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Research development and evaluation of SARS-CoV-2 vaccines
Drug Evaluation Research ; 43(7):1421-1432, 2020.
Article in Chinese | GIM | ID: covidwho-1270236
ABSTRACT
Vaccination plays a leading role in improving immunity, reducing susceptibility and controlling the occurrence and prevalence of some infectious diseases. In this epidemic prevention and control of SARS-COV-2, the Chinese government paid more attention to the development progress of vaccine and made outstanding achievements in the world's research and development (R&D) industry. Based on a brief review of the research progress of the novel vaccine and a new understanding of the scientific issues of vaccine R&D based on the characteristics of the novel vaccine, this paper discusses the research progress and evaluation of the novel vaccine from the perspective of drug evaluation. The key to the successful development of a vaccine is the safety and effectiveness of the product. In this system engineering of R&D, the use of virus structure characteristics, forming new development pathway, through elaborate design, strict domestic and international research and evaluation standard, the scientific quality of preclinical quality and stability tests, the safety and effectiveness in animal tests, phase I, II and III clinical evaluations to achieve development goals. From the research and development to the market of vaccine is a long process, during which many key scientific problems need to be solved. Especially for a SARS-COV-2 such as novel coronavirus that spreads quickly and widely, it may face more risks and challenges. Due to the virus' wide range of popularity and rapid mutation, international coordination and cooperation are needed to obtain more comprehensive virus data, so as to ensure sufficient information and research capacity for the purpose of international sharing of results.

Full text: Available Collection: Databases of international organizations Database: GIM Type of study: Experimental Studies Topics: Vaccines Language: Chinese Journal: Drug Evaluation Research Year: 2020 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: GIM Type of study: Experimental Studies Topics: Vaccines Language: Chinese Journal: Drug Evaluation Research Year: 2020 Document Type: Article