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

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.