Use of Monoclonal Antibody to Treat COVID-19 in Children and Adolescents: Risk of Abuse of Prescription and Exacerbation of Health Inequalities.

Susanna Esposito,Nicola Principi,Giovanni Battista Migliori,Andrea Pession,Stefano Zona,Lorenzo Iughetti

doi:10.3390/ph14070673

Abstract

Monoclonal antibodies (mAbs) that neutralize SARS-CoV-2 in infected patients are a new class of antiviral agents approved as a type of passive immunotherapy. They should be administered to adults and children (≥12 years old, weighing ≥ 40 kg) with SARS-CoV-2 positivity, and who are suffering from a chronic underlying disease and are at risk of severe COVID-19 and/or hospitalization. The aim of this manuscript is to discuss the benefit-to-risk of mAb therapy to treat COVID-19 in pediatric age, according to current reports. A problem is that the authorization for mAbs use in children was given without studies previously evaluating the efficacy, safety and tolerability of mAbs in pediatric patients. Moreover, although the total number of children with chronic severe underlying disease is not marginal, the risk of severe COVID-19 in pediatric age is significantly reduced than in adults and the role of chronic underlying disease as a risk factor of severe COVID-19 development in pediatric patients is far from being precisely defined. In addition, criteria presently suggested for use of mAbs in children and adolescents are very broad and may cause individual clinicians or institutions to recommend these agents on a case-by-case basis, with an abuse in mAbs prescriptions and an exacerbation of health inequalities while resources are scarce. Several questions need to be addressed before their routine use in clinical practice, including what is their associated benefit-to-risk ratio in children and adolescents, who are the patients that could really have benefit from their use, and if there is any interference of mAb therapy on recommended vaccines. While we wait for answers to these questions from well-conducted research, an effective and safe COVID-19 vaccine for vulnerable pediatric patients remains the best strategy to prevent COVID-19 and represents the priority for public health policies.

Highlights

Monoclonal antibodies that can neutralize the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in infected patients are a novel class of antiviral intervention for which the US Food and Drug Administration (FDA) and European Medicines Agency
They should be administered to adults and children (≥12 years old, weighing ≥ 40 kg) with positive results of direct SARS-CoV-2 testing, and who are suffering from a chronic underlying disease that may favor progression to severe COVID-19 and/or hospitalization [1,2]
The criteria currently used for Monoclonal antibodies (mAbs) therapy against SARS-CoV-2 are very broad and allow individual clinicians or institutions to use these agents on a case-by-case basis, adding to abuse in mAbs prescription and an exacerbation of health inequalities while resources are scarce

Summary

Background

In the current coronavirus disease 2019 (COVID-19) pandemic, several prophylactic and therapeutic approaches are being developed or repurposed to combat COVID-19. All mAbs are approved as a type of passive immunotherapy to minimize virulence for the treatment of non-hospitalized patients with mild-to-moderate COVID-19. They should be administered to adults and children (≥12 years old, weighing ≥ 40 kg) with positive results of direct SARS-CoV-2 testing, and who are suffering from a chronic underlying disease that may favor progression to severe COVID-19 and/or hospitalization [1,2]. Looking at EUAs, the logic of considering older children as adults could be debated The aim of this manuscript is to discuss the benefit-torisk of mAb therapy to treat COVID-19 in pediatric age according to current reports

Monoclonal Antibodies against SARS-CoV-2

Findings

Conclusions