Former Fox News host and SiriusXM broadcaster Megyn Kelly announced that she has confirmed reporting that President Donald Trump’s Food and Drug Administration may put a so-called “black-box warning” on COVID-19 vaccines after Biden-era data showed at least 10 minors died from myocarditis after receiving the jab.
The move comes after Dr. Vinay Prasad, the FDA’s top vaccine official, said in a memo that he was proposing new regulatory procedures for the shots.
The memo was first reported by The New York Times on Nov. 28, the same day it was sent to others within the agency.
“This is a profound revelation,” Dr. Prasad wrote. “For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children.
“Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death. In many cases, such mandates were harmful. It is difficult to read cases where kids aged 7 to 16 may be dead as a result of COVID vaccines.”
The memo looked at 96 deaths of minors between 2021 and 2024 catalogued on the Vaccine Adverse Event Reporting System, or VAERS. Out of them, investigators found, 10 were found to be due to myocarditis caused by the shot itself.
Prasad also dismissed the theory that COVID itself might cause more myocarditis than the COVID vaccine as being “wrong.”
“In order to study how often people have myocarditis after the virus, you would want to collect everyone who got covid, and see how many get myocarditis,” the memo reads. “Yet, studies on this topic don’t do this. They take people who presented to health care systems and had covid-19 and ask how many have myocarditis. But we all know most people who get covid simply recover at home. People who seek medical care are the sickest ones. These studies use a false denominator.
“Second, the demographic matters. I have no doubt COVID vaccines were life saving for an 80 year old who never had COVID, but should a 20 year old get his 6th dose this fall? These studies often fail to look at the balance in younger people. Finally, you still get COVID anyway. No amount of covid vaccines stops a person from getting covid, so the risk is not virus vs vaccine. It is vaccine + virus vs virus alone.”
The acknowledgement led to reporting that a “black box” warning might be added to vaccine packaging. The possibility of requiring the warning — the strongest that the FDA can require for a drug with serious, sometimes deadly, side effects — was first reported by Substacker Alex Berenson. Megyn Kelly at Sirius subsequently confirmed it:
We have independently confirmed @AlexBerenson’s excellent reporting below. The Biden Admin lied to us all about the Covid vaccines and our children. Kids died as a result. And they actively covered it up and misled about it. https://t.co/M250D8hMAr
— Megyn Kelly (@megynkelly) December 3, 2025
Whether or not the black box ends up getting added to vaccines for kids, the fact remains that the government’s behavior has thoroughly radicalized many Americans against experts — especially the young.
We were told that we not only needed to lock down and immolate our personal, professional, and social lives because of a bug, we were told that a vaccine would protect us from that bug. We were then promised that not only were the lockdowns worth it for everyone, so was the jab — because it came with virtually no risk.
Those were all lies.
Yes, COVID is bad. However, we realized from the earliest days of the virus that minors didn’t seem to be a group of concern. Moreover, we sounded the alarm that their lives would be permanently altered by keeping them at home and insisting that they take a shot they didn’t need.
We now have good reason to believe that not only were kids badly served by this advice, some were actually killed by it. Ten is a low number — and we’re not sure whether the 96 in the control group were randomly selected from the paper — but we do know that the number is non-zero. And it’s likely a lot higher than that.
“When it comes to vaccine deaths, VAERS is passively reported,” Prasad wrote. “It requires a motivated person, often a doctor, to submit the information. The submission process is tedious and most people who start the form give up along the way. Many more deaths may be unreported. Finally, the FDA has failed to properly enforce many required post market commitments for COVID-19 vaccines, including for pregnant women and to document subclinical myocarditis.”
“There is no doubt that without this FDA commissioner, we would not have performed this investigation and identified this safety concern. This fact also demands serious introspection and reform. Why were these deaths not actively reviewed in real time? Why did it take until 2025 to perform this analysis, and take necessary further actions? Deaths were reported between 2021 and 2024, and ignored for years,” Prasad added, saying he thought “the answer is cultural and systemic.”
“The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm,” Prasad said.
Not only that, but forcing it upon America is a great way for us to stop trusting those who foist their ideology on us in the form of medicine. One hopes this is just the start of a housecleaning of America’s public health hierarchy. While we’re waiting for that, it’s time to call people before Congress to explain why information like this wasn’t given to every American citizen before they took the COVID vaccine.
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