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Moderna completes full FDA approval request of COVID vaccine

The data from Moderna's latest study showed 93% efficacy through at least six months after the second dose of its COVID-19 vaccine.

WASHINGTON — Moderna announced Wednesday that it has completed the application process to the U.S. Food and Drug Administration for full approval of its COVID-19 vaccine.

According to a press release from the company, the process has been ongoing for months, as Moderna has been submitting data for what's called a Biologics License Application (BLA) on a rolling basis since June of this year. This specific license would be for people ages 18 and older.

Moderna Chief Executive Officer Stéphane Bancel called the completion of the process, "an important milestone in our battle against COVID-19."

The latest submission to the FDA includes data from Moderna's phase 3 efficacy study, which showed a 93% efficacy rate through sixth months after the second dose. 

It's not immediately clear how long the FDA will take to go over the data and issue a decision. Earlier this week, the administration approved the Pfizer-BioNTech COVID vaccine for people 16 and older. That application began in May 2021, so should the FDA take a similar amount of time to rule on Moderna's application, a decision might be expected by November 2021. Pfizer is currently the only COVID-19 vaccine with the FDA's full approval. 

Moderna's vaccine is currently approved for Emergency Use Authorization for people 18 and older in the U.S., and the company applied to add adolescents to that authorization back in June.

The next step is booster shots. Pfizer announced Wednesday that it's begun the approval process for a third booster shot of the vaccine for people 16 and up. The company said it expects that application to be compete by the end of this week.

So far none of the three major vaccines in the U.S. — Pfizer, Moderna and Johnson & Johnson — have been approved for people under 12 in the U.S., under an emergency use authorization or otherwise.

Earlier this month, U.S. regulators said transplant recipients or others with weakened immune systems can get an extra dose of Pfizer or Moderna vaccines.

The Associated Press contributed to this report

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