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. ECVM was conducted in collaboration with the EU Pharmacoepidemiology & Pharmacovigilance Research Network (EU PE&PV) and VAC4EU.
-
(Early) COVID-19 Vaccine Monitor - cohort event monitoring via primary and secondary data collection
This study aimed to monitor AESI prior and following COVID-19 vaccination, in order to estimate incidence rates and pick up signals.
-
(Early) COVID-19 Vaccine Monitor - cohort event monitoring via primary data collection
The objectives of this study were (1) to generate incidence rates of patient-reported ADRs of COVID-19 vaccine brand in near real-time, and (2) to describe...
