Related Experiment Video
Updated: Nov 4, 2025

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
Published on: September 15, 2023
SARS-CoV-2 Monoclonal Antibodies in Children: Ethical Considerations
1Department of Clinical Ethics, Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota.
Insights
Monoclonal antibodies (mAbs) for high-risk children with COVID-19 are approved but lack efficacy data. Healthcare providers must ethically balance using these unproven treatments against withholding potentially life-saving care.
Area of Science:
- Pediatric Infectious Diseases
- Medical Ethics
- Health Equity
Background:
- US FDA approved monoclonal antibodies (mAbs) for high-risk children with COVID-19 under Emergency Use Authorization.
- Limited data exist on the tolerability and efficacy of mAbs in pediatric populations (<18 years).
- Disproportionate numbers of eligible children are from Black, Native American, and other minority communities.
Purpose of the Study:
- To analyze the ethical challenges faced by health systems, hospitals, and clinicians regarding mAb use in children.
- To provide recommendations for ethically balancing the use of an untested therapy versus withholding potentially life-saving treatment.
Main Methods:
- Ethical analysis of the tensions between experimental treatment and withholding care.
- Identification of strategies for health systems, hospitals, and clinicians.
Main Results:
- Healthcare providers face a dilemma when administering unproven mAbs to high-risk pediatric patients.
- Ethical frameworks are needed to navigate the risks and potential benefits of these therapies.
Conclusions:
- Health systems must develop clear guidelines for the ethical use of mAbs in children.
- Balancing innovation with patient safety and equity is crucial when using novel treatments.
Abstract:
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.
More Related Videos
07:52Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
Published on: September 10, 2018
10:25Detection of SARS-CoV-2 Neutralizing Antibodies using High-Throughput Fluorescent Imaging of Pseudovirus Infection
Published on: June 5, 2021
Related Concept Videos
Pharmacokinetics in Pediatric Patients: Drug Excretion
Cross-reactivity
Pharmacokinetics in Pediatric Patients: Drug Distribution
Pharmacokinetics in Pediatric Patients: Drug Metabolism