Pence says US 'a week and a half away' from 'likely approval' of first coronavirus vaccine

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By
Brooke Singman

Pence says US 'a week and a half away' from 'likely approval' of first coronavirus vaccine

Vice President Mike Pence said Friday that the U.S. is “maybe just a week and a half away” from the “likely approval” of the first vaccine to protect against the novel coronavirus.

During an event at the Centers for Disease Control and Prevention (CDC) in Atlanta, Ga., on Friday, Pence thanked CDC staff, saying he is “deeply inspired” by their work, “not just as your vice president, but as an American.”

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“We are in a challenging time in the course of this pandemic, and all of us have a role to play,” Pence said, noting that people should be washing their hands, practicing social distancing and wearing masks.

“We’re also in a season of hope,” Pence continued, saying that “this time of year is always filled with hope, through faith traditions in the hearts of the American people, especially our children.”

“But to be as we are, Bob, maybe just a week and a half away from what will be the likely approval of the first coronavirus vaccine for the American people is inspiring for the people of this country,” Pence added, nodding at CDC Director Robert Redfield who said he is “optimistic” about the approval.

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A source close to the White House Coronavirus Task Force told Fox News that the Emergency Use Authorization (EUA) could come as early as Dec. 11.

Food and Drug Administration (FDA) Commissioner Stephen Hahn also on Friday said that they are “very hopeful” of approval, and that they are “moving very quickly.”

Hahn, this week, was summoned to the White House to conduct a briefing on the coronavirus vaccine approval process.

The FDA is scheduled to meet on Dec. 10 regarding Pfizer’s application EUA of its coronavirus vaccine, three weeks after the company filed for it.

The FDA also plans to meet on Dec. 17 to discuss Moderna’s EUA.

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Earlier this week, Hahn said that the FDA’s scientists “have to make the decision and they will take the time that’s needed to make the right call on this important decision.”

“We want to move quickly because this is a national emergency, bu we will make sure that our scientists take the time they need to make an appropriate decision,” Hahn said in a statement to Fox News. “It is our job to get this right and make the correct decision regarding vaccine safety and efficacy.”

The agency’s scientists have been working non-stop on a “massive amount of data,” according to information provided to Fox News. The quickest approval process involving this amount of data ever completed before was 3.5 months, putting the current schedule on pace for historic speed.

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An FDA spokesperson added that the thousands of pages of data must be divided up and reviewed by experts from different disciplines, and then integrated into an overall review.

“Completion of these reviews involves such things as ensuring that the manufacturing process and the controls on manufacturing are appropriate, checking statistical analyses performed to ensure that they were done properly, and doing additional analyses, as necessary, to look at the effect of the vaccine on subsets of individuals who might be at greater risk of adverse effects,” the spokesperson said.

Meanwhile, Redfield this week upheld a vote by a panel of independent experts that health care workers and residents of long-term care facilities should be the first to receive the vaccine.

“Dr. Redfield supports their recommendations and has signed the memo and accepted these interim recommendations,” reads a statement released by the CDC.

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“If the Food and Drug Administration (FDA) authorizes or approves a COVID-19 vaccine, ACIP will quickly hold a public meeting to review all available data about that vaccine,” reads the CDC’s webpage, updated Thursday. “From these data, ACIP will then vote on whether to recommend the vaccine and, if so, who should receive it.”

Fox News’ Alex Hein, Kayla Rivas, John Roberts and Madeline Farber contributed to this report.

Source: Foxnews.com

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