Omicron Variant New Coronavirus Inactivated Vaccine Approved to Enter Clinical Trials

The reporter learned at the online press conference held by Sinopharm Group China Biology on the 27th that Sinopharm Group China Biopharmaceutical Omicron variant new coronavirus inactivated vaccine received clinical approval from the State Food and Drug Administration on the 26th, which means that the vaccine will be Enter the clinical trial stage
.

 

Yang Xiaoming, chief engineer of Sinopharm Group and chairman of Sino Bio, introduced that according to the guidelines and research and development strategies of the improved new crown vaccine of the State Food and Drug Administration, since December 9, 2021, the research and development of the new coronavirus inactivated vaccine of the Omicron variant strain has been launched.
The Group's China Bio-utilized the newly built P3 high-level biosafety laboratory, which has completed the screening, passage, and expansion of the Omicron variant strains, established a three-level virus seed library, completed process verification, and completed multiple batches of large-scale products.
Preparation, quality standard research, animal in vivo safety evaluation and immunogenicity research, the results show that the inactivated vaccine of the new coronavirus of the Omicron variant strain can produce high titer neutralization against the Omicron variant strain and a variety of variant strains antibody
.

 

"Whether it can produce neutralizing antibodies that are effective against Omicron mutants is a difficult problem in vaccine development.
Preclinical studies have shown that the vaccine has good neutralizing activity against Omicron mutants.
Variant infection has a certain protective effect
.
" Zhang Yuntao, chief scientist and vice president of Sinopharm China Biotechnology, introduced that the protective power of the vaccine needs to be further observed in clinical research
.

 

It is reported that China Biotechnology will use the form of 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 new coronavirus of the Omicron variant.
Safety and immunogenicity of inactivated vaccines, and study clinical vaccination regimens for those who have not yet been vaccinated against COVID-19
.

　　The reporter learned at the online press conference held by Sinopharm Group China Biology on the 27th that Sinopharm Group China Biopharmaceutical Omicron variant new coronavirus inactivated vaccine received clinical approval from the State Food and Drug Administration on the 26th, which means that the vaccine will be Enter the clinical trial stage
.

 

　　Yang Xiaoming, chief engineer of Sinopharm Group and chairman of Sino Bio, introduced that according to the guidelines and research and development strategies of the improved new crown vaccine of the State Food and Drug Administration, since December 9, 2021, the research and development of the new coronavirus inactivated vaccine of the Omicron variant strain has been launched.
The Group's China Bio-utilized the newly built P3 high-level biosafety laboratory, which has completed the screening, passage, and expansion of the Omicron variant strains, established a three-level virus seed library, completed process verification, and completed multiple batches of large-scale products.
Preparation, quality standard research, animal in vivo safety evaluation and immunogenicity research, the results show that the inactivated vaccine of the new coronavirus of the Omicron variant strain can produce high titer neutralization against the Omicron variant strain and a variety of variant strains antibody
.

 

　　 "Whether it can produce neutralizing antibodies that are effective against Omicron mutants is a difficult problem in vaccine development.
Preclinical studies have shown that the vaccine has good neutralizing activity against Omicron mutants.
Variant infection has a certain protective effect
.
" Zhang Yuntao, chief scientist and vice president of Sinopharm China Biotechnology, introduced that the protective power of the vaccine needs to be further observed in clinical research
.

 

　　It is reported that China Biotechnology will use the form of 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 new coronavirus of the Omicron variant.
Safety and immunogenicity of inactivated vaccines, and study clinical vaccination regimens for those who have not yet been vaccinated against COVID-19
.