FDA Head Expects Vaccine Emergency Use Soon

Dr. Stephen Hahn, commissioner of the U.S. Food and Drug Administration. (Graeme Jennings via AP)

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WASHINGTON — The head of the Food and Drug Administration says his agency has told Pfizer that it “will rapidly work” to grant emergency use of its COVID-19 vaccine following a positive recommendation by government advisers.

The FDA decision will kick-start an unprecedented vaccination campaign needed to eventually defeat the virus. The FDA’s greenlight of the vaccine, co-developed with BioNtech, was practically assured after the positive vote by agency advisers Dec. 10.

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The FDA’s brief statement came less than an hour Dec. 11 after President Donald Trump tweeted directly at FDA Commissioner Stephen Hahn, complaining that FDA “is still a big, old, slow turtle.”

Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. https://t.co/FscjZJvLYe — Dr. Stephen M. Hahn (@SteveFDA) December 11, 2020

FDA staff have repeatedly said they expect to issue a decision within days of the Dec. 10 meeting. Many FDA observers predict action by Dec. 12 ahead of a Dec. 13 meeting by the Centers for Disease Control and Prevention.

The panel of CDC advisers will vote on who should get priority for the initial shots. Federal officials plan to allocate the first 6.4 million doses of the vaccine to states based on their population.

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