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The Latest: Moderna seeks full FDA approval for its vaccine

The Latest: Moderna seeks full FDA approval for its vaccine

ABC News
Tuesday, June 01, 2021 01:58:58 PM UTC

American pharmaceutical company Moderna says it has begun the process to win full U.S. regulatory approval for the use of its COVID-19 vaccine in adults

CAMBRIDGE, Mass. -- American pharmaceutical company Moderna says it has begun the process to win full U.S. regulatory approval for the use of its COVID-19 vaccine in adults. Moderna announced Tuesday it has begun a “rolling submission” to the Food and Drug Administration of data from its studies of the two-dose vaccine. Moderna’s vaccine already has been cleared for emergency use by the FDA and regulators in numerous other countries. So far, more than 124 million doses have been administered in the United States. Large-scale studies of the shots continued after Moderna’s emergency authorization. The FDA will scrutinize the information to see if the vaccine meets stringent criteria for full licensure.
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