Dec 07, 2020
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The Food and Drug Administration could authorize a coronavirus vaccine as early as the end of this week. The move would be a pivotal moment in the pandemic, as public health officials say the U.S. is likely to face its worst public health crisis in history this winter.
The FDA is scheduled to convene a meeting of its Vaccines and Related Biological Products Advisory Committee, known as VRBPAC, on Thursday to review Pfizer’s Covid-19 vaccine with German drugmaker BioNTech for emergency use authorization.
James Hildreth, a member of the committee, told NBC’s “Weekend Today” on Saturday that an authorization could come as early as Friday.
“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 said.
Emergency use authorization means the FDA will allow some adults to receive the vaccine as the agency continues to evaluate data. It isn’t the same as a full approval, which can typically take months. The FDA granted emergency clearance for Gilead Sciences’ remdesivir in May before giving full approval in late October.
Two days before the meeting, the FDA is expected to release a roughly 100-page document evaluating the companies’ clinical trial data, said Dr. Paul Offit, a voting member of the advisory committee, offering a glimpse into the agency’s view of the vaccine.
“The public will see everything that we see,” said Offit, who is also the director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
If the meeting Thursday goes well and the advisory committee formally votes to OK the vaccine, the FDA could announce its authorization “within days,” Health and Human Services Secretary Alex Azar told ABC News’ “This Week” on Sunday. “But it’s going to go according to FDA’s gold-standard process, and I’m going to make sure it does,” he added.
The vaccine could not come at a more crucial time. Hospitals across the U.S. already have a higher load of Covid patients than ever before, and the country’s outbreak is primed to set even more grim records this week. Dr. Deborah Birx, the White House coronavirus response coordinator, warned on Sunday that the escalating coronavirus surge is likely to be the most trying event in U.S. history.
“This is not just the worst public health event. This is the worst event that this country will face, not just from a public health side,” she told NBC’s “Meet the Press,” echoing comments made by Centers for Disease Control and Prevention Director Dr. Robert Redfield on Wednesday.