‘Children Died’ And 20 Other Shocking Things An FDA Scientist Just Said About Covid Shots

'Like many academic physicians, we felt the FDA and CDC abdicated their duty to the American people,' Prasad wrote.

FDA finally admits COVID-19 vaccine killed kids: 'This is a profound revelation'



Millions of Americans across the country were told during the pandemic to offer up their arms for the COVID-19 vaccines — the first-ever mRNA vaccines approved by the U.S. Food and Drug Administration — if they wanted to keep their jobs, eat in public, stay in school, or visit their loved ones.

Government officials, the establishment media, and pharmaceutical representatives claimed that the vaccines were "safe and effective." Those who dared to suggest otherwise about the experimental drugs that were making liability-shielded vaccine manufacturers record profits were often attacked and censored.

Months after the Department of Health and Human Services concluded that "mRNA technology poses more risks than benefits for these respiratory viruses," the Food and Drug Administration admitted in an internal letter that the COVID-19 vaccines killed numerous children.

'Healthy young children who faced tremendously low risk of death were coerced.'

Dr. Vinay Prasad, chief medical officer at the FDA and director at the Center for Biologics Evaluation and Research, noted in an email to staff on Friday that FDA Office of Biostatistics and Pharmacovigilance career staff "have found that at least 10 children have died after and because of receiving COVID-19 vaccination."

In the email, which was reviewed by multiple publications and shared online by the Washington Post, Prasad indicated that the OBPV performed an analysis of 96 deaths between 2021 and 2024 and concluded "that no fewer than 10 are related. If anything, this represents conservative coding, where vaccines are exculpated rather than indicated in cases of ambiguity. The real number is higher."

"These deaths are related to vaccination (likely/probable/possible attribution made by staff). That number is certainly an underestimate due to underreporting, and inherent bias in attribution," wrote Prasad. "This safety signal has far-reaching implications for Americans, the U.S. pandemic response, and the agency itself."

RELATED: Pfizer COVID shot sales plummet after Trump administration ends universal recommendations

Photo by SAUL LOEB/AFP via Getty Images

Despite the strong improbability of a healthy child getting seriously ill from COVID, former National Institute of Allergy and Infectious Diseases Director Anthony Fauci, former Centers for Disease Control and Prevention Director Rochelle Walensky, and other health officials championed injecting kids with the novel vaccines.

On Nov. 2, 2021, then-President Joe Biden's health officials gave final approval to Pfizer's COVID-19 shot for kids ages 5 to 11. Biden said at the time, "It is a major step forward for our nation in our fight to defeat the virus."

COVID-19 vaccination for children younger than 5 began across the U.S. in June 2022.

"These vaccines are safe, highly effective, and will give parents the peace of mind of knowing their child is protected from the worst outcomes of COVID-19," said Biden.

Prasad noted in his Friday letter that despite evidence that the COVID-19 vaccine put boys and young men at great risk of myocarditis, Biden health officials "did not quickly attempt mitigation strategies such as spacing doses apart, lowering doses, omitting doses among those with prior COVID-19."

Myocarditis is inflammation of the heart muscle that can manifest as various symptoms, including heart palpitations, chest pain, fainting, and weakness, and can also cause fatal cardiac arrest.

"Worse, the FDA delayed acknowledgement of the safety signal until after it could extend marketing authorization to younger boys 12-15," continued Prasad. "Had the acknowledgement come early, these younger boys, who likely did not require COVID-19 vaccination, may have chosen to avoid the products."

The FDA's chief medical officer stressed that the OBPV's finding that the COVID vaccine contributed to the deaths of children amounted to "a profound revelation."

"For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children," continued Prasad, whose agency revoked emergency-use authorization for COVID vaccines earlier this year. "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."

Peter Marks, Prasad's predecessor, complained to the New York Times about the "political tone" of Prasad's letter and noted, "I would not be surprised if the attributions turn out to be debatable, as these cases are often quite complex."

FDA commissioner Dr. Marty Makary said in a "Fox & Friends" interview on Saturday that his agency would no longer "rubber-stamp things with no data," adding that such a "mockery of science" was alternatively "the M.O. in the Biden administration with the eternal COVID booster approvals for young, healthy kids."

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Trump faces drugmakers that treat sick Americans like ATMs



President Donald Trump struck a second deal last month with the world’s largest drugmakers, promising lower costs for American patients. The industry claims cooperation, offering help for consumers and expanded domestic production. Yet those same companies have raised prices on nearly 700 prescription drugs since January.

Big Pharma hopes the most unconventional president will fall back on the most conventional policy: granting the largest firms regulatory advantages, taxpayer-funded promotion, and freedom to keep ratcheting prices upward.

Trumpshould expose the game Big Pharma has played for years and force the industry to compete in a real marketplace.

Trump’s instincts are right. Americans pay inflated prices, and he has confronted the industry’s excesses. But Big Pharma spent decades building cartel-level dominance. Few industries mastered regulatory capture more effectively. The pharma industry wins higher prices while concealing the system that keeps costs rising.

The industry’s tactics follow a predictable pattern. With its right hand, Big Pharma announces a partnership with the White House. With its left, it secures guaranteed government contracts, political protection, and federally promoted products. Independent analysts warn that rebate schemes encourage price hikes. The dynamic mirrors a retailer inflating list prices before Black Friday to create the illusion of deep discounts.

The federal government helps tip the scales. Regulatory frameworks favor the largest drugmakers and block smaller competitors, keeping profits high and patients in the dark.

Patients pay the price

What the industry calls reform resembles a shell game that protects profits and punishes patients. The Food and Drug Administration created an “accelerated approval” pathway to speed lifesaving treatments. In practice, the system advantages the largest corporations. A 2020 study found that increases in FDA regulations boosted sales for major firms while cutting sales for smaller companies by 2.2%. Smaller manufacturers cannot absorb substantial compliance costs, which means cheaper or more effective drugs never reach the market or arrive years late.

Patients pay the price. Follow-up studies for expedited approvals lag for years, and many drugs never show clear benefits. Harvard researchers found that nearly half of cancer drugs granted accelerated approval fail to improve survival or quality of life. The FDA withdrew one in four such drugs and confirmed substantial benefit for only 12% of the rest. The drugs generated revenue, but they offered little hope to patients who paid dearly for treatments that did not deliver.

RELATED: The hidden hospital scam driving up drug prices, coming to a state near you

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Meanwhile, prices keep climbing. Since Trump left office after his first term, cancer drug prices rose faster than Biden-era inflation. Median list prices for new medicines more than doubled between 2021 and 2024, surpassing $300,000 a year. In 2023 alone, drug companies raised prices by 35%. The Rand Corporation found that Americans spent more than $600 billion on prescriptions in 2022 — almost triple what patients in other developed nations pay.

Competition, not cronyism

Families facing cancer now shoulder thousands more out of pocket while Big Pharma posts record profits. Trump deserves credit for recognizing how unfair practices and Democrat policies pushed drug costs beyond the reach of average households.

A better path is within reach. Real reform depends on competition rather than political connections. Trump can break the illusion by opening the market, lowering barriers to entry, and cutting regulatory burdens that keep smaller firms out. He should expose the game Big Pharma has played for years and force the industry to compete in a real marketplace.

PepsiCo to release several new MAHA-friendly chips — but the old ones aren't going anywhere



Amid Robert F. Kennedy Jr.'s initiative to make our food healthy again, one major company has announced some new products stripped down to the "fundamentals" to please the MAHA crowd.

PepsiCo announced Thursday that it has developed a new line of Cheetos and Doritos without the artificial petroleum-based dyes — the ingredients that give them their intense color.

'NKD is an additive option, not a replacement, introduced to meet consumer demand.'

While the old recipes are not going anywhere, PepsiCo announced the release of a new collection of snacks called Simply NKD, notably without the artificial dyes.

The press release boasts that the development process for these new snacks "came to life in just eight weeks."

RELATED: MAHA agenda scores major win with announcement from food giant

Photo Illustration by Justin Sullivan/Getty Images

"Rest assured, our iconic Cheetos and Doritos remain unchanged. NKD is an additive option, not a replacement, introduced to meet consumer demand," says Rachel Ferdinando, CEO of PepsiCo Foods U.S. "This move underscores our commitment to flavor leadership, demonstrating that our taste remains strong even without visual cues. As part of our broader transformation, we are expanding choices while still protecting our iconic brands. More choices, same flavor, same brand power."

The new chips come in familiar flavors. Doritos will have Cool Ranch and Nacho Cheese, and Cheetos will have Puffs and Flamin' Hot.

The new snacks appear to be a pale yellow, not the vibrant colors of the old recipe.

While the new Simply NKD varieties are supposed to taste like the originals, they will have shorter ingredient lists. As the AP reported, the new products do not have flavor-enhancing ingredients disodium inosinate and disodium guanylate, for example.

PepsiCo joins a growing list of companies that have removed or begun to phase out artificial ingredients from their foods lately. In-N-Out, Tyson Foods, Kraft Heinz, and McCormick have made similar commitments previously, to name a few.

These commitments come after the Food and Drug Administration banned Red No. 3 just before the beginning of Trump's second term.

In response to a request for comment, HHS referred Blaze News to Robert F. Kennedy Jr.'s July 19, 2025, celebration of PepsiCo's previous announcement that it planned to remove artificial colors and flavors from Lay's and Tostitos.

At the time, RFK said, "PepsiCo just announced it will eliminate artificial colors and flavors from Lay’s and Tostitos by year’s end — and expand the use of avocado and olive oil in place of canola and soybean oil. I urge every other food company to follow their lead and join the movement to Make America Healthy Again."

The new chips will be available in stores on December 1.

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The Government Gives Too Much Authority To Leftist Academics, And That Needs To Stop

Highly politicized private groups are given fiefdoms within our government, and their left-wing views are not regarded as opinions, but facts.

Can leucovorin cure autism? Meet the moms determined to find out



A humble, decades-old folate compound — used not to fight cancer but to ease the side effects of chemotherapy — has become the latest flashpoint in America’s health wars.

On September 10, the Trump administration announced that the FDA would move toward approving leucovorin for children with cerebral folate deficiency, a rare metabolic disorder linked to autism in some cases. Supporters hailed it as long-overdue recognition of promising small studies; critics called it another example of the MAHA agenda politicizing science.

While bureaucrats and scientists bicker, families with real skin in the game tirelessly run their own experiments and share their results, hoping the science will eventually catch up.

The debate since has been fierce, with professional groups such as the American Academy of Pediatrics advising against the off-label use of leucovorin for autism, warning that the evidence remains preliminary — while prominent physicians call for larger, biomarker-guided trials to confirm what early studies suggest.

A parent’s love

All parties insist their motives are pure, but this latest skirmish is a reminder of how tangled those motives can be. What drives the people and institutions pushing medical science forward is often a sincere desire to help people, yes — mixed in with ambition, rivalry, financial interest, and the unspoken urge to be the one who’s right.

But there’s another force at work here, deeper and simpler, and it tends to override all the rest: a parent’s love for a child.

This is the same love that kept the parents of children with cystic fibrosis pushing to understand a condition doctors considered hopeless, or that led a Hollywood father to resurrect a forgotten epilepsy therapy to help his son. And now it’s the force animating hundreds of parents who believe a decades-old folate compound has literally given their autistic children a voice.

While bureaucrats and scientists bicker, families with real skin in the game tirelessly run their own experiments and share their results, hoping the science will eventually catch up.

Even before the FDA signaled approval of leucovorin for cerebral folate deficiency — a rare metabolic disorder with links to autism — parents have been sharing reports of progress with the drug on Reddit forums and in Facebook groups to share anecdotal reports of progress. A few families have also told their stories in clinic-produced or news-segment videos.

A treatment’s hope

Leucovorin, also called folinic acid, is a bioactive form of folate. It’s been used for decades to “rescue” patients from high-dose chemotherapy. In autism, it’s being repurposed to bypass what some researchers call a “folate transport blockade.”

Up to 70% of autistic children in certain studies test positive for folate receptor alpha autoantibodies — immune proteins that prevent folate from reaching the brain. The result: cerebral folate deficiency. High-dose folinic acid appears to restore that supply, sometimes with striking behavioral effects.

Dr. Richard Frye, a pediatric neurologist at Phoenix Children’s Hospital, led one of the first controlled trials in 2016. His team found improved verbal communication in FRAA-positive children treated with leucovorin. Later case studies described language bursts, better eye contact, and calmer affect.

RELATED: Tylenol fights autism claims, slams proposed FDA warning label as 'unsupported' by science

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From ‘no words’ to the Pledge of Allegiance

The parents themselves provide more affecting testimony. Carolyn Connor’s son Mason was 1 when she realized something was amiss: “He wasn’t talking. No language. No words.”

When their pediatrician downplayed this lag in development as typical in boys, she and her husband began doing their own research, which led them to Frye. Three days after starting leucovorin, Mason spoke his first words.

Now 6, he continues to take the medication, and continues to thrive.

Beth Ann Kersse’s daughter was diagnosed with autism at age 3. “In her vocabulary she had about three or four words,” Kersse said in a video uploaded by Washington, D.C.-based Potomac Psychiatry.

“But she didn’t call me ‘Mom.’ She kind of would point at me,” she added.

That’s when Kersse and her husband began exploring leucovorin. Two years later, Kersse describes her almost 5-year-old daughter’s transformation as “incredible.”

“The other day she stood up and put her hand over her heart, and she recited the Pledge of Allegiance, and we were just like, OK ... I didn’t know we knew that. ... She’s able to have a full conversation; she can tell us how she’s feeling.”

Late last month, Nebraska pediatrician Dr. Phil Boucher posted a case study detailing how a 3.5-year-old autistic girl responded to leucovin treatment, citing texts from her mother reporting that she was “blown away” by the changes she observed:

She is starting to consistently look at people when they call her name. ... She’s becoming more interested in her little sister. ... She also has started taking some of the baby dolls that we have and has been covering them up with a blanket, giving them a kiss, and saying, “Night night.”

As Boucher is careful to point out, anecdotal success stories like these don’t prove the drug works. But to those experiencing the improvement firsthand, they’re a promising sign that a simple, inexpensive vitamin derivative can do what years of therapy can’t.

And if this promise does indeed bear fruit, leucovorin treatment will be the latest of many homegrown revolutions in medical care spearheaded by determined mothers and fathers unwilling to wait for consensus.

Woman Coerced Into Abortion Asks FDA To Stop Shielding Abusers And Their Drug Dealers

Markezich was 'so happy' when she became pregnant. Now, after her coerced abortion, the thought of her lost baby 'never really goes away.'

Lax Abortion Pill Rules Make Already Vulnerable Women More Susceptible To Harm And Abuse

Every day the FDA fails to reinstate the safeguards rolled back by Biden, the risk of abortion pill-related abuse only continues.

Tylenol fights autism claims, slams proposed FDA warning label as 'unsupported' by science



The maker of Tylenol is fighting back against proposed changes to its label.

Kenvue, the American company behind Tylenol, says changes proposed by a recent petition would be "improper."

'Fight like hell not to take it.'

After the Trump administration linked the use of Tylenol during pregnancy to autism, the Informed Consent Action Network urged the FDA to "change the labels" for Tylenol and provide "crucial warnings for pregnant women and their care providers."

No evidence for risk?

Kenvue responded directly to the petition in its own document and said that changing the labeling to its over-the-counter acetaminophen products in such a manner would be "unsupported by the scientific evidence and legally and procedurally improper."

Requesting that the consumer-facing warning addresses a risk between "acetaminophen use and neurodevelopmental disorders" would allegedly go against the "overwhelming weight of the evidence contradicts the existence of any such risk," Kenvue claimed.

The manufacturer called acetaminophen one of the "most studied medicines in history," with evidence regarding its use during pregnancy being "continuously evaluated by the FDA for more than a decade."

It further claimed that available evidence does not support "a causal association between acetaminophen use in pregnancy and neurodevelopmental disorders, including ASD and ADHD."

RELATED: Tylenol's concerns about possible autism risk date back more than a decade, documents reportedly show

Billion-dollar brand

CNN reported that Tylenol generates about $1 billion annually for Kenvue and is considered to be its top-selling brand.

If the FDA agrees with ICAN's demand, Tylenol labels would need to be updated from its current instructions that say, "If pregnant or breast-feeding, ask a health professional before use."

President Trump had previously said during a press conference in September that if used during pregnancy, Tylenol was linked to a "very increased risk of autism."

"Fight like hell not to take it," Trump added.

RELATED: 'TrumpRx' website to offer discounted drugs as part of landmark Big Pharma deal

Photo by Jordan Bank/NWSL via Getty Images

New autism drug

At the same time, the U.S. Food and Drug Administration had begun its process to approve a treatment for autism-related symptoms.

The FDA announced in late September that it had approved leucovorin calcium tablets for patients with "cerebral folate deficiency."

The neurological condition affects folate transfer into the brain, the FDA said, adding that "individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features."

"We have witnessed a tragic four-fold increase in autism over two decades," said FDA Commissioner Marty Makary. "Children are suffering and deserve access to potential treatments that have shown promise. We are using gold standard science and common sense to deliver for the American people."

According to the Mayo Clinic, leucovorin has a few side effects, all of which are listed as rare. These include skin rash, hives or itching, and wheezing. "Convulsions (seizures)" are also listed.

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SSRIs and mass shootings: A link we can't afford to dismiss



There’s no link between antidepressant use and mass shootings, at least not according to a new study published in the journal Psychiatry Research.

Certainly good news for the pharmaceutical industry — but does one study really mean case closed?

The FDA’s own adverse event reporting system shows a consistent link between SSRIs and violence among adults.

It’s a controversial topic that has only become more so in recent years, especially now that Robert F. Kennedy Jr. is the secretary of health and human services under President Trump.

Deplorable questions?

Kennedy has long maintained that antidepressants are causing mass shootings. In an interview with Elon Musk in 2023, for example, Kennedy said, “Prior to the introduction of Prozac [a selective serotonin reuptake inhibitor], we had none of these events [mass shootings].”

In his confirmation hearings in February, he told the Senate that the link “should be studied, along with other possible culprits.”

He was asked to clarify his views about antidepressants and mass shootings by his Democrat interrogators, because they were intended to be discrediting just by being uttered aloud — just like his views on water fluoridation, vaccination, and the origins of COVID-19. A whole basket of deplorable ideas.

In short, we’re talking about yet another partisan political issue, even though, surely, we can all agree that mass shootings are terrible and we need to do everything we can to stop them.

Guns, not drugs?

And that includes, obviously, understanding what motivates the shooters.

The new study looked at over 800 mass-shooting incidents that took place between 1990 and 2023. The researchers used publicly available data — news reports, court records, and police statements — to see whether the perpetrators had any history of antidepressant or psychotropic drug use and whether there was a link between suicidality and mass shootings. Previous research had suggested there was such a link.

The researchers found evidence of lifetime antidepressant use in just 34 out of 852 cases and evidence of psychotropic drug use more broadly in 56 cases — just 6.6%. There was no unusual association between suicidality and mass shootings either. Suicide attempts were slightly more common among those with a history of medication use, but the difference was not statistically meaningful.

Population-level data also indicated that antidepressant use among mass shooters was lower than among the general public. If antidepressants were causing mass shootings, we’d expect levels of antidepressant use to be higher, not lower.

QED — or so the researchers believe.

“The vast majority of mass shootings have nothing to do with mental illness,” Ragy R. Girgis, one of the study authors, told medical news website PsyPost.

“The primary modifiable population-level risk factor for mass shootings is firearm availability.”

Prevent people from getting their hands on guns, prevent mass shootings. It’s that simple.

Or is it?

RELATED: Groomed for violence? The dark world of furries and transgenderism in America's classrooms

Blaze Media illustration

Premature conclusions

There’s a glaring problem: The data simply isn't good enough to allow any kind of firm conclusion to be reached. The writers at "PsyPost" do at least acknowledge there’s a serious problem, although it doesn’t stop them from trumpeting “new study finds no evidence” in their headline.

Here’s what "PsyPost" says about the reliability of the evidence on offer.

Data were collected from publicly available sources, such as news articles and online records. This approach may miss cases where medication use was not reported or was kept confidential. The study also could not determine whether medications were being taken as prescribed during the attack or whether the person had recently stopped taking them.

Data is often kept confidential, even in the most high-profile cases. Take the Columbine shooters, Eric Harris and Dylan Klebold. At the time of the massacre, which claimed the lives of 14 people and left another 20 wounded, it was widely reported that Harris had been on the powerful new SSRI Luvox, generic name fluvoxamine. The New York Times claimed Harris had been rejected by Marine recruiters just five days before the attack for taking the drug.

There were suggestions that he had tried to go cold turkey as a result and that this might have affected his actions on that dreadful, bloody day. The Times noted that “patients taking Luvox are warned that if combined with other drugs, including alcohol, the drug can cause extreme agitation progressing to delirium, coma and death. The package also carries a warning about suicide.”

While officials said neither shooter had drugs or alcohol in his system at time of death, the coroner refused to say whether they had been tested for antidepressants, including Luvox.

And so we still don’t know, 26 years later, whether antidepressants played a role in the Columbine killings.

Mandatory screenings

Thankfully, there are now some attempts to provide answers. Unsurprisingly, they’re coming from Republican politicians and red states.

Tennessee has become the first state in the U.S. to introduce mandatory screening for psychotropic drugs in mass killings, defined as incidents in which four or more people are killed. In every mass killing that takes place in Tennessee, a detailed toxicology report will be produced and made available to the public. Investigators will study drug interactions in the killer’s body — because drugs have different effects when used in combination, a fact that is poorly understood — and they’ll also consult with providers of mental health services if the killer was receiving treatment.

Here’s something we do know for sure. A clear, well-established link exists between SSRIs and all forms of violent behavior. A huge Swedish study from 2020 that looked at 250,000 people revealed a significant association between SSRI use and violent crime, especially among 15- to 24-year-olds and 25- to 35-year-olds. The study also showed that risk of violence remained elevated up to 12 weeks after discontinuation of the drugs. The FDA’s own adverse event reporting system shows a consistent link between SSRIs and violence among adults.

A tall order

Instead of dismissing the possibility of a link between antidepressant use and mass shootings, we actually need to do some proper research. Gather data and interpret it objectively — meaning dispassionately, without imposing an ideological agenda that fixes the conclusions in advance.

I know that’s a tall order, given how emotional a subject mass murder is — especially mass murder of children — and how unwilling we all are to talk across the growing political divide, but that’s the scientific ideal, and that’s the only way we’re ever going to get to the truth.

As every first-year history undergraduate knows — and I was one, once upon a time — absence of evidence is not evidence of absence. Let’s not get twisted. Lives are at stake.