On April 26, China Biotechnology Co., Ltd. announced on its official public account that Sinopharm's inactivated covid-19 vaccine against COVID-19 of Sinopharm China Bio-Aomi Kerong Mutant Strain (hereinafter referred to as "Aodu") has been clinically approved by the State Food and Drug Administration of China.
On the same day, Kexing Holding Biotechnology Co., Ltd. also announced that the company's inactivated vaccine for the new crown virus based on Aomi Kerong also received clinical approval from the China Food and Drug Administration.
According to public information, the above two companies started the research and development of the Olmikron inactivated vaccine at almost the same time in December 2021.
Coxing COVID-19 inactivated vaccine
According to the official public account article of China Biologics, Sinopharm China Biologics introduced the Opichron variant strain from the University of Hong Kong for the first time on the basis of the inactivated COVID-19 vaccine that had been listed in the early stage and completed the research and development of the beta and Delta variant inactivated vaccines, and quickly launched the research and development of the Ao strain inactivated vaccine on December 9, 2021.
According to the guiding principles and research and development strategies of the improved COVID-19 vaccine of the State Food and Drug Administration, Sinopharm China Bio-using the newly built P3 high-grade biosafety laboratory, completed the screening, passage and amplification of the Ao zhu poison, established a three-level poison pool, completed the process verification, the preparation of multiple batches of large-scale products, quality standard research, animal in vivo safety evaluation and immunogenicity research, and the results showed that the Ao Zhu new crown inactivated vaccine can produce high-titer neutralizing antibodies against the Ao strain and a variety of variant strains.
On March 3, 2022, the Beijing Institute of Biological Products and the Wuhan Institute of Biological Products and the Hong Kong Research Institute determined the clinical plan and related details, obtained the verification report of the China Institute of Pharmaceutical and Food Testing on March 26 and 30 respectively, submitted clinical application materials to the Hong Kong Department of Health on April 1, obtained ethical approval on April 12, and obtained clinical research approval on April 13, becoming the world's earliest inactivated vaccine approved to enter the clinic.
Sinopharm Beijing Bio-COVID-19 inactivated vaccine
At the same time, Sinopharm China Biologics began to submit domestic clinical declaration materials to the Drug Evaluation Center of the State Food and Drug Administration on a rolling basis from January 26, and launched a technical review.
On April 26, the inactivated vaccine of the New Coronavirus of the Aomi Kerong Variant of the Beijing Institute of Biological Products of China was approved by the State Food and Drug Administration of China. China Biologics will conduct sequential immunological clinical studies in people aged 18 years and older who have completed 2 or 3 doses of COVID-19 vaccination in the form of randomized, double-blind, cohort studies to evaluate the safety and immunogenicity of the Omiljung variant of the new coronavirus inactivated vaccine.
According to the data, China Biologics has independently developed 4 new crown diagnostic reagents, 4 new crown special treatment drugs and successfully developed 4 new crown vaccines on three technical routes.
According to the news released by Kexing Biology, on December 5, 2021, SINOVAC Kexing obtained nasopharyngeal swab samples from people infected with the New Coronavirus Olmi kerong variant, and cooperated with professor Qin Chuan's team at the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences to carry out virus isolation and whole gene sequencing. On December 9, 2021, SINOVAC introduced samples of the Omiljunn strain of the new coronavirus isolated from the University of Hong Kong.
After obtaining samples of the new coronavirus Semikron mutant strain, SINOVAC Kexing actively promoted the research on the strain, cell matrix and process quality of the New Coronavirus vaccine of the Aomi Kerong strain, and has established a tertiary seed bank for vaccine production in accordance with the requirements of GMP, and on the basis of the prototype vaccine, in accordance with the second generation of improved vaccine research and development ideas, the vaccine preparation process has been determined, and many batches of products have passed the self-inspection and review inspection of the Central Inspection Institute. The results of animal model studies show that the SINOVAC Cosyn Olmikron variant inactivated vaccine is safe and effective in test animals.
On January 30, 2022, the company began to submit the pre-review data of the application for clinical trials to the Drug Review Center (CDE) of the State Food and Drug Administration on a rolling basis, and completed the submission of the paper and electronic versions of the full set of registration declaration materials on April 15, and officially applied for clinical trials to cde.
At the same time, since the end of February 2022, SINOVAC Has successively submitted clinical applications for inactivated vaccines for the Opichron variant to many countries and regions outside the Chinese mainland.
On April 14, 2022, the inactivated covid-19 vaccine developed by SINOVAC Based on the Aumicron variant was clinically approved in the Hong Kong SAR.
Coxing Bio said that in the next step, SINOVAC will continue to carry out extensive cooperation with global partners, and actively promote the study of various novel coronavirus variants in different populations of prototype vaccines, as well as the sequential vaccination studies of new crown vaccines prepared by mutants.
After obtaining clinical approval, how long will it take for the Omilon vaccine to be marketed? Industry experts said that after the clinical approval, the research and development of the vaccine still needs to undergo rigorous clinical research before it can be approved for use.
Previously, it was reported that the inactivated vaccine of the new crown virus at the Beijing Institute of Biological Products took 8 months from clinical declaration to conditional listing, and this development speed had set a historical record for the speed of vaccine research and development at that time.
Liang Xiaofeng, dean of the Vaccine Industry Research Institute of Jinan University, pointed out that compared with the new crown vaccine using the original strain, the new crown vaccine of Aomi Kerong is expected to be further improved in terms of protection. As for the time to market, since enterprises have accumulated rich experience in vaccine preparation and production processes, the future mainly depends on whether there can be enough patients in clinical research to be enrolled in the observation.
[Reporter] Yan Huifang
【Author】 Yan Huifang
Healthy living circle