EMA is engaging early with researchers to ensure that a European infrastructure will be in place to effectively monitor COVID-19 vaccines in the real world, once authorized in the European Union. The Agency has signed a contract with Utrecht University as coordinator of the EU Pharmacoepidemiology and Pharmacovigilance Research Network, a public-academic partnership of 22 European research centers, to conduct the ACCESS (vACcine Covid-19 monitoring readinESS) project. The researchers will identify a Europe-wide network of data sources and examine their utility in monitoring the coverage, safety and effectiveness of COVID-19 vaccines.
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