Twenty-five COVID-19 Vaccines In China Enter Stages Of Clinical Trials
"There are currently 25 COVID-19 vaccines in stages of clinical trials in China, of which 4 have been approved for conditional marketing by the NMPA, 3 have recently been approved for emergency use in China, and 14 have been approved for III stages of clinical trials overseas." Zheng Zhongwei, director of the National Health Commission's Medical and Health Science and Technology Development Research Center, introduced.
5 technical routes have achieved full coverage of stages of clinical trials
Since the outbreak of COVID-19, China has immediately deployed five technical routes including inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, nucleic acid vaccines, and attenuated influenza virus vector vaccines. Zheng zhongwei pointed out that one adenovirus vector vaccine has been conditionally approved by the NMPA, and large-scale vaccination is being carried out in China. The other 3 are undergoing phaseⅠand Ⅱ clinical trials, and the progress is generally smooth. The recombinant protein vaccine is not yet on the market. Four recombinant protein vaccines from China are currently undergoing Ⅳ stages of clinical trials abroad.
It is reported that one section of the attenuated influenza vector vaccine has been approved by Foreign III stages of clinical trials, and III stages of clinical trials will be launched abroad in the near future. Among the nucleic acid vaccines, one mRNA vaccine and one DNA vaccine have been approved for III stages of clinical trials abroad, and related research has been started recently.
The study results show that the vaccine produced in China has good safety and efficacy
Data show that Chinese vaccines have good safety and low side effects in the more than 1 billion doses of overseas high-endemic countries and more than 2 billion domestic doses.
Zheng Zhongwei said that the protective power of the inactivated vaccines of Sinopharm Zhongsheng Wuhan Institute and Beijing Institute against symptomatic infection was 72.8% and 78.1% respectively, and the protection power of the two vaccines against severe cases was 100%. Sinovac's Phase III clinical trials in Turkey and Indonesia show that the vaccine's protection against symptomatic infection is 83.5% and 65.3%, respectively, and the protection against severe disease is 100%.
Regarding the probability of infection of the COVID-19 among the vaccinated population of public concern, 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 infection were reported, all of which were infected with the Delta strain. Preliminary analysis shows that only 5 of the infected people who were ≥14 days after inoculation with two doses developed severe disease, accounting for about 5% of all severe cases. None of the patients were vaccinated. In Guangdong Province, a total of 190 local cases have been reported as of May 2021, and the main infected virus 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 two inactivated vaccines of Sinopharm Zhongsheng and Kexing Zhongwei have a protective effect of 70.2% in the prevention of moderate new coronary pneumonia and a protective effect of 100% in severe cases.
Once severe mutations occur, the vaccine can be quickly put into production
At present, the national epidemic situation is still at a high incidence, so has the mutation of the COVID-19 accelerated?
"Globally, the COVID-19 continues to mutate, but is relatively stable. And judging by recent outbreaks in China, the chinese-made vaccine is still effective against the delta strain." Zheng Zhongwei said that in order to be prepared, all countries are promoting mutation strain vaccine development. China has made plans in advance, and each vaccine research and development unit has carried out a series of work on the main variant vaccines, which is not 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; Preclinical studies of valent vaccines.
Zheng Zhongwei introduced that some units have completed animal efficacy and safety tests for adenovirus vector vaccines and nucleic acid vaccines of beta strains and Delta strains, and are preparing to apply for clinical trials.
In addition, relevant institutions have also preliminarily formulated guidelines for the development and evaluation of variant vaccines.
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