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“They say they are doing everything they can to get this done as quickly as possible,” a senior administration official said, adding that the FDA has told administration officials it is working “24/7. 24 and 7/7 “on the effort.
An FDA spokesperson declined to provide a specific timeline for the expected approval, but confirmed that the sharp rise in Covid-19 infections induced by the Delta variant prompted the agency to speed up its work.
“Recognizing the urgency of the current state of the pandemic, we have taken a comprehensive approach,” the spokesperson said, a priority that included diverting additional staff and resources to the review.
The White House has publicly downplayed the impact the approval could have on its vaccination campaign, instead highlighting the ample evidence that vaccines are already safe and effective. And he was careful not to get involved in the FDA review for fear of appearing to be pressuring the agency.
But privately, the months-long process has frustrated some administration officials who believe such a long wait is unjustified, said two people with knowledge of the matter. The administration is also eager to use the full approval to undermine vaccine skeptics who have opposed injection until the FDA officially approves it.
According to a recent Kaiser Family Foundation survey, around 30% of unvaccinated people would be more likely to receive a fully approved vaccine rather than an authorized emergency vaccine. But pollsters argued that many respondents either didn’t know the difference or thought the vaccines were already approved, suggesting that the latter benchmark could be an indicator of the 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 published the FDA’s early September schedule for vaccine approval.
Emergency clearances can only arise during a public health emergency and expire with a declaration of emergency. They also mean that the FDA believes that a vaccine, therapy or test could be of benefit, while the approval marks the agency indicating that a product is safe and effective.
Vaccination rates have increased in recent weeks amid concerns over the spread of the more transmissible Delta variant, which has led to increased hospitalizations and reignited mask warrants across the country. The country hit President Joe Biden’s goal of 70% adult immunization this week, just a month ahead of the original target and days after the president said federal workers needed to be vaccinated or tested regularly .
But the suspended vaccines represent tens of millions of Americans, many in hard-hit southern and midwestern states where coronavirus outbreaks have strained hospitals and public health resources. At the same time, some governors are resisting other measures such as reinstating mask mandates, angering the president.
“I say to the governors, please help us. If you’re not going to help, stay away from people who are trying to do the right thing, ”Biden said Tuesday.
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