The Role of EudraVigilance in Protecting and Promoting Public Health in the European Economic Area in the Context of the Sars-Cov-2 Pandemic

ABSTRACT: The EudraVigilance database is the central pillar for pharmacovigilance activities in the European Economic Area. The reporting of adverse reactions in the EEA through the EudraVigilance system enables the management of reported data and the analysis of adverse medicine reactions, with the information being available anywhere in the EEA. This article aims to analyze, on the one hand, the EU legislation on pharmacovigilance, the key activities and developments that will take place through the implementation of the EudraVigilance Operational Plan 2020–2022, a document launched by the European Medicines Agency to ensure the sustainability of EudraVigilance and the associated actions in support of EU pharmacovigilance and public health protection activities. On the other hand, the article aims to analyze how, in accordance with a specific pharmacovigilance plan and using the EudraVigilance system, the EMA and the national competent authorities (NCA) of the EU member states have monitored suspected adverse reactions to the COVID-19 vaccines, thereby contributing to the protection of the health of European citizens.

KEYWORDS: EU pharmacovigilance legislation, EudraVigilance, public health, European Economic Area, COVID-19 vaccines