The FDA's Role In A COVID-19 Vaccine
We're exploring how the FDA will be involved in the release of a COVID-19 vaccine. Sarah Silbiger/Sarah Silbiger/Getty Images hide caption
We're exploring how the FDA will be involved in the release of a COVID-19 vaccine.
Sarah Silbiger/Sarah Silbiger/Getty ImagesFood and Drug Administration (FDA) commissioner Stephen Hahn wants America to trust his agency. But is America convinced?
The FDA has an outsize role during this pandemic. They're tasked with trying to balance the need for speed against the methodical scientific process.
Reporter Sarah Owermohle, Professor Holly Fernandez-Lynch, and former FDA commissioner Dr. Mark McClellan talked with us about the FDA, the vaccine trial process and what politicization of the FDA means for our country as we continue to deal with the pandemic.
The FDA declined a request to join us on today's episode but provided this statement.
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.
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