SAFETY-VAC: Network of Data Sources for Vaccine Safety Evaluation
Creators
-
Durán, Carlos E.
(Project leader)1
-
Gini, Rosa
(Project member)2
- Davide, Messina (Project member)2
-
Riefolo, Fabio
(Project manager)3
- Riera, Judit (Project member)
- Hoxhaj, Vjola (Project member)
- Mohammadi, Sima (Project member)4
-
Pazos Capell, Irene
(Project manager)3
- Ehrenstein, Véra (Project member)5
- Roberto, Giuseppe (Project member)2
-
Souverein, Patrick
(Project member)6
- Gardarsdottir, Helga (Project member)6
- Giraldi, Ana (Project member)2
- Hyeraci, Giulia (Project member)2
- Giaquinto, Carlo (Project member)7
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Barbieri, Elisa
(Project member)7
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Stona, Luca
(Project member)8
- Villalobos, Felipe (Project member)9
- Solórzano, Martín (Project member)9
- Bissacco, Carlo Alberto (Project member)9
-
Gimeno-Miguel, Antonio
(Project member)10
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Poblador-Plou, Beatriz
(Project member)10
- Aza, Mercedes (Project member)10
- Moreno, Aida (Project member)10
- Moreno, Aida (Project member)10
- Santos, Alejandro (Project member)10
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Svingel, Lise Skovgaard
(Project member)5
- Johannesen, Benjamin Randeris (Project member)5
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Droz-Perroteau, Cécile
(Project member)11
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Carcaillon-Bentata, Laure
(Project member)12
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Tolppanen, Anna-Maija
(Project member)13
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Hartikainen, Sirpa
(Project member)13
- Vo, Thuan (Project member)13
- Paakinaho, Anne (Project member)13
-
Rajamaki, Blair
(Project member)13
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Nordeng, Hedvig
(Project member)14
- Hayati, Saeed (Project member)14
- Zidan, Mahmoud (Project member)14
- Carreras Martínez, Juan José (Project member)15
- Urchueguía Fornes,, Arantxa (Project member)15
- Correcher Martínez, Elisa (Project member)15
- Domingo Díez, Javier (Project member)15
- Martin, Mar (Project member)16
- Garcia-Poza, Patricia (Project member)16
- Martín-Merino, Elisa (Project member)16
- de Burgos, Airam (Project member)15
- Castillo-Cano, Belen (Project member)16
- Klungel, Olaf (Project member)6
-
Sturkenboom, Miriam
(Project leader)1
- 1. University Medical Center Utrecht
-
2.
Agenzia Regionale di Sanità della Toscana
- 3. Teamit Institute
- 4. VAC4EU
-
5.
Aarhus University
-
6.
Utrecht University
-
7.
University of Padua
- 8. Fondazione Penta ONLUS
- 9. IDIAP JGol
- 10. Instituto Aragonés de Ciencias de la Salud
- 11. University of Bordeaux
-
12.
Université de Bordeaux
-
13.
University of Eastern Finland
- 14. University of Oslo
-
15.
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
-
16.
Agencia Española de Medicamentos y Productos Sanitarios
Description
In October 2023, the European Medicines Agency (EMA) launched a tender for building a framework for the post-authorization safety monitoring and evaluation of vaccines in the European Union (EU) and the European Economic Area (EEA).
The EU PE & PV and the VAC4EU network received and implemented the tender, thus developing the SAFETY-VAC study. This report focuses on the first objective of the study aimed to provide and describe a network of data sources for the post-authorization safety monitoring and evaluation of vaccines in Europe.
A multi-database cohort design study was conducted from January 1st, 2017, till the last data availability, accessing data from 10 different electronic health record data sources from seven EEA countries that have proven to be able to convert data (n=9) into the ConcePTION common data model (CDM) or are willing to do this (n=1). INSIGHT data quality level 1 and 2 checks were required and reported to assess the data quality.
The results presented in this report and the corresponding fit-for-purpose assessment of the data sources are based on the currently available data instances. The study population comprised 53,283,613 persons. Incidence rates of 39 events are reported, and the coverage indicators of 12 selected vaccines were produced and benchmarked against WHO and ECDC value indicators. Finally, this report summarizes the fitness-for-purpose assessment of the participating data sources using the "Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework" (SPIFD) tool.
Files
SAFETY-VAC_D2_Report_OB1_25072024_Zenodo.pdf
Files
(8.9 MB)
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Additional details
Software
- Repository URL
- https://github.com/VAC4EU/ROC18
- Programming language
- R