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Moderna seeks full vaccine approval in US

Moderna Inc. announced on Tuesday that it started "the rolling submission process" with the United States Food and Drug Administration (FDA) in an effort to gain full approval for use of its coronavirus vaccine in adults in the country.

"We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine. We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission," CEO Stephane Bancel said in a statement.

Moderna explained that the FDA will inform the company about its request for a Priority Review once the rolling submission is finalized. The shot received Emergency Use Authorization (EUA) on December 18, after which 124 million doses of the vaccine have been administered in the US.

Breaking the News / MS