(CNN)– The U.S. Food and Drug Administration intends to put a Black Box warning on Covid-19 vaccines, according to people familiar with the agency’s plans.

Black box warnings appear at the top of prescribing information for medicines.

It is the FDA’s most serious warning, intended to warn about risks, such as death or life-threatening or disabling reactions that should be weighed against the benefits.

The plan has not been finalized and may still change.

The plan is expected to be unveiled by the end of the year.

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