This WILL slow down the final approval for a virus vaccine from the four companies in final testing…
Seems the NY Times put out that the increased steps for the vaccine manufactures was going nowhere at the White House…Then where abruptly ok’d to the surprise of the FDA people….
Trump is already complaining about this which was sent to the White House’s Office of Management and Budget, a month ago for review….
The guidelines can be countermanded by Trump….
The Food and Drug Administration released new guidelines on Tuesday for coronavirus vaccine developers — a step that had been held up for two weeks by top White House officials. The guidelines make it highly unlikely that a vaccine could be authorized by Election Day.
The move, which was cleared by the White House’s Office of Management and Budget, appeared to be an abrupt reversal a day after The New York Times reported that White House officials, including Mark Meadows, the chief of staff, were blocking the guidelines. Top F.D.A. officials were caught by surprise when they learned midafternoon that the new guidelines had been cleared.
The new recommendations, which do not carry the force of law, call for gathering comprehensive safety data in the final stage of clinical trials before an emergency authorization can be granted.
On Tuesday evening, President Trump showed his displeasure at the action of his own White House, and charged that the new guidelines were a conspiracy against his reelection prospects….