2026-04-13T13:09:56Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/127112025-10-24T10:26:39Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Bots, Sophie Heleen
author
Belitser, Svetlana V.
author
Groenwold, Rolf
author
Schultze, Anna
author
Durán, Carlos E.
author
Riera-Arnau, Judit
2025-10-24T10:26:39Z
2025-10-24T10:26:39Z
2025-03-07T11:22:02Z2025-03-07T11:22:02Z20242025-01
http://hdl.handle.net/11351/12711
COVID-19 vaccine safety; Pharmacoepidemiology; Quantitative bias analysisSeguridad de la vacuna COVID-19; Farmacoepidemiología; Análisis de sesgo cuantitativoSeguretat de la vacuna COVID-19; Farmacoepidemiologia; Anàlisi de biaix quantitatiuWe 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.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
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
Applying two approaches to detect unmeasured confounding due to time-varying variables in a self-controlled risk interval design evaluating COVID-19 vaccine safety signals, using myocarditis as a case example
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion