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Overview

These resources were developed in collaboration with the Department of Health, Office of Developmental Programs, ASERT and HCQUs to provide information to self-advocates about the COVID-19 vaccines. The goal is to help self-advocates make informed decisions about getting the vaccine, and provide information on what to expect after receiving the vaccines.

For additional information on COVID-19, visit the Department of Health website.

For more information and answers to questions about the COVID-19 vaccine, visit the COVID-19 Vaccine FAQ page.

What is an Emergency Use Authorization (EUA)?

The COVID-19 vaccine was developed very quickly, and you may have heard that it received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). This resource provides information about what an EUA is and the process a new drug or vaccine must go through to get an EUA. 

The Food and Drug Administration (FDA) reviews many things to make sure they are safe for us to use. This includes vaccines for COVID-19.

In emergency situations, the FDA may say that it’s okay to use medicine or vaccines that are not yet approved. This is an Emergency Use Authorization (EUA).

 

The COVID-19 pandemic is an emergency situation. It is a life-threatening disease that has spread around the world. It is a brand new disease. There were no vaccines to prevent COVID-19 or medicines to cure it. 

Scientists worked to create new vaccines to prevent COVID-19. It normally takes years for a new drug or vaccine to be created and approved by the FDA.

Even though scientists worked very quickly to make these new vaccines, they followed the same rules required by the FDA:

1. First scientists gathered information about the risks and benefits of the vaccine. They did this through clinical trials where the vaccine was given to people. Tens of thousands of people participated in clinical trials.

2. After they had enough information on how well the vaccine works and that no one had a bad effect, they looked at the data. The data showed that the vaccine was safe and effective. So an EUA was submitted to the FDA.

3. After the FDA got the request for the EUA, scientists and doctors looked at all of the data.

4. Then an advisory committee of experts had a public meeting to talk about the safety and effectiveness data. This was so the public and scientific community could understand how a decision was made.

5. The FDA used the information from the advisory committee and decided the data supported granting an EUA for the vaccine.

Because the COVID-19 vaccines are new, scientists will continue to study how well they work and report that information to the FDA and Centers for Disease Control and Prevention (CDC).

Scientists will continue to study long-term effects of the vaccine. This is to make sure there are no new problems with the vaccine. They will also study how long the vaccine lasts.

For more information about Emergency UseAuthorization, visit:

Emergency Use Authorization for COVID-19 Vaccines Fact Sheet


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