FDA to hold emergency use authorization hearings for Pfizer, Moderna vaccines
Secretary Azar expressed optimism that vaccine could be authorized 'within days'
The Food and Drug Administration will consider Emergency Use Authorization (EUA) for Pfizer’s coronavirus vaccine candidate on Thursday and Moderna’s vaccine candidate on Dec. 17.
The FDA’s deliberations come after Pfizer and Moderna claim their vaccine was over 90% effective in clinical trials.
Last week, the United Kingdom cleared EUA for Pfizer’s vaccine and is preparing to begin inoculating patients this week.
U.S. Health and Human Services Secretary Alex Azar expressed optimism Sunday that the vaccine could be authorized “within days.”
"If things are on track, the advisory committee goes well, I believe we could see FDA authorization within days," Azar told ABC News’ “This Week.” But it's going to go according to FDA gold-standard processes ... and I'm going to make sure it does."
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Asked if there was any reason the vaccine’s approval could be delayed, Azar responded: "I don't know of any reason why the system is in any way off track."
A Centers for Disease Control and Prevention (CDC) panel recommended last week that the vaccine first be distributed to essential health care workers first, followed by nursing home residents. Azar said by February or March the vaccine would be available widespread. "By the second quarter of next year, we'll have enough vaccine for every American that wants it."
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The U.S. added one million new coronavirus cases in five days from Tuesday to Saturday and deaths have passed 281,513. States are reenacting lockdown restrictions. Most of California entered a sweeping new lockdown on Sunday.
Azar said that the Trump administration is “quite concerned” about COVID-19 spreading rapidly following the Thanksgiving holiday and is "worried about people and the behaviors coming up with Christmas."
"We want to make sure everyone's loved ones are there next Christmas, especially when we have so much hope of vaccine," Azar said.