Moderna seeks full FDA approval for its Covid-19 vaccine in people ages 18 and up. It's currently available through an emergency use authorization.
A healthcare worker administers a dose of Moderna's Covid-19 vaccine at the American Museum of Natural History in New York on April 30. Gabby Jones/Bloomberg/Getty Images
The company says it will continue to submit trial data “on a rolling basis over the coming weeks with a request for a Priority Review.” A priority review asks the US Food and Drug Administration to take action within six months, compared to the 10 months designated under standard review. Since December, Moderna’s two-shot vaccine has been distributed under an emergency use authorization for people ages 18 and up. In April, the company announced its vaccine maintained over 90% efficacy six months out – the amount of follow-up time needed to apply for FDA approval.
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