EMA Sets Up Infrastructure for Monitoring COVID-19 Treatments and Vaccines

The European Medicines Agency (EMA) has set up an infrastructure in collaboration with public and private partners to help monitor COVID-19 vaccines and treatments as soon as they are authorized.

The agency chose Utrecht University and the University Medical Center Utrecht as coordinators of the COSIGN project, aimed at monitoring COVID-19 vaccines and treatments in pregnant women. It partnered with IQVIA in June to build a framework for conducting multicenter cohort studies on the use of medicines for COVID-19 patients.

The EMA commissioned the ACCESS project with Utrecht University in May to study data sources and methods that can be used for the postmarketing evaluation of COVID-19 vaccines.