A framework for the post-authorisation safety evaluation of vaccines in the EU

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

Project information

Full title

A framework for the post-authorisation safety evaluation of vaccines in the EU (SAFETY-VAC)

Principal investigator

Dr. Carlos Durán, UMC Utrecht

Participating organisations

  • Utrecht University, The Netherlands - consortium lead
  • UMC Utrecht, The Netherlands - project co-lead
  • VAC4EU, Belgium - project co-lead
  • AEMPS, Spain
  • FISABIO, Spain
  • University of Verona, Italy
  • VHIR, Spain
  • Aarhus University, Denmark
  • University of Eastern Finland, Finland
  • Bordeaux PharmacoEpi, France
  • ARS Toscana, Italy
  • SoSeTe - Pedianet, Italy
  • University of Oslo, Norway
  • IDIAPJGol, Spain
  • IACS, Spain
  • Teamit Institute, Spain
  • DSRU, UK 

Status

Completed (2025)

Deliverables

  • Study protocol and report Objective 1 (network of data sources for vaccine safety evaluation)​
  • Study protocol and report Objective 2 (occurrence of flares of chronic conditions)​
  • Study report Objective 3 (literature review + immunocompromised clinical definitions and algorithm)​

Peer-reviewed scientific publications