Moderna applies for full FDA approval for COVID-19 vaccine

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Moderna said June 1 it applied for its COVID-19 vaccine's full FDA approval for use in people ages 18 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, Moderna 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.

Moderna's vaccine is the second COVID-19 vaccine to be reviewed for full FDA approval, as Pfizer sought full FDA approval for its COVID-19 vaccine May 7.

 

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