FDA Targets Early September for Approving Pfizer’s Covid-19 Vaccine

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The Food and Drug Administration is expected to approve Pfizer’s coronavirus vaccine by early September, amid a resurgence of cases that has heightened pressure on the administration to get more Americans vaccinated.

While the agency had long eyed the fall for granting full licensure, officials have recently accelerated their work, and now hope to finalize approval in a matter of weeks, according to three people familiar with the matter.

Regulators authorized Pfizer’s two-dose vaccine for emergency use last December, followed quickly by Moderna. But full approval is a higher bar that health officials hope will nudge hesitant Americans towards getting vaccinated.

“They are saying that they are pulling out all the stops to get it done as quickly as possible,” said one senior administration official, adding that the FDA has told administration officials it’s working “24/7” on the effort.

An FDA spokesperson declined to provide a specific timetable for the expected approval, but confirmed that the sharp rise in Covid-19 infections driven by the Delta variant spurred the agency to speed its work.

“Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach,” the spokesperson said, a prioritization that has included diverting additional personnel and resources toward the review.

The White House has publicly downplayed the impact that the approval could have on its vaccination campaign, stressing instead the extensive evidence that the vaccines are already safe and effective. And it’s taken pains not to get involved with the FDA’s review, for fear of appearing to put pressure on the agency.

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