FDA Authorization of COVID Vaccines – What Does it Mean?

One year ago, in March of 2020, the Secretary of the U.S. Department of Health and Human Services (Secretary) declared that, because of the public health emergency resulting from the number of confirmed cases of 2019 Novel Coronavirus (COVID), circumstances exist to justify the authorization by the Food and Drug Administration (FDA) of emergency use of drugs and biological products during the COVID-19 pandemic. This action followed similar declarations permitting so-called “Emergency Use Authorizations” or “EUAs” for in vitro diagnostics and for ventilators, respirators and other medical devices.  Since that time, the FDA has issued hundreds of EUAs for the use of various medical products in the diagnosis, treatment or prevention of COVID.  Last week, the FDA issued an EUA authorizing the use of a third vaccine for the prevention of COVID. There are now 3 COVID vaccines available for use in the prevention of COVID in Americans over 18 years of age (note that the Moderna and Janssen vaccines are authorized for individuals 18 and older, while the Pfizer vaccine is authorized for individuals 16 and older).

Americans have experienced different stages of “pandemic-life” over the past year, and are currently experiencing differing stages of opportunity in relation to the authorized vaccines.  Some have already received one or more doses, some are eagerly awaiting their upcoming vaccination appointments, some have chosen not to get the vaccine, and others (many of whom are not yet eligible to receive the vaccine) are still considering their options.  For each of these groups, it may be helpful to understand more about the FDA’s authority for issuing Emergency Use Authorizations, and its process for granting a request for an EUA.  This article provides a very high-level look at those issues.

What is an Emergency Use Authorization?

An EUA is a mechanism, available under Section 564 of the Food Drug & Cosmetics Act, that gives the FDA the ability to allow unapproved medical products to be used, or approved medical products to be used for unapproved uses, in the course of a public health or other declared emergency. An EUA is not the same as an FDA approval or clearance. It is a temporary measure to allow for access to medical products (or so-called “medical countermeasures”) on an expedited basis and under specific circumstances when such an emergency has been declared. The FDA has the authority to issue EUAs only after the Secretary of HHS has issued an EUA declaration based on a determination of (in very general terms) domestic emergency, military emergency, public health emergency, or material threat to national security by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary of HHS, as appropriate. Unless revised or revoked, an EUA will remain in effect only until such declaration is terminated.

What is the Process for Issuing an EUA?

Although an EUA is a temporary and expedited pathway to make needed medical products available under emergency circumstances, it is not a blank check on which product manufacturers cash-in unfettered. Before submitting a formal EUA request, manufacturers are encouraged to engage in pre-submission communications with the FDA and, ultimately, are required to provide detailed product information in the EUA request to the FDA.  Before granting an EUA request, the FDA must conclude that the following four criteria (paraphrased in broad, general terms) are met:

  1. The existence of a threat capable of causing a serious or life-threatening disease or condition.
  2. Based on the totality of the scientific evidence available, it is reasonable to believe that the medical product under consideration may be effective to prevent, diagnose, or treat the serious or life-threatening disease or condition.
  3. The known and potential benefits of the product under consideration, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product.
  4. There are no adequate, approved, and available alternative to the product under consideration for diagnosing, preventing, or treating the disease or condition.

In assessing these regulatory criteria, the FDA considers the scientific evidence that is available in relation to the product such as clinical trial data and in vivo or vitro testing, and may also give consideration to the quality and quantity of evidence that is available.

The Road Ahead

As noted above, an Emergency Use Authorization is effective only until the Secretary’s declaration is terminated.  Once the COVID declaration issued in March of last year is terminated, the currently authorized vaccines will no longer be authorized for distribution unless the manufacturers have pursued and been granted FDA approval for those vaccines.  In the meantime, additional testing and reporting information will be made available and, most likely, additional vaccine EUAs will be granted.  Industry experts and the public in general will be able to find updated vaccine and other COVID-related information on the FDA’s website (https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19). General information on the vaccines authorized to date can be found at https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained.  Our Dickinson Wright attorneys are experienced in addressing a variety of COVID-related issues and can provide such additional information and assistance as you may need.

Originally published in Healthcare Michigan, March 2021.

About the Author:

Billee Lightvoet Ward is Of Counsel in Dickinson Wright’s Grand Rapids office. She can be reached at 616-336-1008 or bward@dickinsonwright.com. Her firm bio can be accessed here.