Healthcare Apr 26, 2022 03:52 PM (GMT+8) · EqualOcean
On April 26, 2022, the inactivated vaccine of Sinopharm China biological Omicron mutant novel coronavirus was approved by the State Food and drug administration. Sinopharm China Bio introduced the Omicron variant strain from the University of Hong Kong for the first time on the basis of the prototype strain of Xinguan inactivated vaccine listed in the early stage and the research and development of beta and delta variant inactivated vaccine. On December 9, 2021, Sinopharm China Bio quickly launched the research and development of Austrian strain inactivated vaccine. On March 3, 2022, Sinopharm Zhongsheng Beijing Institute of biology and Wuhan Institute of biology determined the clinical scheme and relevant details with Hong Kong research institutions. On March 26 and 30, they obtained the certification report of China Institute of drug and food control respectively. On April 1, they submitted clinical application materials to the Hong Kong Department of health. On April 12, they obtained ethical approval and on April 13, they obtained clinical research approval, becoming the first inactivated vaccine of Omicron strain approved for clinical use in the world. Sinopharm China biology will conduct a sequential immune clinical study in the population aged 18 and above who have completed 2 or 3 doses of neocoronavirus vaccine in the form of randomized, double-blind and cohort study to evaluate the safety and immunogenicity of the inactivated novel coronavirus vaccine of Omicron variant.