FDA grants Pfizer ‘priority review’ for full approval, company says

COVID-19 vaccine has been authorized under emergency use

In this March 2021 photo provided by Pfizer, vials of the Pfizer-BioNTech COVID-19 vaccine are prepared for packaging at the companys facility in Puurs, Belgium. Pfizer is about to seek U.S. authorization for a third dose of its COVID-19 vaccine, saying Thursday, July 8, 2021, that another shot within 12 months could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant. (Pfizer via AP) (Uncredited, Pfizer)

Pfizer is one step closer to getting full approval from the U.S. Food and Drug Administration for its COVID-19 vaccine.

The company said the FDA granted priority review for the shot it developed with BioNTech.

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That review process generally allows six-month progress and the companies set a target date for approval in January 2022, but approval could come sooner.

According to the Associated Press, more than 186 million doses of the vaccine made by Pfizer and its German partner BioNTech have been administered in the U.S. alone since December. Many more doses have gone to other countries that have authorized emergency use of the vaccine during the pandemic.

In May, the Pfizer vaccine’s emergency use authorization expanded to children 12 through 15 years old.

There are currently no FDA-approved vaccines for COVID-19 in the U.S. All three vaccines being administered — Pfizer, Moderna and Johnson & Johnson — are allowed under the FDA’s emergency use authorization program.

Pfizer submitted its vaccine for approval for people ages 16 and over in May.


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