Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study

Willame, C.; Dodd, C.; Durán, C. E.; Elbers, R.J.H.J.; Gini, R.; Bartolini, C.; Paoletti, O.; Wang, L.; Ehrenstein, V.; Kahlert, J.; Haug, U.; Schink, T.; Diez-Domingo, J.; Mira-Iglesias, A.; Carreras, J. J.; Vergara-Hernández, C.; Giaquinto, C.; Barbieri, E.; Stona, L.; Huerta, C.; Martín-Pérez, M.; García-Poza, P.; de Burgos, A.; Martínez-González, M.; Bryant, V.; Villalobos, F.; Pallejà-Millán, M.; Aragón, M.; Souverein, P.; Thurin, N. H.; Weibel, D.; Klungel, O. H.; Sturkenboom, M. C.J.M.

doi:https://doi.org/10.1016/j.vaccine.2022.11.031

Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study

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Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study

Willame, C.; Dodd, C.; Durán, C. E.; Elbers, R.J.H.J.; Gini, R.; Bartolini, C.; Paoletti, O.; Wang, L.; Ehrenstein, V.; Kahlert, J.; Haug, U.; Schink, T.; Diez-Domingo, J.; Mira-Iglesias, A.; Carreras, J. J.; Vergara-Hernández, C.; Giaquinto, C.; Barbieri, E.; Stona, L.; Huerta, C.; Martín-Pérez, M.; García-Poza, P.; de Burgos, A.; Martínez-González, M.; Bryant, V.; Villalobos, F.; Pallejà-Millán, M.; Aragón, M.; Souverein, P.; Thurin, N. H.; Weibel, D.; Klungel, O. H.; Sturkenboom, M. C.J.M.

(2023) Vaccine, volume 41, issue 1, pp. 251 - 262

(Article)

Abstract

Background: In May 2020, the ACCESS (The vACCine covid-19 monitoring readinESS) project was launched to prepare real-world monitoring of COVID-19 vaccines. Within this project, this study aimed to generate background incidence rates of 41 adverse events of special interest (AESI) to contextualize potential safety signals detected following administration of COVID-19 ... read more vaccines. Methods: A dynamic cohort study was conducted using a distributed data network of 10 healthcare databases from 7 European countries (Italy, Spain, Denmark, The Netherlands, Germany, France and United Kingdom) over the period 2017 to 2020. A common protocol (EUPAS37273), common data model, and common analytics programs were applied for syntactic, semantic and analytical harmonization. Incidence rates (IR) for each AESI and each database were calculated by age and sex by dividing the number of incident cases by the total person-time at risk. Age-standardized rates were pooled using random effect models according to the provenance of the events. Findings: A total number of 63,456,074 individuals were included in the study, contributing to 211.7 million person-years. A clear age pattern was observed for most AESIs, rates also varied by provenance of disease diagnosis (primary care, specialist care). Thrombosis with thrombocytopenia rates were extremely low ranging from 0.06 to 4.53/100,000 person-years for cerebral venous sinus thrombosis (CVST) with thrombocytopenia (TP) and mixed venous and arterial thrombosis with TP, respectively. Interpretation: Given the nature of the AESIs and the setting (general practitioners or hospital-based databases or both), background rates from databases that show the highest level of completeness (primary care and specialist care) should be preferred, others can be used for sensitivity. The study was designed to ensure representativeness to the European population and generalizability of the background incidence rates. Funding: The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE.

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Keywords: Adverse events of special interest, Background rates, COVID-19, Vaccine safety, Molecular Medicine, General Immunology and Microbiology, General Veterinary, Public Health, Environmental and Occupational Health, Infectious Diseases

DOI: https://doi.org/10.1016/j.vaccine.2022.11.031

ISSN: 0264-410X

Publisher: Elsevier

Note: Funding Information: The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network which is a public academic partnership coordinated by the Utrecht University, The Netherlands. EU PE&PV collaborated with the Vaccine Monitoring Collaboration for Europe (VAC4EU) association The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE. The content of this paper expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties. Access to databases was approved by local scientific and ethics committees. Use of CPRD data in this study was approved by the Independent Scientific Advisory Committee for MHRA database research (protocol 20_000177). All authors contributed equally to the conduct of the study. All authors reviewed and approved the study design and study protocol. All authors approved the final version of the manuscript before submission. Funding Information: The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network which is a public academic partnership coordinated by the Utrecht University, The Netherlands. EU PE&PV collaborated with the Vaccine Monitoring Collaboration for Europe (VAC4EU) association The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE. The content of this paper expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties. Publisher Copyright: © 2022 The Author(s)

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