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Trump administration to block FDA guidelines that could delay coronavirus vaccine: report



The White House is trying to potentially block proposed guidelines from the Food and Drug Administration regarding the approval of a coronavirus vaccine for emergency use.

Instead, the FDA is looking for other ways to ensure vaccines meet the guidelines, according to a New York Times report on Monday, which cited people familiar with the approval process. The FDA’s moves potentially include sending the standards to an external panel of experts as soon as this week.

One of the big points of contention is that, in order for the vaccine to be approved, participants in clinical trials would have to be followed up for two months after completion of treatment to monitor for possible side effects.

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Several companies are in the final stages of clinical trials, but this requirement would make it unlikely that a vaccine will receive approval before November 3.

The FDA presented the guidance to the White House on Sept. 21, reportedly igniting an immediate disagreement on the process.

Approval of the measures is said to be unlikely, and the White House has the authority to intervene regarding this type of guidance, the Times reported.

White House and FDA spokespersons did not immediately respond to Fox News’ request for comment.

The president has repeatedly said that a vaccine could be approved by November, including during last week’s presidential debate.

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Trump, meanwhile, returned to the White House from Walter Reed Medical Center on Monday, where he was hospitalized on Friday after his positive diagnosis of COVID-19.

The president on Monday warned Americans not to let the virus “dominate” them or “take over” their lives, indicating a vaccine was imminent.

“Get out of there. Be careful, “Trump said.” We have the best medicines in the world. They will all happen very soon and they will all be approved. And the vaccines are coming soon. “

The new coronavirus has infected more than 7.4 million Americans and killed at least 210,127.


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