Source: Bloomberg
By Drew Armstrong; August 30, 2020, 11:44 AM EDT Updated on
- ‘We’re going to let the data’ dictate vaccine look, Hahn says
- FDA’s Hahn speaks in interview with Bloomberg News on Sunday
The head of the U.S. Food and Drug Administration promised that the review of a potential Covid-19 vaccine in the U.S. will be transparent to the public, with any clearance by the agency driven by data alone.
In an interview on Sunday, Commissioner Stephen Hahn responded to questions about the different ways the FDA could clear a vaccine for use: either under an emergency authorization, likely based on more limited data and for use in a narrow group, or a broader approval that could lead to wider use.
“We’ve said all along we’re not going to pre-judge what mechanism we’re going to use to authorize or approve a vaccine,” Hahn told Bloomberg News by phone. “We’re going to let the data dictate that. The data will dictate what kind of decision is made on the vaccine.”
No decision on that has been made, because the agency hasn’t seen trial results yet, he said.
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Categories: Vaccine
FDA willing to fast track coronavirus vaccine before phase three trials end
Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.
“It is up to the [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. We may find that inappropriate, we will make a determination.”
The comments come a week after the FDA granted emergency authorization of convalescent plasma to treat hospitalized Covid-19 patients, despite concerns among some health officials that data from clinical trials is too weak to support widespread application of the treatment yet. That announcement was on the heels of President Trump accusing the FDA, without any evidence, of trying to hurt him politically by dragging its feet in approving new coronavirus vaccines and treatments.
https://www.cnbc.com/2020/08/30/fda-willing-to-fast-track-coronavirus-vaccine-before-phase-three-trials.html
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