FDA Deciding Whether Moderna Vaccine Can Cause a Rare Side Effect in Teens

Written by on November 1, 2021

As of yesterday, the U.S. Food and Drug Administration (FDA) announced that they will need more time to decide whether or not they will approve Moderna’s COVID-19 vaccine for use in children ages 12 to 17. The FDA informed Moderna on Friday of a rare side effect from the vaccine known as myocarditis, or the inflammation of the heart muscle.

According to Moderna, the government’s review of Moderna’s application for an emergency use authorization of its vaccine in adolescents ages 12-17 may not be completed before January. In a statement, Moderna said: “The safety of vaccine recipients is of paramount importance to Moderna. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.”

Source: NPR


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