June 1 (UPI) -- Moderna announced on Tuesday that it's begun filing for full Food and Drug Administration approval for its COVID-19 vaccine, which would allow it to directly market the shot to Americans.
Moderna has been allowed to distribute the vaccine nationwide since December under the more temporary emergency use authorization from the FDA.
Moderna said as part of the process, it will submit data to the FDA on a rolling basis in the coming weeks.
To date, Moderna said more than 124 million doses of its vaccine have been administered nationally.
"We are pleased to announce this important step in the U.S. regulatory process for a biologics license application of our COVID-19 vaccine," Moderna CEO Stephane Bancel said in a statement.
Requests for full approval require at least six months of data.
Dr. Paul Offit, a voting member of the FDA's Vaccines and Related Biological Products Advisory Committee, said scientists will review the data for safety.
"They want to make sure that the company has fairly and accurately displayed all those data," he said, according to CNBC.
Moderna's vaccine is given in two doses 28 days apart and has been found to be more than 90% effective in adults. In children between 12 and 17, the company says the shot is 100% effective. The vaccine is soon expected to receive approval for use in children.
Last month, the FDA authorized Pfizer's coronavirus vaccine for children 12 to 15. Pfizer has also applied for full FDA approval for its vaccine.