FDA not ready to approve Moderna for ages 12-17

Moderna said Sunday the FDA needs more time to assess the company's COVID-19 vaccine for use in adolescents ages 12 to 17.

The company said the U.S. Food and Drug Administration told Moderna Friday it may take until January 2022 to complete the review, dealing a potential setback to the timing of an emergency use authorization for that age group.

Moderna CEO Stephane Bancel told Reuters last week that based on conversations with the agency, he believed the vaccine would be authorized for 12 to 17-year-olds in the next few weeks.

The U.S. biotech company said it was told the FDA needed to evaluate recent international studies on the risk of heart inflammation called myocarditis after vaccination, a rare side effect that has mainly affected young males.

Moderna said it is conducting its own review of the new studies on the myocarditis risk in children as they become available.

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