The FDA is not prepared to approve Modern for ages 12-17

Moderna said Sunday that the FDA needs more time to evaluate the social vaccine against COVID-19 for use in adolescents aged 12 to 17 years.

The company said the U.S. Food and Drug Administration on Friday told Moderna it may take until January 2022 to complete the review, which could lead to a delay in the time of approval of emergency use for this age group.

Moderna CEO Stephane Bancel told Reuters last week that based on talks with the agency, she believes the vaccine will be approved for ages 12 to 17 in the next few weeks.

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

Moderna said she is conducting her own review of new studies on the risk of myocarditis in children when they become available.

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