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Why hasn’t the FDA approved the Moderna COVID-19 vaccine for kids yet? They want to investigate rare side effect

The FDA has announced they need more time to decide if the Moderna vaccine should be approved for kids ages 12-17.

A rare side effect called myocarditis, which is the inflammation of the heart muscle, needs to be investigated first.

Moderna said safety is their number one concern and they want to work with the FDA to support their review.


Finland, Sweden, and Denmark all stopped giving the Moderna vaccine due to the rare side effect in October.

Many ask if myocarditis is a symptom of COVID-19, but it appears to be tied to the vaccine. At this time Moderna is not FDA approved for adults, it’s authorized for emergency use.

Related: Children show stronger immunity from Moderna vaccine than adults



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