2.11: Emergency Use Authorization (EUA)

Note

The four types of determinations are referenced in the HHS Secretary issued 4 COVID-19 EUA Declarations cited below.

Under Section 564 of the FD&C Act, 21 U.S.C. 360bbb-3(opens in new window), the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA) authorizing:

1. the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or
2. an unapproved use of an approved drug, approved or cleared device, or licensed biological product.

Before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of four determinations:

1. a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a, chemical, biological, radiological, or nuclear (“CBRN”) agent or agents;
2. the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F-2 of the Public Health Service (PHS) Act ^[1] sufficient to affect national security or the health and security of United States citizens living abroad;
3. a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; or
4. a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents.[2]

Note

The Federal Register covered the initial two EUAs issued for COVID-10 vaccines as follows:

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for biological products for use during the COVID-19 pandemic. FDA issued one Authorization for a biological product as requested by Pfizer, Inc, and one Authorization for a biological product as requested by ModernaTX, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.[3]

The Authorization for Pfizer, Inc. is effective as of December 11, 2020; the Authorization for ModernaTX, Inc. is effective as of December 18, 2020.[3]

Note

FDA website policies. Downloaded January 7, 2026.

Linking to or Copying Information on the FDA Website

Unless otherwise noted, the contents of the FDA website (www.fda.gov) — both text and graphics — are not copyrighted. They are in the public domain and may be republished, reprinted and otherwise used freely by anyone without the need to obtain permission from FDA. Credit to the U.S. Food and Drug Administration as the source is appreciated but not required.

People are also free to link to any URL on FDA's site. FDA's preference is that people link to the material on the FDA site (rather than copying it to their personal websites) because the agency continuously updates the information on the website as better information becomes available. A person copying documents to another website, instead of linking to them, would then have to monitor the original documents to know when these documents were updated by FDA or else risk giving bad or incorrect advice to visitors to their website. Providing consumers or health professionals with advice that is not fully up to date can lead to serious public health consequences. Providing industry advice that is not fully up to date can lead to companies being out of compliance with regulatory requirements.

If a person, nonetheless, decides to copy content or images, FDA strongly recommends that the copied item lists the date that the material was copied and provides a link back to its source on the FDA website. Users can then see for themselves if the copied material has been updated or changed.