The coronavirus vaccine could soon be available to U.S. healthcare workers and nursing home residents.
After an all-day meeting Thursday, a vaccine advisory panel to the Food and Drug Administration voted to recommend the FDA grant emergency-use authorization to Pfizer and BioNTech’s COVID-19 vaccine.
Voting results were 17-4 in favor of approval, with one member abstaining.
The vaccine developed by Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) has already been approved for emergency use by the governments of the U.K. and Canada.
PFE stock rose about 2% in after-hours trading when the panel’s decision was announced.
Two of the panel members who voted against approval provided comments. Their concerns included insufficient safety data and the use of the vaccine in patients under age 18, as the younger population is believed to be at lower risk for complications of the virus.
The FDA is under no obligation to follow the panel’s recommendation, although historically it usually does.
Pfizer and BioNTech analysis indicates the vaccine is 95% effective at preventing COVID-19 infections.
The recommendation is against a dark backdrop as the U.S. death rate spikes.
Deaths exceeded 3,000 on both Wednesday and Thursday. Each day’s tally totals more deaths than the September 11, 2001 terrorist attacks, which claimed 2,977 lives.
The historic vote paves the way for the first vaccine to be granted emergency-use authorization in the United States. Final FDA approval could come at any time.
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