Monitoring the benefits and safety of the new corona vaccines

Utrecht scientists will lead a European project that is funded by the European Medicines Agency (EMA) with the aim to create European preparedness to monitor the benefits and safety of the new corona vaccines, when they come to the market.  The project called ACCESS (vACcine Covid-19 monitoring ReadinESS) works together with 22 organizations and is led by the University Medical Center Utrecht in close collaboration with Utrecht University, RIVM, Netherlands Pharmacovigilance center LAREB and the PHARMO Institute in the Netherlands

The project is led by prof. dr. Miriam Sturkenboom  from the UMCU in collaboration with prof. dr. Olaf Klungel from Utrecht University and is based on the Blueprint of a system that was developed by the European Centre for Disease Prevention and Control.  The blueprint describes an infrastructure for monitoring vaccines that is now implemented in the Vaccine monitoring Collaboration for Europe VAC4EU, an important partner of the ACCESS project. This infrastructure was designed and tested as part of the ADVANCE project following the lessons learned from the 2009 H1N1 pandemic, which showed that European collaboration is needed to adequately and rapidly monitor benefits and risks of novel vaccines.  

The ACCESS project

Goal of the project is to activate the infrastructure and prepare European organizations to collaboratively monitor the benefits, coverage and risks of the novel COVID-19 vaccines in their post-licensure phase.

COVID-19 vaccines will be licensed by regulatory authorities such as the European Medicines Agency after thorough review of available data on quality, efficacy and safety. Because the pre-licensure period is short and the number of tested subjects is limited, use in a broader population requires a continuous monitoring of benefits and risks of the vaccines.  The ACCESS project will prepare countries to do this in a harmonized and collaborative manner by preparing protocols to measure effectiveness, safety and uptake of the vaccines, and by identifying and training organizations across Europe to implement this.

The ACCESS project will already calculate the natural (independent of vaccine) occurrence of rare and serious conditions in 7 different countries, to have these data ready for the rapid interpretation of reports of adverse events after vaccines are used.  The ACCESS project will last 6 months and includes 22 organizations across Europe. As a result, a non-for-profit infrastructure will be ready to monitor the novel vaccines collaboratively across Europe.