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Article History

Received: 28 January 2022

Accepted: 21 February 2022

First Online: 12 May 2022

Declarations

:

: Ethical approval of this protocol was received on May 28, 2021 by Vanderbilt University Medicine Center IRB, a single IRB as part of an NIH-funded consortium, IDCRC. Written informed consent will be obtained from each participant.

: Not applicable.

: F.M.M. is an investigator of pediatric studies of COVID-19 vaccines for Pfizer and Moderna, and for a pediatric remdesivir study conducted by Gilead Sciences, Inc.; serves as investigator on projects supported by an NIH contract for a Vaccine Treatment and Evaluation Unit (VTEU), serves as member of the Data Safety monitoring Board (DSMB) for clinical trials conducted by Pfizer, Moderna, Meissa Vaccines, Virometix, and the NIH; and is a member of the American Academy of Pediatrics Committee of Infectious Diseases (COID_, the Immunization Expert Group of the American College of Obstetrics and Gynecology (ACOG), and Co-Chair of the COVAX Maternal Immunization Working Group.K.M.N. is a member of the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization, serves as co-investigator on an NIH contract for a Vaccine Treatment and Evaluation Unit (VTEU), serves as Co-chair of the NIH COVID Prevention Network (CoVPN), and served as an investigator for Phase I/II Pfizer COVID-19 vaccine grant, with a grant to the institution, but no salary support.B.R. currently holds a position on the Data and Safety Monitoring Board (DSMB) for clinical trials at Gilead Sciences, Inc.All authors have completed relevant conflicts of interest in the Disclosure of Potential Conflicts of Interest section of the Authorship Form.