Early safety monitoring of SARS-CoV-2 vaccines in EU Member States (ECVM)

For more information on this project, please contact the EU PE&PV research network at eupepv@uu.nl.

Project information

  • EU PE&PV research network
  • EUPAS40404
  • EUPAS39798
  • Specific Contract 05 implementing Framework service contract EMA/2018/28/PE 

Full title

Early safety monitoring of SARS-CoV-2 vaccines in EU Member States (ECVM) 

Principal investigator

Prof. Dr. Miriam Sturkenboom, University Medical Center Utrecht

Participating organisations

  • Utrecht University, The Netherlands - consortium lead
  • UMC Utrecht, The Netherlands - coordinator
  • FAMHP, Belgium
  • VAC4EU, Belgium
  • HALMED, Croatia
  • Bordeaux PharmacoEpi, France
  • Paul-Ehrlich-Institut, Germany
  • ARS, Italy
  • University of Verona, Italy
  • Lareb, The Netherlands
  • PHARMO Institute, The Netherlands
  • AEMPS, Spain
  • RTI Health Solutions, Spain
  • DSRU, UK 

Status

Completed (2022)

Deliverables

 

 

Peer-reviewed scientific publications

Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose. Raethke M, van Hunsel F, Thurin NH, Dureau-Pournin C, Mentzer D, Kovačić B, Mirošević Skvrce N, De Clercq E, Sabbe M, Trifirò G, Luxi N, Giovanazzi A, Shakir S, Klungel OH, Schmikli S, Sturkenboom M. Drug Saf. 2023 Apr;46(4):391-404. doi: 10.1007/s40264-023-01281-9. Epub 2023 Apr 7. PMID: 37024736; PMCID: PMC10079486. 

Pre-prints

Cohort monitoring of 29 Adverse Events of Special Interest prior to and after COVID-19 vaccination in four large European electronic healthcare data sources. Miriam Sturkenboom, Davide Messina, Olga Paoletti, Airam de Burgos-Gonzalez, Patricia García-Poza, Consuelo Huerta, Ana Llorente- García, Mar Martin-Perez, Maria Martinez, Ivonne Martin, Jetty Overbeek, Marc Padros-Goossens, Patrick Souverein, Karin Swart, Olaf Klungel, Rosa Gini  medRxiv 2022.08.17.22278894; doi:https://doi.org/10.1101/2022.08.17.22278894