Updated Guidance on Use and Prioritization of Monoclonal Antibody Therapy for Treatment of COVID-19 in Adolescents

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  • Joshua Wolf
    Department of Infectious Diseases, St. Jude Children’s Research Hospital , Memphis, Tennessee , USA
  • Mark J Abzug
    Department of Pediatrics, University of Colorado School of Medicine and Children’s Hospital Colorado , Aurora, Colorado , USA
  • Brenda I Anosike
    Department of Pediatrics, Children’s Hospital at Montefiore , New York, New York , USA
  • Surabhi B Vora
    Department of Pediatrics, University of Washington and Seattle Children’s Hospital , Seattle, Washington , USA
  • Alpana Waghmare
    Department of Pediatrics, University of Washington and Seattle Children’s Hospital , Seattle, Washington , USA
  • Paul K Sue
    Department of Pediatrics, University of Texas Southwestern Medical Center , Dallas, Texas , USA
  • Rosemary M Olivero
    Department of Pediatrics and Human Development, Helen DeVos Children’s Hospital of Spectrum Health, Michigan State College of Human Medicine , Grand Rapids, Michigan , USA
  • Carlos R Oliveira
    Department of Pediatrics, Yale University School of Medicine , New Haven, Connecticut , USA
  • Scott H James
    Department of Pediatrics, University of Alabama at Birmingham , Birmingham, Alabama , USA
  • Theodore H Morton
    Department of Pharmacy, St Jude’s Children’s Research Hospital , Memphis, Tennessee , USA
  • Gabriela M Maron
    Department of Infectious Diseases, St. Jude Children’s Research Hospital , Memphis, Tennessee , USA
  • Jennifer L Young
    Department of Pharmacy, Washington University and St. Louis Children’s Hospital , St. Louis, Missouri , USA
  • Rachel C Orscheln
    Department of Pediatrics, Washington University and St. Louis Children’s Hospital , St. Louis, Missouri , USA
  • Hayden T Schwenk
    Department of Pediatrics, Stanford University School of Medicine and Lucile Packard Children’s Hospital Stanford , Stanford, California , USA
  • Laura L Bio
    Department of Pharmacy, Stanford University School of Medicine and Lucile Packard Children’s Hospital Stanford , Stanford, California , USA
  • Zachary I Willis
    Department of Pediatrics, University of North Carolina Chapel Hill School of Medicine , Chapel Hill , North Carolina , USA
  • Elizabeth C Lloyd
    Department of Pediatrics, University of Michigan and CS Mott Children’s Hospital , Ann Arbor, Michigan , USA
  • Adam L Hersh
    Department of Pediatrics, University of Utah and Primary Children’s Hospital , Salt Lake City, Utah , USA
  • Charles W Huskins
    Department of Pediatrics, Mayo Clinic College of Medicine and Science , Rochester, Minnesota , USA
  • Vijaya L Soma
    Department of Pediatrics, Hassenfeld Children’s Hospital, NYU Grossman School of Medicine , New York, New York , USA
  • Adam J Ratner
    Department of Pediatrics, Hassenfeld Children’s Hospital, NYU Grossman School of Medicine , New York, New York , USA
  • Molly Hayes
    Center for Healthcare Quality & Analytics, The Children’s Hospital of Philadelphia , Philadelphia, Pennsylvania , USA
  • Kevin Downes
    Department of Infectious Diseases, Children’s Hospital of Philadelphia , Philadelphia, Pennsylvania , USA
  • Kathleen Chiotos
    Department of Anesthesia and Critical Care Medicine, Children’s Hospital of Philadelphia , Philadelphia, Pennsylvania , USA
  • Steven P Grapentine
    Department of Pharmacy, University of California–San Francisco , San Francisco, California , USA
  • Rachel L Wattier
    Department of Pediatrics, University of California–San Francisco , San Francisco, California , USA
  • Gabriella S Lamb
    Department of Pediatrics, Division of Infectious Diseases, Boston Children’s Hospital , Boston, Massachusetts , USA
  • Philip Zachariah
    Department of Pediatrics, Columbia University Irving Medical Center , New York, New York , USA
  • Mari M Nakamura
    Antimicrobial Stewardship Program and Department of Pediatrics, Division of Infectious Diseases, Boston Children’s Hospital , Boston, Massachusetts , USA

Description

<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>Starting in November 2020, the US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for multiple novel virus-neutralizing monoclonal antibody therapies, including bamlanivimab monotherapy (now revoked), bamlanivimab and etesivimab, casirivimab and imdevimab (REGEN-COV), and sotrovimab, for treatment or postexposure prophylaxis of Coronavirus disease 2019 (COVID-19) in adolescents (≥12 years of age) and adults with certain high-risk conditions. Previous guidance is now updated based on new evidence and clinical experience.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacotherapy, and pediatric critical care medicine from 18 geographically diverse US institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on a review of the best available evidence and expert opinion.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>The course of COVID-19 in children and adolescents is typically mild, though more severe disease is occasionally observed. Evidence supporting risk stratification is incomplete. Randomized controlled trials have demonstrated the benefit of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-specific monoclonal antibody therapies in adults, but data on safety and efficacy in children or adolescents are limited. Potential harms associated with infusion reactions or anaphylaxis are reportedly low in adults.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>Based on evidence available as of August 31, 2021, the panel suggests a risk-based approach to administration of SARS-CoV-2 monoclonal antibody therapy. Therapy is suggested for the treatment of mild to moderate COVID-19 in adolescents (≥12 years of age) at the highest risk of progression to hospitalization or severe disease. Therapeutic decision-making about those at moderate risk of severe disease should be individualized. Use as postexposure prophylaxis could be considered for those at the highest risk who have a high-risk exposure but are not yet diagnosed with COVID-19. Clinicians and health systems should ensure safe and timely implementation of these therapeutics that does not exacerbate existing healthcare disparities.</jats:p> </jats:sec>

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