Twenty-five new coronavirus vaccines in my country have entered clinical trials

　　“There are currently 25 new coronavirus vaccines in my country that have entered the clinical trial stage. Among them, 4 vaccines have been approved by the my country Food and Drug Administration for conditional marketing, 3 vaccines have recently been approved for emergency use in my country, and 14 vaccines have been approved for overseas use III Phase clinical trials are progressing generally smoothly.” According to Zheng Zhongwei, the leader of the vaccine research and development team of the Joint Prevention and Control Mechanism Research Team of the State Council, and the director of the National Health Commission's Medical Science and Technology Development Research Center.

5 technical routes have achieved full coverage of clinical trials

　　Since the outbreak of the new crown pneumonia epidemic, my country has immediately deployed five technical routes: inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, nucleic acid vaccines, and attenuated influenza virus vector vaccines.

"At the same time, the research and development of the new coronavirus vaccine has been promoted, and the full coverage of clinical trials on 5 technical routes has been achieved." Zheng Zhongwei said.

　　He pointed out that one adenovirus vector vaccine has been approved by the State Food and Drug Administration for conditional marketing, and large-scale vaccination is being carried out in China.

Another 3 models are undergoing phase I and II clinical trials, and the progress is generally smooth.

　　Previously, recombinant protein vaccines had not yet been on the market.

"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 there are still 4 recombinant protein vaccines in my country that are undergoing phase III clinical trials abroad, and 4 recombinant protein vaccines are under development. Phase I and II clinical trials.

　　According to reports, one of the attenuated influenza virus vector vaccines has been approved for phase III clinical trials abroad, and phase III clinical trials will be launched overseas 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 related research has been launched recently.

Research results show that domestic vaccines have good safety and effectiveness

　　Since the beginning of research and development, my country's regulatory agencies, research and development institutions, and research and development personnel have put the safety and effectiveness of the new crown vaccine in the first place.

Zheng Zhongwei pointed out that in accordance with relevant approval requirements, the current new coronavirus vaccines have been approved by relevant agencies for conditional marketing or emergency use. Phase I, II, and III clinical trials have been carried out in the whole population. The research results show that the vaccine has good results. Safety and effectiveness.

　　The data shows that the safety of my country's vaccines in more than 1 billion doses of overseas countries with high epidemic epidemics and more than 2 billion doses of domestic vaccines has good safety and low side effects.

　　Zheng Zhongwei said that the inactivated vaccines of Sinopharm Wuhan Institute and Beijing Institute of Medicine have 72.8% and 78.1% protection against symptomatic infections, respectively, and the two vaccines have 100% protection against severe illnesses.

The results of the Phase III clinical trials of Kexing in Turkey and Indonesia showed that the vaccine's protection against symptomatic infections was 83.5% and 65.3%, respectively, and the protection against severe cases was 100%.

　　Regarding the probability of the vaccinated population of public concern being infected with the new crown virus, Zheng Zhongwei said that taking the epidemic situation in Jiangsu and other places around August this year as an example, as of August 25, a total of 1,388 cases of infected people have been reported, all infected with Delta (Delta). Strain.

According to preliminary analysis, only 5 of the infected persons ≥ 14 days after vaccination developed into severe illness, accounting for about 5% of all severe cases, 97% of severe cases over 60 years old had not been vaccinated or had not completed two doses of vaccination, and were critically ill. None of the patients were vaccinated.

In Guangdong Province, as of May 2021, a total of 190 local cases have been reported, and the main infection strain is the Delta strain.

A study on the protective effect of vaccines in the Guangdong epidemic organized by Academician Zhong Nanshan showed that the protective effect of the two inactivated vaccines of Sinopharm Zhongsheng and Kexing Zhongwei to prevent moderate new coronary pneumonia can reach 70.2%, and the protective effect of severe disease can reach 100%. .

　　"At the same time, our preliminary analysis of severe cases in Guangdong, Jiangsu, Fujian, Inner Mongolia and other epidemics shows that even if they become severely ill, most vaccinated patients can be converted to normal in a short period of time." Zheng Zhongwei emphasized that it is worth noting. Yes, the existing critically ill patients in Guangdong and Jiangsu who have not been converted to the general type are those who have not been vaccinated.

Vaccines related to severe mutant strains can be put into production soon

　　At present, the national epidemic situation is still in a high-incidence situation, so has the mutation of the new crown virus accelerated?

　　"Relatively speaking, the new coronavirus continues to mutate globally, but it is still relatively stable. Moreover, judging from the recent domestic outbreaks, domestic vaccines are still effective against the Delta strain." Zheng Zhongwei said that in order to be prepared, all countries are Promote the development of variant vaccines.

my country has planned ahead of time, and each vaccine research and development unit has carried out a series of work on the major variant strain vaccines, and has not fallen behind.

　　According to Zheng Zhongwei, my country has carried out research on inactivated vaccines of the Gamma strain and Delta strain. At present, the preclinical research has been completed, and some units have submitted clinical trial application materials to the Drug Evaluation Center of the China Food and Drug Administration ; Some units are carrying out preclinical studies of bivalent vaccines.

　　"For the research on broad-spectrum or multivalent recombinant protein vaccines of different mutant strains, some units have also submitted clinical trial application materials to the Drug Evaluation Center of the China Food and Drug Administration." Zheng Zhongwei introduced, targeting the Beta strain and Delta For the research and development of adenovirus vector vaccines and nucleic acid vaccines, some units have completed animal effectiveness and safety experiments and are preparing to apply for clinical trials.

　　In addition, relevant agencies have also initially formulated guidelines for the development and evaluation of variant vaccines.

Zheng Zhongwei said: "Once a severe mutant strain appears, a vaccine against the mutant strain can be quickly put into production."

(Reporter Jin Zhenya)