【Explanation】 On April 24, the new coronavirus inactivated vaccine jointly developed by China National Pharmaceutical Group Wuhan Biological Products Research Institute and Wuhan Institute of Virology, Chinese Academy of Sciences entered the second phase of clinical trials. Virus inactivated vaccine. On the same day, Yang Xiaoming, chairman of Sinopharm Group's China Biology, was interviewed by a reporter from China News Service in Beijing.
[Explanation] Yang Xiaoming introduced that the principle of the inactivated vaccine is to inactivate the virus in the laboratory to make it lose toxicity, but retain its effective ingredients, thereby mobilizing the human immune system to produce antibodies to eliminate the virus. China's first new inactivated vaccine for clinical trials has successfully completed the first phase of clinical trials. The subjects are all healthy adults aged 18-60, and the current vaccination shows good safety. The second phase of the clinical trial will expand the scope of the test. In addition to observing safety, it is also necessary to test the effectiveness index of the vaccine.
[Same period] Chairman of China Biotechnology Co., Ltd. Yang Xiaoming, Chief Scientist of the National Ministry of Science and Technology "863" Plan Vaccine Project
(Phase II) Observe that besides its safety, after adding a vaccine into it, does the human body produce corresponding antibodies? He (subject) is still a healthy person, appropriately extended to older age and younger age, the older age is above 60 years old, and the younger age is below 6 years old.
[Explanation] For the new coronavirus inactivated vaccine, how many injections and doses are required, Yang Xiaoming said, this is a problem that needs to be solved in the course of clinical research. The most important thing at present is to evaluate the safety and effectiveness of vaccines.
[Explanation] The new crown inactivated vaccine of China Biotechnology was approved by the State Food and Drug Administration on April 12, and the first phase of clinical trials was started. The second phase of clinical research was started on April 24. Yang Xiaoming pointed out that compared with other vaccines, the development efficiency of the new coronavirus vaccine is very high, which is mainly due to the acceleration of the approval process.
[Same period] Chairman of China Biotechnology Co., Ltd. Yang Xiaoming, Chief Scientist of the National Ministry of Science and Technology "863" Plan Vaccine Project
Now the new crown vaccine, as a national priority, even now the focus of the world, they (the State Food and Drug Administration) all the power is adjusted to this, after we give him materials, anytime, anywhere, anytime, anywhere, 24 nights Hours, evening to evening, meeting in the evening, materials in the afternoon, call the phone at any time, and the video conference will be opened.
[Commentary] Yang Xiaoming emphasized that despite the improvement in efficiency, the procedures to ensure the effectiveness and safety of the vaccine will not be reduced in one step. The second-phase clinical trial will take at least one month, and then a third-phase clinical trial will be conducted in the disease-endemic area to test whether the antibodies produced by the human body after injection of the vaccine can effectively resist the disease.
[Same period] Chairman of China Biotechnology Co., Ltd. Yang Xiaoming, Chief Scientist of the National Ministry of Science and Technology "863" Plan Vaccine Project
After these three phases of clinical observation, it proves that your vaccine is safe. The second phase of serology can produce serological antibodies, and the third phase can be clinically protected. In this case, this vaccine is safe and effective. It can be approved for human use and can be used by the general public.
[Explanation] Yang Xiaoming said that the biggest difficulty in the development of the new coronavirus vaccine is unknown. Because it is facing a completely new virus, its origin, host, and changes in the human body are not clear. Fortunately, China Biotech's previous research work on diagnostic technology and plasma therapy has provided assistance in vaccine research and development.
[Same period] Chairman of China Biotechnology Co., Ltd. Yang Xiaoming, Chief Scientist of the National Ministry of Science and Technology "863" Plan Vaccine Project
For example, if I want to find a virus, I must use certain technological means. The current technological method is called multiple fluorescent PCR technology, which is a gene diagnosis technology. After I get the virus, I will use the virus. Strains, poisonous seeds, seeds. At the same time, the plasma treatment in the treatment, plasma treatment is the plasma of the recovered patient. Since the patient has recovered, it shows that he has a set of methods to deal with the virus, such as antibodies and cellular immunity. We went to test his methods, the titer of the antibody, the strength of the virus, and using these evaluations in turn proved that my future vaccine should mobilize this antibody in the human body.
[Explanation] Yang Xiaoming told reporters that at present, China Bio has completed the construction of a new coronavirus vaccine production workshop. After the new coronavirus vaccine is launched, the annual output of the vaccine will reach more than 100 million doses. According to relevant national laws and regulations, it has been fully prepared for emergency use.
Wen Mengxin reports from Beijing
Editor in charge: [Wang Kai]