FDA intends to put its most serious warning on Covid vaccines, sources say

[BlueWaveNeverEnd]

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

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.

Boxed warnings on opioids, for example, warn about risks of abuse, addiction, overdose and death. The acne medication Accutane carried a warning about the risks of birth defects when used during pregnancy. ACAM2000, a smallpox and mpox vaccine, has a warning about complications such as heart inflammation and encephalitis

The plan to install the warnings for Covid-19 vaccines is being orchestrated by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, according to one person, who declined to be named because they weren’t authorized to share the information publicly.

[Irish_Dem]

1. How many Americans can Trump kill with this death plan?

[spanone]

2. Absolutely disgusting. Killing people in plain sight.

[bucolic_frolic]

3. It's all about cost-cutting and downsizing federal agencies

[Blues Heron]

4. Playing doctor without a license

[harumph]

5. I've had four or five? MRNA Covid Vaccines. I'm in my early 60s and no problems whatsoever.

I am so tempting fate. I used to carry those little vaccine cards with the stamps and apparently, the pharmacies don't
do that anymore? I loathe what T and RFK Jr. have done to our medical system. Maybe that's a side effect of the vaccines - heh heh.

[sinkingfeeling]

10. I just got my 10th. Covid shot last week.

[Johonny]

6. This will kill a lot of GOP voters

So they getting what they voted for.

Liberal are still taking vaccines . . .

[BootinUp]

7. What a joke. Nt

[Ritabert]

8. I guess I'll get my booster next month then.

[surfered]

9. -idiots