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WASHINGTON – U.S. Food and Drug Administration officials, under pressure to quickly grant full approval for the Pfizer Covid-19 vaccine, are in an intense debate over whether the agency will make the decision this month or will extend the schedule until early or mid-September, according to people familiar with the discussions.
There has been a wave of internal discussions about this timeline within the agency over the past two days, according to three people familiar with or involved in the talks.
Some agencies and White House officials are hoping the vaccine from Pfizer-BioNTech, the only vaccine maker to submit all the necessary documents, will get full, non-urgent approval as early as August 15, according to two of the people. But discussion over the past 24 hours has evolved into an agreement that full approval of Pfizer’s vaccine is not likely until early or mid-September, two of the people said.
President Biden said last week that he expected a fully approved vaccine in early fall. Some officials in the Biden administration have publicly pressured the FDA to act faster.
“I hope it will be in the next two weeks,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN Tuesday. “They said hopefully by the end of the month. I hope it’s even earlier than that.
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