CNN reporting, but also throwing shade on Trump while they do it:
FDA intends to put its most serious warning on COVID vaccines, sources say
and
FDA intends to put its most serious warning on COVID vaccines, sources say
The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans, the latest move by President Donald Trump’s health officials to undermine a vaccine that was a standout victory of his first term. The plan shocked outside experts, who said there was no basis for the warning
A boxed warning, which appears at the top of prescribing information for medicines, is the agency’s most serious, designed to warn about risks such as death or life-threatening or disabling reactions that should be weighed against the intervention’s benefits. They can also be used when a risk might be lowered by using a medicine in a targeted way, such as only in certain groups.

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