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FDA targets early September for approving Pfizer’s Covid-19 vaccine

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.

But in private, the monthslong process has frustrated some administration officials who believe there’s little justification for such a lengthy wait, said two people with knowledge of the matter. The administration is also eager to use the full approval to undercut vaccine skeptics who have argued against getting the shot until the FDA formally endorses it.

Roughly 30 percent of unvaccinated people would be more likely to get a fully approved vaccine rather than an emergency authorized shot according to recent polling by the Kaiser Family Foundation. But pollsters couched that many respondents did not know the difference or thought the vaccines already were approved, suggesting that this latest benchmark could be a proxy for skeptics’ broader concerns.

Pfizer filed for full approval in May, followed by Moderna in June. FDA reviews typically take months.

The New York Times first reported the FDA‘s early September timetable for approving the vaccine.

Emergency authorizations can only occur during a public health emergency and expire with an emergency declaration. They also signify that FDA believes there could be a benefit to a vaccine, therapy or test, whereas approval marks the agency saying that a product is safe and effective.

Vaccination rates ticked upward in recent weeks as concerns about the more transmissible Delta variant spread, spurring hospitalization surges and revived mask mandates around the country. The country hit President Joe Biden’s goal of 70 percent adult vaccination this week, just a month shy of the original target and days after the president said federal workers must be vaccinated or undergo regular testing.

But vaccine holdouts represent tens of millions of Americans, many of them in hard-hit Southern and Midwest states where coronavirus surges have strained hospitals and public health resources. At the same time, some governors are resisting other measures such as reinstituting mask mandates, earning ire from the president.

“I say to the governors, please help. If you’re not going to help, get out of the way of people that are trying to do the right thing,” Biden said Tuesday.

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