteers, and some have obtained preliminary data on the production of safety and protective antibodies; the second phase of the clinical trial has cumulatively completed the vaccination of 2036 volunteers. Carry out the whole process of vaccination and the evaluation of safety and effectiveness. The so-called full process vaccination refers to not only one vaccination, some two vaccination, and some three vaccination. It is in the process of being carried out. During the clinical trials of these projects, no reports of major adverse reactions have been received. According to the plan, if all goes well, the above projects will complete phase II clinical trials in July this year.
Zeng Yixin said that in addition to adenoviral vectors, several other technical routes for vaccine research and development are also progressing smoothly and orderly, and some have found that the results are not satisfactory during the research process and have been adjusted. Faster progress has already begun to submit submissions such as pharmaceutical research, preclinical research, and clinical trial programs to the Drug Administration Center of the State Food and Drug Administration. It is expected that some projects will be approved by the State Food and Drug Administration to enter clinical trials starting in June. stage.