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Article History

Accepted: 18 May 2025

First Online: 31 July 2025

Declarations

:

: This study was funded by AstraZeneca.

: DL: during the conduct of this study, DL was an employee of and received a salary from PEPI Consultancy Ltd and funded by AstraZeneca Ltd, Ariello SRO, and Annexon Biosciences Inc. DL is now employed as the Drug Safety Lead at Lane Clark and Peacock (LCP) LLP, UK. DL is an Editorial Board member of Drug Safety. DL was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. DC reports consulting fees from Oxford University Consulting and Bristol Myers Squibb, and grants from UK Research and Innovation, Wellcome Trust, NIHR, Hong Kong ITC, AstraZeneca, and Glaxo Smith Kline (GSK) and patents held by Oxford University Innovation. DC acknowledges funding from the NIHR Oxford Biomedical Research Centre. JMOM, DK, XF, FF, SNA, MJ, and AT have no conflicts of interest that are directly relevant to the content of this article. AA, AL, and LM are employees of AstraZeneca and may own stock/shares. SdL has received funding from AstraZeneca, Eli Lilly, GSK, Moderna, MSD, Novo Nordisk, Pfizer, Sanofi, Seqirus, and Takeda and been a member of advisory boards for GSK, Moderna, Sanofi, and Seqirus. He has had meeting expenses funded by AstraZeneca.

: Ethics approval was granted by the Yorkshire & The Humber–Bradford Leeds Research Ethics Committee (REC) on 3 June, 2021 (REC reference: 21/YH/0126).

: Routinely collected secondary data were used for this study, therefore informed consent was not required. All patients with flags in their medical records to indicate they have opted out of data sharing did not have their data analyzed or retained, in accordance with the UK National Data Guardian consent/opt-out model (). This research also comes under the COVID-19 COPI Notice for the use of confidential patient information without consent for COVID-19 research purposes.

: Not applicable.

: Data underlying the findings described in this article may be obtained in accordance with AstraZeneca’s data-sharing policy described at . Data for studies directly listed on Vivli can be requested through Vivli at . Data for studies not listed on Vivli could be requested through Vivli at . The AstraZeneca Vivli member page is also available outlining further details at .

: All analysis code is stored in the Oxford-Royal College of General Practitioners (RCGP) Clinical Informatics Digital Hub (ORCHID), which is a trusted research environment, and can be provided by the authors upon request.

: JMOM contributed to the conceptualization of the project and formal analysis. DK performed data curation. XF performed data curation. FF contributed to the conceptualization of the project, data curation, project administration, and resources. SNA contributed to data curation, project administration, and resources. DL contributed to the conceptualization of the project, formal analysis, methodology, and project administration. SdL, MJ, DC, AT, and AA contributed to the conceptualization of the project and formal analysis. AL contributed to the conceptualization of the project, methodology, and supervision. LM contributed to the conceptualization of the project, formal analysis, and methodology. All authors contributed to the project protocol and statistical analysis plan, discussed the results, and reviewed and commented on the manuscript at all stages of development. All authors read and approved the final version.