Accepted for Publication: April 21, 2022.
Published: June 8, 2022. doi:10.1001/jamanetworkopen.2022.15984
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Lin DY et al. JAMA Network Open.
Corresponding Author: Dan-Yu Lin, PhD, Department of Biostatistics, University of North Carolina, Chapel Hill, NC 27599-7420 (lin@bios.unc.edu).
Author Contributions: Drs Baden and Miller had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Lin, Baden, El Sahly, Neuzil, Corey, Miller.
Acquisition, analysis, or interpretation of data: Lin, Baden, El Sahly, Essink, Neuzil.
Drafting of the manuscript: Lin, Baden.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Lin, Essink.
Obtained funding: Baden, El Sahly, Corey.
Administrative, technical, or material support: Baden.
Supervision: Baden, El Sahly, Essink, Corey, Miller.
Conflict of Interest Disclosures: Dr Baden reported receiving grants from the National Institute of Allergy and Infectious Disease of the National Institutes of Health (NIAID/NIH) during the conduct of the study and being involved in HIV and COVID vaccine clinical trials conducted in collaboration with the NIH, HIV Vaccine Trials Network, COVID Vaccine Prevention Network, International AIDS Vaccine Initiative, Crucell/Janssen, Moderna, Military HIV Research Program, Gates Foundation, and the Ragon Institute. Dr El Sahly reported receiving grants from NIAID/NIH for research funding during the conduct of the study. Dr Neuzil reported receiving grants from Pfizer to conduct clinical trials of COVID-19 vaccines and grants from NIH to participate in overall organization of COVID-19 vaccine trials and for participation in vaccine trials during the conduct of the study. Dr Corey reported receiving grants from NIH/NIAID during the conduct of the study. Dr Miller reported being employed by Moderna during the conduct of the study and having stock options and receiving grants from Moderna outside the submitted work. No other disclosures were reported.
Funding/Support: This work was supported by grant R01 AI029168 from the National Institutes of Health (Dr Lin).
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group information: The COVE Study Group members are listed in Supplement 2.
Additional Information: Moderna provided the data for this study to the COVID-19 Prevention Network.