“An Enormous Scandal”: Doctors and scientists worry FDA and CDC pandemic response too political
In an interview with The Financial Times, Stephen Hahn, the head of the U.S. Food and Drug Administration, said he would authorize a coronavirus vaccine before Phase Three clinical trials were complete if the benefits outweigh the risks, but denied that he would rush the process to benefit Donald Trump’s re-election campaign, according to a report by FairWarning.
“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told The Financial Times. “If they do that before the end of Phase Three, we may find that appropriate.”
Both China and Russia have approved vaccines before Phase Three trials were completed, and have faced criticism from public health officials in the U.S. and elsewhere for doing so before more rigorous tests for side effects and efficacy were performed.
Trump has accused “deep state” elements at the FDA of holding up coronavirus treatments to harm his political campaign and image.
After the interview was published, public health officials sounded the alarm again, prompting Hahn to promise in an interview with CBS News that the vaccine approval process would not be politicized.
It’s the latest in a series of missteps at the FDA and the Centers for Disease Control and Prevention that have doctors and scientists concerned, Denise Chow reports for NBC News. “It’s an enormous scandal,” Carl Bergstrom, a biologist at the University of Washington and an outspoken critic of the U.S. pandemic response, told NBC. “What it looks like at this point is you have a White House altering public health advice to improve election chances to the detriment of American lives.”