《全球疫苗安全蓝图》解读及思考

摘要

目的：提高我国疫苗上市后安全监测的能力，明确我国疫苗上市后监测未来发展的方向。方法：介绍世界卫生组织《全球疫苗安全蓝图》出台的背景、战略目标与执行目标，分析我国疫苗上市后安全监测现状。结果与结论：近年来，我国疫苗上市后安全性监测发展迅速，取得的成绩也得到了国际的认可。但与《全球疫苗安全蓝图》提出的目标相比，我们在主动监测、信号分析、数据规范等方面仍存在不足。可以借助世界卫生组织和其他国际组织的力量，推动我国疫苗上市后监测迈上新的台阶。%OBJECTIVE:To improve the ability of vaccine post-marketing surveillance,and clearly define the development di-rection of it in China. METHODS:Though introducing the background,strategic objective and operation objective of Global Vac-cine Safety Blueprint,the situation of vaccine post-marketing surveillance in China was analyzed. RESULTS&CONCLUSIONS:Vaccine post-marketing surveillance have developed fast in China recent years and get generally confirmation. However,compared with the goals in the blueprint,there are some activities should be strengthened,such as active surveillance,signal analysis and da-ta standardization,etc. We should take use of the opportunity offered by WHO and other international organizations to shrink the gap between our country and the advanced countries. Drawing support from WHO and other international institutions,vaccine post-marketing surveillance can step on the new level in China.