FDA Approves the Pfizer COVID-19 Vaccine for Emergency Use
As cases of the novel coronavirus (COVID-19) continue to skyrocket and ICUs across the United States near capacity, a glimmer of hope arrived Friday when the FDA issued an emergency use authorization of Pfizer's COVID-19 vaccine.
This means that the Pfizer-BioNTech COVID-19 Vaccine can begin to be distributed to people 16 years and older, marking "a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world," FDA Commissioner Stephen M. Hahn, M.D., said in a press release.
The vaccine has met the FDA's criteria for an emergency use authorization, the government agency said Friday, and that "totality of the available data provides clear evidence" that the vaccine "may be effective in preventing COVID-19."
The FDA also said that the "potential benefits outweigh the known and potential risks" and assured the public and medical community that "a thorough evaluation of the available safety, effectiveness and manufacturing quality information" was conducted.
In the U.S. alone, the contagious respiratory virus has infected more than 15.9 million people, and at least 295,664 people have died as a result of COVID-19, according to data from the New York Times.
The FDA’s vaccine advisory panel voted 17 to 4 on Thursday in favor of authorizing the vaccine for use in Americans 16 years old and up, with one member abstaining. The FDA released a scientific review on Tuesday, saying they found Pfizer’s two-dose vaccine to be safe and effective, with the first shot providing more than 50 percent immunity and the second bringing immunity up to just under 100 percent.
"The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide," Hahn added Friday.
So — when will Americans begin to receive the vaccine now that it has been approved?
Alex Azar, the U.S.’s secretary of Health and Human Services, said earlier on Friday that the first inoculations could start as early as next week.
"We could see people getting vaccinated Monday, Tuesday of next week," he said on Good Morning America.
Vaccines will be free, thanks to a deal between Pfizer and the U.S. government to supply 100 million doses by March 2021, the New York Times reported. All 50 states have already submitted locations to which the vaccines can be shipped.
Another COVID-19 vaccine developed by Moderna is also under review by the FDA and may soon be approved for the same emergency use authorization.
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