U.S. regulators under President Donald Trump plan to slap their harshest safety label—a “black box” warning—on Covid-19 vaccines, sources tell CNN, flipping the script on a first-term triumph now under fire from appointees like vaccine sceptic Robert F Kennedy Jr. Independent experts balk at the move, citing zero evidence for it.
Black box warnings, the FDA’s most severe alerts, appear prominently at the top of drug labelling and prescribing information to highlight potentially fatal, life-threatening, or permanently disabling side effects that must be carefully balanced against the treatment’s benefits. They are particularly employed when risks can be mitigated through precise, targeted administration—such as restricting use to specific patient groups, dosages, or conditions.
For example, opioid medications carry these notices emphasising dangers like misuse, physical dependence, fatal respiratory depression from overdose, and addiction potential; the acne drug Accutane (isotretinoin) bore a stark advisory on severe birth defects and fetal harm if taken during pregnancy; similarly, the ACAM2000 vaccine for smallpox and mpox warns of serious complications including myocarditis, pericarditis, encephalitis, and other inflammatory conditions affecting the heart and brain.
Dr. Vinay Prasad, FDA’s science chief and biologics head, is reportedly leading, per an off-record source.
“Unless the FDA announces it, any claim about what it will do is pure speculation,” HHS spokesperson Andrew Nixon said Thursday.
Moderna and Pfizer reaffirmed safety in September statements after risk probes, with billions of doses showing no new child/pregnancy issues.
“The FDA takes very seriously any death that is attributed to a regulated medical product,” Nixon said.
“What’s happening now is death by a thousand cuts,” a former official said. “What we’re watching is misinformation and lies in aggregate that will discourage the population from vaccination. It will lead us to, ultimately, to having loss of life unnecessarily, and it’s very disturbing.”