Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents
Although monoclonal antibody therapies for coronavirus disease 2019 have received emergency use authorization for treatment of adolescents in specified high-risk categories, there is currently insufficient evidence for necessity, safety, or efficacy to recommend routine use, even in those with speci...
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creator | Wolf, Joshua Abzug, Mark J Wattier, Rachel L Sue, Paul K Vora, Surabhi B Zachariah, Philip Dulek, Daniel E Waghmare, Alpana Olivero, Rosemary Downes, Kevin J James, Scott H Pinninti, Swetha G Yarbrough, April Aldrich, Margaret L MacBrayne, Christine E Soma, Vijaya L Grapentine, Steven P Oliveira, Carlos R Hayes, Molly Kimberlin, David W Jones, Sarah B Bio, Laura L Morton, Theodore H Hankins, Jane S Maron, Gabriela M Timberlake, Kathryn Young, Jennifer L Orscheln, Rachel C Schwenk, Hayden T Goldman, David L Groves, Helen E Huskins, W Charles Rajapakse, Nipunie S Lamb, Gabriella S Tribble, Alison C Lloyd, Elizabeth C Hersh, Adam L Thorell, Emily A Ratner, Adam J Chiotos, Kathleen Nakamura, Mari M |
description | Although monoclonal antibody therapies for coronavirus disease 2019 have received emergency use authorization for treatment of adolescents in specified high-risk categories, there is currently insufficient evidence for necessity, safety, or efficacy to recommend routine use, even in those with specified conditions.
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. |
doi_str_mv | 10.1093/jpids/piaa175 |
format | Article |
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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.</description><identifier>ISSN: 2048-7207</identifier><identifier>EISSN: 2048-7207</identifier><identifier>DOI: 10.1093/jpids/piaa175</identifier><identifier>PMID: 33388760</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Adolescent ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Humanized ; Antiviral Agents - therapeutic use ; Child ; COVID-19 - epidemiology ; COVID-19 Drug Treatment ; Drug Approval ; Female ; Humans ; Male ; Pandemics ; Pneumonia, Viral - drug therapy ; Pneumonia, Viral - epidemiology ; Pneumonia, Viral - virology ; SARS-CoV-2 ; United States - epidemiology ; United States Food and Drug Administration</subject><ispartof>Journal of the Pediatric Infectious Diseases Society, 2021-05, Vol.10 (5), p.629-634</ispartof><rights>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. 2021</rights><rights>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.</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c365t-f658d9eee4fb033422c4a8b14a2efee52c7e849c344ea5db15c38ce0cdbb2a4a3</citedby><cites>FETCH-LOGICAL-c365t-f658d9eee4fb033422c4a8b14a2efee52c7e849c344ea5db15c38ce0cdbb2a4a3</cites><orcidid>0000-0003-2268-9470 ; 0000-0002-5080-1573 ; 0000-0003-1761-794X ; 0000-0002-9750-9107 ; 0000-0002-9912-3646 ; 0000-0001-5015-8146</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33388760$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wolf, Joshua</creatorcontrib><creatorcontrib>Abzug, Mark J</creatorcontrib><creatorcontrib>Wattier, Rachel L</creatorcontrib><creatorcontrib>Sue, Paul K</creatorcontrib><creatorcontrib>Vora, Surabhi B</creatorcontrib><creatorcontrib>Zachariah, Philip</creatorcontrib><creatorcontrib>Dulek, Daniel E</creatorcontrib><creatorcontrib>Waghmare, Alpana</creatorcontrib><creatorcontrib>Olivero, Rosemary</creatorcontrib><creatorcontrib>Downes, Kevin J</creatorcontrib><creatorcontrib>James, Scott H</creatorcontrib><creatorcontrib>Pinninti, Swetha G</creatorcontrib><creatorcontrib>Yarbrough, April</creatorcontrib><creatorcontrib>Aldrich, Margaret L</creatorcontrib><creatorcontrib>MacBrayne, Christine E</creatorcontrib><creatorcontrib>Soma, Vijaya L</creatorcontrib><creatorcontrib>Grapentine, Steven P</creatorcontrib><creatorcontrib>Oliveira, Carlos R</creatorcontrib><creatorcontrib>Hayes, Molly</creatorcontrib><creatorcontrib>Kimberlin, David W</creatorcontrib><creatorcontrib>Jones, Sarah B</creatorcontrib><creatorcontrib>Bio, Laura L</creatorcontrib><creatorcontrib>Morton, Theodore H</creatorcontrib><creatorcontrib>Hankins, Jane S</creatorcontrib><creatorcontrib>Maron, Gabriela M</creatorcontrib><creatorcontrib>Timberlake, Kathryn</creatorcontrib><creatorcontrib>Young, Jennifer L</creatorcontrib><creatorcontrib>Orscheln, Rachel C</creatorcontrib><creatorcontrib>Schwenk, Hayden T</creatorcontrib><creatorcontrib>Goldman, David L</creatorcontrib><creatorcontrib>Groves, Helen E</creatorcontrib><creatorcontrib>Huskins, W Charles</creatorcontrib><creatorcontrib>Rajapakse, Nipunie S</creatorcontrib><creatorcontrib>Lamb, Gabriella S</creatorcontrib><creatorcontrib>Tribble, Alison C</creatorcontrib><creatorcontrib>Lloyd, Elizabeth C</creatorcontrib><creatorcontrib>Hersh, Adam L</creatorcontrib><creatorcontrib>Thorell, Emily A</creatorcontrib><creatorcontrib>Ratner, Adam J</creatorcontrib><creatorcontrib>Chiotos, Kathleen</creatorcontrib><creatorcontrib>Nakamura, Mari M</creatorcontrib><title>Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents</title><title>Journal of the Pediatric Infectious Diseases Society</title><addtitle>J Pediatric Infect Dis Soc</addtitle><description>Although monoclonal antibody therapies for coronavirus disease 2019 have received emergency use authorization for treatment of adolescents in specified high-risk categories, there is currently insufficient evidence for necessity, safety, or efficacy to recommend routine use, even in those with specified conditions.
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.</description><subject>Adolescent</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Child</subject><subject>COVID-19 - epidemiology</subject><subject>COVID-19 Drug Treatment</subject><subject>Drug Approval</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Pandemics</subject><subject>Pneumonia, Viral - drug therapy</subject><subject>Pneumonia, Viral - epidemiology</subject><subject>Pneumonia, Viral - virology</subject><subject>SARS-CoV-2</subject><subject>United States - epidemiology</subject><subject>United States Food and Drug 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Alpana</creator><creator>Olivero, Rosemary</creator><creator>Downes, Kevin J</creator><creator>James, Scott H</creator><creator>Pinninti, Swetha G</creator><creator>Yarbrough, April</creator><creator>Aldrich, Margaret L</creator><creator>MacBrayne, Christine E</creator><creator>Soma, Vijaya L</creator><creator>Grapentine, Steven P</creator><creator>Oliveira, Carlos R</creator><creator>Hayes, Molly</creator><creator>Kimberlin, David W</creator><creator>Jones, Sarah B</creator><creator>Bio, Laura L</creator><creator>Morton, Theodore H</creator><creator>Hankins, Jane S</creator><creator>Maron, Gabriela M</creator><creator>Timberlake, Kathryn</creator><creator>Young, Jennifer L</creator><creator>Orscheln, Rachel C</creator><creator>Schwenk, Hayden T</creator><creator>Goldman, David L</creator><creator>Groves, Helen E</creator><creator>Huskins, W Charles</creator><creator>Rajapakse, Nipunie S</creator><creator>Lamb, Gabriella S</creator><creator>Tribble, Alison C</creator><creator>Lloyd, Elizabeth C</creator><creator>Hersh, Adam L</creator><creator>Thorell, Emily A</creator><creator>Ratner, Adam J</creator><creator>Chiotos, Kathleen</creator><creator>Nakamura, Mari M</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2268-9470</orcidid><orcidid>https://orcid.org/0000-0002-5080-1573</orcidid><orcidid>https://orcid.org/0000-0003-1761-794X</orcidid><orcidid>https://orcid.org/0000-0002-9750-9107</orcidid><orcidid>https://orcid.org/0000-0002-9912-3646</orcidid><orcidid>https://orcid.org/0000-0001-5015-8146</orcidid></search><sort><creationdate>20210528</creationdate><title>Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents</title><author>Wolf, Joshua ; Abzug, Mark J ; Wattier, Rachel L ; Sue, Paul K ; Vora, Surabhi B ; Zachariah, Philip ; Dulek, Daniel E ; Waghmare, Alpana ; Olivero, Rosemary ; Downes, Kevin J ; James, Scott H ; Pinninti, Swetha G ; Yarbrough, April ; Aldrich, Margaret L ; MacBrayne, Christine E ; Soma, Vijaya L ; Grapentine, Steven P ; Oliveira, Carlos R ; Hayes, Molly ; Kimberlin, David W ; Jones, Sarah B ; Bio, Laura L ; Morton, Theodore H ; Hankins, Jane S ; Maron, Gabriela M ; Timberlake, Kathryn ; Young, Jennifer L ; Orscheln, Rachel C ; Schwenk, Hayden T ; Goldman, David L ; Groves, Helen E ; Huskins, W Charles ; Rajapakse, Nipunie S ; Lamb, Gabriella S ; Tribble, Alison C ; Lloyd, Elizabeth C ; Hersh, Adam L ; Thorell, Emily A ; Ratner, Adam J ; Chiotos, Kathleen ; Nakamura, Mari 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Soc</addtitle><date>2021-05-28</date><risdate>2021</risdate><volume>10</volume><issue>5</issue><spage>629</spage><epage>634</epage><pages>629-634</pages><issn>2048-7207</issn><eissn>2048-7207</eissn><abstract>Although monoclonal antibody therapies for coronavirus disease 2019 have received emergency use authorization for treatment of adolescents in specified high-risk categories, there is currently insufficient evidence for necessity, safety, or efficacy to recommend routine use, even in those with specified conditions.
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.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>33388760</pmid><doi>10.1093/jpids/piaa175</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0003-2268-9470</orcidid><orcidid>https://orcid.org/0000-0002-5080-1573</orcidid><orcidid>https://orcid.org/0000-0003-1761-794X</orcidid><orcidid>https://orcid.org/0000-0002-9750-9107</orcidid><orcidid>https://orcid.org/0000-0002-9912-3646</orcidid><orcidid>https://orcid.org/0000-0001-5015-8146</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 2048-7207 |
ispartof | Journal of the Pediatric Infectious Diseases Society, 2021-05, Vol.10 (5), p.629-634 |
issn | 2048-7207 2048-7207 |
language | eng |
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source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
subjects | Adolescent Antibodies, Monoclonal - therapeutic use Antibodies, Monoclonal, Humanized Antiviral Agents - therapeutic use Child COVID-19 - epidemiology COVID-19 Drug Treatment Drug Approval Female Humans Male Pandemics Pneumonia, Viral - drug therapy Pneumonia, Viral - epidemiology Pneumonia, Viral - virology SARS-CoV-2 United States - epidemiology United States Food and Drug Administration |
title | Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents |
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