Posted on 12/12/2025 9:38:18 AM PST by Angelino97
The FDA is drawing up plans to put a 'black box' warning on Covid vaccines, the agency's most serious warning over potential side effects, reports suggest.
The move was revealed to CNN by two people familiar with the matter, who spoke on condition of anonymity because they were not authorized to speak to the media.
A black box warning, which appears at the top of prescribing information, is placed on drugs or vaccines to highlight major risks such as serious side effects or restrictions.
Sources did not specify what the warning would contain, or whether it would apply to only mRNA Covid vaccines or all Covid vaccines.
One individual said the effort was being led by Dr Vinay Prasad, a hematologist-oncologist and the FDA's director for the Center for Biologics Evaluation and Research (CBER), the center that evaluates products such as vaccines for their effectiveness and safety.
Dr Prasad raised concerns over Covid vaccines late last month, saying in an email to staff that 'at least' 10 children had died after receiving the shots, although he did not reveal further details. The FDA has now launched a thorough investigation into the reports.
Officials stressed that discussions were still in the early stages and that no changes to the warnings had been finalized.
A spokesman for the Department of Health and Human Services said: 'Unless the FDA announces it, any claim about what it will do is pure speculation. The FDA takes very seriously any death that is attributed to a regulated medical product.'
There are three Covid vaccines available in the US, the Moderna and Pfizer vaccines, which use mRNA, and the Novavax vaccine, which uses the virus's spike protein, and none currently carry a black box warning on their label.
(Excerpt) Read more at dailymail.co.uk ...
Anonymous leaks are just that, anonymous. So this means nothing until such time that happens.
Pure bloods in our house.
FDA aka Federal Dumb Asses
A spokesman for the Department of Health and Human Services said: ‘Unless the FDA announces it, any claim about what it will do is pure speculation.
Come back when the source isn’t ‘anonymous’.
How many adults have died ? I’m not sure how stupid they think we are but 10 kids dying is truly rare.
Wow, leftists heads are exploding all over as “anti-science” anti-mRNA shot people are proven right, yet again.
"I came up with a vaccine, with three vaccines all are very, very good.”
It’s good to wait more than three weeks between the shots. Both to offset side effects AND to boost long term efficacy.
Singapore’s health ministry advises against strenuous exercise after each dose for at least a week or two. To protect your heart. No joke.
https://nuhsplus.edu.sg/article/after-covid-19-vaccination-to-work-out-or-not-to-work-out
“The vaccine is one of the greatest achievements of mankind.”
“I came up with a vaccine, with three vaccines all are very, very good.”
The number of deaths that have been attributed to other things are being look at again, the athletes, the airline pilots, the verified healthy people who got the vax and just died.
Those who know want to drag it out as long as possible to try and mediate and reduce the anger.
It’s not going to work.
When the full amount of lies and direct obfuscation come out.
YA THINK
“The vaccine is one of the greatest achievements of mankind.”
“I came up with a vaccine, with three vaccines all are very, very good.”
Whose quotes are those? Not in the article........
RIP DG,DF,DW,PW The perfect crime against innocent, unsuspecting human beings. Plausible deniability. Condolences to family and friends.
The covid vaccine was a life saver for some and a death bringer for others.
The problem was the one size fits all of centralized govt.
Trump was working on informed consent as much as possible. Information was hard to come by, only in hind sight to we see the problem.
I repeat, The covid vaccine was a life saver for some and a death sentence for others.
“It has long been known that in a race, one horse will beat another. The question is which one? Differences are crucial”
Lazarus Long
Oooh, a “black box warning”. Now that’s series!
Seriously, do we not know now that the jab does not do what we were told? It doesn’t prevent transmission, it doesn’t protect against contracting the disease. It does, however, cause miocarditis, turbo cancer, strokes, and more. Why are they still allowed to push that poison?
A beautiful young woman at the gym was on the cardio machines alternately running on the eliptical and stopping to clutch her chest in severe pain.
Alarmed, I asked if she was okay.
“As a nurse, I was required to take the Covid shot. I came down with serious heart problems within 24 hours of the shot. I’m damaged for life! And I can’t sue anybody!”
“in hind sight to we see the problem”
Vaccines that have not had many years of human testing are very risky.
This was commonly understood by almost all homo sapiens until recent years.
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