Pfizer files for COVID-19 vaccine's full FDA approval

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Pfizer on May 7 applied for its COVID-19 vaccine's full FDA approval for use in people ages 16 and older, as opposed to the emergency use authorization under which the shot is currently being administered.

Over a few weeks and on a rolling basis, Pfizer will submit data on its manufacturing sites and practices to prove the vaccine's production is consistent and reliable. The FDA also requires submission of all pre-clinical and clinical trial data.

The drugmaker has requested priority review, meaning it is seeking a decision within six months, rather than the 10 months the FDA designates under standard review.

Pfizer's vaccine is the first COVID-19 vaccine to be reviewed for full FDA approval.

 

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