Disclaimer & acknowledgement The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network (led by Utrecht University) in collaboration with the Vaccine Monitoring Collaboration for Europe network (VAC4EU). Scientific work for this project was coordinated by the University Medical Center Utrecht. The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/23/PE. This report expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

This is the statistical analysis plan related to the protocol published in the EU PAS register at https://www.encepp.eu/encepp/viewResource.htm?id=42637 for the COVID-19 vaccine monitoring study (CVM)