FDA has authorized the first COVID-19 vaccine [Updated]

Enlarge / Stephen Hahn, commissioner of the US Food and Drug Administration. (credit: Getty | Bloomberg)

Update 11:25pm EST: The US Food and Drug Administration has issued an emergency use authorization for the COVID-19 vaccine developed by Pfizer and BioNTech.

In a late-night statement, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said:

While not an FDA approval, today's emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States... With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine's known and potential benefits clearly outweigh its known and potential risks.

The announcement comes just hours after reports that the Trump administration pressured the agency and reportedly threatened FDA Commissioner Stephen Hahn to finalize the authorization Friday. The FDA announced Friday morning that it was "rapidly" working to finalize the issuance, which was initially expected Saturday.

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