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Published February 27, 2023 | Version 1.0.2
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BY-COVID - WP5 - Baseline Use Case: COVID-19 vaccine effectiveness assessment - Study protocol


This publication corresponds to the study protocol of the Baseline Use Case proposed in T.5.2 (WP5) in the BY-COVID project on “SARS-CoV-2 Vaccine effectiveness in preventing SARS-CoV-2 infection.

Research question: We aim to investigate the real-world effectiveness of SARS-CoV-2 primary vaccination as compared to partial or no vaccination in preventing SARS-CoV-2 infection in virtually all resident populations spanning different countries.

Study design: An observational retrospective longitudinal (cohort) study using routinely collected social, health and care data from several countries/regions in Europe. We have designed the observational study to emulate a hypothetical Target Trial (TT) of the causal effect of SARS-CoV-2 vaccination programs in preventing SARS-CoV-2 infections.

File included in this publication: 

Study protocol (PDF): The protocol provides a work plan, including details on the research team, study rationale, methodology, and ethical aspects. The implementation of this study is supported by supplementary documents including a causal model (DAG), a common data model specification, and a simulated dataset following the specification of the common data model. This information is available at




The contents of this document are the sole responsibility of their authors. All rights reserved. Copying and distribution by any means is permitted provided that the authors are acknowledged, that no commercial use is made of the works and that no modifications are made (CC-BY INT 4.0.).



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Other: 10.5281/zenodo.6913045 (DOI)


BY-COVID – Beyond COVID 101046203
European Commission