Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents.
Identifieur interne : 000079 ( Main/Corpus ); précédent : 000078; suivant : 000080Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents.
Auteurs : Joshua Wolf ; Mark J. Abzug ; Rachel L. Wattier ; Paul K. Sue ; Surabhi B. Vora ; Philip Zachariah ; Daniel E. Dulek ; Alpana Waghmare ; Rosemary Olivero ; Kevin J. Downes ; Scott H. James ; Swetha G. Pinninti ; April Yarbrough ; Margaret L. Aldrich ; Christine E. Macbrayne ; Vijaya L. Soma ; Steven P. Grapentine ; Carlos R. Oliveira ; Molly Hayes ; David W. Kimberlin ; Sarah B. Jones ; Laura L. Bio ; Theodore H. Morton ; Jane S. Hankins ; Gabriella M. Mar N-Alfaro ; Kathryn Timberlake ; Jennifer L. Young ; Rachel C. Orscheln ; Hayden T. Schwenk ; David L. Goldman ; Helen E. Groves ; W Charles Huskins ; Nipunie S. Rajapakse ; Gabriella S. Lamb ; Alison C. Tribble ; Elizabeth E. Lloyd ; Adam L. Hersh ; Emily A. Thorell ; Adam J. Ratner ; Kathleen Chiotos ; Mari M. NakamuraSource :
- Journal of the Pediatric Infectious Diseases Society [ 2048-7207 ] ; 2021.
Abstract
BACKGROUND
In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for two novel virus-neutralizing monoclonal antibody therapies, bamlanivimab, and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate COVID-19 in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products.
METHODS
A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion.
RESULTS
The course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis.
CONCLUSIONS
Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence, and ensure implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.
DOI: 10.1093/jpids/piaa175
PubMed: 33388760
PubMed Central: PMC7799019
Links to Exploration step
pubmed:33388760Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents.</title><author><name sortKey="Wolf, Joshua" sort="Wolf, Joshua" uniqKey="Wolf J" first="Joshua" last="Wolf">Joshua Wolf</name><affiliation><nlm:affiliation>Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Abzug, Mark J" sort="Abzug, Mark J" uniqKey="Abzug M" first="Mark J" last="Abzug">Mark J. Abzug</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Wattier, Rachel L" sort="Wattier, Rachel L" uniqKey="Wattier R" first="Rachel L" last="Wattier">Rachel L. Wattier</name><affiliation><nlm:affiliation>Division of Infectious Diseases and Global Health, Department of Pediatrics, University of California-San Francisco, San Francisco, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sue, Paul K" sort="Sue, Paul K" uniqKey="Sue P" first="Paul K" last="Sue">Paul K. Sue</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Vora, Surabhi B" sort="Vora, Surabhi B" uniqKey="Vora S" first="Surabhi B" last="Vora">Surabhi B. Vora</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington, Seattle; Children's Hospital, Seattle, Washington, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Zachariah, Philip" sort="Zachariah, Philip" uniqKey="Zachariah P" first="Philip" last="Zachariah">Philip Zachariah</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Columbia University, New York, New York, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dulek, Daniel E" sort="Dulek, Daniel E" uniqKey="Dulek D" first="Daniel E" last="Dulek">Daniel E. Dulek</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University and Monroe Carell Jr. Children's Hospital, Nashville, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Waghmare, Alpana" sort="Waghmare, Alpana" uniqKey="Waghmare A" first="Alpana" last="Waghmare">Alpana Waghmare</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington, Seattle; Children's Hospital, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Olivero, Rosemary" sort="Olivero, Rosemary" uniqKey="Olivero R" first="Rosemary" last="Olivero">Rosemary Olivero</name><affiliation><nlm:affiliation>Section of Infectious Diseases, Department of Pediatrics and Human Development, Helen DeVos Children's Hospital of Spectrum Health, Michigan State College of Human Medicine, Grand Rapids, Michigan, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Downes, Kevin J" sort="Downes, Kevin J" uniqKey="Downes K" first="Kevin J" last="Downes">Kevin J. Downes</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation></author><author><name sortKey="James, Scott H" sort="James, Scott H" uniqKey="James S" first="Scott H" last="James">Scott H. James</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Pinninti, Swetha G" sort="Pinninti, Swetha G" uniqKey="Pinninti S" first="Swetha G" last="Pinninti">Swetha G. Pinninti</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Yarbrough, April" sort="Yarbrough, April" uniqKey="Yarbrough A" first="April" last="Yarbrough">April Yarbrough</name><affiliation><nlm:affiliation>Department of Pharmacy, Children's of Alabama, Birmingham, Alabama, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Aldrich, Margaret L" sort="Aldrich, Margaret L" uniqKey="Aldrich M" first="Margaret L" last="Aldrich">Margaret L. Aldrich</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital at Montefiore, New York, New York, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Macbrayne, Christine E" sort="Macbrayne, Christine E" uniqKey="Macbrayne C" first="Christine E" last="Macbrayne">Christine E. Macbrayne</name><affiliation><nlm:affiliation>Department of Pharmacy, Children's Hospital Colorado, Aurora, Colorado, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Soma, Vijaya L" sort="Soma, Vijaya L" uniqKey="Soma V" first="Vijaya L" last="Soma">Vijaya L. Soma</name><affiliation><nlm:affiliation>Department of Pediatrics, Division of Infectious Diseases, New York University Grossman School of Medicine and Hassenfeld Children's Hospital, New York, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Grapentine, Steven P" sort="Grapentine, Steven P" uniqKey="Grapentine S" first="Steven P" last="Grapentine">Steven P. Grapentine</name><affiliation><nlm:affiliation>Department of Pharmacy, University of California-San Francisco Benioff Children's Hospital, San Francisco, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Oliveira, Carlos R" sort="Oliveira, Carlos R" uniqKey="Oliveira C" first="Carlos R" last="Oliveira">Carlos R. Oliveira</name><affiliation><nlm:affiliation>Division of Infectious Diseases and Global Health, Department of Pediatrics, Yale University School of Medicine, New Haven, CT, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Hayes, Molly" sort="Hayes, Molly" uniqKey="Hayes M" first="Molly" last="Hayes">Molly Hayes</name><affiliation><nlm:affiliation>Antimicrobial Stewardship Program, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kimberlin, David W" sort="Kimberlin, David W" uniqKey="Kimberlin D" first="David W" last="Kimberlin">David W. Kimberlin</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Jones, Sarah B" sort="Jones, Sarah B" uniqKey="Jones S" first="Sarah B" last="Jones">Sarah B. Jones</name><affiliation><nlm:affiliation>Department of Pharmacy, Boston Children's Hospital, Boston, Massachusetts, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Bio, Laura L" sort="Bio, Laura L" uniqKey="Bio L" first="Laura L" last="Bio">Laura L. Bio</name><affiliation><nlm:affiliation>Department of Pharmacy, Lucile Packard Children's Hospital Stanford, Palo Alto, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Morton, Theodore H" sort="Morton, Theodore H" uniqKey="Morton T" first="Theodore H" last="Morton">Theodore H. Morton</name><affiliation><nlm:affiliation>Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hankins, Jane S" sort="Hankins, Jane S" uniqKey="Hankins J" first="Jane S" last="Hankins">Jane S. Hankins</name><affiliation><nlm:affiliation>Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mar N Alfaro, Gabriella M" sort="Mar N Alfaro, Gabriella M" uniqKey="Mar N Alfaro G" first="Gabriella M" last="Mar N-Alfaro">Gabriella M. Mar N-Alfaro</name><affiliation><nlm:affiliation>Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Timberlake, Kathryn" sort="Timberlake, Kathryn" uniqKey="Timberlake K" first="Kathryn" last="Timberlake">Kathryn Timberlake</name><affiliation><nlm:affiliation>Department of Pharmacy, The Hospital for Sick Children, Toronto, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Young, Jennifer L" sort="Young, Jennifer L" uniqKey="Young J" first="Jennifer L" last="Young">Jennifer L. Young</name><affiliation><nlm:affiliation>Department of Pharmacy, St. Louis Children's Hospital, St. Louis, Missouri, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Orscheln, Rachel C" sort="Orscheln, Rachel C" uniqKey="Orscheln R" first="Rachel C" last="Orscheln">Rachel C. Orscheln</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Washington University and St. Louis Children's Hospital, St. Louis, Missouri, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Schwenk, Hayden T" sort="Schwenk, Hayden T" uniqKey="Schwenk H" first="Hayden T" last="Schwenk">Hayden T. Schwenk</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Stanford, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Goldman, David L" sort="Goldman, David L" uniqKey="Goldman D" first="David L" last="Goldman">David L. Goldman</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital at Montefiore, New York, New York, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Groves, Helen E" sort="Groves, Helen E" uniqKey="Groves H" first="Helen E" last="Groves">Helen E. Groves</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics,; Hospital for Sick Children, Toronto, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Huskins, W Charles" sort="Huskins, W Charles" uniqKey="Huskins W" first="W Charles" last="Huskins">W Charles Huskins</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatric and Adolescent Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.</nlm:affiliation></affiliation></author><author><name sortKey="Rajapakse, Nipunie S" sort="Rajapakse, Nipunie S" uniqKey="Rajapakse N" first="Nipunie S" last="Rajapakse">Nipunie S. Rajapakse</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatric and Adolescent Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.</nlm:affiliation></affiliation></author><author><name sortKey="Lamb, Gabriella S" sort="Lamb, Gabriella S" uniqKey="Lamb G" first="Gabriella S" last="Lamb">Gabriella S. Lamb</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Tribble, Alison C" sort="Tribble, Alison C" uniqKey="Tribble A" first="Alison C" last="Tribble">Alison C. Tribble</name><affiliation><nlm:affiliation>Department of Pediatrics, Division of Infectious Diseases, University of Michigan and CS Mott Children's Hospital, Ann Arbor, Michigan, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lloyd, Elizabeth E" sort="Lloyd, Elizabeth E" uniqKey="Lloyd E" first="Elizabeth E" last="Lloyd">Elizabeth E. Lloyd</name><affiliation><nlm:affiliation>Department of Pediatrics, Division of Infectious Diseases, University of Michigan and CS Mott Children's Hospital, Ann Arbor, Michigan, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hersh, Adam L" sort="Hersh, Adam L" uniqKey="Hersh A" first="Adam L" last="Hersh">Adam L. Hersh</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, University of Utah and Primary Children's Hospital, Salt Lake City, Utah, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Thorell, Emily A" sort="Thorell, Emily A" uniqKey="Thorell E" first="Emily A" last="Thorell">Emily A. Thorell</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, University of Utah and Primary Children's Hospital, Salt Lake City, Utah, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ratner, Adam J" sort="Ratner, Adam J" uniqKey="Ratner A" first="Adam J" last="Ratner">Adam J. Ratner</name><affiliation><nlm:affiliation>Department of Pediatrics, Division of Infectious Diseases, New York University Grossman School of Medicine and Hassenfeld Children's Hospital, New York, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Microbiology, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Chiotos, Kathleen" sort="Chiotos, Kathleen" uniqKey="Chiotos K" first="Kathleen" last="Chiotos">Kathleen Chiotos</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Division of Critical Care Medicine, Department of Anesthesia and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Nakamura, Mari M" sort="Nakamura, Mari M" uniqKey="Nakamura M" first="Mari M" last="Nakamura">Mari M. Nakamura</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Antimicrobial Stewardship Program, Boston Children's Hospital, Boston, Massachusetts, USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:33388760</idno><idno type="pmid">33388760</idno><idno type="doi">10.1093/jpids/piaa175</idno><idno type="pmc">PMC7799019</idno><idno type="wicri:Area/Main/Corpus">000079</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000079</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents.</title><author><name sortKey="Wolf, Joshua" sort="Wolf, Joshua" uniqKey="Wolf J" first="Joshua" last="Wolf">Joshua Wolf</name><affiliation><nlm:affiliation>Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Abzug, Mark J" sort="Abzug, Mark J" uniqKey="Abzug M" first="Mark J" last="Abzug">Mark J. Abzug</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Wattier, Rachel L" sort="Wattier, Rachel L" uniqKey="Wattier R" first="Rachel L" last="Wattier">Rachel L. Wattier</name><affiliation><nlm:affiliation>Division of Infectious Diseases and Global Health, Department of Pediatrics, University of California-San Francisco, San Francisco, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sue, Paul K" sort="Sue, Paul K" uniqKey="Sue P" first="Paul K" last="Sue">Paul K. Sue</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Vora, Surabhi B" sort="Vora, Surabhi B" uniqKey="Vora S" first="Surabhi B" last="Vora">Surabhi B. Vora</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington, Seattle; Children's Hospital, Seattle, Washington, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Zachariah, Philip" sort="Zachariah, Philip" uniqKey="Zachariah P" first="Philip" last="Zachariah">Philip Zachariah</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Columbia University, New York, New York, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dulek, Daniel E" sort="Dulek, Daniel E" uniqKey="Dulek D" first="Daniel E" last="Dulek">Daniel E. Dulek</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University and Monroe Carell Jr. Children's Hospital, Nashville, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Waghmare, Alpana" sort="Waghmare, Alpana" uniqKey="Waghmare A" first="Alpana" last="Waghmare">Alpana Waghmare</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington, Seattle; Children's Hospital, Seattle, Washington, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Olivero, Rosemary" sort="Olivero, Rosemary" uniqKey="Olivero R" first="Rosemary" last="Olivero">Rosemary Olivero</name><affiliation><nlm:affiliation>Section of Infectious Diseases, Department of Pediatrics and Human Development, Helen DeVos Children's Hospital of Spectrum Health, Michigan State College of Human Medicine, Grand Rapids, Michigan, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Downes, Kevin J" sort="Downes, Kevin J" uniqKey="Downes K" first="Kevin J" last="Downes">Kevin J. Downes</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation></author><author><name sortKey="James, Scott H" sort="James, Scott H" uniqKey="James S" first="Scott H" last="James">Scott H. James</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Pinninti, Swetha G" sort="Pinninti, Swetha G" uniqKey="Pinninti S" first="Swetha G" last="Pinninti">Swetha G. Pinninti</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Yarbrough, April" sort="Yarbrough, April" uniqKey="Yarbrough A" first="April" last="Yarbrough">April Yarbrough</name><affiliation><nlm:affiliation>Department of Pharmacy, Children's of Alabama, Birmingham, Alabama, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Aldrich, Margaret L" sort="Aldrich, Margaret L" uniqKey="Aldrich M" first="Margaret L" last="Aldrich">Margaret L. Aldrich</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital at Montefiore, New York, New York, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Macbrayne, Christine E" sort="Macbrayne, Christine E" uniqKey="Macbrayne C" first="Christine E" last="Macbrayne">Christine E. Macbrayne</name><affiliation><nlm:affiliation>Department of Pharmacy, Children's Hospital Colorado, Aurora, Colorado, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Soma, Vijaya L" sort="Soma, Vijaya L" uniqKey="Soma V" first="Vijaya L" last="Soma">Vijaya L. Soma</name><affiliation><nlm:affiliation>Department of Pediatrics, Division of Infectious Diseases, New York University Grossman School of Medicine and Hassenfeld Children's Hospital, New York, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Grapentine, Steven P" sort="Grapentine, Steven P" uniqKey="Grapentine S" first="Steven P" last="Grapentine">Steven P. Grapentine</name><affiliation><nlm:affiliation>Department of Pharmacy, University of California-San Francisco Benioff Children's Hospital, San Francisco, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Oliveira, Carlos R" sort="Oliveira, Carlos R" uniqKey="Oliveira C" first="Carlos R" last="Oliveira">Carlos R. Oliveira</name><affiliation><nlm:affiliation>Division of Infectious Diseases and Global Health, Department of Pediatrics, Yale University School of Medicine, New Haven, CT, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Hayes, Molly" sort="Hayes, Molly" uniqKey="Hayes M" first="Molly" last="Hayes">Molly Hayes</name><affiliation><nlm:affiliation>Antimicrobial Stewardship Program, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kimberlin, David W" sort="Kimberlin, David W" uniqKey="Kimberlin D" first="David W" last="Kimberlin">David W. Kimberlin</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Jones, Sarah B" sort="Jones, Sarah B" uniqKey="Jones S" first="Sarah B" last="Jones">Sarah B. Jones</name><affiliation><nlm:affiliation>Department of Pharmacy, Boston Children's Hospital, Boston, Massachusetts, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Bio, Laura L" sort="Bio, Laura L" uniqKey="Bio L" first="Laura L" last="Bio">Laura L. Bio</name><affiliation><nlm:affiliation>Department of Pharmacy, Lucile Packard Children's Hospital Stanford, Palo Alto, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Morton, Theodore H" sort="Morton, Theodore H" uniqKey="Morton T" first="Theodore H" last="Morton">Theodore H. Morton</name><affiliation><nlm:affiliation>Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hankins, Jane S" sort="Hankins, Jane S" uniqKey="Hankins J" first="Jane S" last="Hankins">Jane S. Hankins</name><affiliation><nlm:affiliation>Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mar N Alfaro, Gabriella M" sort="Mar N Alfaro, Gabriella M" uniqKey="Mar N Alfaro G" first="Gabriella M" last="Mar N-Alfaro">Gabriella M. Mar N-Alfaro</name><affiliation><nlm:affiliation>Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Timberlake, Kathryn" sort="Timberlake, Kathryn" uniqKey="Timberlake K" first="Kathryn" last="Timberlake">Kathryn Timberlake</name><affiliation><nlm:affiliation>Department of Pharmacy, The Hospital for Sick Children, Toronto, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Young, Jennifer L" sort="Young, Jennifer L" uniqKey="Young J" first="Jennifer L" last="Young">Jennifer L. Young</name><affiliation><nlm:affiliation>Department of Pharmacy, St. Louis Children's Hospital, St. Louis, Missouri, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Orscheln, Rachel C" sort="Orscheln, Rachel C" uniqKey="Orscheln R" first="Rachel C" last="Orscheln">Rachel C. Orscheln</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Washington University and St. Louis Children's Hospital, St. Louis, Missouri, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Schwenk, Hayden T" sort="Schwenk, Hayden T" uniqKey="Schwenk H" first="Hayden T" last="Schwenk">Hayden T. Schwenk</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Stanford, California, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Goldman, David L" sort="Goldman, David L" uniqKey="Goldman D" first="David L" last="Goldman">David L. Goldman</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital at Montefiore, New York, New York, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Groves, Helen E" sort="Groves, Helen E" uniqKey="Groves H" first="Helen E" last="Groves">Helen E. Groves</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics,; Hospital for Sick Children, Toronto, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Huskins, W Charles" sort="Huskins, W Charles" uniqKey="Huskins W" first="W Charles" last="Huskins">W Charles Huskins</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatric and Adolescent Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.</nlm:affiliation></affiliation></author><author><name sortKey="Rajapakse, Nipunie S" sort="Rajapakse, Nipunie S" uniqKey="Rajapakse N" first="Nipunie S" last="Rajapakse">Nipunie S. Rajapakse</name><affiliation><nlm:affiliation>Division of Pediatric Infectious Diseases, Department of Pediatric and Adolescent Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.</nlm:affiliation></affiliation></author><author><name sortKey="Lamb, Gabriella S" sort="Lamb, Gabriella S" uniqKey="Lamb G" first="Gabriella S" last="Lamb">Gabriella S. Lamb</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Tribble, Alison C" sort="Tribble, Alison C" uniqKey="Tribble A" first="Alison C" last="Tribble">Alison C. Tribble</name><affiliation><nlm:affiliation>Department of Pediatrics, Division of Infectious Diseases, University of Michigan and CS Mott Children's Hospital, Ann Arbor, Michigan, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lloyd, Elizabeth E" sort="Lloyd, Elizabeth E" uniqKey="Lloyd E" first="Elizabeth E" last="Lloyd">Elizabeth E. Lloyd</name><affiliation><nlm:affiliation>Department of Pediatrics, Division of Infectious Diseases, University of Michigan and CS Mott Children's Hospital, Ann Arbor, Michigan, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hersh, Adam L" sort="Hersh, Adam L" uniqKey="Hersh A" first="Adam L" last="Hersh">Adam L. Hersh</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, University of Utah and Primary Children's Hospital, Salt Lake City, Utah, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Thorell, Emily A" sort="Thorell, Emily A" uniqKey="Thorell E" first="Emily A" last="Thorell">Emily A. Thorell</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, University of Utah and Primary Children's Hospital, Salt Lake City, Utah, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ratner, Adam J" sort="Ratner, Adam J" uniqKey="Ratner A" first="Adam J" last="Ratner">Adam J. Ratner</name><affiliation><nlm:affiliation>Department of Pediatrics, Division of Infectious Diseases, New York University Grossman School of Medicine and Hassenfeld Children's Hospital, New York, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Microbiology, New York University Grossman School of Medicine, New York, New York, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Chiotos, Kathleen" sort="Chiotos, Kathleen" uniqKey="Chiotos K" first="Kathleen" last="Chiotos">Kathleen Chiotos</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Division of Critical Care Medicine, Department of Anesthesia and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Nakamura, Mari M" sort="Nakamura, Mari M" uniqKey="Nakamura M" first="Mari M" last="Nakamura">Mari M. Nakamura</name><affiliation><nlm:affiliation>Division of Infectious Diseases, Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Antimicrobial Stewardship Program, Boston Children's Hospital, Boston, Massachusetts, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of the Pediatric Infectious Diseases Society</title><idno type="eISSN">2048-7207</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for two novel virus-neutralizing monoclonal antibody therapies, bamlanivimab, and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate COVID-19 in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>The course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence, and ensure implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.</p></div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">33388760</PMID><DateRevised><Year>2021</Year><Month>01</Month><Day>26</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2048-7207</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2021</Year><Month>Jan</Month><Day>03</Day></PubDate></JournalIssue><Title>Journal of the Pediatric Infectious Diseases Society</Title><ISOAbbreviation>J Pediatric Infect Dis Soc</ISOAbbreviation></Journal><ArticleTitle>Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">piaa175</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1093/jpids/piaa175</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for two novel virus-neutralizing monoclonal antibody therapies, bamlanivimab, and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate COVID-19 in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence, and ensure implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.</AbstractText><CopyrightInformation>© The Author(s) 2021. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wolf</LastName><ForeName>Joshua</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Abzug</LastName><ForeName>Mark J</ForeName><Initials>MJ</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wattier</LastName><ForeName>Rachel L</ForeName><Initials>RL</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases and Global Health, Department of Pediatrics, University of California-San Francisco, San Francisco, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sue</LastName><ForeName>Paul K</ForeName><Initials>PK</Initials><AffiliationInfo><Affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vora</LastName><ForeName>Surabhi B</ForeName><Initials>SB</Initials><AffiliationInfo><Affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington, Seattle; Children's Hospital, Seattle, Washington, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zachariah</LastName><ForeName>Philip</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Columbia University, New York, New York, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dulek</LastName><ForeName>Daniel E</ForeName><Initials>DE</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University and Monroe Carell Jr. Children's Hospital, Nashville, Tennessee, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Waghmare</LastName><ForeName>Alpana</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington, Seattle; Children's Hospital, Seattle, Washington, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Olivero</LastName><ForeName>Rosemary</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Section of Infectious Diseases, Department of Pediatrics and Human Development, Helen DeVos Children's Hospital of Spectrum Health, Michigan State College of Human Medicine, Grand Rapids, Michigan, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Downes</LastName><ForeName>Kevin J</ForeName><Initials>KJ</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>James</LastName><ForeName>Scott H</ForeName><Initials>SH</Initials><AffiliationInfo><Affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pinninti</LastName><ForeName>Swetha G</ForeName><Initials>SG</Initials><AffiliationInfo><Affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yarbrough</LastName><ForeName>April</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Children's of Alabama, Birmingham, Alabama, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aldrich</LastName><ForeName>Margaret L</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital at Montefiore, New York, New York, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>MacBrayne</LastName><ForeName>Christine E</ForeName><Initials>CE</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Children's Hospital Colorado, Aurora, Colorado, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Soma</LastName><ForeName>Vijaya L</ForeName><Initials>VL</Initials><AffiliationInfo><Affiliation>Department of Pediatrics, Division of Infectious Diseases, New York University Grossman School of Medicine and Hassenfeld Children's Hospital, New York, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grapentine</LastName><ForeName>Steven P</ForeName><Initials>SP</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, University of California-San Francisco Benioff Children's Hospital, San Francisco, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oliveira</LastName><ForeName>Carlos R</ForeName><Initials>CR</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases and Global Health, Department of Pediatrics, Yale University School of Medicine, New Haven, CT, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hayes</LastName><ForeName>Molly</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Antimicrobial Stewardship Program, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kimberlin</LastName><ForeName>David W</ForeName><Initials>DW</Initials><AffiliationInfo><Affiliation>Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jones</LastName><ForeName>Sarah B</ForeName><Initials>SB</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Boston Children's Hospital, Boston, Massachusetts, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bio</LastName><ForeName>Laura L</ForeName><Initials>LL</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Lucile Packard Children's Hospital Stanford, Palo Alto, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morton</LastName><ForeName>Theodore H</ForeName><Initials>TH</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hankins</LastName><ForeName>Jane S</ForeName><Initials>JS</Initials><AffiliationInfo><Affiliation>Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marόn-Alfaro</LastName><ForeName>Gabriella M</ForeName><Initials>GM</Initials><AffiliationInfo><Affiliation>Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Timberlake</LastName><ForeName>Kathryn</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, The Hospital for Sick Children, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Young</LastName><ForeName>Jennifer L</ForeName><Initials>JL</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, St. Louis Children's Hospital, St. Louis, Missouri, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Orscheln</LastName><ForeName>Rachel C</ForeName><Initials>RC</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Washington University and St. Louis Children's Hospital, St. Louis, Missouri, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schwenk</LastName><ForeName>Hayden T</ForeName><Initials>HT</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Stanford, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goldman</LastName><ForeName>David L</ForeName><Initials>DL</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital at Montefiore, New York, New York, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Groves</LastName><ForeName>Helen E</ForeName><Initials>HE</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics,; Hospital for Sick Children, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huskins</LastName><ForeName>W Charles</ForeName><Initials>WC</Initials><AffiliationInfo><Affiliation>Division of Pediatric Infectious Diseases, Department of Pediatric and Adolescent Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rajapakse</LastName><ForeName>Nipunie S</ForeName><Initials>NS</Initials><AffiliationInfo><Affiliation>Division of Pediatric Infectious Diseases, Department of Pediatric and Adolescent Medicine, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lamb</LastName><ForeName>Gabriella S</ForeName><Initials>GS</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tribble</LastName><ForeName>Alison C</ForeName><Initials>AC</Initials><AffiliationInfo><Affiliation>Department of Pediatrics, Division of Infectious Diseases, University of Michigan and CS Mott Children's Hospital, Ann Arbor, Michigan, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lloyd</LastName><ForeName>Elizabeth E</ForeName><Initials>EE</Initials><AffiliationInfo><Affiliation>Department of Pediatrics, Division of Infectious Diseases, University of Michigan and CS Mott Children's Hospital, Ann Arbor, Michigan, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hersh</LastName><ForeName>Adam L</ForeName><Initials>AL</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, University of Utah and Primary Children's Hospital, Salt Lake City, Utah, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thorell</LastName><ForeName>Emily A</ForeName><Initials>EA</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, University of Utah and Primary Children's Hospital, Salt Lake City, Utah, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ratner</LastName><ForeName>Adam J</ForeName><Initials>AJ</Initials><AffiliationInfo><Affiliation>Department of Pediatrics, Division of Infectious Diseases, New York University Grossman School of Medicine and Hassenfeld Children's Hospital, New York, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Microbiology, New York University Grossman School of Medicine, New York, New York, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chiotos</LastName><ForeName>Kathleen</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Division of Critical Care Medicine, Department of Anesthesia and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nakamura</LastName><ForeName>Mari M</ForeName><Initials>MM</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Antimicrobial Stewardship Program, Boston Children's Hospital, Boston, Massachusetts, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>01</Month><Day>03</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Pediatric Infect Dis Soc</MedlineTA><NlmUniqueID>101586049</NlmUniqueID><ISSNLinking>2048-7193</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Bamlanivimab</Keyword><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">Casirivimab</Keyword><Keyword MajorTopicYN="N">Imdevimab</Keyword><Keyword MajorTopicYN="N">Pediatric</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>12</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2021</Year><Month>1</Month><Day>3</Day><Hour>20</Hour><Minute>35</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2021</Year><Month>1</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>1</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33388760</ArticleId><ArticleId IdType="pii">6060076</ArticleId><ArticleId 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