1. Updated Guidance on Use and Prioritization of Monoclonal Antibody Therapy for Treatment of COVID-19 in Adolescents
- Author
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Wolf, Joshua, Abzug, Mark J, Anosike, Brenda I, Vora, Surabhi B, Waghmare, Alpana, Sue, Paul K, Olivero, Rosemary M, Oliveira, Carlos R, James, Scott H, Morton, Theodore H, Maron, Gabriela M, Young, Jennifer L, Orscheln, Rachel C, Schwenk, Hayden T, Bio, Laura L, Willis, Zachary I, Lloyd, Elizabeth C, Hersh, Adam L, Huskins, Charles W, Soma, Vijaya L, Ratner, Adam J, Hayes, Molly, Downes, Kevin, Chiotos, Kathleen, Grapentine, Steven P, Wattier, Rachel L, Lamb, Gabriella S, Zachariah, Philip, and Nakamura, Mari M
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Infectious Diseases ,Biodefense ,Pneumonia & Influenza ,Pediatric Research Initiative ,Lung ,Pediatric ,Vaccine Related ,Pneumonia ,Prevention ,Patient Safety ,Biotechnology ,Emerging Infectious Diseases ,Clinical Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,Adolescent ,Adult ,Antibodies ,Monoclonal ,Antibodies ,Monoclonal ,Humanized ,Antibodies ,Neutralizing ,Antibodies ,Viral ,Child ,Drug Combinations ,Humans ,Practice Guidelines as Topic ,SARS-CoV-2 ,COVID-19 Drug Treatment ,bamlanivimab and etesevimab ,COVID-19 ,pediatric ,REGEN-COV ,sotrovimab ,Medical microbiology ,Paediatrics - Abstract
BackgroundStarting in November 2020, the US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for multiple novel virus-neutralizing monoclonal antibody therapies, including bamlanivimab monotherapy (now revoked), bamlanivimab and etesivimab, casirivimab and imdevimab (REGEN-COV), and sotrovimab, for treatment or postexposure prophylaxis of Coronavirus disease 2019 (COVID-19) in adolescents (≥12 years of age) and adults with certain high-risk conditions. Previous guidance is now updated based on new evidence and clinical experience.MethodsA panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacotherapy, and pediatric critical care medicine from 18 geographically diverse US institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on a review of the best available evidence and expert opinion.ResultsThe course of COVID-19 in children and adolescents is typically mild, though more severe disease is occasionally observed. Evidence supporting risk stratification is incomplete. Randomized controlled trials have demonstrated the benefit of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-specific monoclonal antibody therapies in adults, but data on safety and efficacy in children or adolescents are limited. Potential harms associated with infusion reactions or anaphylaxis are reportedly low in adults.ConclusionsBased on evidence available as of August 31, 2021, the panel suggests a risk-based approach to administration of SARS-CoV-2 monoclonal antibody therapy. Therapy is suggested for the treatment of mild to moderate COVID-19 in adolescents (≥12 years of age) at the highest risk of progression to hospitalization or severe disease. Therapeutic decision-making about those at moderate risk of severe disease should be individualized. Use as postexposure prophylaxis could be considered for those at the highest risk who have a high-risk exposure but are not yet diagnosed with COVID-19. Clinicians and health systems should ensure safe and timely implementation of these therapeutics that does not exacerbate existing healthcare disparities.
- Published
- 2022