全球主要经济体构建新型冠状病毒疫苗上市后安全性监测与研究体系的启示

Enlightening from optimizing post-authorization safety monitoring system of SARS-CoV-2 vaccines in major economies worldwide

严重急性呼吸综合征冠状病毒2(简称“新冠病毒”)引起的新冠病毒感染持续全球大流行,促使了新冠病毒疫苗研发和接种在全球范围内以前所未有的规模和速度推进。如何有效应对可预期的新冠病毒疫苗上市后不良事件的规模性增长,是全球面临的共同问题。全球多个国家和地区在不同层面提前布局,从强化基础、促进合作、加强方法和能力、提高透明度和公众沟通等角度优化原有疫苗安全性监测体系,确保了该体系的良性、高效运行,可为我国相关领域建设提供一定借鉴。

Ongoing global pandemic of Coronavirus Disease 2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)has promoted the unprecedented rapid development and large-scale rolling out of different platform-based COVID-19 vaccines worldwide.How to effectively respond to the expected scale increasing adverse events after vaccination campaign of COVID-19 vaccines is a common problem faced by the world.A lot of countries and regions around the world have arranged in advance at different levels,optimizing the original vaccine safety monitoring system from the perspectives of strengthening the foundation and capabilities,promoting internal and external cooperation,upgrading methods,as well as improving transparency and public communication,which has ensured the good and efficient operation of the system and can provide reference for the construction of relevant fields in China.