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There's Been a Date Shift for FDA's Full OK on Pfizer Vax

Labor Day was the initial target. Sources now say full approval could come as soon as Monday.
By Jenn Gidman,  Newser Staff
Posted Aug 21, 2021 7:00 AM CDT
There's Been a Date Shift for FDA's Full OK on Pfizer Vax
In this Jan. 15, 2021, file photo, a doctor extracts the Pfizer COVID-19 vaccine out of a vial at a vaccination site in New York.   (AP Photo/Mary Altaffer, File)

(Newser) – Earlier this month, the Food and Drug Administration signaled that it hoped to offer full approval for Pfizer-BioNTech's coronavirus vaccine by Labor Day, an unofficial deadline that now looks like it's been expedited. A senior federal official tells CNN that such an FDA OK is "imminent," while another source mentions it may happen sometime next week. A Biden administration official gets even more specific, noting full approval could come "as early as Monday." Sources "familiar with the agency's planning" back that up to the New York Times, telling the outlet that the FDA is making a hard push to reach that Monday deadline, with regulators sifting through "a substantial amount of paperwork" and negotiating with Pfizer.

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Per Politico, the Pfizer vaccine would be the first to receive full licensure from the federal government, "a milestone in the nation's year-and-a-half pandemic battle," which now includes fighting the more contagious delta variant. Up till this point, the Pfizer vaccine has been under an emergency use authorization, or EUA. Health officials are hoping that full approval will nudge those who've been hesitant to get vaccinated. In recent surveys by the Kaiser Family Foundation, about 30% of people who remain unvaxxed said they'd be more inclined to get vaccinated if the vaccine had full FDA approval rather than just an EUA.

Full approval would open the door for Pfizer to request a quick green light from the FDA to start administering a third booster shot. It would also clear the path for further vaccine mandates, especially within hospitals and colleges. Earlier this month, the Pentagon announced that all members of the US military would have to be vaccinated by Sept. 15 or after full FDA approval—whichever date came first. Regulators are still going over data on giving a full OK to Moderna's vaccine, a process the Times notes should take "at least several weeks." (Read more Pfizer stories.)

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