Fifth Chinese COVID-19 Vaccine Entered Phase 3 Trials
Fifth Chinese COVID-19 Vaccine Entered Phase 3 clinical trials, which will be carried out in Uzbekistan. According to XinhuanetThe English version of November 14 news, recently told the media that the government of Uzbekistan, by the Anhui Zhifei Feilong Kema biopharmaceutical limited. research and development of new vaccines crown will carry out Phase III clinical trials in Uzbekistan. This is China’s fifth vaccine candidate to enter Phase III clinical trials.
Screenshot of the English version of Xinhuanet. The news also stated that the vaccine has been delivered to Uzbekistan, and several Chinese experts have also been in place. They will be responsible for monitoring volunteers and training Uzbekistan doctors.
According to China News Agency Xinjiang Branch Public No. “New Silk Road Watch” October 30 news, Uzbekistan epidemic prevention and control work headquarters, one expert said: “If you volunteer any complications or adverse reactions, will be free for its treatment In addition, volunteers for the COVID-19 vaccination can also receive corresponding subsidies.” Earlier, Uzbek’s Minister of Innovation and Development Ibrahim Abdurakhmonov said in an interview with Uzbekistan TV’s Channel 24, The safety of China’s COVID-19 vaccine is much higher than other similar vaccines.
According to Reuters eastern standard time reported November 11, Uzbekistan has said it is also with the drugmaker Sinopharm Group and Russia “satellite V” test the vaccine on potential negotiations . More than 69,000 people have been diagnosed with the COVID-19 in Uzbekistan, with 589 deaths and about 200 new cases in a single day. Uzbekistan has implemented a nationwide blockade twice, but there is no plan to block it again. Uzbekistan’s President Mirziyoyev has instructed officials to learn to live and work in a pandemic .
This vaccine, which will enter Phase III clinical trials, was jointly developed by the Institute of Microbiology, Chinese Academy of Sciences and Zhifeilongkoma.
According to the Institute of Microbiology, Chinese Academy of Sciences previously announced, on June 19, the vaccine was formally approved by the State Drug Administration Bureau clinical trials of the drug approval documents to start clinical trials. The recruitment of 18-59-year-old healthy adults in Beijing, Chongqing, and Hunan Province began on June 23. Phase I clinical trials were launched in the Second Affiliated Hospital of Chongqing Medical University and Beijing Chaoyang Hospital. Clinical II was launched on July 10 Periodic test. On October 22, the vaccine phase I/II clinical trial unblinding meeting was held. The unblinding results were in line with expectations. The new coronavirus recombinant subunit vaccine has good safety and immunogenicity in the population that meets the clinical trial protocol. Continue to carry out the next clinical trial.
Genetically engineered recombinant subunit vaccines, also known as recombinant protein vaccines. Regarding the technical characteristics of the vaccine developed in cooperation with Zhifeilongkoma , the Institute of Microbiology of the Chinese Academy of Sciences once introduced that recombinant protein vaccines are genetically engineered to express and purify pathogen antigen proteins in engineered cells, and then prepare them into vaccines. Gao Fu microorganisms team and Yan Jinghua team developed this COVID-19 virus vaccine antigens are based on the S protein receptor domain structure design (RBD) dimer antigen, has a unique structure, does not carry any form of foreign labels , with independent knowledge property rights . The challenge experiment of hACE2 transgenic mice proved that the vaccine has obvious protective effect. The results of the rhesus monkey challenge protection test showed that vaccine immunity can induce high levels of neutralizing antibodies, significantly reduce the viral load of lung tissue, reduce lung damage caused by virus infection, and have obvious protective effects. The vaccine strain by engineering cells of industrial production and high productivity, cost is low, a strong accessibility.
This vaccine is a key special project of the National Emergency Special-Key R&D Plan “Public Safety Risk Prevention and Control and Emergency Technology and Equipment” (Project Number: 2020YFC0842300). The technical route is the “reorganization” in the “5 routes” of the COVID-19 vaccine deployed by the Ministry of Science and Technology Subunit vaccine”.
This recombinant subunit vaccine is some countries’s fifth vaccine to enter Phase III clinical trials. The previous four vaccines that entered Phase III clinical trials adopted two technical routes: inactivated vaccines and adenovirus vector vaccines. The four vaccines are two inactivated vaccines developed by Sinopharm Group, an inactivated vaccine developed by Kexing Zhongwei, and an adenovirus vector vaccine developed by the team of Academician Chen Wei.
October 20, the State Council joint prevention and control mechanism of scientific research vaccine development group dedicated team long, director of the National Health Committee of Medical Science and Technology Development Center for Health Zheng Zhongwei was at the press conference, the first four vaccine to enter Phase III clinical trials in general It is progressing smoothly. So far, a total of about 60,000 subjects have been vaccinated, and no serious adverse reactions have been reported , which initially shows good safety.