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Oxford University Press - PMC COVID-19 Collection logoLink to Oxford University Press - PMC COVID-19 Collection
. 2021 Jan 3:piaa175. doi: 10.1093/jpids/piaa175

Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents

Joshua Wolf 1,2,, Mark J Abzug 3, Rachel L Wattier 4, Paul K Sue 5, Surabhi B Vora 6, Philip Zachariah 7, Daniel E Dulek 8, Alpana Waghmare 6,9, Rosemary Olivero 10, Kevin J Downes 11, Scott H James 12, Swetha G Pinninti 12, April Yarbrough 13, Margaret L Aldrich 14, Christine E MacBrayne 15, Vijaya L Soma 16, Steven P Grapentine 17, Carlos R Oliveira 18, Molly Hayes 19, David W Kimberlin 20, Sarah B Jones 21, Laura L Bio 22, Theodore H Morton 1, Jane S Hankins 23, Gabriella M Marόn-Alfaro 1, Kathryn Timberlake 24, Jennifer L Young 25, Rachel C Orscheln 26, Hayden T Schwenk 27, David L Goldman 14, Helen E Groves 28, W Charles Huskins 29, Nipunie S Rajapakse 29, Gabriella S Lamb 30, Alison C Tribble 31, Elizabeth E Lloyd 31, Adam L Hersh 32, Emily A Thorell 32, Adam J Ratner 16,33, Kathleen Chiotos 11,34, Mari M Nakamura 30,35,
PMCID: PMC7799019  PMID: 33388760

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.

Keywords: COVID-19, Pediatric, Bamlanivimab, Casirivimab, Imdevimab


Articles from Journal of the Pediatric Infectious Diseases Society are provided here courtesy of Oxford University Press

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