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    What's the Difference Between FDA Emergency Use Authorization and Approval?

    vaccine-approval-desktop
    Post Date: May 2021

    Updated 2/8/22

     

    The U.S. Food and Drug Administration (FDA) sets vigorous and globally respected standards for vaccine safety. The gold standard for vaccines is acquiring FDA approval, but in times of crisis like a public health emergency when there are no available alternatives, the FDA can grant an Emergency Use Authorization (EUA) to speed up the manufacturing and administration processes to help get safe & effective vaccines to market quickly.  

     

    During a public health emergency, like the current COVID-19 pandemic, the FDA allows for companies with vaccines to apply for an EUA rather than a standard license. An EUA does not affect the development of a vaccine; the research, number of clinical studies and the evaluation of side effects and adverse reactions of a vaccine are the same regardless whether the vaccine manufacturer is seeking an EUA or standard approval. Where an EUA differs from the standard licensing process is in how long participants are studied before authorization is granted. 

     

    The Standard Process

     

    Picture the standard FDA approval process as a long single straight line; there’s step 1, step 2, step 3, etc—each step needs to be completed before the next step can be started. These steps are: 

     

    • Development: Studying the virus and figuring out how to create a vaccine that can protect you from it.

    • Testing: Clinical trials of the potential vaccine are done under the supervision of the FDA. In the standard FDA approval process, the testing phase can take up to a couple of years.

    • Review: At the end of testing, the FDA reviews all the information collected during the testing phases to determine if the vaccine is safe. If it is, it’s approved and the company that created the vaccine is given a license to produce the vaccine.

    • Production: Large quantities of the approved vaccine are made.

    • Distribution: Vaccines are distributed to retail locations like Rite Aid to be administered to the public. 

     

    This is a simplified version of a complex process, but it gives you a good understanding of what a standard FDA vaccine approval process looks like.

    The EUA Process


    EUA is slightly different, but consists of all the same steps, but not necessarily in the same linear order. Development of a vaccine during an EUA is the same as during the standard FDA process. In this case, COVID-19 was studied (on a global, never-before-seen scale) and companies like Pfizer, Moderna, Johnson & Johnson created vaccines. These companies then tested their vaccines in clinical trials under the supervision of the FDA. These trials followed the same practices as the standard process described above except in the EUA process, companies can ask the FDA to review the vaccine for EUA status before final long-term testing and information, that is required in the standard process, is complete. This means there are less long-term results for the FDA to review, but the information that is available is still thoroughly reviewed and includes the information needed to determine if a vaccine is safe. 

     

    Ultimately, for the FDA to grant a vaccine with EUA status it must determine if the vaccine’s benefits outweigh any possible risks. If the FDA determines that the information from the vaccine’s testing proves this, then an EUA is granted. The FDA then continues to work with the creator of the vaccine to ensure proper production and distribution.

     

    A vaccine’s monitoring and testing is not over once it receives EUA status. The long-term testing that is required to receive a standard license continues to be done and information from these long-term tests is collected and reviewed by the FDA. Pfizer was granted full FDA approval on August 13, 2021, and Moderna received full approval on February 1, 2022. It is expected that Johnson & Johnson and other COVID-19 vaccine developers will also seek standard FDA approval once these tests are complete. 

     

    Emergency Use Authorization (EUA) is a critical part of combating the spread and impact of COVID-19 in our communities. While it may be different than the standard FDA approval process, the information and consideration that go into granting EUAs ensure their safety before they are administered to consumers. 


    To schedule an appointment or learn more, visit our COVID-19 vaccine page.