The White House is considering potentially blocking guidelines proposed by the Food and Drug Administration regarding the approval of the coronavirus vaccine for immediate use.
Instead, the FDA, in a New York Times report on Monday, citing people familiar with the approval process, is looking for other ways to ensure it meets vaccine guidelines. The steps taken by the FDA include sending the standards to an outside committee of experts as early as this week.
A major point of contention is that – for the vaccine to be approved – participants in the clinical trial will need to follow up for two months after their treatment is completed to monitor possible side effects.
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Some companies are in the final stages of a clinical trial, but the requirement is that the vaccine be approved before November 3.
The FDA submitted the guidance to the White House on Sept. 21, according to which it would ignore immediate disagreements over the process.
Approval of these measures is considered impossible and the White House has the right to intervene where such guidance is in question, the Times reported.
A White House and FDA spokesman did not immediately return a request for comment from Fox News.
The president has repeatedly said the vaccine could be approved by November, including during last week’s presidential debate.
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Trump, meanwhile, returned to the White House on Monday from Verter Reed Medical Center, where he was admitted Friday after a positive Covid-19 diagnosis.
On Monday, the president warned Americans against letting the virus “dominate” or “control” their lives, indicating that the vaccine was imminent.
“Get out of there. Be careful, “Trump said. “We have the best medicines in the world. It’s all happening very soon, and it will all be approved. And the vaccine is coming in a moment. “
The novel coronavirus has infected more than 7.4 million Americans and killed at least 210,127 people.
