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 localization and adaptation, template protocols for COVID-19 vaccine safety, effectiveness and coverage monitoring studies, and a final report with a feasibility assessment.
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ACCESS - Background rates
This study aimed to generate background rates of 27 adverse events of special interest for monitoring of COVID-19 vaccines, creating a series of event definition...
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ACCESS - Template protocol for COVID-19 vaccine coverage monitoring
The goal of this study was to develop a template protocol for vaccine coverage studies through the secondary use of electronic healthcare databases and/or immunisation...
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ACCESS - Template protocols for COVID-19 vaccine effectiveness monitoring
The goal of this study was to develop template protocols for two study designs that monitor the effectiveness of COVID-19 vaccines: (1) a test negative...
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ACCESS - Template protocols for COVID-19 vaccine safety monitoring
The goal of this study was to develop template protocols for four different safety monitoring designs: (1) cohort event monitoring to assess safety, (2) rapid...
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COVID-19 Vaccines Effectiveness
The primary objective of this study was to estimate the effectiveness and waning of effectiveness in adults and adolescents (heterologous vs homologous primary vaccinations), children...
