Moderna files for full US approval of COVID-19 vaccine

Moderna Inc said on Tuesday it has started an application for full U.S. approval of its COVID-19 vaccine, which is currently only authorized for emergency use in the country.

The development comes weeks after rival Pfizer Inc and its German partner BioNTech SE sought full approval for their COVID-19 vaccine in the United States.

Full approval for the vaccines, which are at the forefront of global immunization efforts, could be an important step in allaying vaccine hesitancy, a growing concern in the United States and other wealthy nations.


Moderna said it will continue to submit data to the U.S. Food and Drug Administration on a rolling basis over the coming weeks with a request for a priority review.

Once the rolling submission is complete, the FDA will notify the company when it is formally accepted for review, Moderna added.

Under a rolling submission, a drug developer can submit completed sections of its marketing application for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.