EMA

A framework for the post-authorisation SAFETY Evaluation of VACcines in the EU (SAFETY-VAC)

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Finished project

2024-present

The primary aim of this project was to assess the capacity to conduct safety studies in a netowrk of electronic health record data sources from VAC4EU and the EU PE&PV Research Network. The second study aimed 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. Both studies employ a retrospective, multi-database, population-based cohort design using data from 2017 up to the most recent updates.