Sun, Tianyu
Li, Linwei
Mues, Katherine E.
Georgieva, Mihaela V.
Kirk, Brenna
Mansi, James A.
Van de Velde, Nicolas
Beck, Ekkehard C.
Funding for this research was provided by:
Moderna, Inc.
Article History
Received: 22 February 2024
Accepted: 6 June 2024
First Online: 25 June 2024
Declarations
:
: Tianyu Sun, Linwei Li, Mihaela Georgieva, James Mansi, Ekkehard Beck and Nicolas Van de Velde are employees of Moderna, Inc. and may hold stock/stock options in the company.
: Institutional review board approval was not necessary for conducting this study. The linked dataset only contains de-identified data as per the de-identification standard defined in Section §164.514(a) of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The process by which the data is de-identified is attested to through a formal determination by a qualified expert as defined in Section §164.514(b)(1) of the HIPAA Privacy Rule. Because this study used only deidentified patient records, it is therefore no longer subject to the HIPAA Privacy Rule and is therefore exempt from Institutional Review Board approval and for obtaining informed consent according to US law. This study was conducted in compliance with the Declaration of Helsinki and used only de-identified data.
: Medical writing and editorial assistance were provided by K Ian Johnson BSc, MBPS, SRPharmS of MEDiSTRAVA, in accordance with Good Publication Practice (GPP) guidelines, funded by Moderna, Inc., and under the direction of the authors.