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Article History

Received: 9 November 2025

Accepted: 16 December 2025

First Online: 9 March 2026

Declarations

:

: The COVIDRIVE master protocol and the study site-specific study protocols developed from it were approved by the relevant ethics committees following local regulations. Approval from the COVIDRIVE steering committee was obtained for this secondary data use study.

: Written informed consent for primary data collection was obtained from all study participants included in the study or from their legally acceptable representative. This included consent for anonymized data to be published. Waiver of informed consent was authorized by local ethics committees for prospective data collection for the Spanish study sites (GTUPH and HUVH), as the tests carried out and information collected were part of routine clinical practice and epidemiological surveillance there. Additionally, waiver of informed consent was approved for retrospective data collection for all study sites participating in retrospective data collection (retrospective meaning that the patient was admitted to the hospital before the study site activation date and enrolled in the study retroactively).

: WM and SV are employees of AstraZeneca and hold AstraZeneca stocks/shares. ST was an employee of AstraZeneca at the time of this research and held AstraZeneca stocks/shares. EC-S, KB, KC, SM-L, and WH-M are employees of P95 Clinical & Epidemiology Services. IP was an employee of P95 Clinical & Epidemiology Services at the time of this research. KB and WHM hold P95 stocks/shares. JGB is an employee of the Coalition for Epidemic Preparedness Innovations (CEPI), which funds COVID-19 vaccine research and development. JGB and M-AW are members of the COVIDRIVE (now id.DRIVE) Independent Scientific Committee and have received reimbursement of expenses for travel and accommodation to attend COVIDRIVE meetings (JGB) and compensation for time reviewing the COVIDRIVE study protocol and methodology (M-AW). AO received support for participation on a Data Safety Monitoring Board or Advisory Board, for attending meetings and/or travel from GlaxoSmithKline, Sanofi, Moderna, MSD, Sequirus, Novavax, and support for attending meetings and/or travel from AstraZeneca. AO declares grants or contracts for conduct of clinical trials and observational studies from GlaxoSmithKline, Moderna, Sanofi, Pfizer and MSD. SOR declares consulting fees from Sanofi and Moderna. SOR and AO declare payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events by GlaxoSmithKline. Such funding was also received by SOR from AstraZeneca and by AO from MSD, Moderna, and Sequirus. IC received support from Pfizer for attending a congress. All other authors declare no competing interests.