Moderna (NASDAQ:MRNA) on Tuesday asked the Food and Drug Administration for full U.S. approval of its COVID-19 vaccine — the second drug maker in the U.S. to seek a biologics license that will allow it to market the shots directly to consumers.
The mRNA vaccine is currently on the U.S. market under an emergency use authorization, which was granted by the FDA in December. It gives conditional approval based on two months of safety data. It’s not the same as a biologics license application, or a request for full approval, which requires at least six months of data. Over 100 million of the shots have already been administered, according to data compiled by the Centers for Disease Control and Prevention.
"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," Moderna CEO Stephane Bancel said in a press release. "We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission."
The FDA approval process is likely to take months.
Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks.
Once companies submit applications to the FDA, agency scientists painstakingly look through the clinical trial data, including for any discrepancies or safety concerns, said Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee.
MRNA shares tumbled Tuesday $1.45 to $183.56.
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