By Associated Press
November 1, 2021
The bureau says it wants to further survey the hazard of myocarditis, oregon the inflammation of the bosom muscle, successful children.
U.S. regulators are delaying their determination connected Moderna's COVID-19 vaccine for 12-to-17-year-olds portion they survey the uncommon hazard of bosom inflammation, the institution said Sunday.
The FDA told the institution Friday evening that its reappraisal could past until January, Moderna said.
The institution besides said it volition hold filing a petition for emergency-use authorization of a little dose of the vaccine for 6-to-11-year-olds.
Heart inflammation is an exceedingly uncommon hazard of some the Pfizer and Moderna vaccines, and is much commonly seen successful young men oregon boys. It’s hard for objective trials to observe specified a uncommon problem. And nationalist wellness officials person repeatedly stressed that COVID-19 itself tin origin bosom inflammation astatine higher rates than the uncommon cases caused by the vaccine.
In the U.S., the Moderna vaccine is authorized for radical 18 and older.
Moderna said much than 1.5 cardinal adolescents astir the satellite person received its vaccine and that the fig of bosom inflammation reports “does not suggest an accrued risk" for those nether 18.
Moderna besides has been investigating 2 shots, 1 period apart, for children 6-11, astatine fractional the dose fixed to adults.