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.

Project information

  • EU PE&PV research network
  • Specific Contract 01 implementing Framework service contract EMA/2018/23/PE

Full title

Safety monitoring of COVID-19 vaccines in the EU (Covid-Vaccine-Monitor, CVM) 

Principal investigator

Dr. Miriam Sturkenboom, 木瓜福利影视 Medical Center Utrecht

Participating organisations

  • Utrecht 木瓜福利影视, The Netherlands - consortium lead
  • UMC Utrecht, The Netherlands - coordinator
  • VAC4EU, Belgium
  • HALMED, Croatia 
  • Bordeaux Pharmacoepi, France 
  • Paul-Ehrlich-Institut, Germany 
  • Rotunda Hospital Dublin, Ireland 
  • ARS, Italy 
  • Department of Epidemiology Lazio Regional Health Service, Italy 
  • INSPIRE, Italy
  • MEDBRAINS, Italy  
  • SoSeTe-Pedianet, Italy 
  • 木瓜福利影视 of Verona, Italy 
  • Lareb, The Netherlands 
  • PHARMO Institute, The Netherlands 
  • 木瓜福利影视 of Oslo, Norway 
  • Aibili-CLPP, Portugal 
  • `Iuliu Hatieganu` 木瓜福利影视 of Medicine and Pharmacy Cluj-Napoca, Romania
  • SLOVACRIN, Slovakia 
  • AEMPS, Spain 
  • FISABIO, Spain 
  • IDIAPJGol, Spain 
  • RTI Health Solutions, Spain
  • Teamit Institute, Spain 
  • 木瓜福利影视 of Bern, Switzerland 
  • DSRU, UK 
  • LSHTM, UK 

Status

Completed (2023)

Deliverables

  • Final study report (methods work)

Peer-reviewed scientific publications

  • Ahmadizar F, Luxi N, Raethke M, Schmikli S, Riefolo F, Saraswati PW, Bucsa C, Osman A, Liddiard M, Maques FB, Petrelli G, Sonderlichov谩 S, Thurin NH, Villalobos F, Trifir貌 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.
  • . Bots SH, Riera-Arnau J, Belitser SV, Messina D, Arag贸n M, Alsina E, Douglas IJ, Dur谩n CE, Garc铆a-Poza P, Gini R, Herings RMC, Huerta C, Sisay MM, Mart铆n-P茅rez M, Martin I, Overbeek JA, Paoletti O, Pallej脿-Mill谩n 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.
  • . 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, Sonderlichov谩 S, Belitser S, Klungel O, Trifir貌 G, Sturkenboom MC. Vaccine. 2024 Mar 6:S0264-410X(24)00273-1. doi: 10.1016/j.vaccine.2024.03.001. PMID: 38448322.
  • . Ciccimarra F, Luxi N, Bellitto C, L鈥橝bbate L, Raethke M, van Hunsel F, Lieber T, Mulder E, Riefolo F, Dureau-Pournin C, et al.  Vaccines. 2024; 12(3):241.
  • . Schultze A, Martin I, Messina D, Bots S, Belitser S, Jos茅 Carreras-Mart铆nez J, Correcher-Martinez E, Urchuegu铆a-Fornes A, Mart铆n-P茅rez M, Garc铆a-Poza P, Villalobos F, Pallej脿-Mill谩n M, Alberto Bissacco C, Segundo E, Souverein P, Riefolo F, Dur谩n 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.
  • . 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, Sonderlichov谩 S, Farcas A, Janneke GE, Sturkenboom MC, Trifir貌 G. Drug Saf. 2024 Oct;47(10):1011-1023. doi: 10.1007/s40264-024-01449-x. Epub 2024 Jun 22. PMID: 38907947; PMCID: PMC11399172.
  • . 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, Sonderlichov谩 S, Thurin NH, Villalobos F, Riefolo F, Sturkenboom MC, Trifir貌 G. Vaccines (Basel). 2024 Sep 17;12(9):1059. doi: 10.3390/vaccines12091059. PMID: 39340089; PMCID: PMC11435548.
  • I. Dur谩n CE, Riefolo F, Gini R, Barbieri E, Messina D, Garcia P, Martin M, Villalobos F, Stona L, Carreras JJ, Urchuegu铆a A, Correcher-Mart铆nez 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.
  • . Bots SH, Belitser S, Groenwold RHH, Dur谩n CE, Riera-Arnau J, Schultze A, Messina D, Segundo E, Douglas I, Carreras JJ, Garcia-Poza P, Gini R, Huerta C, Mart铆n-P茅rez M, Martin I, Paoletti O, Bissacco CA, Correcher-Mart铆nez E, Souverein P, Urchuegu铆a-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.

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. contain valuable and insightful content from this meeting.