VACcine Covid-19 monitoring readinESS (ACCESS)

ACCESS was an EMA-funded project with the goal of preparing a European infrastructure to monitor COVID-19 vaccines. The project started May 2020 and ended February 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 (See the “Dashboard Background Rates of Adverse Events of Special Interest for COVID-19 Vaccines” tool for more information), guides for localization and adaptation, and a final report with a feasibility assessment. The project also produced template protocols for the following types of real world evidence studies: signal detection based on cohort event monitoring, rapid assessment of new safety signals based on EHR data, safety signal evaluation studies based on EHR data, safety signal evaluation studies with EHR or hospital data, effectiveness studies with EHR or hospital data, and a coverage study with EHR and registry data. Links to these templates can be found on the side bar.