EMA has now set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. This is underpinned by three contracts for observational research that EMA has signed with academic and private partners over recent months, to be ready to effectively monitor medicines and vaccines in the real world as soon as they are authorised, and support the safe and effective use of COVID-19 vaccines and medicines. The three projects are:

• with Utrecht University and the University Medical Center Utrecht as coordinators of the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’)
• with IQVIA company with a project to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients.
• ACCESS project (‘vACcine Covid-19 monitoring readinESS’)commissioned by EMA for preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice, once authorised.

The outcome of the various projects conducted on observational research will be fed into the work of EMA’s COVID-19 pandemic Task Force (COVID-ETF) and EMA’s scientific committees, to ensure that this evidence is translated into scientific opinions on the optimal use of the medicines and vaccines concerned.

More information is available here.