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On April 26th, 2022, the inactivated COVID-19 vaccine of China Bio-Omicron mutant (hereinafter referred to as Austrian strain) of Sinopharm Group was approved for clinical use by the State Medical and Drug Administration.

China Bio, a subsidiary of Sinopharm Group, has already sold the inactivated vaccine of prototype strain COVID-19, and developed the β and δ mutant inactivated vaccine products in the early stage. Basically, the Omicron mutant was introduced from the University of Hong Kong at the first time, and the research and development of Austrian inactivated vaccine products was quickly started on February 9, 20021.

P3 Advanced Microbiology Laboratory established by Sinopharm Group China Bio-Utilization completed the breeding, passage and enrichment of Austrian strain according to the specific guiding standards and product research and development countermeasures of the State Administration of Pharmaceutical Products to improve COVID-19 vaccine, established the third-level virus seed bank, and completed the process verification, preparation of many batches of industrialized commodities, scientific research on detection standards, safety evaluation of small animals and scientific research on antigenicity. The data showed that COVID-19 inactivated vaccine against Austrian strains and various variants could produce neutralizing antibodies with high titer.

On March 3, 2022, Beijing Institute of Biological Products, Wuhan Institute of Biological Products and Hong Kong research institutions defined the clinical medical plan and related points. On March 26th and 30th, I received the metrological verification report from China Institute for Drug and Food Verification, submitted the application materials of clinical medicine to the Hong Kong Department of Health on April 1, received the ethical approval on April 12, and received the approval of clinical research on April 13. At the same time, China Bio, Sinopharm Group, began to submit the application materials of clinical drugs in China to the Drug Evaluation Center of the State Pharmaceutical Products Administration from 65438+126, and ran the technical evaluation.

On April 26th, the inactivated Omicron mutant COVID-19 vaccine produced by China Institute for Biological Products Control obtained the clinical medical approval from the State Administration of Pharmaceutical Products. China Bio will conduct a clinical study on conditional random field immunization in people aged 65,438+08 and above who have completed 2 or 3 doses of COVID-19 vaccine, and evaluate the safety factor and antigenicity of Omicron mutant COVID-19 inactivated vaccine.