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November 01, 2021

FDA delays decision on Moderna's COVID-19 vaccine for adolescents

Scientists want to further investigate the risk of myocarditis

The U.S. Food and Drug Administration has pushed back its decision on Moderna's COVID-19 shot for children ages 12-17 so its scientists can investigate reports of myocarditis after vaccination, the company said.

An increased risk of myocarditis – inflammation of the heart muscle – has been linked to both the Pfizer and Moderna vaccines. The potentially serious side effect has occurred most often in adolescent males and young adults, and after the second dose.  

Still, the U.S. Centers for Disease Control and Prevention and the World Health Organization have said the likelihood of myocarditis after vaccination is rare and cases are generally mild. 

Moderna said the FDA informed the company last week that it needs additional time to evaluate recent international analyses of the risk of myocarditis. The review may not be completed before January. 

Moderna said it is fully committed to working closely with the FDA on its review. Over 1.5 million adolescents ages 12-17 have received the Moderna COVID-19 vaccine at the 100-microgram dose level. So far, the data in the company's global safety database does not suggest an increased risk of myocarditis.

The company said it also plans to delay filing for emergency use authorization for its vaccine for children ages 6-11 years. Last month, it released interim data suggesting the vaccine is safe for this population, too.

The Moderna's vaccine currently is authorized for adults ages 18 and older.

U.S. children between the ages of 12 and 17 currently can receive Pfizer's COVID-19 vaccine. The Pfizer vaccine for children ages to 5-11 also has received the nod from the FDA, but the CDC must sign off on the authorization before it can be administered within this age group. 

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