What is an Emergency Use Authorization (EUA)?
The United States FDA has made monoclonal antibody treatment available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services' (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
Monoclonal antibody treatment has not undergone the same type of review as an FDA approved or cleared product. The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.
The EUA for monoclonal antibody treatment is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the product may no longer be used).