Moderna applies for full FDA approval of COVID-19 vaccine

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Moderna on Tuesday asked the Food and Drug Administration for full approval of its COVID-19 vaccine in Americans 18 and older.

Moderna is the second COVID vaccine maker to apply for full US approval, called a biologics license application, which would allow the company to market the vaccine directly to consumers, such as through TV commercials and online advertisements.

It would also mean that the vaccine can continue to be sold after the US is no longer in an official state of emergency.

The FDA granted Moderna an emergency use authorization for its two-shot vaccine in December, which allowed it to hit the market as more data was collected.

Since then, the US has distributed more than 151 million doses in the US, and more than 124 million have been administered, according to data from the Centers for Disease Control and Prevention.

A health worker administers a vaccine to a patient in their vehicle.
Moderna is the second COVID-19 vaccine manufacturer to apply for full US approval.
Getty Images

“We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission,” Stephane Bancel, CEO of Moderna, said in a statement.

Pfizer and its German partner BioNTech announced last month that they had applied for full approval of their COVID-19 vaccine.

The approval process is expected to take months as agency scientists comb through months of safety and efficacy data.

Stephane Bancel, CEO of Moderna.
“We look forward to working with the FDA,” Moderna CEO Stephane Bancel said in a statement. 
MediaNews Group via Getty Images

If the FDA grants Moderna’s request, it would be the biotech company’s first-ever approved product.

Shares of Moderna traded about 1 percent lower Monday morning.

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