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Report: FDA to give Pfizer COVID-19 vaccine final approval soon

The move is expected to clear the way for more vaccine mandates.

Report: FDA to give Pfizer COVID-19 vaccine final approval soon

The Food and Drug Administration (FDA) is expected to give final approval to the Pfizer COVID-19 vaccine early next month hopefully giving a boost to efforts aimed at increasing uptake of the shots.

According to a report from The New York Times, the FDA has accelerated the timetable on Pfizer’s full approval with the goal of completing the process by early September. The move is expected to spur some of the vaccine hesitant to get the shot and clear the way for more vaccine mandates among employers and governments.

Pfizer began their push for full approval of the vaccine in May after 170 million doses had been delivered across the country.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Albert Bourla, chairman and CEO of Pfizer, said at the time. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

Moderna filed paperwork for full application in June and Johnson and Johnson has stated its ambition to file by the end of the year, the Times reports.

Currently, Pfizer is pushing for a third dose of its vaccine and has been releasing studies touting the increased efficacy after the booster and the reduced protection of the two-dose regimen over time.

Leaders of the FDA and the Centers for Disease Control and Prevention have said that the third dose is not currently necessary despite the increased prevalence of the highly transmissible Delta variant.

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Jay W. Lee, MD, MPH, FAAFP headshot | © American Association of Family Practitioners