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Emergency Use Authorization for COVID-19 Vaccines Fact Sheet​

Background

An Emergency Use Authorization (EUA) is used by the FDA to approve the use of safe and effective medical products during a public health emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions. An EUA can be used to approve a number of medical products, including vaccines and COVID-19 tests. Right now, there are several companies working to create a safe and effective COVID-19 vaccine and when they are ready, they will submit an EUA request to the FDA for approval.

How Will a COVID-19 Vaccine Become Available by EUA?

Vaccine manufacturers are following this process to make a COVID-19 vaccine available through an EUA:

  • First, manufacturers start the development process that includes tens of thousands of participants to gather nonclinical, clinical and manufacturing information needed by the FDA to determine if the known and potential benefits outweigh the known and potential risks of a vaccine to prevent COVID-19. This is also known as a clinical trial.
  • Once the manufacturers get enough information on how well the vaccine prevents COVID-19, the manufacturer will discuss with the FDA and a data safety monitoring board will review the data. Based on this data, and additional input from the FDA, manufacturers will then decide whether and when they should submit an EUA request to the FDA.
  • After the FDA receives an EUA request, scientists and physicians will examine all of the information included in the submission.
  • While the FDA reviews the submission, they will schedule a public meeting among their Vaccines and Related Biological Products Advisory Committee where experts will discuss the safety and efficacy data so the public and scientific community can clearly understand what data is being used to make a decision.
  • After the advisory committee meeting, the FDA will use the advisory's input and continue to evaluate the submission to determine if the available data support an EUA of a COVID-19 vaccine.
  • Once an EUA for a COVID-19 vaccine is issued, the director of the Centers for Disease Control and Prevention (CDC) will give an approval after considering the Advisory Committee on Immunization Practices' (ACIP) recommendation.
  • Lastly, the CDC will issue a Morbidity and Mortality Weekly Report that will lay out all the specifics of the vaccine.

Does This Mean the COVID-19 Vaccines Going Through an EUA Are Less Safe?

No. It is important to remember that in public health emergencies, such as a pandemic, the development process may not follow routine procedures. However, these COVID-19 vaccines are going through clinical trials that are being conducted according to the rigorous standards set by the FDA. With advanced technology available today, this process is able to be expedited. For an EUA to be issued for a vaccine, the FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine.

Resources for More Information

For information on the EUA process for vaccines, visit the FDA.

For information on COVID-19 vaccines in Pennsylvania, visit the department's website.

Help is available, contact the Crisis Text Line by texting PA to 741-741.

Date created: December 10, 2020