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Updated November 2021

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 on Feb. 27, 2021.

The developers had to show their vaccine candidate was more than 50% effective in preventing COVID-19, with no serious safety risks. According to reported data, the Moderna and Pfizer vaccines were about 95% effective in preventing symptomatic COVID-19. The J&J vaccine was about 70% effective against mild to moderate COVID-19 and even more effective against severe disease.

Since issuing the original EUA for the Pfizer vaccine, the FDA has expanded it to include children 5 and older. The Pfizer vaccine is fully approved for people 16 and older, while children aged 5-15 are eligible to receive it under EUA.

The Moderna and J&J vaccines are authorized for Americans 18 and older.

The FDA also granted — and later revoked — an EUA for hydroxychloroquine. This occurred after further use showed its benefits did not outweigh its known and potential risks.

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

For more information, visit UPMC.com/COVID19.

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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