EMA Picks University to Lead Real-World Monitoring of COVID-19 Vaccines

The European Medicines Agency (EMA) has signed a contract with Utrecht University to lead a research project for real-world monitoring of COVID-19 vaccines once they are authorized in the European Union.

The ACCESS project is a partnership of 22 European research centers that will look into data sources, such as insurance or hospital health records, which can be used to monitor COVID-19 vaccines in clinical practice.

The data collection system put in place by Utrecht University and the University Medical Center Utrecht will add to the data collected from clinical trials and postmarket reporting, EMA said. The project will also identify possible adverse events that might need special attention.