Impact of EU label changes and regulatory communication on SARS-CoV-2 adenovirus vector vaccines
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
- EUPAS44970
- Specific Contract 02 implementing Framework service contract EMA/2018/23/PE
Full title
Impact of EU label changes and regulatory communication on SARS-CoV-2 adenovirus vector vaccines in context of thrombosis with thrombocytopenia syndrome (TTS): risk awareness and adherence (RiskAwareTTS)
Principal investigator
Dr. Teresa Meneses Leonardo Alves, RIVM - project coordinator
Prof. Dr. Olaf Klungel, Utrecht University, EU PE&PV lead
Participating organisations
- Utrecht University, The Netherlands - consortium lead
- RIVM, The Netherlands - coordinator
- University of Copenhagen, Denmark
- University of Porto, Portugal
- Democritus University of Thrace, Greece
- Rīga Stradiņš University, Latvia
- University of Ljubljana, Faculty of Pharmacy, Slovenia
Status
Completed (2023)
Deliverables
- Study protocol
- Summary of study results
- Full study report will be available soon
Peer-reviewed scientific publications
- Public's perspective on COVID-19 adenovirus vector vaccines after thrombosis with thrombocytopenia syndrome (TTS) reports and associated regulatory actions - A cross-sectional study in six EU member states. Buhl C, Jacobsen R, Almarsdóttir AB, Abtahi S, Andersen A, Deligianni E, Dermiki-Gkana F, Kontogiorgis C, Oikonomou C, Kursite M, Poplavska E, Hegger I, van der Goot M, Sousa Ferreira PB, Ribeiro-Vaz I, Silva AM, Kos M, Lipovec NČ, van Vliet E, Alves TL. Vaccine. 2024 Jan 4:S0264-410X(23)01511-6. doi: 10.1016/j.vaccine.2023.12.065. Epub ahead of print. PMID: 38182460.
- Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID-19 Adenovirus Vector Vaccines on European Healthcare Professionals. van Vliet E, Lipovec NČ, van der Goot M, Abtahi S, Ribeiro-Vaz I, Poplavska E, Dermiki-Gkana F, Oikonomou C, Deligianni E, Kontogiorgis C, Silva AM, Ferreira PBS, Kos M, Almarsdóttir AB, Jacobsen R, Buhl C, de Bruijn A, Hegger I, Alves TL. Pharmacoepidemiol Drug Saf. 2024 Dec;33(12):e70057. doi: 10.1002/pds.70057. PMID: 39586738; PMCID: PMC11589195.