EMA Selects Research Collaboration to Prepare for Rapid Assessment Of COVID-19 Vaccine Effects Post-Approval

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In advance of an approved COVID-19 vaccine, the European Medicines Agency (EMA) has commissioned research to monitor any vaccine that is approved for its safety and effectiveness in clinical practice. This research will be performed by a tender that is composed of several university and other research teams, including RTI Health Solutions (RTI-HS) under the leadership of Utrecht University.

The first project in which RTI-HS will be participating is a feasibility analysis of an EU infrastructure for COVID-19 vaccine monitoring. Within this project, RTI-HS will lead the development of protocol templates for hospital-based, self-controlled case series analyses of specific severe adverse events as well as for monitoring the effectiveness of COVID-19 vaccines using information in healthcare databases. These protocol templates will be designed to enable transparency, replicability, and transportability across data sources. 

This forward-thinking collaboration, known as the ACCESS (vACcine Covid-19 monitoring readinESS) project, will be conducting preparatory research to identify data sources and methods which can be used in future research that will monitor vaccine safety and efficacy. Alejandro Arana, Senior Director of Epidemiology at RTI Health Solutions, shares, “The RTI-HS team is excited to be part of this collaboration to help protect the health and wellbeing of people in the EU during the search for a vaccine to fight COVID-19.”