Use of Routinely Collected "Real-world" Data for the Postlicensure Safety Assessment of Vaccination During Pregnancy

利用常规收集的“真实世界”数据进行疫苗上市后妊娠期安全性评估

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Abstract

Real-world data can be used to evaluate the postlicensure safety of vaccines during pregnancy. However, these studies often require special design considerations to minimize bias. We offer 4 recommendations for maximizing the use of real-world data for vaccine safety evaluations during pregnancy, including the application of robust methodology, standardized outcome definitions, global collaboration and platforms for data sharing.

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