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The FDA And COVID-19: The Food And Drug Administration’s Role In A Vaccine

A sign for the Food And Drug Administration is seen outside of the headquarters on in White Oak, Maryland.
A sign for the Food And Drug Administration is seen outside of the headquarters on in White Oak, Maryland.

The Food and Drug Administration (FDA), along with the Centers for Disease Control and the National Institutes of Health, is getting a lot of attention lately. 

The agency will host the first meeting of the panel that will decide which vaccines for COVID-19 will move forward and will be shelved. The online event could viewed by tens of thousands of people, which would make it the most-watched FDA livestream ever.

But there’s some confusion about which of the health-related federal government agencies is doing what. And that confusion comes at a time when the public is already very anxious for a vaccine. California already plans to independently review a vaccine approved by an FDA working under the Trump administration.

From the FDA:

Since the start of this global pandemic, the U.S. Food and Drug Administration has been open and transparent about the process we will follow to help make safe and effective COVID-19 vaccines available to the American public. We have said time and again that we understand the great responsibility we hold to work as quickly as possible while also ensuring that the process is not rushed and that our high standards are followed. The dedicated career staff at the FDA monitor vaccine development from beginning to end, and then put all submissions through a rigorous, first-hand analysis of the study’s safety and efficacy data. The FDA wants the public to feel confident in the process and know that we will only authorize a COVID-19 vaccine that has demonstrated clear and compelling efficacy in a large, well-designed, phase 3 clinical trial.

What exactly does the agency do? And what will its role be in the development of a COVID-19 vaccine?

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Avery Kleinman