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The Pfizer vaccine gains full FDA approval

Pfizer vaccine full approval
Photo via Marco Verch/Flickr (CC BY 2.0)

The Pfizer-BioNTech vaccine gained full approval from the Food and Drug Administration on Aug. 23. Hopes are high that the FDA’s announcement will spark a rise in people seeking a vaccination.

The Pfizer vaccine is the first to gain formal approval by the FDA. The full approval replaces the Emergency Use Authorization the vaccine earned last December. In order for a vaccine to gain full approval, it must first undergo a rigorous review process examining its safety, quality, and effectiveness. The fully approved Pfizer vaccine will be marketed as Comirnaty, and will be used “for the prevention of COVID-19 disease in individuals 16 years of age and older,” according to the FDA.

Employers and schools have been torn over whether or not to require vaccines among eligible groups for months. The Pfizer vaccine’s full approval will make this decision easier, as many groups were concerned about mandates for a vaccine that had not been formally approved. Experts also anticipate that the move by the FDA will help urge the vaccine hesitant to seek a shot. A June poll from the Kaiser Family Foundation found that a full 31% of people interviewed would be more likely to seek a COVID vaccination once one was approved by the FDA.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” FDA acting Commissioner Janet Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Around 73% of adults in the U.S. have received at least one dose of either the Pfizer, Moderna, or Johnson & Johnson vaccines. The Pfizer version is the most common vaccine among Americans, with around 56% of overall administered doses coming from Pfizer. The Moderna and Johnson & Johnson vaccines have yet to gain full approval, but Moderna is expected to reach this goalpost soon.

Sources: NPR, FDA, Washington Post


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