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Hernandez-Villena, Hollie Dunford, Somsuvro Basu, and Kaatje Bollaerts are employed by P95. Kaatje Bollaerts has received consulting fees from Pfizer for conducting this study, may own P95 stocks, and reported consulting fees from AstraZeneca, CEPI, GSK, Pfizer, Valneva, and WHO. She also reported book royalties. C\u00e1tia Marques, Farid L. Khan, Hannah R. Volkman, Negar Aliabadi, Elizabeth Begier, and Jennifer L. Nguyen are employed by Pfizer and may own Pfizer stocks or stock options. Ekaterina Maslova and Chengbin Wang are employed by AstraZeneca and may own AstraZeneca stocks or stock options. Susana Otero-Romero declares consulting fees from Moderna and Sanofi, honoraria from AstraZeneca and GSK, and support from Pfizer for meeting attendance and travel. Irma Casas reports support from GSK and Pfizer for meeting attendance and travel. Elisa Martr\u00f3 reports grants\/contracts and support for meeting attendance and travel from Gilead Sciences. Giancarlo Icardi, coordinator of the CIRI-IT network, received funding from P95 via id.DRIVE for the study. Federico Martin\u00f3n-Torres reports grants\/contracts paid to his institution from GSK, Pfizer, and Sanofi-AstraZeneca; consulting or advisory fees from GSK, Pfizer, Sanofi Pasteur, Janssen Pharmaceuticals, MSD, Seqirus, Biofabri, and AstraZeneca; and support for meeting attendance and travel from Pfizer, MSD, GSK, and Sanofi. He is also a member of the European Technical Advisory Group of Experts on Immunization, coordinator of the Spanish Pediatric Critical Trials Network, and coordinator of the WHO collaborating Center for Vaccine Safety of Santiago de Compostela. He is a principal investigator in randomised controlled trials of Ablynx, Abbott, Seqirus, Sanofi Pasteur MSD, Sanofi Pasteur, Cubist, Wyeth, Merck, Pfizer, Roche, Regeneron, Jansen, MedImmune, Novavax, Novartis, and GSK, with honoraria paid to his institution. Ainara Mira-Iglesias, co-PI from VAHNSI (FISABIO), reports that her foundation received funding from P95 via id.DRIVE for the study. Her institution also received a grant from the Foundation for Influenza Epidemiology via the Global Influenza Hospital Surveillance Network (GIHSN) for VAHNSI surveillance. Alejandro Orrico-S\u00e1nchez, co-PI from VAHNSI (FISABIO), reports that his foundation received funding from P95 through id.DRIVE for the study. Antoni Torres reports consulting fees and honoraria from Jansen OM Pharma, MSD, Pfizer, and Polyphor. The other authors (Andr\u00e9s Ant\u00f3n, Beate Gr\u00fcner, Carlos M. O\u00f1oro-L\u00f3pez, Oleguer Par\u00e9s-Badell, and Wolfgang Gleiber) report no conflicts of interest.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was performed in accordance with the 1964 Declaration of Helsinki and its later amendments. All data were pseudonymised prior to analysis and processed in accordance with the European Union General Data Protection Regulation [GDPR; Regulation (EU) 2016\/679]. The id.DRIVE surveillance protocol (EUPAS1000000012) was approved by independent ethics committees (IECs) at all participating hospitals or hospital networks: Comitato Etico Regionale della Liguria (Genoa); Comit\u00e9 \u00c9tico de Investigaci\u00f3n con Medicamentos del Departamento de Salud Arnau de Vilanova (Valencia); Comit\u00e9 \u00c9tico de Investigaci\u00f3n con Medicamentos del Hospital Universitari Vall d\u2019Hebron (Barcelona); Comit\u00e9 de \u00c9tica de la Investigaci\u00f3n con Medicamentos del Hospital Universitario La Paz; Ethikkommission des Fachbereichs Medizin der Goethe-Universit\u00e4t (Frankfurt); Ethikkommission Ulm. Individuals (or their legally acceptable representative) provided informed consent when applicable. Waiver of informed consent was authorised by local IECs for retrospective data collection for Hospital Germans Trias i Pujol, Hospital Clinic Barcelona, and Vall d'Hebron, as the tests carried out and information collected were part of routine clinical practice and epidemiological surveillance.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}