U.S. regulators are delaying their choice on Moderna’s COVID-19 vaccine for 12- to 17-year-olds whereas they examine the uncommon danger of coronary heart irritation, the corporate mentioned Sunday.
The U.S. Meals and Drug Administration informed the corporate Friday night that its evaluation might final till January, Moderna mentioned.
The corporate additionally mentioned it’s going to delay submitting a request for emergency-use authorization of a decrease dose of the vaccine for 6- to 11-year-olds.
Coronary heart irritation is an exceedingly uncommon danger of each the Pfizer and Moderna vaccines, and it extra generally seen in younger males or boys. It’s troublesome for medical trials to detect such a uncommon downside. And public well being officers have repeatedly confused that COVID-19 itself could cause coronary heart irritation at increased charges than the uncommon circumstances brought on by the vaccine.
Within the U.S., the Moderna vaccine is allowed for individuals 18 and older.
Moderna mentioned greater than 1.5 million adolescents world wide have obtained its vaccine and that the variety of coronary heart irritation reviews “doesn’t counsel an elevated danger” for these beneath 18.
U.S. kids from 12 to 17 can get the vaccine produced by Pfizer and its companion BioNTech.
COVID-19: Former FDA commissioner says he thinks children aged 5-11 may very well be vaccinated as early as Nov. 4 or 5
The FDA final week moved to permit use of the Pfizer pictures in kids between 5 and 11. The Facilities for Illness Management and Prevention is debating that this week.
Moderna additionally has been testing two pictures, one month aside, for kids 6 to 11, at half the dose given to adults.
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