The U.S. Food and Drug Administration (FDA) is preparing for immediate emergency approval of Pfizer's coronavirus vaccine after a panel of experts recommended its adoption, the agency reported Friday. it's a statement.
An advisory committee voted in favor of the vaccine, considering it safe and effective in people over 16 years of age, after an extensive meeting held Thursday.
Following this positive opinion, the regulatory agency informed Pfizer and BioNTech that it will work "quickly to finalize and issue" the authorization of the vaccine, which is expected to be supplied in a first stage to the most vulnerable groups such as medical personnel and residents of homes of seniors.
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The FDA has also notified the US Centers for Disease Control and Prevention and Operation
Warp Speed
so that they can execute their plans for the timely distribution of the vaccine in the coming days.
UPS President Wesley Wheeler shows an example of the vial that will be used to transport the Pfizer vaccine.
Together with FedEx, the company will handle the distribution in the US AP
Health Secretary Alex Azar said in an interview with ABC on Friday morning that the vaccines
could begin shipping as early as Monday.
"I have good news for you," Azar said, noting that the FDA has informed that it intends to proceed with the authorization.
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"So in the next few days, probably as we work to negotiate with Pfizer the information that doctors need to properly prescribe it, we should see the authorization of this first vaccine," Azar continued.
"
We could see people getting vaccinated on Monday and Tuesday next
week," he said.
Gustave Perna, director of operations for Operation Warp Speed, has anticipated that
the first vaccines will
begin to be administered as soon as 96 hours after they are approved.
The first shipment will be
almost 3 million doses
and will be destined for priority groups.
It is estimated that the general population will be able to access the vaccine as of spring 2021.
No clinical trials of the vaccines report serious safety concerns, although volunteers have experienced side effects.
This is common in vaccinations and they do not cause permanent or long-term diseases.
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The FDA advisory panel will meet again virtually on December 17 to consider a similar coronavirus vaccine made by drugmaker Moderna.