EMA Commissions Research On Real-World Monitoring Of COVID-19 Vaccines
Experts Offer Guidance On Pharmacoepidemiological Analyses During Pandemic
The European Medicines Agency is taking steps to establish infrastructure for monitoring COVID-19 vaccines whenever they reach the European market.
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The European Medicines Agency has finalized infrastructure to monitor the safety and effectiveness of COVID-19 medicines and vaccines when they are used in day-to-day clinical practice following marketing authorization.
An EU guideline on the methodological aspects of pharmacoepidemiology has been updated to promote collaboration by researchers on high-quality, multi-centre observational studies in the context of COVID-19.
As the efficacy of most COVID-19 vaccines will likely be assessed using biomarkers and limited clinical data, monitoring their performance in the real-world is essential.