On April 26, 2022, Sinopharm China Bio-Omicoron variant strain (hereinafter referred to as Ao strain) new coronavirus inactivated vaccine received clinical approval from the State Food and Drug Administration.
Sinopharm Group China Biotech introduced Omic from the University of Hong Kong for the first time on the basis of the prototype inactivated vaccine against COVID-19 already on the market and the completion of the research and development of beta and delta variant inactivated vaccines. Rong mutant strain, on December 9, 2021, the development of the Austrian strain inactivated vaccine was quickly launched.
According to the guidelines and research and development strategies of the improved new crown vaccine of the State Food and Drug Administration, Sinopharm China Biotechnology has completed the screening and passage of the Austrian strain using the newly built P3 high-level biosafety laboratory. , expanded, established a three-level virus seed bank, completed process verification, preparation of multiple batches of large-scale products, quality standard research, animal in vivo safety evaluation and immunogenicity research. The Austrian strain and various variant strains produce high titers of neutralizing antibodies. On March 3, 2022, the Beijing Institute of Biological Products, the Wuhan Institute of Biological Products and the Hong Kong research institute determined the clinical plan and related details, and obtained the certification qualification report of the China National Institute for Drug and Food Control on March 26 and 30 respectively. 4 The clinical application materials were submitted to the Hong Kong Department of Health on April 1, the ethics approval was obtained on April 12, and the clinical research approval was obtained on April 13, making it the world’s first inactivated Chronomicron vaccine approved for clinical use.
At the same time, Sinopharm Group China Biotechnology started to submit domestic clinical application materials to the Drug Evaluation Center of the State Food and Drug Administration on a rolling basis from January 26, and started the technical review.
On April 26, China Bio-Beijing Institute of Biological Products Omicron Variant Novel Coronavirus Inactivated Vaccine received clinical approval issued by the State Food and Drug Administration of China. Sino Bio will use a randomized, double-blind, cohort study to conduct a sequential immunization clinical study in people aged 18 and over who have completed 2 or 3 doses of the new crown vaccine to evaluate the inactivated vaccine against the new coronavirus of the Omicron variant safety and immunogenicity.
Should the political responsibility and social responsibility of the central enterprise, China Biotechnology has independently developed 4 new crown diagnostic reagents, 4 new crown specific treatment drugs and Four new crown vaccines have been successfully developed along three technical routes, giving full play to the role of the national team, main force and pillar of the pharmaceutical industry, creating a strategic scientific and technological force for maintaining national biosecurity, and promoting Chinese vaccines and therapeutic drugs to benefit the Chinese people and the world.
Source: China Biotechnology