Europe Expands COVID-19 Vaccine Safety Review

The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) announced on April 26, 2021, a new initiative aimed at strengthening post-marketing monitoring of the safety, effectiveness, and impact of COVID-19 vaccines in the European Union (EU) and the European Economic Area (EEA). 

With the ongoing authorization and rollout of several COVID-19 vaccines in the EU, jointly coordinated, large-scale, EU-wide effectiveness and safety studies are an essential tool to monitor how these novel vaccines perform in real life closely, stated the EMA press release.

As of April 26th, the EMA had issued emergency authorization for four COVID-19 vaccines and is reviewing three other vaccines. 

“Observational research is an important pillar in the post-marketing surveillance of COVID-19 vaccines, and increased EU level collaboration is needed so that Member States can join forces and organize large studies that meet the needs of both medicines regulators and national institutes for public health and vaccination,” commented Emer Cooke, EMA’s Executive Director.

In line with their respective mandates and in collaboration with EU/EEA countries, EMA leads on monitoring the safety, and ECDC the effectiveness, of these vaccines. A Joint Advisory Board will support this work to the two Agencies that held their first meeting today.