Moderna: FDA delaying decision on its shot for adolescents
ABC News
U.S. regulators are delaying their decision on Moderna’s COVID-19 vaccine for 12- to 17-year-olds while they study the rare risk of heart inflammation
CAMBRIDGE, Mass. -- U.S. regulators are delaying their decision on Moderna's COVID-19 vaccine for 12- to 17-year-olds while they study the rare risk of heart inflammation, the company said Sunday.
The U.S. Food and Drug Administration told the company Friday evening that its review could last until January, Moderna said.
The company also said it will delay filing a request for emergency-use authorization of a lower dose of the vaccine for 6- to 11-year-olds.
Heart inflammation is an exceedingly rare risk of both the Pfizer and Moderna vaccines, and it more commonly seen in young men or boys. It’s difficult for clinical trials to detect such a rare problem. And public health officials have repeatedly stressed that COVID-19 itself can cause heart inflammation at higher rates than the rare cases caused by the vaccine.
