The U.S. Food and Drug Administration intends to place a black box warning on COVID-19 vaccines, CNN reported, citing sources.

Black box warnings appear at the top of prescribing information for medicines. They are the FDA’s most serious warnings, intended to alert the public to risks such as death or life-threatening reactions that should be weighed against the benefits.

The plan has not been finalized and may still change. It is expected to be unveiled by the end of the year.

The move follows the FDA’s requirement for updated warning labels on mRNA COVID-19 vaccines regarding myocarditis and pericarditis. The vaccines have been associated with a rare risk of myocarditis, which causes damage to heart muscle cells.

Earlier this week, Stanford University released a study showing that

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