[关键词]
[摘要]
疫苗的预防接种对提高人群免疫力、降低人群易感性、控制某些传染病的发生和流行起着主导作用。在这次新型冠状病毒(SARS-CoV-2)疫情防控中,我国政府高度关注疫苗的研发进展,并在世界研发行业中成绩卓越。在简要回顾SARS-CoV-2疫苗的研究进展和从SARS-CoV-2特点再认识疫苗研发的科学问题的基础上,从药物评价研究的角度,就SARS-CoV-2疫苗研发进展与评价问题予以论述。冠状病毒疫苗开发成功的关键是产品的安全性和有效性。在其研发的系统工程中,利用病毒结构的特性,形成新的研发路征,通过精心设计,严格执行国内国际研发评价规范,进行科学的临床前质量和稳定性试验、动物的安全性和有效性试验,进行I、Ⅱ、Ⅲ期临床评价去实现研发目标。疫苗从研发到上市是一个漫长的过程,期间需要解决众多的关键科学问题,尤其是针对像SARS-CoV-2这样传播速度快、传播途径广的病毒,可能会面临更多的风险与挑战。由于SARS-CoV-2流行范围广和变异速度快的特点,为了获取更全面的病毒数据需要国际间的协调与合作,以确保足够的信息和研究能力,达到成果国际共享的目的。
[Key word]
[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.
[中图分类号]
[基金项目]