Moderna has begun applying for a full license from the FDA for its coronavirus vaccine. In December, the Food and Drug Administration has authorized the use of the Moderna two-shot vaccine on an emergency basis. Modena vaccine is available for 18 and above.
The Moderna is the second vaccine maker, after Pfizer / BioNTech, to apply for full FDA approval.
“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,” Stéphane Bancel, CEO of Moderna, said in a statement. “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 full license approval will allow the company to market the vaccine directly to the consumer, such as through online advertisement and TV commercials
According to the data from the Centers for Disease Control and Prevention, the US has distributed more than 151 million doses in the US.
The approval process is projected to take months as agency scientists examine through months of safety and efficiency of the data
It would be the biotech company’s first-ever approved product if the FDA approves Moderna’s application