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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