Raethke, Monika http://orcid.org/0000-0002-5334-1840
van Hunsel, Florence http://orcid.org/0000-0001-8965-3224
Thurin, Nicolas H. http://orcid.org/0000-0003-3589-0819
Dureau-Pournin, Caroline http://orcid.org/0000-0002-3643-683X
Mentzer, Dirk
Kovačić, Barbara
Mirošević Skvrce, Nikica
De Clercq, Evelien
Sabbe, Martine http://orcid.org/0000-0003-2824-1087
Trifirò, Gianluca http://orcid.org/0000-0003-1147-7296
Luxi, Nicoletta
Giovanazzi, Alexia
Shakir, Saad
Klungel, Olaf H.
Schmikli, Sandor
Sturkenboom, Miriam http://orcid.org/0000-0003-1360-2388
Funding for this research was provided by:
European Medicines Agency (EMA/2018/28/PE)
the Agency for Medicinal Products and Medical Devices of Croatia
Paul-Ehrlich-Institut
Ministère de la Santé et des Solidarités and the Ministère de l’Enseignement supérieur, de la Recherche et de l’Innovation
Ministerie van Volksgezondheid, Welzijn en Sport
Article History
Accepted: 19 February 2023
First Online: 7 April 2023
Declarations
:
: 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. The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE. This document expresses the opinions of the authors of the paper, 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. In Croatia, the study was funded partially by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED). In Germany, the SafeVac 2.0 study was funded by the German ministry of Health and conducted by Paul-Ehrlich-Institut the national competed authority for vaccines and biomedicinal products in Germany. The French part of the study, named EVANESCO, was partially funded by the European Medicines Agency. In France, EVANESCO was identified as a National research priority (<i>priorité nationale de recherche</i>) by the CAPNET, and received a complementary funding from the <i>Ministère de la Santé et des Solidarités</i> and the <i>Ministère de l’Enseignement supérieur, de la Recherche et de l’Innovation.</i> The Dutch part of the study was funded by a grant from the Dutch Ministry of Health, Welfare and Sport. The Dutch Ministry of Health, Welfare and Sport had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. In the United Kingdom the project was funded by the European Medicines Agency through the cohort event monitoring project.
: Nicolas Thurin and Caroline Dureau-Pournin work for Bordeaux PharmacoEpi, an independent research platform of the Bordeaux University and its subsidiary the ADERA, which performs financially supported studies for public and private partners, in compliance with the ENCePP Code of Conduct. Miriam Sturkenboom and Sandor Schmikli work for the University Medical Center Utrecht, which performs COVID-19 vaccine trials and post-licensure vaccine effectiveness and safety studies for public and private organisations, according to ENCePP code of conduct of scientific independence. Gianluca Trifirò reported to advisory boards on topics not related to this presentation and was sponsored by the following pharmaceutical companies in the last two years: Eli Lilly, Sanofi, Amgen, Novo Nordisk, Sobi, Gilead, Celgene, Daikii Sankyo.The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
: The datasets for this manuscript are not publicly available. Requests to access the datasets should be directed and motivated to the first author and will be granted upon reasonable request and permission from partners.
: The structured query language (SQL) statements for the data used in this article are not publicly available. Requests to access the datasets should be directed and motivated to the first author and will be granted upon reasonable request and permission from partners.
: The study in Belgium was approved by the Ethics Committee Research of University Hospitals Leuven. The study in Croatia received approval from Central Ethics Committee (CEC). The study in France was approved by the <i>Comité de Protection des personnes</i> (CPP – 21.00821.210217) and the <i>Commission nationale de l'informatique et des libertés</i> (CNIL – DR-2021-209) under the name EVANESCO. If a study in the Netherlands is subject to the Medical Research Involving Human Subjects Act (WMO), it must undergo a review by an accredited Medical Research Ethics Committee or the central committee on research involving human subjects (CCMO). After submission to an accredited review committee (METC Brabant), this study was deemed not to fall under the WMO act. The study in the UK was approved by the London – Brent Research Ethics Committee (REC reference: 21/HRA/2077) & obtained HRA and Health and Care Research Wales (HCRW) Approval. The study in Germany was approved by the Ethics Committee at the Regional Medical Council of Hessen. Participants in the study provided the consent electronically via the smartphone application. The study in Italy was approved by the <i>Comitato Etico dell’Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.</i> under the name “Cohort Event Monitoring of safety of COVID-19 vaccines”.
: Participants in the study provided written informed consent before participation to the study.
: Participants in the study provided a written statement of consent at the time of registration for their data to be used for the purpose of this research and publication of study results.
: The original study protocol was designed by all authors. The queries and dataset were established by MR. Data analysis was performed by MR and FHL. The design of the manuscript was determined by MR, FHL and MS. All authors contributed to the manuscript drafting and revision. All authors approved the final version to be published and agree to be accountable for the work they performed and the methods and reporting of results.
Free to read: This content has been made available to all.