The European Medicines Agency said on Wednesday 22 July that it is ready to monitor the effectiveness and safety of Covid-19 treatments and vaccines once they are on the market.
In a press release, the EU agency states that the necessary infrastructure has been put in place. It refers to three observational research contracts concluded with academic and private partners in recent months.
The first project is entitled ACCESS (“vACcine Covid-19 monitoring readinESS”) and is preparatory research on data sources and methods that can be used to monitor the safety, efficacy and coverage of Covid-19 vaccines in clinical practice once they are authorised.
In June, the EMA awarded IQVIA a project to create a framework for conducting multi-centre cohort studies on medicines-use in patients with Covid-19.
The third and final contract was finalised in mid-July with the University of Utrecht and the Utrecht University Medical Centre, which will coordinate the CONSIGN project (“Covid-19 infectiOn and medicineS in preGNancy”), a project to collect data on the impact of Covid-19 during pregnancy. (Original version in French by Sophie Petitjean)