The Covid-19 is composed of a complete virus, and its pathogenicity is inactivated through physical and chemical methods, while still maintaining all or part of the immunogenicity of the virus. The candidate vaccine is prepared through inactivation verification and purification processes. After vaccination, the viral antigen can stimulate the body to produce an immune response and produce antibodies to achieve a protective effect. my country has a good foundation for research and development of inactivated vaccines. At present, many domestic research institutions and companies are intensively developing new crown inactivated vaccines.
COP vials
"The vaccine inspection cycle takes longer than other drugs." said Xiang Jinzhong, chief reviewer of the Department of Pharmacy of Biological Products of the Center for Drug Evaluation. For this reason, the State Drug Administration's special affairs office supports applicants in advance The hospital conducts inspection and quality standard review of inoculation sub-banks, clinical samples, etc., and does a good job of docking with the China Inspection Institute on quality review and other related work to save vaccine inspection time.
In accordance with the requirements of emergency inspections, the China National Inspection Institute intervened in vaccine research and development in advance. For new vaccines developed in emergency situations, the task of communicating vaccine quality standards and inspection-related issues with the research and development unit has been several times heavier than usual.
Undertaking the inspection task of the new crown inactivated vaccine is the Li Changgui team of the respiratory virus vaccine room of the National Inspection Institute and the technical backbones such as Xu Kangwei and Quan Yaru. "There are four companies involved in the research and development of inactivated vaccines, and the characteristics and conditions of each research and development product are different. Therefore, the quality standards and inspection methods of each product need to be more targeted." Li Changgui said that the team used technical reserves to Prepared and purified goat anti-new crown virus, goat anti-new crown virus Spike protein, rabbit anti-new crown virus, rabbit anti-new crown virus Spike protein, rabbit anti-new crown virus Spike protein RBD region and other antibodies, and provided them to many inactivated vaccine manufacturers to establish The antigen content detection method has laid a foundation for advancing the process of vaccine research and development and ensuring vaccine quality.
The virus seed is the basis for the development and preparation of vaccines, and the quality of the virus seed directly affects the safety and effectiveness of the vaccine. Li Changgui introduced that because there is no high school and titer antiserum, companies cannot perform virus identification, mycoplasma, and foreign factor testing. Therefore, the team adopted multiple approaches and multiple immunization strategies, and took the lead in preparing high-titer antiserum from SPF rabbits, which was used in the detection of virus species used in production by all domestic enterprises, solving the problem of virus species quality control. ——Enable enterprises to accelerate the conditions for applying for registration and inspection.
The in vivo efficacy test of the vaccine directly reflects the effectiveness of the vaccine. However, this experiment needs to be completed in a P3 laboratory (three-level biosafety protection laboratory), and the number of domestic P3 laboratories is far from meeting the needs of many R&D teams . "At that time, the detection methods established in the early stages of all companies needed to be tested by virus neutralization experiments, which had a high biosafety risk. The team and the company jointly tackled key problems and tested total antibodies after immunizing mice, establishing that no P3 is required. In vivo efficacy testing methods in laboratories.” He said that this testing method makes vaccine development progress no longer restricted by the number of laboratories.
Layout in advance and continuously solve multiple problems, laying the foundation for emergency inspection. On March 15, Beijing Kexing Zhongwei Biotechnology Co., Ltd. sent the first batch of inactivated vaccines for the new crown, and the China National Inspection Institute quickly launched the inspection. Take the respiratory virus vaccine room of the National Inspection Institute as an example. Up to now, 36 batches of new crown inactivated vaccines, 18 batches of original solutions and 4 batches of placebo have been tested by 4 R&D units, accounting for 132 batches of vaccines and For 44% of the original solution and placebo/control, 42 inspection reports have been issued, creating a prerequisite for China's new crown inactivated vaccine to enter clinical trials in the world.
(Source: National Center for Drug Administration and Evaluation)
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