EMA Early COVID-19 Vaccine Monitor (ECVM): Cohort Event Monitoring of Safety of COVID-19 Vaccines (Early-) Covid-Vaccine-Monitor
This project was a complement to an EU passive surveillance system for the four COVID-19 vaccines available on the market at the time. The project monitored these vaccines using two complementary methodologies: (1) prospective cohort event monitoring, where vaccinated persons were included and monitored through the internet and incidence rates were calculated, and (2) a retrospective cohort study, where the incidence rates of ACCESS adverse events of special interest were monitored. The study monitored 29 different AESIs both before and after COVID-19 vaccination, including data from nearly 26 million people across eight countries. The focus was primarily on monitoring of incidence rather than signal detection of evaluation.
