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A conversation with the FDA Chief Scientist: Learn about the Emergency Use Authorization (EUA) Process

In this episode, RADM Araojo discusses FDA’s Emergency Use Authorization process with RADM Denise Hinton, FDA’s Chief Scientist.

Health Equity Forum Podcast: Episode 4 – Transcript

RADM Araojo: Hello, and welcome to the Health Equity Forum podcast. Hosted by the FDA Office of Minority Health and Health Equity. I'm your host, Rear Admiral Richardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity.

In this episode, we will be talking about FDA's Emergency Use Authorization or EUA process. The EUA is one means by which FDA is addressing the urgent need for safe and effective products to fight COVID-19.

Today, I'm joined by FDA’s Chief Scientist, Rear Admiral Denise Hinton, who will tell us more about how the EUA process helps make medical products, like vaccines, available for public health emergencies. Welcome Rear Admiral Hinton.

RADM Hinton: Thank you for having me on the show today, Rear Admiral Araojo.

RADM Araojo: Can you tell us about your role as the FDA Chief Scientist and describe the work of your office?

RADM Hinton: Sure. As FDA's Chief Scientist, I lead the coordination of FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA's product centers, providing strategic leadership and support for FDA's regulatory science and innovation initiatives, including the Advancing Regulatory Science Initiative, health informatics, scientific professional development, scientific integrity, and the Medical Countermeasures Initiative (MCMi).

Our work related to Medical Countermeasures, or MCMs, is very important. MCMs are FDA-regulated products that may be used in public health emergencies stemming from, for example, a terrorist attack, or an emerging infectious disease. MCMs prevent, protect against, treat, or diagnose diseases, or health effects caused by chemical, biological, radiological, nuclear, and emerging infectious diseases. To prepare for and respond to certain emerging threats, the Secretary of Health and Human Services may in some circumstances, issue a declaration that is appropriate for FDA to issue Emergency Use Authorizations to enable access to MCMs prior to approval, or for unapproved uses. We have seen this recently with FDA's efforts in response to COVID-19.

RADM Araojo: Rear Admiral Hinton, can you tell us more about what an Emergency Use Authorization is? Or what an EUA is?

RADM Hinton: Congress developed the Emergency Use Authorization--or EUA for short--as a way for the FDA to respond quickly to public health emergencies. An EUA is used to provide more timely access to drugs, diagnostic tests, or other critical medical products that may help during a public health emergency. It's only allowed when no adequate and approved options are available and after carefully considering the product's benefits and risks.

I would say the FDA's EUA authority can be used in two ways. The first, is to allow the use of medical products that have not yet been approved by the FDA. And the second way is to allow medical products that have been approved by the FDA to be used in new ways. During the pandemic, we issued over 300 Emergency Use Authorizations for products, such as COVID-19 tests, treatments, and vaccines.

RADM Araojo: Can you describe what it means when a product has received an EUA?

RADM Hinton: The EUA process is different from the full approval process, because in some situations, we can't wait for all the evidence typically required for a product to receive full FDA approval. I want to emphasize to our listeners, that medical products that haven't received an EUA still go through rigorous review and scrutiny. After FDA receives an EUA request from a manufacturer, our scientists evaluate all the information in the submission. The manufacturer is required to include data on the safety and effectiveness of the medical product. FDA scientists reviewing an EUA then balance the known or potential risk of these unproven products with the known or potential benefits of making the product available during a public health emergency. During this review period, the FDA may hold a Public Advisory Committee Meeting to discuss the safety and effectiveness of the product with an independent expert panel. For example, FDA organized Vaccines and Related Biological Products Advisory Committee Meetings for the COVID-19 vaccines to get the advice of independent experts and to let the public and scientific community know what information FDA was evaluating in each vaccine EUA request.

RADM Araojo: How can people learn about the benefits and risks of medical products that have received an EUA?

RADM Hinton: Well, the FDA keeps the list of products that have received an EUA on our website. And then for each product, there is a fact sheet for patients. That includes specific information on benefits and risks.

RADM Araojo: You mentioned the recent FDA Vaccines and Related Biological Products Advisory Committee meetings. Can you share more information about the FDA review process for the recent COVID-19 vaccines that received an EUA?

RADM Hinton: The Center for Biologics Evaluation and Research, which is led by Dr. Peter Marks, is responsible for the oversight of vaccines. The public can be assured that COVID-19 vaccines that are authorized through an EUA, have received a thorough evaluation of their safety, effectiveness, and manufacturing quality. Vaccine manufacturers provide FDA with the vaccine's Safety and Effectiveness Information from their clinical trials.

There are three types or phases of clinical trials, each providing different information: 
In phase one trials, the vaccine is given to a small number of generally healthy people to assess its safety. 
In phase two trials, the vaccine is given to hundreds of people to get information on its safety and effectiveness. 
Then in phase three trials, the vaccine is given to thousands of people who make up a sample of the population intended for its use. 
The people that are participating in these trials represent diverse backgrounds by characteristics such as age, gender, race, and ethnicity. COVID-19 manufacturers must submit the safety data they have collected when requesting an EUA. If they haven't completed the phase three trial, they can submit an interim analysis of the phase three data. FDA also reviews data on participants who have been followed for at least one month after receiving the vaccine as well as information about the vaccines manufacturing processes. This is a lot of data that must meet FDA specific standards, representing tens of thousands of people who have received the vaccine.

RADM Araojo: What is the FDA doing to monitor the safety and effectiveness of COVID-19 vaccines and other medical products that have received an EUA?

RADM Hinton: The FDA and the Centers for Disease Control and Prevention have primary responsibility to quickly detect safety problems if they exist. We use multiple systems to monitor the safety of COVID-19 vaccines after receiving an EUA, such as the Vaccine Adverse Event Reporting System, the Vaccine Safety Data Link, MedWatch, and the Biologics Effectiveness and Safety Initiatives, as well as the Medicare Claims Data.

RADM Araojo: Rear Admiral Hinton, can you tell our listeners where people can report an adverse event with the COVID-19 vaccine?

RADM Hinton: People can submit an Adverse Event Report to the Vaccine Adverse Event Reporting System. We encourage consumers to report any significant adverse event to the Vaccine Adverse Event Reporting System at www.vaers.hhs.gov.  Even if you are unsure whether a vaccine caused the event, we encourage you to report it there.

RADM Araojo: And finally, is there anything else you want our listeners to know?

RADM Hinton: They should know that the Emergency Use Authorization authority is a vital part of the FDA's efforts to protect the public’s health. Our scientists and medical experts use the most rigorous and strict guidelines to review an application. Your listeners should also know that the FDA has not sacrificed its high standards for safety, accuracy, and effectiveness to authorize the use of vaccines or other medical products for COVID-19. And we have not, and will not, authorize the use of any COVID-19 product that does not meet the agency's high standards. And finally, I'd like to encourage the public to get vaccinated as soon as they are able.

RADM Araojo: Rear Admiral Hinton, thank you so much for taking time to help us better understand how FDA uses the EUA authority to allow access to critical medical products such as COVID-19 vaccines during a public health emergency.

RADM Hinton: My pleasure. Thanks again for having me.

RADM Araojo: Before we close today's episode, I want to encourage everyone to check out our video on COVID-19 Vaccines Safety and Diversity. That can be found on our website at www.fda.gov/healthequity. While you're there, check out our library of resources, sign up for our newsletter, and learn more information about the Health Equity Forum podcast series.

Also, don't forget to follow us on Twitter at @FDAHealthEquity. Remember, together we can create a world where health equity is a reality for all.

[end of transcript]

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