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FDA to add 'black-box warning' to COVID-19 vaccines, the strongest warning agency can issue

Covid vaccine
Katherine Davis-Young/KJZZ
A medical worker administers a COVID-19 vaccine.

The FDA plans to add a “black-box warning” to COVID-19 vaccines — that’s the strongest warning the agency can issue. But Will Humble, the Arizona Public Health Association president, says the move isn’t as alarming as it sounds.

Humble says the vaccines have been linked to a rare and temporary heart inflammation, mainly in young men up to age 19.

"This doesn't mean the vaccine isn't safe. It just means that there's that advisory out there for that small demographic for this extremely rare event that, by the way, is a lot less rare than the complications to the heart from the infection itself," Humble said.

Humble is a longtime vaccine advocate and says adding the warning is reasonable. More than 400 drugs currently carry a black-box warning.

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KJZZ senior field correspondent Kathy Ritchie has 20 years of experience reporting and writing stories for national and local media outlets — nearly a decade of it has been spent in public media.