A top U.S. health regulator who will help decide the fate of a coronavirus vaccine has vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective, Reuters has learned.
The FDA has scheduled a meeting of its advisory committee of outside experts on coronavirus vaccines on Oct. 22.
The discussion then turned to concerns about a so-called October surprise announcement, in which the Trump administration rushes to unveil a vaccine candidate, the sources said. The agency’s commissioner Hahn, a political appointee, typically has the power to issue an emergency authorization for a vaccine, expediting the traditional approval process in situations like the current pandemic.
Hahn, Marks and another FDA official penned an article in the Journal of the American Medical Association this month acknowledging public anxiety about lowering regulatory standards to approve a coronavirus vaccine. It is unclear whether any of the vaccine trials will enroll enough subjects and yield meaningful data for the FDA to review ahead of the U.S. election.
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Top FDA official says he would resign if agency rubber-stamps an unproven Covid-19 vaccineA top U.S. health regulator who will help decide the fate of a coronavirus vaccine has vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective, Reuters has learned.
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