Global Vaccine Safety Project (GCoVS)
The GCoVS project, led by Global Vaccine Data Network (GVDN) and supported by funding from the U.S. Centers for Disease Control and Prevention (CDC), aims to evaluate the safety of COVID-19 vaccines across diverse and extensive study populations, leveraging the participation of 26 countries within the GVDN consortium. VAC4EU serves as the coordinating centre for […]
A framework for the post-authorisation SAFETY Evaluation of VACcines in the EU (SAFETY-VAC)
The primary aim of this project was to assess the capacity to conduct safety studies in a netowrk of electronic health record data sources from VAC4EU and the EU PE&PV Research Network. The second study aimed to estimate the background and cumulative incidence of the flares of 10 pre-defined autoimmune diseases, while also analysing the […]
vACcine COVID-19 monitoring ReadinESS (ACCESS)
The goal of this project was to prepare a European infrastructure for monitoring COVID-19 vaccines, initiated prior to their rollout in early 2021. The main outputs of the project were a publicly available list of 27 events of interest along with definitions and codes, a calculation of the background rates of adverse events, guides for […]
COVID-19 Vaccines Effectiveness (CoVE)
The aim of this project was to study waning immunity after primary COVID-19 vaccine regimens as well as booster vaccinations. The study complemented common test-negative case-control studies, using real world data pulled from other VAC4EU studies, highlighting the advantages of readiness. These data sources represent five countries across Southern, Central, and Eastern Europe, and an […]
Early COVID-19 Vaccine Monitor (ECVM)
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 […]
COVID-19 Vaccine Monitor (CVM)
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 […]