China's twenty-five COVID-19 vaccines enter clinical trial stage

2021-11-22

"At present, there are 25 COVID-19 vaccines entering the clinical trial stage in our country, of which 4 vaccines have been approved by the China Pharmaceutical Regulatory Commission for conditional listing, 3 vaccines have been approved for emergency use in China recently, and 14 vaccines have been approved for phase III clinical trials abroad. The progress is generally smooth." Zheng Zhongwei, director of the medical and health science and technology development research center of the National Health Commission, introduced. Five technical routes have achieved full coverage of clinical trials Since the outbreak of novel coronavirus pneumonia, 5 technologies have been deployed: inactivated vaccine, recombinant protein vaccine, adenovirus vector vaccine, nucleic acid vaccine and attenuated influenza virus vector vaccine. "At the same time, it has promoted the development of COVID-19 vaccine, and has achieved the full coverage of the clinical trials of the 5 technical routes," Zheng said. He pointed out that one adenovirus vector vaccine has been approved by the State Food and Drug Administration for conditional listing, and mass vaccination is being carried out in China. Another three models are in phase I and II clinical trials, which are progressing smoothly on the whole. Previously, the recombinant protein vaccine has not been listed. "Now one has been approved by the State Food and Drug Administration for emergency use, and it is expected to apply for conditional listing in the near future." Zheng Zhongwei pointed out that four recombinant protein vaccines in China are undergoing phase III clinical trials abroad, and four recombinant protein vaccines are undergoing phase I and II clinical trials. It is reported that one attenuated influenza virus vector vaccine has been approved for phase III clinical trial abroad, and phase III clinical trial will be carried out abroad in the near future. Among the nucleic acid vaccines, one mRNA vaccine and one DNA vaccine have been approved by foreign phase III clinical trials, and relevant studies have been launched recently. The results showed that the domestic vaccine had good safety and effectiveness Since the beginning of R & D, China's regulators, R & D institutions and R & D personnel have put the safety and effectiveness of the new crown vaccine in the first place. Zheng Zhongwei pointed out that in accordance with the relevant approval requirements, the COVID-19 vaccine currently used has carried out the first phase, second and third phase clinical trials of the whole population before the relevant agencies approved the conditional listing or emergency use, and the results showed that the vaccine had good safety and effectiveness. The data show that China's vaccine has good safety and low side effects in the vaccination of more than 1 billion doses in overseas epidemic countries and more than 2 billion doses in China. Zheng Zhongwei said that the protection of inactivated vaccines of Sinopharm Wuhan Institute and Beijing Institute against symptomatic infection was 72.8% and 78.1% respectively, and the protection of the two vaccines against severe infection was 100%. The results of phase III clinical trials of Kexing in Turkey and Indonesia showed that the protective power of the vaccine against symptomatic infection was 83.5% and 65.3% respectively, and the protective power against severe infection was 100%. For the public concerned about the probability of infection with COVID-19, Zheng Zhongwei said that in August and around August this year, as an example, as of August 25th, a total of 1388 cases of infection were reported, all infected with Delta strain. After preliminary analysis, only 5 of the infected persons ≥ 14 days after the two doses of vaccination developed into severe cases, accounting for about 5% of all severe cases. 97% of the severe cases over 60 years old did not vaccinate or completed the two doses of vaccination, and the critically ill patients did not vaccinate. In Guangdong Province, a total of 190 local cases have been reported by may 2021, and the main infected virus strain is delta strain. The research on novel coronavirus pneumonia vaccine in Guangdong has been carried out by the academician Zhong Nanshan. The results showed that the two inactivated vaccines of Zhongsheng and Ke Xing in Chinese medicine can prevent 70.2% cases of moderate new crown pneumonia and the protective effect on severe cases is 100%. "At the same time, our preliminary analysis of severe cases in Guangdong, Jiangsu, Fujian, Inner Mongolia and other epidemic situations shows that even if they develop into severe cases, most vaccinated people can be converted to ordinary type in a short time." Zheng Zhongwei stressed that it is worth noting that the existing severe patients who have not been converted to ordinary type in Guangdong and Jiangsu are all unvaccinated. Once severe mutants appear, the related vaccines can be put into production soon At present, the national epidemic is still at a high incidence. So, has COVID-19's mutation accelerated? "COVID-19 is relatively variable in the world, but it is relatively stable. And from the recent domestic epidemic, the domestic vaccine is still effective for Delta strain," Zheng Zhongwei said. Prepared against want, all countries are promoting the development of variant vaccine. China has made plans in advance, and various vaccine R & D units have carried out a series of work for the main variant vaccines, which has not lagged behind people. According to Zheng Zhongwei, China has carried out research on inactivated vaccines of gamma and delta strains. At present, preclinical research has been completed, and some units have submitted clinical trial application materials to the drug evaluation center of the food and drug administration; Some units are carrying out preclinical research on bivalent vaccine. "For the research on broad-spectrum or multivalent recombinant protein vaccines of different mutant strains, some units have also submitted the application materials for clinical trials to the drug examination center of the food and drug administration." Zheng Zhongwei introduced that some units have completed animal effectiveness and safety experiments for the research and development of adenovirus vector vaccines and nucleic acid vaccines of beta and delta strains, We are preparing to apply for clinical trials. In addition, relevant institutions have also preliminarily formulated the guiding principles for completing the R & D and evaluation of mutant vaccine. "Once there is a serious mutant strain, the vaccine against the mutant strain can be put into production soon," Zheng Zhongwei said (outlook new era)

Edit:He Chuanning    Responsible editor:Su Suiyue

Source:Guang Ming Daily

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