Initial guidance on use of monoclonal antibody therapy for treatment of coronavirus disease 2019 in children and adolescents

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; Gabriela M. Maron; 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 C. Lloyd; Adam L. Hersh; Emily A. Thorell; Adam J. Ratner; Kathleen Chiotos; Mari M. Nakamura

doi:10.1093/jpids/piaa175

Initial guidance on use of monoclonal antibody therapy for treatment of coronavirus disease 2019 in children and adolescents

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. KimberlinSarah B. Jones, Laura L. Bio, Theodore H. Morton, Jane S. Hankins, Gabriela M. Maron, 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 C. Lloyd, Adam L. Hersh, Emily A. Thorell, Adam J. Ratner, Kathleen Chiotos, Mari M. Nakamura

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

52 Citations (Scopus)

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.

Original language	English
Pages (from-to)	629-634
Number of pages	6
Journal	Journal of the Pediatric Infectious Diseases Society
Volume	10
Issue number	5
Early online date	03 Jan 2021
DOIs	https://doi.org/10.1093/jpids/piaa175
Publication status	Published - 01 May 2021
Externally published	Yes

Bibliographical note

Funding Information:
J. W. reports support to his institution from Karius Inc., Merck Inc. and Astellas Inc. for participation in sponsored research unrelated to this work; K. J. D. reports support to his institution from Merck Inc. for participation in sponsored research unrelated to this work; S. H. J. reports payment for work as a consultant to Bayer unrelated to this work; P. K. S. reports support to his institution from Merck Inc., Allovir Inc., and Gilead Sciences Inc. for participation in sponsored research unrelated to this work; W. C. H. reports payment for work as a member of an Advisory Board to ADMA Biologics and a member of an Adjudication Committee for Pfizer, both unrelated to this work; D. W. K. reports support to his institution from Gilead Sciences Inc. for participation in sponsored research unrelated to this work; A. W. reports support from Kyorin Pharmaceutical as an Advisory Board Member, support to her institution from Ansun Biopharma and Allovir Inc. for participation in sponsored research, and research support from VB Tech and Amazon Inc., all unrelated to this work.; G. M. M reports support to her institution from Astellas Inc. for participation in sponsored research unrelated to this work; R. L. W. reports employment of a family member by Lucence Diagnostics unrelated to this work; J. S. H. reports payment for work as a consultant to Global Blood Therapeutics and MJH Lifesciences, and research support from Global Blood Therapeutics, all unrelated to this work; A. J. R. reports payment for work as a consultant to Pfizer Inc. unrelated to this work. No other conflicts of interest were reported. All authors have submitted the ICMJE Form for Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Publisher Copyright:
© 2021 The Author(s). Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved.

Keywords

bamlanivimab
casirivimab
COVID-19
imdevimab
pediatric

ASJC Scopus subject areas

General Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1093/jpids/piaa175Licence: Unspecified

Cite this

Wolf, J., Abzug, M. J., Wattier, R. L., Sue, P. K., Vora, S. B., Zachariah, P., Dulek, D. E., Waghmare, A., Olivero, R., Downes, K. J., James, S. H., Pinninti, S. G., Yarbrough, A., Aldrich, M. L., Macbrayne, C. E., Soma, V. L., Grapentine, S. P., Oliveira, C. R., Hayes, M., ... Nakamura, M. M. (2021). Initial guidance on use of monoclonal antibody therapy for treatment of coronavirus disease 2019 in children and adolescents. Journal of the Pediatric Infectious Diseases Society, 10(5), 629-634. https://doi.org/10.1093/jpids/piaa175

@article{357dae5beeac48dfaae0b98607dff751,

title = "Initial guidance on use of monoclonal antibody therapy for treatment of coronavirus disease 2019 in children and adolescents",

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. ",

keywords = "bamlanivimab, casirivimab, COVID-19, imdevimab, pediatric",

author = "Joshua Wolf and Abzug, {Mark J.} and Wattier, {Rachel L.} and Sue, {Paul K.} and Vora, {Surabhi B.} and Philip Zachariah and Dulek, {Daniel E.} and Alpana Waghmare and Rosemary Olivero and Downes, {Kevin J.} and James, {Scott H.} and Pinninti, {Swetha G.} and April Yarbrough and Aldrich, {Margaret L.} and Macbrayne, {Christine E.} and Soma, {Vijaya L.} and Grapentine, {Steven P.} and Oliveira, {Carlos R.} and Molly Hayes and Kimberlin, {David W.} and Jones, {Sarah B.} and Bio, {Laura L.} and Morton, {Theodore H.} and Hankins, {Jane S.} and Maron, {Gabriela M.} and Kathryn Timberlake and Young, {Jennifer L.} and Orscheln, {Rachel C.} and Schwenk, {Hayden T.} and Goldman, {David L.} and Groves, {Helen E.} and Huskins, {W. Charles} and Rajapakse, {Nipunie S.} and Lamb, {Gabriella S.} and Tribble, {Alison C.} and Lloyd, {Elizabeth C.} and Hersh, {Adam L.} and Thorell, {Emily A.} and Ratner, {Adam J.} and Kathleen Chiotos and Nakamura, {Mari M.}",

note = "Funding Information: J. W. reports support to his institution from Karius Inc., Merck Inc. and Astellas Inc. for participation in sponsored research unrelated to this work; K. J. D. reports support to his institution from Merck Inc. for participation in sponsored research unrelated to this work; S. H. J. reports payment for work as a consultant to Bayer unrelated to this work; P. K. S. reports support to his institution from Merck Inc., Allovir Inc., and Gilead Sciences Inc. for participation in sponsored research unrelated to this work; W. C. H. reports payment for work as a member of an Advisory Board to ADMA Biologics and a member of an Adjudication Committee for Pfizer, both unrelated to this work; D. W. K. reports support to his institution from Gilead Sciences Inc. for participation in sponsored research unrelated to this work; A. W. reports support from Kyorin Pharmaceutical as an Advisory Board Member, support to her institution from Ansun Biopharma and Allovir Inc. for participation in sponsored research, and research support from VB Tech and Amazon Inc., all unrelated to this work.; G. M. M reports support to her institution from Astellas Inc. for participation in sponsored research unrelated to this work; R. L. W. reports employment of a family member by Lucence Diagnostics unrelated to this work; J. S. H. reports payment for work as a consultant to Global Blood Therapeutics and MJH Lifesciences, and research support from Global Blood Therapeutics, all unrelated to this work; A. J. R. reports payment for work as a consultant to Pfizer Inc. unrelated to this work. No other conflicts of interest were reported. All authors have submitted the ICMJE Form for Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Publisher Copyright: {\textcopyright} 2021 The Author(s). Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved.",

year = "2021",

month = may,

day = "1",

doi = "10.1093/jpids/piaa175",

language = "English",

volume = "10",

pages = "629--634",

journal = "Journal of the Pediatric Infectious Diseases Society",

issn = "2048-7193",

publisher = "Oxford University Press",

number = "5",

}

Wolf, J, Abzug, MJ, Wattier, RL, Sue, PK, Vora, SB, Zachariah, P, Dulek, DE, Waghmare, A, Olivero, R, Downes, KJ, James, SH, Pinninti, SG, Yarbrough, A, Aldrich, ML, Macbrayne, CE, Soma, VL, Grapentine, SP, Oliveira, CR, Hayes, M, Kimberlin, DW, Jones, SB, Bio, LL, Morton, TH, Hankins, JS, Maron, GM, Timberlake, K, Young, JL, Orscheln, RC, Schwenk, HT, Goldman, DL, Groves, HE, Huskins, WC, Rajapakse, NS, Lamb, GS, Tribble, AC, Lloyd, EC, Hersh, AL, Thorell, EA, Ratner, AJ, Chiotos, K & Nakamura, MM 2021, 'Initial guidance on use of monoclonal antibody therapy for treatment of coronavirus disease 2019 in children and adolescents', Journal of the Pediatric Infectious Diseases Society, vol. 10, no. 5, pp. 629-634. https://doi.org/10.1093/jpids/piaa175

TY - JOUR

T1 - Initial guidance on use of monoclonal antibody therapy for treatment of coronavirus disease 2019 in children and adolescents

AU - Wolf, Joshua

AU - Abzug, Mark J.

AU - Wattier, Rachel L.

AU - Sue, Paul K.

AU - Vora, Surabhi B.

AU - Zachariah, Philip

AU - Dulek, Daniel E.

AU - Waghmare, Alpana

AU - Olivero, Rosemary

AU - Downes, Kevin J.

AU - James, Scott H.

AU - Pinninti, Swetha G.

AU - Yarbrough, April

AU - Aldrich, Margaret L.

AU - Macbrayne, Christine E.

AU - Soma, Vijaya L.

AU - Grapentine, Steven P.

AU - Oliveira, Carlos R.

AU - Hayes, Molly

AU - Kimberlin, David W.

AU - Jones, Sarah B.

AU - Bio, Laura L.

AU - Morton, Theodore H.

AU - Hankins, Jane S.

AU - Maron, Gabriela M.

AU - Timberlake, Kathryn

AU - Young, Jennifer L.

AU - Orscheln, Rachel C.

AU - Schwenk, Hayden T.

AU - Goldman, David L.

AU - Groves, Helen E.

AU - Huskins, W. Charles

AU - Rajapakse, Nipunie S.

AU - Lamb, Gabriella S.

AU - Tribble, Alison C.

AU - Lloyd, Elizabeth C.

AU - Hersh, Adam L.

AU - Thorell, Emily A.

AU - Ratner, Adam J.

AU - Chiotos, Kathleen

AU - Nakamura, Mari M.

N1 - Funding Information: J. W. reports support to his institution from Karius Inc., Merck Inc. and Astellas Inc. for participation in sponsored research unrelated to this work; K. J. D. reports support to his institution from Merck Inc. for participation in sponsored research unrelated to this work; S. H. J. reports payment for work as a consultant to Bayer unrelated to this work; P. K. S. reports support to his institution from Merck Inc., Allovir Inc., and Gilead Sciences Inc. for participation in sponsored research unrelated to this work; W. C. H. reports payment for work as a member of an Advisory Board to ADMA Biologics and a member of an Adjudication Committee for Pfizer, both unrelated to this work; D. W. K. reports support to his institution from Gilead Sciences Inc. for participation in sponsored research unrelated to this work; A. W. reports support from Kyorin Pharmaceutical as an Advisory Board Member, support to her institution from Ansun Biopharma and Allovir Inc. for participation in sponsored research, and research support from VB Tech and Amazon Inc., all unrelated to this work.; G. M. M reports support to her institution from Astellas Inc. for participation in sponsored research unrelated to this work; R. L. W. reports employment of a family member by Lucence Diagnostics unrelated to this work; J. S. H. reports payment for work as a consultant to Global Blood Therapeutics and MJH Lifesciences, and research support from Global Blood Therapeutics, all unrelated to this work; A. J. R. reports payment for work as a consultant to Pfizer Inc. unrelated to this work. No other conflicts of interest were reported. All authors have submitted the ICMJE Form for Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Publisher Copyright: © 2021 The Author(s). Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved.

PY - 2021/5/1

Y1 - 2021/5/1

N2 - 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.

AB - 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.

KW - bamlanivimab

KW - casirivimab

KW - COVID-19

KW - imdevimab

KW - pediatric

U2 - 10.1093/jpids/piaa175

DO - 10.1093/jpids/piaa175

M3 - Article

C2 - 33388760

AN - SCOPUS:85105560744

SN - 2048-7193

VL - 10

SP - 629

EP - 634

JO - Journal of the Pediatric Infectious Diseases Society

JF - Journal of the Pediatric Infectious Diseases Society

IS - 5

ER -

Initial guidance on use of monoclonal antibody therapy for treatment of coronavirus disease 2019 in children and adolescents

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Fingerprint

Cite this