China has so far approved three vaccines of the novel coronavirus disease (COVID-19) for clinical trials, said an official on Tuesday in Beijing.
Wu Yuanbin, director-general of the department of science and technology for social development with the Ministry of Science and Technology, briefed the media on the vaccine development progress at a press briefing.
“Three vaccines have been approved for clinical trials so far, among which the adenovirus vector vaccine developed by a research team led by Chen Wei, academician of Chinese Academy of Engineering, is the first approved for clinical trials,” Wu said.
“The inoculation for the subjects in phase I clinical trial has been finished at the end of March, and we have started to recruit volunteers for the phase II clinical trials since April 9. This is the world’s first COVID-19 vaccine which has launched the phase II clinical trials,” he added.
On April 12, the National Medical Products Administration approved an inactivated vaccine jointed developed by the Wuhan Institute of Biological Products and the Wuhan Institute of Virology under the Chinese Academy of Sciences for clinical trials.
On April 13, another inactivated vaccine developed by the Sinovac Research and Development Co., Ltd. in Beijing has also been approved for clinical trials.
Wu said there are five technical routes for the vaccine development against the virus in China.
“The development of the vaccines on the other technical routes is also being sped up. The construction of attenuated influenza virus vector vaccine strains and the establishment of quality control methods have been completed, quality process research and quality assurance are under way, and intermediate tests, animal challenge experiments and safety evaluation experiments are also carried out at the same time. The nucleic acid vaccine has also entered the research stage of animal efficacy and safety evaluation, and meanwhile, the preparation of clinical samples and quality verification are also being carried out,” said Wu.
As for the time when the vaccines will be put into use, Wu said that all the work is implemented on the basic premise that vaccines are scientific, safe and effective, so the necessary procedures will be followed.
“The vaccines of the above technical routes are expected to apply for clinical trials successively in April and May. At present, the fastest developed vaccine in China, such as the adenovirus vector vaccine, has started the phase II clinical trials, and the phase III clinical trials are scheduled to be carried out. The final decision on whether to use the vaccine will be made based on the results of the clinical trials, and some procedures of approval have to go through. The inactivated vaccines approved recently are traditional technical vaccines. It should be said that the production process is relatively mature, the quality standard is controllable, the scope of protection is relatively wide, and there are also international standards for safety and efficacy evaluation, which will enable the vaccines to be put into use at a quicker pace. We will make efforts to do a good job in the development of vaccines, so as to provide services as soon as possible,” Wu concluded.
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