Joshua Wolf1,2, Mark J Abzug3, Rachel L Wattier4, Paul K Sue5, Surabhi B Vora6,7, Philip Zachariah8, Daniel E Dulek9, Alpana Waghmare6,7,10, Rosemary Olivero11, Kevin J Downes12, Scott H James13, Swetha G Pinninti13, April Yarbrough14, Margaret L Aldrich15, Christine E MacBrayne16, Vijaya L Soma17, Steven P Grapentine18, Carlos R Oliveira19, Molly Hayes20, David W Kimberlin13, Sarah B Jones21, Laura L Bio22, Theodore H Morton1, Jane S Hankins23, Gabriela M Maron1, Kathryn Timberlake24, Jennifer L Young25, Rachel C Orscheln26, Hayden T Schwenk27, David L Goldman15, Helen E Groves28, W Charles Huskins29, Nipunie S Rajapakse29, Gabriella S Lamb30, Alison C Tribble31, Elizabeth C Lloyd31, Adam L Hersh32, Emily A Thorell32, Adam J Ratner17,33, Kathleen Chiotos12,34, Mari M Nakamura30,35. 1. Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA. 2. Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee, USA. 3. Department of Pediatrics, Division of Infectious Diseases, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 4. Department of Pediatrics, Division of Infectious Diseases and Global Health, University of California-San Francisco, San Francisco, California, USA. 5. Department of Pediatrics, Division of Pediatric Infectious Diseases, University of Texas Southwestern Medical Center, Dallas, Texas, USA. 6. Department of Pediatrics, Division of Pediatric Infectious Diseases, University of Washington, Seattle. 7. Children's Hospital, Seattle, Washington, USA. 8. Department of Pediatrics, Division of Infectious Diseases, Columbia University, New York, New York, USA. 9. Department of Pediatrics, Division of Infectious Diseases, Vanderbilt University and Monroe Carell Jr. Children's Hospital, Nashville, Tennessee, USA. 10. Fred Hutchinson Cancer Research Center, Vaccine and Infectious Diseases Division, Seattle, Washington, USA. 11. 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. 12. Department of Pediatrics, Division of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. 13. Department of Pediatrics, Division of Pediatric Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA. 14. Department of Pharmacy, Children's of Alabama, Birmingham, Alabama, USA. 15. Department of Pediatrics, Division of Infectious Diseases, Children's Hospital at Montefiore, New York, New York, USA. 16. Department of Pharmacy, Children's Hospital Colorado, Aurora, Colorado, USA. 17. Department of Pediatrics, Division of Infectious Diseases, New York University Grossman School of Medicine and Hassenfeld Children's Hospital, New York, New York, USA. 18. Department of Pharmacy, University of California-San Francisco Benioff Children's Hospital, San Francisco, California, USA. 19. Department of Pediatrics, Division of Infectious Diseases and Global Health, Yale University School of Medicine, New Haven, Connecticut, USA. 20. Antimicrobial Stewardship Program, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. 21. Department of Pharmacy, Boston Children's Hospital, Boston, Massachusetts, USA. 22. Department of Pharmacy, Lucile Packard Children's Hospital Stanford, Palo Alto, California, USA. 23. Department of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA. 24. Department of Pharmacy, The Hospital for Sick Children, Toronto, Ontario, Canada. 25. Department of Pharmacy, St. Louis Children's Hospital, St. Louis, Missouri, USA. 26. Department of Pediatrics, Division of Infectious Diseases, Washington University and St. Louis Children's Hospital, St. Louis, Missouri, USA. 27. Department of Pediatrics, Division of Infectious Diseases, Stanford University School of Medicine and Lucile Packard Children's Hospital Stanford, Stanford, California, USA. 28. Department of Pediatrics, Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada. 29. Department of Pediatric and Adolescent Medicine, Division of Pediatric Infectious Diseases, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA. 30. Department of Pediatrics, Division of Infectious Diseases, Boston Children's Hospital, Boston, Massachusetts, USA. 31. Department of Pediatrics, Division of Infectious Diseases, University of Michigan and CS Mott Children's Hospital, Ann Arbor, Michigan, USA. 32. Department of Pediatrics, Division of Infectious Diseases, University of Utah and Primary Children's Hospital, Salt Lake City, Utah, USA. 33. Department of Microbiology, New York University Grossman School of Medicine, New York, New York, USA. 34. Department of Anesthesia and Critical Care Medicine, Division of Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. 35. Antimicrobial Stewardship Program, Boston Children's Hospital, Boston, Massachusetts, USA.
Abstract
BACKGROUND: In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (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 the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.
BACKGROUND: In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for 2 novel virus-neutralizing monoclonal antibody therapies, bamlanivimab and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate coronavirus disease 2019 (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 the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.
Authors: Raymund R Razonable; Nicole C E Aloia; Ryan J Anderson; Gokhan Anil; Lori L Arndt; Richard F Arndt; Sara E Ausman; Sarah J Bell; Dennis M Bierle; Marcie L Billings; Rachel K Bishop; Carl H Cramer; Tracy L Culbertson; Ala S Dababneh; Amber N Derr; Kevin Epps; Susan M Flaker; Ravindra Ganesh; Mary A Gilmer; Eric Gomez Urena; Christopher R Gulden; Tamara L Haack; Sara N Hanson; Jenna R Herzog; Alexander Heyliger; Lex D Hokanson; Laura H Hopkins; Richard J Horecki; Bipinchandra Hirisave Krishna; W Charles Huskins; Tammy A Jackson; Ryan R Johnson; Betty Jorgenson; Cory Kudrna; Brian D Kennedy; Mary K Klingsporn; Brian Kottke; Jennifer J Larsen; Sarah R Lessard; Larry I Lutwick; Edward J Malone; Jennifer A Matoush; Ivana N Micallef; Darcie E Moehnke; Muhanad Mohamed; Colleena N Ness; Shelly M Olson; Robert Orenstein; Raj Palraj; Janki Patel; Damian J Paulson; David Phelan; Margaret T Peinovich; Wilford L Ramsey; Taunya J Rau-Kane; Kevin I Reid; Karen J Reinschmidt; Maria Teresa Seville; Erin C Skold; Jill M Smith; Leigh L Speicher; Laurie A Spielman; Donna J Springer; Perry W Sweeten; Jennifer M Tempelis; Sidna Tulledge-Scheitel; Paschalis Vergidis; Daniel C Whipple; Caroline G Wilker; Molly J Destro Borgen Journal: Mayo Clin Proc Date: 2021-03-09 Impact factor: 7.616
Authors: Myriam Belén González Viacava; Augusto Varese; Ignacio Mazzitelli; Laura Lanari; Lucía Ávila; María Julia García Vampa; Jorge Geffner; Osvaldo Cascone; José Christian Dokmetjian; Adolfo Rafael de Roodt; Matías Fingermann Journal: Antibodies (Basel) Date: 2022-01-02
Authors: Fabian Zech; Daniel Schniertshauer; Christoph Jung; Alexandra Herrmann; Arne Cordsmeier; Qinya Xie; Rayhane Nchioua; Caterina Prelli Bozzo; Meta Volcic; Lennart Koepke; Janis A Müller; Jana Krüger; Sandra Heller; Steffen Stenger; Markus Hoffmann; Stefan Pöhlmann; Alexander Kleger; Timo Jacob; Karl-Klaus Conzelmann; Armin Ensser; Konstantin M J Sparrer; Frank Kirchhoff Journal: Nat Commun Date: 2021-11-25 Impact factor: 14.919