EMA Sets Up Infrastructure to Support Real-World Monitoring of COVID-19 Vaccines

28 July 2020

BioPharm International

The European Medicines Agency (EMA) has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments, it was revealed in a July 21, 2020 press release.

Underpinned by three contracts that EMA has signed with academic and private partners, the infrastructure will monitor vaccines being administered in a clinical setting as soon as they have been authorized. The information gained will support the safe and effective use of COVID-19 vaccines and medicines.

In May 2020, EMA commissioned the vaccine COVID-19 monitoring readiness (ACCESS) project, aimed at performing 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. In June 2020, EMA contracted IQVIA to build a framework for the conduct of multicenter cohort studies on the use of medicines in COVID-19 patients. The project will be carried out in partnership with the European Health Data and Evidence Network (EHDEN) consortium.

The most recent contract, in mid-July 2020, has been agreed by EMA with Utrecht University and the University Medical Center Utrecht, which will be coordinators of the COVID-19 infection and medicines in pregnancy (CONSIGN) project. The aim of CONSIGN will be to collect data on the impact of COVID-19 in pregnancy to guide decision-making about vaccine indications, vaccination policies, and treatment options for COVID-19 in pregnant women.

More information on the contracts and other works being performed by EMA to support observational research and surveillance of COVID-19 treatments and vaccines can be found on the agency’s website.

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