The COVID-19 pandemic tested the limits of existing vaccine safety surveillance systems, demanding new approaches to monitor novel vaccines at unprecedented speed and scale. This review, published in Vaccine, explores methodological and data challenges in post-market safety monitoring and highlights lessons learned for future surveillance efforts.

Study Overview

Using data from the U.S. and Europe, the paper assesses how passive and active surveillance systems operated during COVID-19 vaccine rollout, focusing on study design, real-world data quality, and confounding control. Key considerations include standardized case definitions, coding validity, and time-to-signal detection—factors critical to ensuring reliable vaccine safety evaluation in large-scale public health settings.

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