肠道病毒71型（enterovirus 71，EV71）是导致手足口病的主要病原体之一，近年来在我国持续流行，对婴幼儿的健康造成了严重威胁。安全有效的疫苗是控制EV71流行的重要手段。全球有多家研究机构正在开展EV71疫苗的相关研究，目前由我国自主研发的3种EV71疫苗已获准上市。同时，为保证疫苗的安全性、有效性和质量可控性，已在研发中建立了合适且规范的质量标准。

Enterovirus 71 (EV71 ) is one of the primary pathogenic agents of hand , foot, and mouth disease and keeps circulating in China in recent years, which poses a serious threat to the health of infants and children. Safe and effective vaccine is the crucial method for controlling EV71 circulation. Several pharmaceutical companies and institutes are conducting the research and development of EV71 vaccines in the world. Three domestically developed vaccines have been approved at present. To ensure the safety, efficacy and controllability of corresponding vaccines, appropriate and regulated quality standards have been established during the process of research and development.