On June 25, 2021, the Office of the Assistant Secretary for Preparedness and Response and the U.S. Food and Drug Administration sent a memo to health care provider stakeholders regarding the use and distribution of bamlanivimab and etesevimab together in the U.S. The FDA recommended that U.S. health care providers use either the authorized REGEN-COV or sotrovimab monoclonal antibody therapy until further notice. ASPR will pause distribution of bamlanivimab and etesevimab together, and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) in the U.S.
Updated: July 7, 2021
What are monoclonal antibodies?
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.1 “Monoclonal antibodies are basically antibodies that will attach to the spike protein of the SARS-CoV-2 virus (the virus that causes COVID-19). What it does is once it attaches to that spike protein, the virus cannot attach itself to the cells, thereby limiting the spread of the infection and preventing it from progressing further.”2
What monoclonal antibody therapies are available?
There currently are two therapies — bamlanivimab, and casirivimab and imdevimab — that have an emergency use authorization from the U.S. Food and Drug Administration for treatment of COVID-19. Additional details are below.
What’s the difference between convalescent plasma and monoclonal antibodies?
Basically, monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Convalescent plasma is from patients who already have recovered from COVID-19 and may contain antibodies against the virus.
How do I request mAB for my facility?
There is no shortage in supply of these drugs, and there is enough on hand to meet the needs of all treatment facilities. For this reason, casirivimab/imdevimab now are being made available through direct ordering only. All treatment sites meeting EUA requirements now must order casirivimab/imdevimab directly from AmerisourceBergen Corporation (ABC), the drugs’ sole distributor. The products remain free of charge to requesting sites. Treatment sites should review the direct ordering process guide and place orders directly with ABC.
Both Sotrovimab and Actemra (tocilizumab) should be ordered directly from their distributors. Neither of these treatment options are being procured or distributed by the government. However, tocilizumab is widely available and will be reimbursable, and HRSA uninsured patient fund still is operating.
What additional information is available to assist with decision-making and operational Implementation of this treatment for COVID-19?