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Saturday, December 5, 2020

FDA vaccine adviser says approval decision could come within the week | TheHill - The Hill

A top vaccine adviser at the Food and Drug Administration (FDA) said the decision on whether to approve a coronavirus vaccine candidate from Pfizer could come within the week.

James Hildreth, a member of the FDA’s vaccine advisory committee, said that the agency will vote Thursday on whether to provide emergency use authorization (EUA) for the Pfizer vaccine and that distribution of the shot could begin the next day. 

“We'll spend the day on Thursday reviewing the data from Pfizer, and at the end of the day, a vote will be taken. So, by the end of the day next Thursday, there could be a decision made about the vaccine,” he said Saturday on NBC News. 

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“If the FDA commissioner decides to issue approval, the EUA, on that day when the vote is taken, as early as Friday of next week, we could see vaccinations happening across the country,” he added.

The approval could begin the process of providing much-needed vaccinations across the country as the nation sees an alarming spike in cases. More than 210,000 new coronavirus cases were tallied Friday alone, and the total number of hospitalizations reached a new high of more than 100,000.

Early data shows Pfizer’s vaccine to be 95 percent effective, and the U.K. and Bahrain have already approved it. 

The Centers for Disease Control and Prevention said earlier this week that health workers and residents of long-term care facilities should be the first to receive a vaccine. People older than 65, essential workers and those with underlying medical conditions will be immunized in a second phase.

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