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Moderna begins process for full FDA approval for COVID-19 vaccine

By
Don Johnson
Full FDA approval for a vaccine typically requires at least six months of data, Moderna said Tuesday. File Photo by Debbie Hill/UPI
Full FDA approval for a vaccine typically requires at least six months of data, Moderna said Tuesday. File Photo by Debbie Hill/UPI | License Photo

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.

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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.

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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.

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National Institutes of Health official Dr. Anthony Fauci (C) speaks about the coronavirus during a press briefing at the White House in Washington, D.C. Health and Human Services Secretary Alexander Azar (L) announced that the United States is declaring the virus a public health emergency and issued a federal quarantine order of 14 days for 195 Americans. Photo by Leigh Vogel/UPI | License Photo

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