The White House is blocking strict new coronavirus vaccine guidelines proposed by the Food and Drug Administration due to a provision that would likely prevent any vaccine from being authorized before the November election, several people familiar with the matter told The New York Times.
The guidelines are intended to reassure the public that coronavirus vaccines are being held to a common standard, the Times reports. They were submitted to the Office of Management and Budget for approval on Sept. 21, but White House Chief of Staff Mark Meadows has intervened, questioning the need for researchers to follow vaccine trial volunteers for two months after they receive their final dose. Per the guidelines, this would have to happen before authorization is granted for a vaccine, with FDA officials saying it’s necessary to determine if there are side effects and to make sure the vaccine protects people for longer than a few weeks.
Trump has been promising a vaccine and pushing for one to be released before the Nov. 3 presidential election, and under the guidelines it is highly unlikely a vaccine would be authorized before then. The FDA is now going around the White House, the Times reports, and will share the guidelines with an outside advisory committee with the hope that they will enforce the standards. Read more at The New York Times.
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