Hahn Says COVID Vaccine Review Could Take Months As Trump Floats Rejecting New EUA Guidance
Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.
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Everyone but Donald Trump seems happy that the guidance is finally here, with release appearing to be driven by FDA's disclosure of advisory committee materials.
The median of two months of follow-up is not absolute, but agency flexibility is limited.