FDA intends to put itsmost serious warning on Covid vaccines, sources say [View all]

Source: CNN

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 is 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, such as only in certain groups.

Read more: https://www.cnn.com/2025/12/12/health/fda-black-box-warning-covid-vaccine