Moderna applying for full FDA approval of COVID-19 vaccine

Coronavirus Updates

Boxes containing the Moderna COVID-19 vaccine are prepared to be shipped at the McKesson distribution center in Olive Branch, Miss., Sunday, Dec. 20, 2020. (AP Photo/Paul Sancya, Pool)

(ABC4) – Moderna is now looking to drop the emergency use authorization from its COVID-19 vaccine.

On Tuesday, the company confirmed it has initiated the rolling submission process with the U.S. Food and Drug Administration for the licensure of its mRNA COVID-19 vaccine to prevent the virus in individuals 18-years-old and older.

“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,” says Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

Over the coming weeks, Moderna will submit data to the FDA to support the BLA with a request for a priority review.

In December 2020, the Moderna COVID-19 vaccine became available to Americans under an Emergency Use Authorization. As of June 1, over 124 million doses of the vaccine have been administered in the U.S. In Utah, over 1.09 million doses of the Moderna vaccine have been administered.

Modera recently released data saying its vaccine strongly protects kids as young as 12 from COVID-19. The company studied more than 3,700 12- to 17-year-olds. Preliminary findings showed the vaccine triggered the same signs of immune protection in kids as it does in adults, and the same kind of temporary side effects such as sore arms, headache and fatigue.

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