Safety monitoring of COVID-19 vaccines in the EU

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

Peer-reviewed scientific publications

• Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials. Ahmadizar F, Luxi N, Raethke M, Schmikli S, Riefolo F, Saraswati PW, Bucsa C, Osman A, Liddiard M, Maques FB, Petrelli G, Sonderlichová S, Thurin NH, Villalobos F, Trifirò G, Sturkenboom M; ilmiovaccinoCOVID19 collaborating group. Drug Saf. 2023 Jun;46(6):575-585. doi: 10.1007/s40264-023-01304-5. Epub 2023 Apr 27. PMID: 37103643; PMCID: PMC10136385.
• Myocarditis and pericarditis associated with SARS-CoV-2 vaccines: A population-based descriptive cohort and a nested self-controlled risk interval study using electronic health care data from four European countries. Bots SH, Riera-Arnau J, Belitser SV, Messina D, Aragón M, Alsina E, Douglas IJ, Durán CE, García-Poza P, Gini R, Herings RMC, Huerta C, Sisay MM, Martín-Pérez M, Martin I, Overbeek JA, Paoletti O, Pallejà-Millán M, Schultze A, Souverein P, Swart KMA, Villalobos F, Klungel OH, Sturkenboom MCJM. Front Pharmacol. 2022 Nov 24;13:1038043. doi: 10.3389/fphar.2022.1038043. PMID: 36506571; PMCID: PMC9730238.
• Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study. Raethke M, van Hunsel F, Luxi N, Lieber T, Bellitto C, Mulder E, Ciccimarra F, Riefolo F, Thurin NH, Roy D, Morton K, Villalobos F, Batel Marques F, Farcas A, Sonderlichová S, Belitser S, Klungel O, Trifirò G, Sturkenboom MC. Vaccine. 2024 Mar 6:S0264-410X(24)00273-1. doi: 10.1016/j.vaccine.2024.03.001. PMID: 38448322.
• Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study. Ciccimarra F, Luxi N, Bellitto C, L’Abbate L, Raethke M, van Hunsel F, Lieber T, Mulder E, Riefolo F, Dureau-Pournin C, et al.  Vaccines. 2024; 12(3):241. https://doi.org/10.3390/vaccines12030241
• A comparison of four self-controlled study designs in an analysis of COVID-19 vaccines and myocarditis using five European databases. Schultze A, Martin I, Messina D, Bots S, Belitser S, José Carreras-Martínez J, Correcher-Martinez E, Urchueguía-Fornes A, Martín-Pérez M, García-Poza P, Villalobos F, Pallejà-Millán M, Alberto Bissacco C, Segundo E, Souverein P, Riefolo F, Durán CE, Gini R, Sturkenboom M, Klungel O, Douglas I. Vaccine. 2024 Apr 5:S0264-410X(24)00330-X. doi: 10.1016/j.vaccine.2024.03.043. PMID: 38580517.
• What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European "Covid Vaccine Monitor" Active Surveillance Study. Bellitto C, Luxi N, Ciccimarra F, L'Abbate L, Raethke M, van Hunsel F, Lieber T, Mulder E, Riefolo F, Villalobos F, Thurin NH, Marques FB, Morton K, O'Shaughnessy F, Sonderlichová S, Farcas A, Janneke GE, Sturkenboom MC, Trifirò G. Drug Saf. 2024 Oct;47(10):1011-1023. doi: 10.1007/s40264-024-01449-x. Epub 2024 Jun 22. PMID: 38907947; PMCID: PMC11399172.
• Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study. Luxi N, Ciccimarra F, Bellitto C, Raethke M, van Hunsel F, Lieber T, Mulder E, L'Abbate L, Marques FB, Furci F, Farcas A, Giele-Eshuis J, Morton K, Sonderlichová S, Thurin NH, Villalobos F, Riefolo F, Sturkenboom MC, Trifirò G. Vaccines (Basel). 2024 Sep 17;12(9):1059. doi: 10.3390/vaccines12091059. PMID: 39340089; PMCID: PMC11435548.
• Incidence of severe and non-severe SARS-CoV-2 infections in children and adolescents: a population-based cohort study using six healthcare databases from Italy, Spain, and Norway. Durán CE, Riefolo F, Gini R, Barbieri E, Messina D, Garcia P, Martin M, Villalobos F, Stona L, Carreras JJ, Urchueguía A, Correcher-Martínez E, Zhao J, Lupattelli A, Nordeng H, Sturkenboom M. Eur J Pediatr. 2024 Nov 13;184(1):6. doi: 10.1007/s00431-024-05864-1. PMID: 39535547.
• Applying two approaches to detect unmeasured confounding due to time-varying variables in a self-controlled risk interval design evaluating COVID-19 vaccine safety signals, using myocarditis as a case example. Bots SH, Belitser S, Groenwold RHH, Durán CE, Riera-Arnau J, Schultze A, Messina D, Segundo E, Douglas I, Carreras JJ, Garcia-Poza P, Gini R, Huerta C, Martín-Pérez M, Martin I, Paoletti O, Bissacco CA, Correcher-Martínez E, Souverein P, Urchueguía-Fornes A, Villalobos F, Sturkenboom MCJM, Klungel OH.  Am J Epidemiol. 2025 Jan 8;194(1):208-219. doi: 10.1093/aje/kwae172. PMID: 38960670; PMCID: PMC11735966.
• Cohort event monitoring of booster COVID-19 vaccine safety using patient-reported outcomes in pregnant women. Maisonneuve E, Luxi N, Bellitto C, Ciccimarra F, Raethke M, van Hunsel F, Lieber T, Mulder E, Riefolo F, Villalobos F, Thurin NH, Batel-Marques F, Morton K, O'Shaughnessy F, Cleary B, Sonderlichová S, Farcas A, Bucsa C, Favre G, Siiskonen SJ, Baud D, Sturkenboom MCJM, Trifirò G and Panchaud A (2025) Front. Drug Saf. Regul. 5:1689349. doi: 10.3389/fdsfr.2025.1689349

Symposium: Lessons learned from CVM

On the 10th of October 2023, members of the Covid Vaccine Monitor (CVM) consortium met in Utrecht, the Netherlands, for an inspiring closing event where experts discussed lessons learned from the project and the future of vaccine safety methods. These videos contain valuable and insightful content from this meeting.