Sistema de Salut de Catalunya
Institut Català de la Salut
[Bots SH, Belitser S] Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. [Groenwold RHH] Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands. [Durán CE] Department of Data Science and Biostatistics, Julius Center for Health Sciences and Primary Health, University Medical Center Utrecht, Utrecht, The Netherlands. [Riera-Arnau J] Department of Data Science and Biostatistics, Julius Center for Health Sciences and Primary Health, University Medical Center Utrecht, Utrecht, The Netherlands. Servei de Farmacologia Clínica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Schultze A] Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
Vall d'Hebron Barcelona Hospital Campus
2025-03-07T11:22:02Z
2025-03-07T11:22:02Z
2024
2025-01
COVID-19 vaccine safety; Pharmacoepidemiology; Quantitative bias analysis
Seguridad de la vacuna COVID-19; Farmacoepidemiología; Análisis de sesgo cuantitativo
Seguretat de la vacuna COVID-19; Farmacoepidemiologia; Anàlisi de biaix quantitatiu
We test the robustness of the self-controlled risk interval (SCRI) design in a setting where time between doses may introduce time-varying confounding, using both negative control outcomes (NCOs) and quantitative bias analysis (QBA). All vaccinated cases identified from 5 European databases between September 1, 2020, and end of data availability were included. Exposures were doses 1-3 of the Pfizer, Moderna, AstraZeneca, and Janssen COVID-19 vaccines; outcomes were myocarditis and, as the NCO, otitis externa. The SCRI used a 60-day control window and dose-specific 28-day risk windows, stratified by vaccine brand and adjusted for calendar time. The QBA included two scenarios: (1) baseline probability of the confounder was higher in the control window and (2) vice versa. The NCO was not associated with any of the COVID-19 vaccine types or doses except Moderna dose 1 (IRR = 1.09; 95% CI 1.01-1.09). The QBA suggested that even the strongest literature-reported confounder (COVID-19; RR for myocarditis = 18.3) could only explain away part of the observed effect, from IRR = 3 to IRR = 1.40. The SCRI seems robust to unmeasured confounding in the COVID-19 setting, although a strong unmeasured confounder could bias the observed effect upward. Replication of our findings for other safety signals would strengthen this conclusion.
This project received support from the European Medicines Agency under the Framework service contract EMA/2018/23/PE.
Article
Published version
English
COVID-19 (Malaltia) - Vacunació; Miocarditis - Epidemiologia; DISEASES::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections; CHEMICALS AND DRUGS::Complex Mixtures::Biological Products::Vaccines; PUBLIC HEALTH::Epidemiology and Biostatistics::Epidemiology::Causality::Confounding Factors (Epidemiology); DISEASES::Cardiovascular Diseases::Heart Diseases::Cardiomyopathies::Myocarditis; ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus; COMPUESTOS QUÍMICOS Y DROGAS::mezclas complejas::productos biológicos::vacunas; SALUD PÚBLICA::epidemiología y bioestadística::epidemiología::causalidad::factores de confusión (epidemiología); ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::miocardiopatías::miocarditis
Oxford University Press
American Journal of Epidemiology;194(1)
https://doi.org/10.1093/aje/kwae172
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
Articles científics - HVH [3440]
