Overview

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUA) for monoclonal antibodies to treat COVID-19 for certain patients. Monoclonal antibodies may be available through expanded access programs to treat COVID-19 for immunocompromised patients. However, the efficacy of use for immunocompromised patients is unclear.

During this COCA Call, presenters will discuss the FDA’s role in issuing EUAs for certain monoclonal antibodies, options for compassionate use, the process for ordering and distributing monoclonal antibodies, and current data on using monoclonal antibodies for both non-hospitalized and immunocompromised patients. Presenters will also cover preventing, diagnosing, and treating COVID-19 in immunocompromised patients, including the role of monoclonal antibodies, serologic testing, and potential third dose of COVID-19 vaccinations.

Presenters

Elliot Raizes, MD
Task Force Lead
Health Services and Worker Safety Task Force
COVID-19 Response
Centers for Disease Control​ and Prevention

John Farley, MD, MPH
Director, Office of Infectious Diseases
Center for Drug Evaluation and Research
Office of New Drugs
U.S. Food and Drug Administration

Colin Shepard, MD
CDC Liaison to the Assistant Secretary for Preparedness and Response (ASPR)
Center for Preparedness and Response
Centers for Disease Control and Prevention

Rajesh Gandhi, MD
Director, HIV Clinical Services and Education, Massachusetts General Hospital
Professor of Medicine, Harvard Medical School

Adi V. Gundlapalli, MD, PhD
Co-Lead, Serology and Correlates of Protection Tiger Team, COVID-19 Response
Chief Public Health Informatics Officer
Center for Surveillance, Epidemiology, and Laboratory Services
Centers for Disease Control and Prevention