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

>> A SECOND VACCINE TO PROTECT TEENAGERS FROM COVID-19 COULD AVAILABLE SOON. HERE TO ANSWER YOUR QUESTIONS IS DR. HELEN BOUCHER, CHIEF OF GEOGRAPHIC MEDICINE AND INFECTIOUS DISEASES AT TUF MEDICAL CENTER THE PFIZER VACCINE IS ALREADY AUTHORIZED FOR KIDS AS YOUNG AS 12. TODAY MODERNA ANNOUNCED THAT I VACCINE IS ALSO SAFE AND APPEARS EFFECTIVE. WHAT WOULD BE THE BENEFIT OF HAVING A SECOND OPTION FOR TEENAGERS? IT IS JUST A MATTER OF SUPPLY. WE WOULD HAVE MORE SUPPLY AVAILABLE TO TREAT THE YOUNG PEOPLE AND T SPREAD VACCINATION TO ALL THOSE WHO NEED IT. >> AND HOW QUICKLY COULD THAT HAPPEN WOULD IT BE IN THE NEXT MONTH? WE ARE HEARING CERTAINLY BY THE FALL. THE TIMING IS GOOD, SO WE COULD GET THOSE INDIVIDUALS VACCINATED BEFORE IT’S TIME TO GO BACK TO SCHOOL. >> DID THE KIDS IN THE MODERNA TRIAL RECEIVE THE ADULT DOSE? BOTH SHOTS >> THEY DID. IT’S VERY SIMILAR TO WHAT WE SAW FOR THE PFIZER VACCINE. THE ADOLESCENTS WERE TREATED WITH BOTH DOSES, THE SAME ADULT DOSE AND SAME SCHEDULE. THE RESULTS SHOWED INFECTIONS IN THE VACCINATED INDIVIDUALS COMPARED TO FOUR IN THE PURSUIT -- PLACEBO GROUP. >> WE KNOW PFIZER AND MODERNA HAVE TRIALS UNDERWAY FOR CHILDREN AS YOUNG AS 6 MONTHS OL A LOT OF PARENTS ARE WONDERING WHAT WE MIGHT SEE SOME RESULTS ON THAT. THAT WILL BE LATER, AND IT IS IMPORTANT TO NOTE THAT THE DOSAGE FOR SMALLER CHILDREN WOULD BE LOWER. THERE IS AN ADVISORY COMMITTEE ON JUNE 6 WHERE THE CRITERIA FOR SUCCESS FOR THESE TRIALS AND THE APPROPRIAT USE FOR EMERGENCY WILL B DISCUSSED. MY GUESS IS IT WILL BE WELL INTO THE FALL BEFORE WE HAVE THAT DATA. >> LET’S ANSWER SOME EMAILS FROM VIEWERS. JOANNE WRITES, I RECEIVED MY SECOND COVID SHOT SEVEN WEEKS AGO. HOW LONG DO I HAVE TO WAIT BEFORE I CAN GET THE SHINGRIX VACCINE FOR SHINGLES? GOOD NEWS, IT IS NO LONGER RECOMMENDED BY THE CDC TO WAIT AT ALL BETWEEN VACCINES. YOU COULD HAVE TWO VACCINES AT ONCE ON THAT’S APPROPRIATE AND THAT APPLIES ESPECIALLY TO THE YOUNGER PEOPLE LIKE THE ADOLESCENTS. THEY ALSO -- OFT NEED OTHER VACCINES, THERE IS NO NEED TO WAIT. >> HERE’S ONE FROM ROBERT. HE ASKS, IS IT SAFE TO GET VACCINATED IF YOU HAVE TYPE 1 DIABETES? I WOULD SAY IT’S NOT ONLY SAFE, BUT ESPECIALLY IMPORTANT BECAUSE WITH TYPE 1 DIABETES, YOU ARE AT RISK OF A NUMBER OF INFECTIONS. I WOULD ENCOURAGE YOU TO GET VACCINE -- VACCINATED AS SOON AS YOU CAN. >>

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."Moderna's vaccine already has been cleared for emergency use by the FDA and regulators in numerous other countries. So far, more than 124 million doses have been administered in the United States.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."

Moderna's vaccine already has been cleared for emergency use by the FDA and regulators in numerous other countries. So far, more than 124 million doses have been administered in the United States.

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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