FDA aims to give full approval to Pfizer vaccine by Labor Day: report

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The Food and Drug Administration (FDA) is aiming to give full approval to the Pfizer coronavirus vaccine by Labor Day, multiple people familiar with the discussions told The New York Times.

The FDA has faced pressure to fully approve the vaccine after Pfizer applied for full approval on May 7. Pfizer’s vaccine and another from Moderna have been under emergency authorization since December; Moderna applied for full approval June 1.

“We cannot comment on specific timing” for full approval for the Pfizer vaccine, a spokesperson for the FDA told The Hill in a statement.

“As we have said, our ongoing review of the biologics license application for the Pfizer-BioNTech COVID-19 vaccine is moving forward as rapidly as possible in keeping with the high-quality complete assessment that the public expects from the FDA,” the spokesperson added.

Georgia Gov. Brian Kemp (R) called on President Biden last week to put more pressure on the FDA to fully approve the COVID-19 vaccines, arguing it will encourage more vaccinations.

“I’d love to see the Biden administration put an ‘Operation Warp Speed’ on moving away from the emergency use authorization,” Kemp said.

Biden said last week that he expects full approval of the vaccine by “early fall,” and the reported Labor Day goal is the most detailed estimate yet.

The FDA spokesperson says the agency recognizes full approval of the vaccines “may bring additional confidence and encourage them to get vaccinated.”

“Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge,” the spokesperson said. 

While the vaccine receiving full approval is expected to help with the vaccination push across the country, it is also likely to bolster efforts for mandatory vaccination. 

The Pentagon previously said it will discuss making vaccinations mandatory for U.S. troops once the vaccine is fully approved by the FDA.

In the private industry, some companies have already begun requiring the vaccine as a condition to coming back to work in person.

Moderna has not yet submitted all the data needed to fully approve its vaccine, although it has filed for full approval. 

Johnson & Johnson, which received an emergency authorization for its single-dose vaccine in February, is expected to file for full approval later in the year. 

The Hill has reached out to the FDA for comment.

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