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Moderna seeks full FDA approval for its COVID-19 vaccine

The company is the second drugmaker in the U.S. to begin applying for full FDA approval for its COVID-19 vaccine.

WASHINGTON — Drugmaker Moderna announced on Tuesday it has started the process to request full approval from the U.S. Food and Drug Administration for its mRNA coronavirus vaccine. 

Moderna's vaccine is currently authorized under an Emergency Use Authorization (EUA) for adults 18 and up. Since receiving the EUA in December, more than 124 million doses of Moderna's vaccine have been administered across the U.S. 

The company is the second drugmaker in the U.S. to apply for full FDA approval for its COVID-19 vaccine. Last month, Pfizer and BioNTech announced they had started the approval process. 

Moderna said data to support its vaccine will be submitted to the FDA on a "rolling basis" over the coming weeks. Like Pfizer, Moderna requested a priority review, which asks the FDA to fast-track the application within six months instead of the usual 10 months.

To apply for full approval from the FDA, companies need to submit a Biologics License Application or BLA. These include the most recent analyses on its Phase 3 clinical trial, which found that its vaccine is effective up to six months after the second dose.

“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,” said 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.”

Moderna said it is currently just requesting full approval for adults 18 years and older. 

Last week, the company announced plans to request Emergency Use Authorization for its vaccine to be used starting at age 12. 

For most people, the coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.

The United States has more than 33 million confirmed cases of COVID-19, according to data from Johns Hopkins University.

As of Tuesday, the U.S. had more than 594,000 deaths from the virus. Worldwide, there are more than 170 million confirmed cases with more than 3.5 million deaths.

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