The following is the summary of “Monoclonal Antibody and Antiviral Therapy for Mild-to-Moderate COVID-19 in Pediatric Patients” published in the January 2023 issue of Pediatric Infectious Disease by Vora, et al.
Mild-to-moderate COVID-19 in high-risk patients younger than ≥12 years old is currently treatable with various antiviral and monoclonal antibody treatments. Unfortunately, there is a lack of information on the administration of these agents to youngsters. Researchers discuss patient characteristics, treatment logistics, and associated short-term events in a retrospective review of 94 pediatric patients who requested early therapy following the introduction of the Omicron variant.
New treatments for mild and moderate COVID-19 in high-risk adolescents and adults emerged simultaneously as the spread of the SARS-CoV-2 Omicron variant (B.1.1.529). In the United States, children younger than ≥12 have been granted Emergency Use Authorization (EUA) for the oral antivirals nirmatrelvir/ritonavir and the monoclonal antibody sotrovimab1, even though the research that led to their approval did not include pediatric patients. Around 2,3 Additionally, the trial found that a 3-day course of remdesivir decreased hospitalizations in high-risk outpatients, despite the fact that it involved only 8 patients <18 years of age. About 4 Additionally, molnupiravir was only approved for use in adults after extensive research was conducted on the topic. 5 All in all, there is a lack of information on the application of any of these drugs in juvenile patients.
For patients who are severely immunocompromised or incompletely vaccinated due to risk factors such as severe obesity, medical complexity with respiratory technology dependence, or multiple other risk factors, our institution prioritized monoclonal antibodies and early antivirals based on US Food and Drug Administration (FDA) EUA criteria, pediatric-specific guidance,6 and national prioritization schema,7 respectively. As a result, by the end of December 2021, the Omicron variant made up 95% of all SARS-CoV-2 strains in our area. Here, investigators detail the approval and denial criteria, treatment-related process measures, and early COVID-19 therapy’s short-term outcomes for high-risk pediatric patients.