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
- EU PE&PV research network
- Specific Contract 02 implementing Framework service contract EMA/2020/46/TDA/L5.06
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 ľ¹Ï¸£ÀûÓ°ÊÓ, The Netherlands - consortium lead
- UMC Utrecht, The Netherlands - project co-lead
- VAC4EU, Belgium - project co-lead
- AEMPS, Spain
- FISABIO, Spain
- ľ¹Ï¸£ÀûÓ°ÊÓ of Verona, Italy
- VHIR, Spain
- Aarhus ľ¹Ï¸£ÀûÓ°ÊÓ, Denmark
- ľ¹Ï¸£ÀûÓ°ÊÓ of Eastern Finland, Finland
- Bordeaux PharmacoEpi, France
- ARS Toscana, Italy
- SoSeTe - Pedianet, Italy
- ľ¹Ï¸£ÀûÓ°ÊÓ of Oslo, Norway
- IDIAPJGol, Spain
- IACS, Spain
- Teamit Institute, Spain
- DSRU, UK
Status
Completed (2025)
Deliverables
- Study and Objective 1 (network of data sources for vaccine safety evaluation)​
- Study and Objective 2 (occurrence of flares of chronic conditions)​
- Study Objective 3 (literature review + immunocompromised clinical definitions and algorithm)​
Peer-reviewed scientific publications
Planned.