This project kicked off in early 2024 as a collaboration between VAC4EU and the European Pharmacoepidemiology & Pharmacovigilance network. The primary aim of this EMA-funded project is to assess “the feasibility of participating data sources to participate in vaccine safety studies using electronic healthcare databases in European countries” through two specific studies.
The first study aims to “provide and describe a network of nine EEA real-world data sources for the evaluation of vaccine safety signals,” as well as assessing whether the data are fit for the purpose of real-time safety monitoring of vaccine safety studies. The second study aims to estimate the background and cumulative incidence of the flares of 10 pre-defined autoimmune diseases, while also analysing the contribution of different provenances of data. The protocol for this study was also accepted, and the study report is currently under development. Both studies employ a retrospective, multi-database, population-based cohort design using data from 2017 up to the most recent updates.
