Published June 12, 2025
| Version v1
Report
Open
SAFETY-VAC study. Background incidence estimation of flares of pre-existing chronic diseases using pan-European electronic healthcare data sources.
Creators
-
Durán, Carlos E.
(Project leader)1
-
Gini, Rosa
(Project member)2
- Messina, Davide (Project member)2
- Roberto, Giuseppe (Project member)2
-
Riefolo, Fabio
(Project manager)3
-
Pazos Capell, Irene
(Project manager)3
-
mohammadi, sima
(Project member)1
-
Luxi, Nicoletta
(Project member)1
-
Riera-Arnau, Judit
(Project member)1, 4, 5, 6
-
Weibel, Daniel
(Project member)1
- BORRUEL, NATALIA (Project member)4
-
Vilaseca Jolonch, Andreu
(Project member)4
- Zafon, Carlos (Project member)5
-
Erra Duran, ALBA
(Project member)4
- Lopez-Lasanta, María (Project member)5
-
Riveiro-Barciela, Mar
(Project member)6
- Klungel, Olaf (Project member)7
-
Souverein, Patrick
(Project member)7
-
Gardarsdottir, Helga
(Project member)7
- Giraldi, Anna (Project member)2
- Hyeraci, Julia (Project member)2
- Giaquinto, Carlo (Project member)8
-
Barbieri, Elisa
(Project member)9
- Chiusaroli, Lorenzo (Project member)9
-
Stona, Luca
(Project member)10
-
Villalobos, Felipe
(Project member)11
- Solórzano, Martín (Project member)12
-
Bissacco, Carlo Alberto
(Project member)11
-
Gimeno-Miguel, Antonio
(Project member)13
-
Poblador-Plou, Beatriz
(Project member)13
-
Aza-Pascual-Salcedo, Mercedes
(Project member)13
- Moreno, Aida (Project member)13
-
Santos-Mejias, Alejandro
(Project member)14
-
Ehrenstein, Vera
(Project member)15
-
Svingel, Lise Skovgaard
(Project member)15
- Randeris Johannesen, Benjamin (Project member)15
-
Droz-Perroteau, Cécile
(Project member)16
-
Carcaillon-Bentata, Laure
(Project member)16
- Jove, Jeremy (Project member)16
-
Tolppanen, Anna-Maija
(Project member)17
-
Hartikainen, Sirpa
(Project member)17
- Vo, Thuan (Project member)17
- Rajamaki, Blair (Project member)17
-
Nordeng, Hedvig
(Project member)18, 19
- Zidan, Mahmoud (Project member)19
-
Carreras Martínez, Juan José
(Project member)20, 21
- Urchueguia, Arantxa (Project member)22
- Correcher-Martínez, Elisa (Project member)20
-
Diez-Domingo, Javier
(Project member)23, 24
- Martín, Mar (Project member)25
- García-Poza, Patricia (Project member)25
-
de Burgos Gonzalez, Airam
(Project member)25
- Castillo-Cano, Belén (Project member)25
- Martín-Merino, Elisa (Project member)25
- Morton, Kathryn (Project member)26
- Dhanda, Sandeep (Project member)26
- Davies, Miranda (Project member)26
- Sturniolo, Giulia (Project member)9
- Chiusaroli, Lorenzo (Project member)9
- VIAPIANA, Ombretta (Project member)27
- Rotta, Denise (Project member)27
- Ingrasciotta, Ylenia (Project member)27
- Carollo, Massimo (Project member)27
-
Rossini, Maurizio
(Project member)27
-
Bellitto, Chiara
(Project member)27
-
Sturkenboom, Miriam
(Project leader)1
-
1.
University Medical Center Utrecht
-
2.
Agenzia Regionale di Sanità della Toscana
- 3. Teamit Institute
-
4.
Vall d'Hebron Hospital Universitari
-
5.
Vall d'Hebron Institut de Recerca
-
6.
Universitat Autònoma de Barcelona
-
7.
Utrecht University
- 8. Società Servizi Telematici -Pedianet
-
9.
University of Padua
- 10. Fondazione Penta ONLUS
- 11. Institut de Recerca en Atenció Primària Jordi Gol
-
12.
Institut Universitari d'Investigació en Atenció Primària Jordi Gol
-
13.
Instituto Aragonés de Ciencias de la Salud
- 14. Fundación Instituto de Investigación Sanitaria Aragón
-
15.
Aarhus University
-
16.
Université de Bordeaux
-
17.
University of Eastern Finland
-
18.
Norwegian Institute of Public Health
-
19.
University of Oslo
-
20.
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
-
21.
Conselleria de Sanitat Universal i Salut Pública
-
22.
Fisabio
-
23.
Valencia Catholic University Saint Vincent Martyr
- 24. FISABIO
-
25.
Agencia Española de Medicamentos y Productos Sanitarios
-
26.
Drug Safety Research Unit
-
27.
University of Verona
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 corresponds to the second objective of the study, aiming to develop tailored algorithms, and estimates background incidence rates (IR) and 6- and 12-month cumulative IR in electronic health records (EHRs) of 10 autoimmune diseases selected based on their relevance and potential risk due to vaccination exposure: autoimmune hepatitis (AIH), erythema nodosum (EN), Graves’ disease (GD), Hashimoto´s thyroiditis (HT), multiple sclerosis (MS), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), psoriatic arthritis (PSA), polyarteritis nodose (PAN), and ulcerative colitis (UC).
A multi-database cohort design study was conducted from January 1st, 2017, till the last data availability for each data source, accessing data from 7 different EHR data sources from 5 EEA countries (Spain: BIFAP, SIDIAP, VID; the United Kingdom: CPRD; Italy: PEDIANET; France: SNDS; Norway: National Registries) that have proven to be able to convert data into the ConcePTION common data model (CDM).
Clinical and operational definitions were developed for each flare based on the literature review and experts’ consultations. Study cohorts start with the first diagnosis of the autoimmune disease (diagnostic codes). Flares´ BIRs per 1,000 person-years (PY) were calculated. Follow-up began 30 to 90 days after cohort entry, depending on the disease, was interrupted 30 to 90 days by identification of a new flare or vaccination, and was stopped at the earliest of death, disenrollment, or last data extraction. Kaplan-Meier analyses calculated cumulative IR of first flare episodes at 6- and 12-months. The contribution of different algorithms’ components to BIRs was assessed for each data source. Additionally, this report estimates the background IR of flares of selected auto-immune diseases in the pregnant population, and stratification for age categories (0-17, 18-50, ≥60 years old) and gender is reported.
This report corresponds to the second objective of the study, aiming to develop tailored algorithms, and estimates background incidence rates (IR) and 6- and 12-month cumulative IR in electronic health records (EHRs) of 10 autoimmune diseases selected based on their relevance and potential risk due to vaccination exposure: autoimmune hepatitis (AIH), erythema nodosum (EN), Graves’ disease (GD), Hashimoto´s thyroiditis (HT), multiple sclerosis (MS), systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), psoriatic arthritis (PSA), polyarteritis nodose (PAN), and ulcerative colitis (UC).
A multi-database cohort design study was conducted from January 1st, 2017, till the last data availability for each data source, accessing data from 7 different EHR data sources from 5 EEA countries (Spain: BIFAP, SIDIAP, VID; the United Kingdom: CPRD; Italy: PEDIANET; France: SNDS; Norway: National Registries) that have proven to be able to convert data into the ConcePTION common data model (CDM).
Clinical and operational definitions were developed for each flare based on the literature review and experts’ consultations. Study cohorts start with the first diagnosis of the autoimmune disease (diagnostic codes). Flares´ BIRs per 1,000 person-years (PY) were calculated. Follow-up began 30 to 90 days after cohort entry, depending on the disease, was interrupted 30 to 90 days by identification of a new flare or vaccination, and was stopped at the earliest of death, disenrollment, or last data extraction. Kaplan-Meier analyses calculated cumulative IR of first flare episodes at 6- and 12-months. The contribution of different algorithms’ components to BIRs was assessed for each data source. Additionally, this report estimates the background IR of flares of selected auto-immune diseases in the pregnant population, and stratification for age categories (0-17, 18-50, ≥60 years old) and gender is reported.
Files
SAFETY-VAC_Objective2_D5_Report_Annex_1_Final_20250522.pdf
Files
(9.5 MB)
| Name | Size | Download all |
|---|---|---|
|
md5:6a0ac6f553449e57b5130aa2f62d00c6
|
1.9 MB | Preview Download |
|
md5:2ac08478ed0a45f308834d2746ccea56
|
7.6 MB | Preview Download |
Additional details
Software
- Repository URL
- https://github.com/VAC4EU/ROC18_Objective_2
- Programming language
- R