On Monday, The New York Times reported that top White House officials, including Chief of Staff Mark Meadows, are blocking FDA guidelines for the emergency authorization of a COVID-19 vaccine, taking particular issue with a provision that would make it virtually impossible for any vaccine to be available before the election.
"The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff," reported Sharon LaFraniere and Noah Weiland. "Their approval is now seen as highly unlikely."
The provision to which they object would recommend that participants in clinical trials be followed for two months after the final dose before authorization could be granted. This would mean the earliest a vaccine could be approved for emergency use would be December.
"Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines," said the report. "That includes sharing the standards with an outside advisory committee of experts — perhaps as soon as this week — 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."
President Donald Trump has pledged that a vaccine will be available before Election Day — something that experts warned from the outset was impossible to promise.