TY - JOUR
T1 - SARS-CoV-2 Monoclonal Antibodies in Children
T2 - Ethical Considerations
AU - Wolfe, Ian D.
AU - Patel, Sameer J.
N1 - Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/6
Y1 - 2021/6
N2 - The use of monoclonal antibodies in children with certain conditions and at high risk for severe COVID-19 has been approved by the US Food and Drug Administration under the Emergency Use Authorization mechanism of the Federal Food, Drug, and Cosmetic Act. No data on the tolerability or efficacy of these therapies in persons <18 years of age are available; there is risk. Whether they will work is unknown, but they could. A disproportionate number of these children who meet the criteria for treatment with mAbs are from communities of black, Native American, and other race. How should health systems, hospitals, and clinicians balance the tensions between being seen as experimenting with an untested drug as opposed to withholding a potentially life-saving treatment? This article identifies, analyzes, and makes recommendations on the methods by which health systems, hospitals, and individual clinicians can ethically balance these tensions.
AB - The use of monoclonal antibodies in children with certain conditions and at high risk for severe COVID-19 has been approved by the US Food and Drug Administration under the Emergency Use Authorization mechanism of the Federal Food, Drug, and Cosmetic Act. No data on the tolerability or efficacy of these therapies in persons <18 years of age are available; there is risk. Whether they will work is unknown, but they could. A disproportionate number of these children who meet the criteria for treatment with mAbs are from communities of black, Native American, and other race. How should health systems, hospitals, and clinicians balance the tensions between being seen as experimenting with an untested drug as opposed to withholding a potentially life-saving treatment? This article identifies, analyzes, and makes recommendations on the methods by which health systems, hospitals, and individual clinicians can ethically balance these tensions.
KW - COVID-19
KW - MAbs
KW - SARS-CoV-2
KW - children and adolescents
KW - ethics
KW - monoclonal antibodies
KW - pediatrics
UR - http://www.scopus.com/inward/record.url?scp=85106597069&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85106597069&partnerID=8YFLogxK
U2 - 10.1016/j.clinthera.2021.04.008
DO - 10.1016/j.clinthera.2021.04.008
M3 - Comment/debate
C2 - 34049725
AN - SCOPUS:85106597069
VL - 43
SP - e157-e162
JO - Clinical Therapeutics
JF - Clinical Therapeutics
SN - 0149-2918
IS - 6
ER -