Cambridge-based Moderna announced Tuesday that it is seeking full approval from the Food and Drug Administration for its COVID-19 vaccine for anyone 18 years and older.
The vaccine is currently available in the United States under an Emergency Use Authorization, which was granted on Dec. 18, 2020.
The biotechnology company has initiated the rolling submission process with the FDA for a Biologics License Application for its vaccine.
“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 is the second company to seek full FDA approval.
Pfizer announced it was asking for full approval for its vaccine for people 16 years and older.
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