FDA advisory panel endorses Moderna's Covid-19 vaccine, clearing way for authorization

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An advisory panel on Thursday recommended that the Food and Drug Administration issue an emergency use authorization for a Covid-19 vaccine developed by Moderna, all but guaranteeing the agency will do so.

At the end of a long day, Moderna’s Covid-19 vaccine got a resounding yes, with 20 yes votes and a single abstention.

 

Why the abstention?

Michael Kurilla, the director of clinical innovation at the National Center for Advancing Translational Sciences, part of the NIH, said that he was uncomfortable that wording of the question was too broad and too positive for an emergency use authorization, a protest he had registered before the vote was made. He said afterward that he would have preferred to target the regulatory clearance to people at high risk. “A blanket statement for individuals 18 years and older is far too broad,” he said.

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