FDA expected to grant full approval of Pfizer vaccine on Monday: report


The Food and Drug Administration is preparing to grant full approval of Pfizer-BioNTech’s COVID-19 vaccine on Monday, according to a report on Friday.

The New York Times reported that the approval had originally been targeted for Labor Day, but was expedited due the recent surge of the more infectious Delta variant of the virus.

The two-dose vaccine on Dec. 11, 2020 was the first COVID-19 shot receive emergency use authorization, and would be the first to be fully approved by the federal agency.

The FDA had hoped to finish the approval by Friday, the Times reported, however regulators and the company are continuing to negotiate.

Full approval of the Moderna vaccine could be weeks away as the FDA continues to review it’s application, the report said.

The two-dose Moderna vaccine was granted emergency approval on Dec. 18, 2020, followed by the Johnson & Johnson shot on February 27.

The FDA didn’t immediately return a request for comment from The Post on Friday.

Last week the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) unanimously approved the agency recommending “an additional dose” of the Pfizer or Moderna vaccines for those with compromised immune systems.

Full approval of the Moderna vaccine could be weeks away as the FDA continues to review it’s application, the report said.

President Biden revealed a plan on Wednesday for vaccinated individuals to get a booster shot eight months after their initial jab, pending the FDA’s approval.

The CDC wants to roll out the booster-shot program the week of September 20, said Director Dr. Rochelle Walensky this week — while citing new data showing a decrease in vaccine effectiveness over time against mild and moderate infections.

“We are concerned that the current strong protection against severe infection, hospitalization and death could decrease in the months ahead — especially among those who are at higher risk or who were vaccinated earlier,” Walensky warned at a White House COVID briefing. “In the context of these concerns, we are planning for Americans to receive booster shots.”

Mayor Bill de Blasio announced earlier this week that he expects booster doses to be available to New Yorkers by next month.

“There will be more and more opportunities for folks to get boosters and we’re not only going to encourage it,” de Blasio said. “We’re going to make it easy and free, as always.”

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