What is an Emergency Use Authorization (EUA)?

In certain emergency situations, the Food and Drug Administration (FDA) may issue an Emergency Use Authorization to provide more timely access to critical medical products when there are no other options available. An EUA permits the FDA to release unapproved medical products or allow for unapproved uses of medical products that have met certain criteria, to treat, diagnose, or prevent serious or life-threatening diseases.

Why do EUAs exist?

EUAs were initially introduced in 2004 to prepare for bioterrorism attacks. Under an EUA, the government is able to authorize medical treatments and products in the event of a Chemical, Biological, Radiological, and Nuclear (CBRN) attack.

What is the criteria for an EUA?

The FDA may issue an EUA for a medical product if it meets the following criteria: The disease or CBRN agent in question can cause a serious or life-threatening illness or condition.  There is reasonable belief, after looking at all the scientific evidence, that the product may be effective for its intended use. The phrase “may be effective” lowers the standards for scientific evidence typically required for FDA approvals. The known and potential benefits outweigh the known and potential risks. The FDA will look at all available scientific evidence to determine the risk and benefits of a product.  There... Read More

Is it common for vaccines to be authorized under an EUA?

The only vaccine that has been authorized under an EUA so far was an anthrax vaccine in 2005. This vaccine was given to certain military personnel who were at heightened risk of exposure to anthrax.

When have EUAs been issued in the past?

Although not common, EUAs have been issued multiple times in the past for tests, treatments, and medical equipment.   In 2009, EUAs were issued for diagnostic tests, personal protection equipment, and certain antiviral drugs during the H1N1 Swine Influenza pandemic.   In 2013, EUAs were issued for diagnostic tests related to H7N9 influenza and Middle East Respiratory Syndrome (MERS).  Several EUAs have already been issued for some COVID-19 tests and treatments, for example the antiviral medication remdesivir (recently approved), convalescent plasma, and multiple COVID-19 tests. ... Read More