The decision to change the criteria under which a coronavirus vaccine would get approval or be given an emergency use authorization is, under normal circumstances, up to the US Food and Drug Administration.
And while there might be some legitimate scientific considerations to override the FDA’s proposal, any interference that comes from outside of science is “troublesome,” Dr. Anthony Fauci said Thursday during an online conversation with CNN Chief Medical Correspondent Dr. Sanjay Gupta.
“The issue is that the scientists and the FDA have put this forth as what their proposal for the criteria for EUA. Under normal circumstances, that decision is theirs, the secretary approves it and that's it. Something that comes from without, that is not a scientific consideration, would be troublesome, I'd have to tell you,” Fauci said during the conversation, organized by Emory University.
Fauci was asked about President Trump trying to make an “end run” around an FDA’s proposal to wait at least 60 days after at least 50% of trial participants were vaccinated to evaluate any vaccine for safety. Most adverse events happen within that two-month window.
“But remember there is some degree of flexibility,” said Fauci. “The thing that could modify that, and modify it within the scientific realm of being scientifically justifiable, is that if the vaccine is so overwhelmingly effective that you would say the risk-benefit of having adverse events override the benefit of getting a 98% effective vaccine earlier rather than waiting 60 days. That's something that even we scientists would say, 'You know, we should really take a look at that; you might want to shorten that.'”