FDA grants full approval to Pfizer COVID-19 vaccine

·2 min read

The Food and Drug Administration on Monday granted full approval of the Pfizer COVID-19 vaccine, becoming the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval.

The approval comes in a week prior to federal health officials' earlier estimates that the agency would complete its review by Labor Day.

This full approval indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial.

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This prioritized review entailed government scientists pouring over hundreds of thousands of pages of safety and efficacy data at a rapid-fire pace, conducting meticulous inspections of Pfizer's manufacturing process.

PHOTO: A healthcare worker fills a syringe with Pfizer COVID-19 vaccine at a community vaccination event in Los Angeles, Aug. 11, 2021. (Robyn Beck/AFP via Getty Images, FILE)
PHOTO: A healthcare worker fills a syringe with Pfizer COVID-19 vaccine at a community vaccination event in Los Angeles, Aug. 11, 2021. (Robyn Beck/AFP via Getty Images, FILE)

Pfizer's full and formal approval will now pave the way for further vaccine mandates in both the public and private sector, akin to existing vaccine mandates for other FDA-approved vaccines. Some businesses and state leaders have held off thus far, signaling they'd wait for full approval before imposing tighter requirements.

Federal, state and local health officials have also expressed optimism that full approval will help dissolve some of the lingering hesitancy around taking a shot that until now has been only authorized for emergency use -- a forecast recent polling has also reflected.

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U.S. Surgeon General Dr. Vivek Murthy, predicting on ABC's "This Week" Sunday that full approval may "tip" some fence-sitters towards taking the shot, and prompt more workplaces and schools to move forward on requirements.

"Full approval could not come at a more important time, as the highly contagious Delta variant continues to drive up caseloads and deaths across the U.S.," Dr. Rich Besser, former acting CDC director and president of the Robert Wood Johnson Foundation said. "I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination."

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Pfizer was the first to request full approval in the U.S.; other Covid vaccine makers are likely to follow suit. All three authorized vaccines were granted emergency authorization based on massive clinical trials involving tens of thousands of volunteers.

For emergency authorization, the FDA required two months of safety data largely because prior experience with vaccines indicates that any adverse events are likely to emerge shortly after injection. Full approval required at least six months of safety data, as well as additional manufacturing audits from the FDA.

"We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated," an agency spokesperson told ABC in late July, promising any approved vaccine would meet "rigorous standards for safety, effectiveness, and quality."

FDA grants full approval to Pfizer COVID-19 vaccine originally appeared on abcnews.go.com

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