Covid-19 Inactivated Vaccine of China Bio-Omicron Mutant of Sinopharm Group was approved by National Medical Products Administration Clinical Approval.

According to the official micro-news of China Biology, on April 26th, the inactivated Covid-19 vaccine of China Bio-Omicron mutant of Sinopharm Group won the clinical approval from National Medical Products Administration.

China Bio, Sinopharm Group, introduced Omicron mutant strain from Hongkong University at the first time on the basis of the research and development of the prototype strain COVID-19 inactivated vaccine and the beta and delta mutant inactivated vaccine, and quickly launched the research and development of the Austrian inactivated vaccine on December 9, 2021.

According to the guiding principle and research and development strategy of National Medical Products Administration’s improved COVID-19 vaccine, China Bio-Pharmaceutical Group completed the screening, passage and amplification of Austrian strains by using the newly-built P3 high-level biosafety laboratory, established a three-level virus seed bank, and completed the process verification, preparation of many batches of large-scale products, quality standard research, safety evaluation in animals and immunogenicity research. The results showed that the inactivated vaccine against Austrian strain COVID-19 could produce high titer neutralizing antibodies against Austrian strains and various variants. On March 3, 2022, Beijing Institute of Biological Products, Wuhan Institute of Biological Products and Hong Kong research institutions confirmed the clinical plan and related details. On March 26 and 30, they obtained the verification report from China Institute of Drug and Food Verification, submitted the clinical application materials to the Hong Kong Department of Health on April 1, obtained the ethical approval on April 12, and obtained the clinical research approval on April 13, becoming the first inactivated vaccine of Omicron strain approved for clinical use in the world.

At the same time, Sinopharm Group China Bio started to submit domestic clinical application materials to National Medical Products Administration Drug Evaluation Center on January 26th, and started technical evaluation.

On April 26th, China Institute of Biological Beijing Biological Products obtained the clinical approval issued by National Medical Products Administration, China. China Bio will adopt a randomized, double-blind, cohort study to conduct a sequential immune clinical study among people aged 18 and above who have completed 2 or 3 doses of COVID-19 vaccine, so as to evaluate the safety and immunogenicity of Omicron mutant Covid-19 inactivated vaccine.