Liao C X, Li L M, Wang L, Lyu Jun
School of Public Health, Peking University, Beijing 100191, China.
School of Public Health, Peking University, Beijing 100191, China Peking University Center for Public Health and Epidemic Preparedness and Response, Beijing 100191, China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2022 Jan 10;43(1):7-13. doi: 10.3760/cma.j.cn112338-20210902-00705.
Safe and effective vaccines are essential for the prevention and control of COVID-19 pandemic. In the evaluations of COVID-19 vaccines' safety and efficiency in experimental research and the surveillance for COVID-19 vaccines' safety and population based effectiveness in observational study, epidemiology research has played a critical role. By analyzing research cases both at home and abroad, this paper systematically introduces the applications and design elements of clinical trial, cohort study and case-control study in the evaluations of COVID-19 vaccines' safety and efficiency in clinical trials and safety and population based effectiveness clinical use to enrich epidemiology teaching cases. After the marketing of COVID-19 vaccines, some foreign countries rapidly organized and carried out population based observational research for the clinical evaluation of the vaccines with sample size ranging from several hundred thousand to ten million. Benefiting from the developed public health, medical and medical insurance information systems in these countries, their data can be shared for integrated analysis, which would has important enlightenment for the development of medical big data in China.
安全有效的疫苗对于预防和控制新冠疫情至关重要。在新冠疫苗安全性和有效性的实验研究评估以及观察性研究中新冠疫苗安全性和基于人群有效性的监测方面，流行病学研究发挥了关键作用。通过分析国内外研究案例，本文系统介绍了临床试验、队列研究和病例对照研究在新冠疫苗临床试验安全性和有效性评估以及临床使用中基于人群有效性评估的应用和设计要素，以丰富流行病学教学案例。新冠疫苗上市后，一些国家迅速组织开展了基于人群的观察性研究，对疫苗进行临床评估，样本量从几十万到一千万不等。得益于这些国家发达的公共卫生、医疗和医疗保险信息系统，其数据可共享进行综合分析，这对我国医学大数据的发展具有重要启示。
