WH Blocks New FDA Guidelines On COVID Vaccine

The New York Times reports:

Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process. Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines.

That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction. The struggle over the guidelines is part of a monthslong tug of war between the White House and federal agencies on the front lines of the pandemic response.

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Breaking News: The White House has refused to accept proposed new FDA guidelines that could delay an emergency vaccine approval until after the election. https://t.co/FXxhzFcU9w

— The New York Times (@nytimes) October 5, 2020