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


Video above: Doctor talks about possibility of Moderna COVID-19 vaccine use in kids ages 12-15Moderna announced Tuesday that it has initiated the rolling submission process with the Food and Drug Administration for full approval of its COVID-19 vaccine for people 18 years and older. "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," said Stéphane Bancel, Chief Executive Officer of Moderna. "We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission."Last month, Moderna said its vaccine strongly protects kids as young as 12, a step that could put the shot on track to become the second option for that age group in the U.S. Pfizer's COVID-19 vaccine has received emergency use approval for children as young as 12.Moderna says will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks.

Video above: Doctor talks about possibility of Moderna COVID-19 vaccine use in kids ages 12-15

Moderna announced Tuesday that it has initiated the rolling submission process with the Food and Drug Administration for full approval of its COVID-19 vaccine for people 18 years and older.

"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," said Stéphane Bancel, Chief Executive Officer of Moderna. "We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission."

Last month, Moderna said its vaccine strongly protects kids as young as 12, a step that could put the shot on track to become the second option for that age group in the U.S. Pfizer's COVID-19 vaccine has received emergency use approval for children as young as 12.

Moderna says will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks.


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