Moderna: FDA delaying decision on its shot for adolescents

Moderna Vaccine
Posted at 6:51 PM, Oct 31, 2021
and last updated 2021-10-31 21:51:45-04

CAMBRIDGE, Mass. (AP) — 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.

Moderna said Sunday that the U.S. Food and Drug Administration told the company Friday evening that its review could last until January.

The company also says 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.

Public health officials have repeatedly stressed that COVID-19 itself can cause heart inflammation.