On April 26th, 2022, the SinoPac China biological Novel Coronavirus inactivated vaccine was approved by sFDA for clinical use.
China National Pharmaceutical Group Cooperation introduced the omicron mutant strain from the University of Hong Kong for the first time based on the previously marketed prototype inactivated vaccine of COVID-19 and the completion of the research and development inactivated vaccine of beta and Delta variant strains. On December 9, 2021, China National Pharmaceutical Group Cooperation quickly launched the research and development of the Inactivated vaccine of The Ormictron variant strain.
According to the state food and drug administration, to improve the new vaccine guidelines and development strategy, a new national medical group, the Chinese biotechnology P3 biosafety laboratory high levels, completed the poison of the strain screening, to extend, amplification, established a three-level poison kind of libraries, conducted the process validation, multiple-scale product preparation, quality standard research, animal safety evaluation, and immunogenicity, The results showed that the inactivated vaccine could produce high titer neutralizing antibodies against the influenza strain and various variants. On March 3, 2022, the Beijing Institute of biological products, Wuhan institute of natural products with the Hong Kong research institute to determine the clinical scheme and relevant details; on March 26 and 30, respectively, the Chinese medicine institute of food testing verification qualified report, submit to the Hong Kong Department of Health on April 1, the clinical application data, obtaining ethical approval documents on April 12. On April 13, the vaccine was approved for clinical study, making it the first inactivated omicron strain vaccine approved for clinical use in the world.
To ensure the clinical quality of the vaccine, the new vaccine will be launched by the end of September, depending on the clinical speed and approval requirements of vaccine preparation studies.
ARTICLE FROM: AnyShenzhen