China's vaccine research and development work has always been in the first array in the world
At the press conference of the joint prevention and control mechanism of the State Council on December 31, 2020, Chen Shifei, Deputy Director of the State Food and Drug Administration, said that the State Food and Drug Administration had approved the registration application of the COVID-19 inactivated vaccine of Sinopharm Biotech Beijing in accordance with the law and conditions on the evening of December 30.
On December 23, Sinopharm Sinopharm Beijing formally applied to the Drug Evaluation Center of the State Food and Drug Administration for conditional listing on the basis of the previous rolling submission of research materials. The Drug Examination Center immediately accepts the application. The expert team of the Drug Examination Center also conducted a comprehensive and detailed review of the safety, effectiveness, quality controllability and other research materials and data submitted by the applicant on the basis of the previous rolling review, including pharmacology, toxicology research, Phase I and Phase II clinical trials, as well as Phase III clinical trials carried out overseas, and pharmaceutical research data such as large-scale production process and quality control of Beijing Company, The research and development activities carried out in China and the domestic Phase I and Phase II clinical trial sites were checked.
In addition, the Drug Verification Center of the State Administration also carried out on-site verification of registered production on the production site of Beijing Company according to law, the Beijing Food and Drug Administration carried out inspection on the quality management specifications of drug production, and the China Institute for the Control of Pharmaceutical and Biological Products carried out laboratory inspection and review of quality standards on vaccine samples trial produced by Beijing Company, In addition, Beijing Zhongsheng Company has published 79.34% of the vaccine protection data submitted by the applicant based on the interim analysis results of the large-scale double-blind placebo controlled phase III clinical trial, and conducted a comprehensive analysis, combining the evaluation opinions and suggestions of the third-party expert group on the conditional listing application, as well as the opinions of the expert consultation meeting of the Drug Approval Center. After a series of strict examination, review, verification, inspection and data analysis in accordance with the law and procedures, it is comprehensively believed that the known and potential benefits of Sinopharm Sinopharm Beijing's inactivated COVID-19 vaccine are greater than the known and potential risks, and fully meet the requirements of the preset conditional listing standards.
On December 30, the State Food and Drug Administration approved the conditional listing of Sinopharm Sinopharm Beijing's inactivated COVID-19 vaccine. At the same time, the State Food and Drug Administration will urge Sinopharm Beijing to continue to carry out the Phase III clinical trial according to laws and regulations, complete the Phase III clinical trial and other conditional post marketing research with quality and quantity guaranteed, and update and supplement the instructions and labels of the vaccine in a timely manner according to the research progress and data results obtained, as well as the abnormal reactions in the vaccination after marketing, And shall apply to the drug regulatory authority for approval or filing in accordance with the relevant provisions.