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

Food and Drug Administration (FDA) aims to fully approve Pfizer’s coronavirus vaccine by Labor Day, several people familiar with the discussions Recount The New York Times.

The FDA came under pressure to fully approve the vaccine after Pfizer requested full approval on May 7. Pfizer’s vaccine and another from Moderna have been under emergency clearance since December; Moderna requested full approval on June 1.

“We cannot comment on the exact time” for full approval of the Pfizer vaccine, an FDA spokesperson told The Hill in a statement.

As we said, our ongoing review of the biologics license application for the Pfizer-BioNTech COVID-19 vaccine is proceeding as quickly as possible in accordance with the comprehensive, high-quality assessment that the public expects from the FDA. “said the spokesperson. added.

Governor of Georgia Brian kempBrian Kemp New Spotlight on Secretaries of State as Electoral Battlegrounds Georgia Governor Kemp Says FDA Must Improve Vaccine Clearance The Hill’s Morning Report – Brought to you by Facebook – Huge win for Biden, centrist senators MORE (R) called President BidenJoe BidenThe Hill’s Morning Report – Brought to you by Facebook – White House, Democrats play blame game on evictions GOP skepticism hangs over bipartisan spending deal Biden vaccine rule sets the stage for legal attack MORE last week to pressure the FDA to fully approve COVID-19 vaccines, arguing it will encourage more vaccinations.

“I would love to see the Biden administration set up an ‘Operation Warp Speed’ to move away from emergency use authorization,” Kemp said.

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

The FDA spokesperson said the agency recognizes that full vaccine approval “can provide additional confidence and encourage them to get vaccinated.”

“Recognizing the urgency of the current state of the pandemic, we have taken a holistic approach, including identifying additional resources such as agency-wide staff and technology resources and opportunities to redefine priorities for other activities, in order to complete our review to help combat this pandemic outbreak, ”the spokesperson said.

While the vaccine receiving full approval is expected to help the nationwide immunization campaign, it is also likely to bolster efforts for compulsory immunization.

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

In the private sector, some companies have already started requiring the vaccine as a condition of returning to work in person.

Moderna has yet to submit all the data needed to fully approve its vaccine, although it has filed for full approval.

Johnson & Johnson, which received emergency clearance for its single-dose vaccine in February, are expected to file for full approval later this year.

The Hill has contacted the FDA for comment.