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"Life-threatening", US to place "BL" warning on Covid vaccines

2025-12-12 17:01:39Kosova&Bota SHKRUAR NGA REDAKSIA VOX
"Life-threatening", US to place "BL" warning on Covid
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The US Food and Drug Administration intends to impose a "Black Box" warning on COVID-19 vaccines.

This is reported by CNN, citing two people familiar with the agency's plans.

It was not immediately clear whether the warning for COVID-19 vaccines would apply only to mRNA vaccines or to all coronavirus vaccines, nor whether it would apply to all age groups.

“Black Box” warnings appear at the top of the prescribing information for drugs. It is the FDA’s most serious warning, intended to alert people to risks, such as death or life-threatening reactions or disabilities, that must be weighed against the benefits. The plan has not yet been finalized and could change. It is expected to be unveiled by the end of the year. 


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