【Explanation】Recently, the Phase I/II clinical research trial of the new crown inactivated vaccine of the Wuhan Institute of Biological Products of China Biology was opened. The results showed that the safety after vaccination was good, and there were no serious adverse reactions. After different procedures and different doses of vaccinations, the vaccine group vaccinators all produced neutralizing antibodies. After two doses in the 28-day program, the neutralizing antibody positive conversion rate reached 100%. On June 18, a reporter from China News Service conducted an exclusive interview with Zhang Yuntao, vice president of China Biotechnology.
[Explanation] Zhang Yuntao introduced that uncovering the blind is to publish the conditions of the control group and the experimental group in the double-blind trial for research and judgment. The uncovering of the new crown inactivated vaccine is the most complete vaccine research data published in the clinical research stage in the world. The results show that China Bio-New Crown Inactivated Vaccine has high safety.
[Same period] Zhang Yuntao, Vice President of China Biology
Everyone feels from the data (very safe). The other one, like oral medicine and injection, is called an adverse reaction after the injection. The data shows that there is no serious case of adverse reaction (reaction).
【Explanation】 Phase I/II clinical trials of vaccines provide a guarantee for their safety, but phase III clinical trials will be required to better test the effectiveness of the vaccine. According to reports, the phase III clinical trial of the vaccine needs to be conducted in areas where the disease is endemic to see whether the vaccine can effectively reduce the incidence in the trial area.
【Explanation】Recently, the rebound of Beijing's epidemic situation has attracted people's hearts. Has Beijing become a high-risk area suitable for phase III clinical trials of vaccines?
[Same period] Zhang Yuntao, Vice President of China Biology
At present, the existing morbidity data in Beijing is very difficult to support the phase III clinical trial. It is necessary to vaccinate more than hundreds of thousands of people to capture the case. The cost and cost of this management is still very difficult.
[Explanation] Zhang Yuntao pointed out that the phase III clinical trial is one of the keys to determine whether the vaccine can be marketed, and it cannot be rushed. Therefore, it is expected that the new crown inactivated vaccine will not be available for mass vaccination until at least 2021.
[Same period] Zhang Yuntao, Vice President of China Biology
Due to the reduction in the number of cases and the number of cases in China, it is becoming more and more difficult to carry out phase III clinical trials in China. We hope to carry out more international cooperation, and conduct multi-center international cooperation phase III clinical research globally to promote this The vaccine is on the market. According to the current plan, this vaccine will be on the market at least until next year.
[Explanation] In addition, some experts believe that the new coronavirus in this round of epidemic has mutated. Can the new inactivated vaccine respond to the mutated virus? Zhang Yuntao said that judging from the results of scientific experiments, the mutation of the new coronavirus did not affect the protection of the vaccine.
[Same period] Zhang Yuntao, Vice President of China Biology
As of today, we have not observed that the mutation of the strain itself affects the mutation of the core region of the antibody produced by the vaccine, that is, it does not change the area of the virus itself to produce protective antibodies, so we think that from the current situation, (Vaccine) is still broad-spectrum and globally protected. Variation exists, but it does not change the protection of the vaccine.
Wen Mengxin reports from Beijing
Editor in charge: [Wang Kai]