Moderna completes submission for full FDA approval of COVID-19 vaccine

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Moderna has completed its submission to the US Food and Drug Administration seeking full approval for its COVID-19 vaccine for those aged over 18, the company announced Wednesday.

The drug maker is requesting a priority review for its vaccine as part of the submission.

“We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2,” Moderna’s CEO Stéphane Bancel said in a statement announcing the submission.

Moderna has been submitting sections of its application, known as the Biologics License Application, on a rolling basis since May last year.

The completed submission includes results from Moderna’s phase 3 trials that involved more than 30,000 Americans, the company said.

In that final phase trial, Moderna said its vaccine was 93 percent effective and that the efficacy lasted six months after the second dose.

More than 1.4 million doses of Moderna’s vaccine have already been administered across the US.

Moderna is requesting a priority review for its vaccine as part of the submission to the FDA.
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The Moderna vaccine has been available in the US since December after being granted emergency use authorization by the FDA.

The company has since applied for emergency authorization to provide COVID vaccines to those aged 12-17. That authorization is still pending.

Moderna’s announcement comes just two days after the FDA granted Pfizer full approval for its COVID vaccine.

Worker draws COVID-19 Moderna vaccine from an ampule into a syringe.
More than 1.4 million doses of Moderna’s COVID-19 vaccine have been administered across the US.
Ty O'Neil/SOPA Images/LightRocket via Getty Images

“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” acting FDA Commissioner Janet Woodcock said Monday in announcing full approval, which comes as the US battles the highly contagious Delta variant.

The FDA gave emergency use authorization to Pfizer just one week before issuing the same to Moderna.

It is not clear how long the FDA will take to grant Moderna full approval.

A sign for the Food And Drug Administration.
The FDA has granted Pfizer full approval for its COVID-19 vaccine.
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