This two-year project was requested by the EMA to extend and build on work from the Early Covid Vaccine Monitor Study. CVM supported COVID-19 vaccine safety monitoring in three ways: (1) by repeatedly asking more than 680,000 vaccinated people directly about side effects, (2) with available pseudonymized electronic health records across Europe to quickly evaluate and quantify associations between adverse events and Covid-19 vaccinations, and (3) by evaluating methodologies. CVM was conducted in collaboration with the EU Pharmacoepidemiology & Pharmacovigilance Research Network (EU PE&PV) and VAC4EU.
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COVID-19 Vaccine Monitor - cohort event monitoring in special populations
The primary aim of this study was to generate and compare incidence rates of patient-reported adverse reactions of different COVID-19 vaccines in pregnant and lactating...
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COVID-19 Vaccine Monitor - rapid safety assessment using electronic healthcare datasources
The primary objective for this study was to assess the potential association between the occurrence of specific AESIs and vaccination with COVID-19 vaccines within disease-specific...
