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

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.

journal_name

J Pediatric Infect Dis Soc

journal_title

Journal of the Pediatric Infectious Diseases Society

authors

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 S

doi

10.1093/jpids/piaa175

subject

Has Abstract

pub_date

2021-01-03 00:00:00

eissn

2048-7193

issn

2048-7207

pii

6060076

pub_type

杂志文章

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