Video above: Physician talks about risk of Moderna COVID-19 vaccine use in children ages 12-15Moderna introduced Tuesday that it has initiated the rolling submission course of with the Meals and Drug Administration for full approval of its COVID-19 vaccine for folks 18 years and older. “We’re happy to announce this necessary step within the U.S. regulatory course of for a Biologics License Software (BLA) of our COVID-19 vaccine,” mentioned Stéphane Bancel, Chief Govt Officer of Moderna. “We stay up for working with the FDA and can proceed to submit information from our Part 3 examine and full the rolling submission.”Moderna’s vaccine already has been cleared for emergency use by the FDA and regulators in quite a few different nations. To date, greater than 124 million doses have been administered in the USA.Final month, Moderna mentioned its vaccine strongly protects children as younger as 12, a step that would put the shot on monitor to turn out to be the second possibility for that age group within the U.S. Pfizer’s COVID-19 vaccine has obtained emergency use approval for kids as younger as 12.Moderna says will proceed to submit information to help the BLA to the FDA on a rolling foundation over the approaching weeks.
Video above: Physician talks about risk of Moderna COVID-19 vaccine use in children ages 12-15
Moderna introduced Tuesday that it has initiated the rolling submission course of with the Meals and Drug Administration for full approval of its COVID-19 vaccine for folks 18 years and older.
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“We’re happy to announce this necessary step within the U.S. regulatory course of for a Biologics License Software (BLA) of our COVID-19 vaccine,” mentioned Stéphane Bancel, Chief Govt Officer of Moderna. “We stay up for working with the FDA and can proceed to submit information from our Part 3 examine and full the rolling submission.”
Moderna’s vaccine already has been cleared for emergency use by the FDA and regulators in quite a few different nations. To date, greater than 124 million doses have been administered in the USA.
Final month, Moderna mentioned its vaccine strongly protects children as younger as 12, a step that would put the shot on monitor to turn out to be the second possibility for that age group within the U.S. Pfizer’s COVID-19 vaccine has obtained emergency use approval for kids as younger as 12.
Moderna says will proceed to submit information to help the BLA to the FDA on a rolling foundation over the approaching weeks.
