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Since the start of the COVID-19 pandemic, the FDA has issued emergency use authorization (EUA) for different COVID-19 treatments and tests. That includes EUA for three different COVID-19 vaccines, developed by Pfizer-BioNTech, Moderna, and Johnson & Johnson/Janssen.

But what is an EUA, and what does it mean when the FDA issues one?

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What Is an EUA?

Under an EUA, the FDA can allow the use of a medical product in an emergency, before it receives final approval. There must be a declared public health emergency before the FDA can issue EUAs.

The FDA can issue EUAs for drugs, medical devices, tests, and more. According to the FDA, an EUA can help authorize products that diagnose, treat, or prevent serious diseases when no approved options are available.

EUAs have been used during several public health crises in the 21st century. Examples include the H1N1 flu, Middle East Respiratory Syndrome, ebola, Zika, and most recently COVID-19.

EUAs are based on robust data. For example, COVID-19 vaccine EUAs were issued after the completion of high-quality, randomized clinical trials that enrolled tens of thousands of people.

How Are EUAs Granted?

The process of an emergency use authorization begins with a public health emergency. The Department of Defense, the Department of Health and Human Services, or the Department of Homeland Security must declare an emergency.

A declared emergency allows the developers of medications and other medical products to apply for an EUA.

Before granting the EUA, the FDA will consider the product itself and the need for it. For the FDA to issue an EUA, the product must meet certain criteria:

  • There must be a serious or life-threatening illness.
  • The product should be effective in diagnosing, treating, or preventing illness.
  • The benefits of the product must outweigh the risks.
  • There must be no adequate, approved alternatives.

If the product under consideration meets all those criteria, the FDA may issue an EUA.

Does an EUA Mean Something Is Approved?

Although an EUA allows for the use of medical products during an emergency, it does not mean that product is fully approved. The EUA process is separate from the FDA’s typical approval process. It is done only in cases of emergency, when there is a short-term need for the product.

An EUA for a drug or other product ends when the declared emergency ends.

The FDA also can revoke an EUA if further use shows that the risks of using a product outweigh the benefits.

EUAs and COVID-19

Since the start of the COVID-19 pandemic, scientists have worked to find effective treatments and cures. Many of them have sought EUAs for their products.

More than 200 testing products have received authorization, the FDA reports. On Dec. 15, 2020, the FDA issued an EUA for the first fully at-home diagnostic test.

COVID-19 treatments to receive EUAs include remdesivir and monoclonal antibodies.

Two COVID-19 vaccines, produced by Pfizer-BioNTech and Moderna, respectively, received EUA in December 2020. A third, developed by Johnson & Johnson/Janssen, received EUA in February 2021. A fourth, developed by Novavax, received EUA in July 2022.

The developers had to show their vaccine candidate was more than 50% effective in preventing COVID-19, with no serious safety risks. The authorized COVID-19 all met FDA standards for safety and effectiveness.

Since issuing the original vaccine EUAs, the FDA has expanded them to other age groups. Americans 6 months and older are eligible for the Moderna and Pfizer vaccines. Adults 18 and older are eligible for the Novavax and J&J vaccines.

After many months of vaccine distribution in the U.S., the FDA also fully approved the Moderna and Pfizer vaccines for certain age groups. Pfizer is fully approved for Americans 12 and older, while children 6 months and older can receive it under EUA. Moderna is fully approved for Americans 18 and older, while children 6 months and older can receive it under EUA.

It is likely that the FDA will issue more EUAs to help diagnose, treat, and cure COVID-19 in the coming months.

Editor's Note: This article was originally published on , and was last reviewed on .

Sources

Food and Drug Administration, Emergency Use Authorization. Link

Food and Drug Administration, FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine. Link

Food and Drug Administration, Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19. Link

Food and Drug Administration, Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine. Link

Institute of Medicine (US) Forum on Medical and Public Health Preparedness for Catastrophic Events, Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model, Workshop Summary. Link

Johns Hopkins School of Public Health Expert Insights, What Is Emergency Use Authorization? Link

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