FDA slaps damning warnings on COVID-19 vaccines; highlights Biden administration's safety-risk gloss



Federal health authorities rebuked Florida Surgeon General Dr. Joseph Ladapo for suggesting in 2022 that the benefit of COVID-19 vaccination among healthy young men was outweighed by the risk of heart conditions, myocarditis in particular.

Ladapo issued guidance that stated, "Based on currently available data, patients should be informed of the possible cardiac complications that can arise after receiving a mRNA COVID-19 vaccine."

“Our goal is not to get into like a fight or a tiff, because public health isn’t served well by this,” said Dr. Peter Marks, then-director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research. "Our goal is to help get to … an acceptance that there are overall benefits of these vaccines, despite the fact that yes, it is true that there could be some side effects."

'Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis.'

Marks' former agency has since acknowledged that there is a greater risk of post-vaccination myocarditis than the so-called experts were first willing to publicly admit.

Months after telling both vaccine manufacturers to include new safety information regarding their respective drugs in the stated interest of "radical transparency," the FDA indicated on June 25 that it required Pfizer and Moderna to note the estimated unadjusted incidence of heart conditions following administration of the 2023-2024 formula of the Comirnaty and Spikevax vaccines, as well as the longitudinal results of a 2024 study concerning cardiac manifestations and outcomes of vaccine-associated myocarditis in American youths.

The FDA also required Pfizer and Moderna to describe the new safety information in the adverse reactions section of their vaccine information inserts.

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Photo illustration by Joe Raedle/Getty Images

For years, the fact sheets for the mRNA COVID-19 vaccines noted that reports of adverse events demonstrated increased risks of myocarditis and pericarditis, particularly following the second dose, and that the "observed risk is highest in males 12 through 17 years of age."

Now, the package inserts state that "the observed risk has been highest in males 12 years through 24 years of age" and:

Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age.

The package inserts for both drugs also now state:

Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known. Information is not yet available about potential long-term sequelae of myocarditis or pericarditis following administration of mRNA COVID-19 vaccines.

When discussing the updates, Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, provided a refresher about the effort by the previous administration to downplay the risk of myocarditis.

Prasad, referring to congressional testimony given by Sen. Ron Johnson (R-Wis.) in May, noted that Centers for Disease Control and Prevention and the FDA officials were aware in early 2021 of a safety signal for the heart condition on the basis of Pentagon and Israeli data.

'The FDA's new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science.'

A day after health officials at the agencies acknowledged a safety signal, and after the CDC discussed whether to issue a Health Alert Network message on myocarditis, the Biden White House distributed talking points to top U.S. health officials de-emphasizing the risk.

On May 26, 2021, then-acting FDA Commissioner Janet Woodcock told then-CDC Director Rochelle Walensky that the "FDA does not concur with the issuance of the myocarditis HAN as written."

That day, both agencies reportedly decided to "nix the HAN" alert.

"The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered," Woodcock stated the following month. "The benefits of COVID-19 vaccination continue to outweigh the risks, given the risk of COVID-19 diseases and related, potentially severe, complications."

The nixed alert could have made a difference.

After all, Prasad noted that "in August of 2021, in an FDA regulatory action, we document that based on the health insurance claims Optum dataset, the rate of post-vaccination myocarditis from the Pfizer-BioNTech vaccine was approaching 200 cases per million or approximately 1 in 5,000" among 16- and 17-year-old males.

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FDA Commissioner Martin Makary and Prasad noted in a May article in the New England Journal of Medicine that "the FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk."

Blaze News reached out to the FDA but did not immediately receive a response.

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The EXPLOSION of myocarditis: Dr. Peter McCullough’s bombshell vaccine testimony



In a Senate hearing this week about the safety of the COVID-19 vaccine, Dr. Peter McCullough detailed his experience as a cardiologist — and after the shots, it’s not a good one.

“The topic today is myocarditis or heart damage from the COVID-19 vaccines. I’m a cardiologist. I know the topic well. I’ve examined thousands of patients with this problem — thousands. Before the pandemic, I had two patients ever with this problem,” McCullough testified.

“There’s 1,065 papers in the peer-reviewed literature on COVID vaccine myocarditis, so let me summarize them for you,” McCullough continued. “The first author is Verma and colleagues. New England Journal of Medicine. Forty-two-year-old man comes into Washington University Hospital with vaccine myocarditis.”


“The infection is ruled out; it’s the vaccine. He’s in the hospital. This is one of the best hospitals in the United States. He died three days after taking Moderna. They can’t save him in the hospital,” he explains.

McCullough went on to tell of another, younger man who died within eight hours of being in the hospital after his COVID-19 shot.

“I can tell you, I’m a cardiologist — that doesn’t even happen with heart attacks. He dies within eight hours. I examined all of the slides,” he says, “It looked like somebody took a blowtorch to that heart, it was so completely fried with inflammation.”

“These cases, which were widely known at the time, should have gotten everyone’s attention. Everyone should have been laser-focused on this. We should never have someone die after taking a vaccine,” he added.

“Well, you’re not supposed to ask yourself, ‘What is going on?’” BlazeTV host Pat Gray comments on “Pat Gray Unleashed.”

“You’re not supposed to,” he adds.

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Biden admin covered up potentially deadly COVID vaccine side effects for months: Senate report



A Senate report claims that President Joe Biden's administration was aware for months about heart issues stemming from COVID-19 vaccines and purposely withheld the information from the public.

A report from the Senate Permanent Subcommittee on Investigations said government officials knew as early as February 2021 about the harmful side effects but waited until June to inform the public of the inherent dangers.

'The federal government was very well aware of the myocarditis signal, particularly in young men.'

The report revealed that U.S. health officials "knew about the risks" the vaccines carried related to myocarditis, inflammation of heart muscle, and pericarditis, inflammation of the fibrous sac surrounding the heart, but "downplayed the health concern" and "delayed informing the public about the risk."

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The report, first obtained by the Daily Wire, showed that the U.S. government ignored warnings from several sources.

In February 2021, U.S. entities were notified of adverse effects by the Israeli Ministry of Health, as the country rolled out vaccines faster than America did. Still, CDC officials declined to make public the "large reports of myocarditis, particularly in young people, following the administration of the Pfizer vaccine."

It is unclear whether the Israeli government made an effort to notify the public, either.

That same month, a CDC official who co-led the Vaccine Safety Technical Work Group emailed her colleagues about 19,536 vaccine adverse event reports (through the Vaccine Adverse Event Reporting System) that included 980 deaths after vaccination.

"Where known, the cause of death was often cardiovascular," the report read.

Senator Ron Johnson (R-Wis.) told the Daily Wire that the Biden administration did not want to increase "vaccine hesitancy" by reporting the side effects openly.

"But in being concerned about that, they violated the inviolable principle of informed consent," Johnson told the outlet. “The federal government was very well aware of the myocarditis signal, particularly in young men, as early as February [2021]."

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In May 2021, the CDC omitted information from its "clinical considerations" on its website that advised doctors to restrict patients with myocarditis from "rigorous activity like competitive sports for at least 3 months."

The report also said that in June 2021, the White House distributed talking points to U.S. health officials "downplaying the risk of myocarditis."

"The depths of depravity of this cover-up keep getting deeper. They knew about vaccine side effects early on but withheld that information as they continued to push emergency use authorization even as young people were dying," BlazeTV's Matt Kibbe said about the report.

Kibbe added, "This scandal is ultimately about self-dealing between government bureaucrats and pharmaceutical companies, who all had financial incentives to bury the truth and keep pushing the vaccines."

Blaze News reached out to the National Institutes of Health and Health and Human Services for comment but did not immediately receive a response.

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HHS scrapping COVID jab recommendations for pregnant moms and kids: Report



The Department of Health and Human Services is reportedly preparing to scrap its recommendation that pregnant women and kids get the COVID-19 vaccines. Individuals said to be familiar with the matter told the Wall Street Journal that the announcement is imminent and will coincide with the Centers for Disease Control and Prevention kicking off a new vaccine approval framework.

While the relevant agencies apparently did not respond to the Journal's requests for comment, U.S. Food and Drug Commissioner Dr. Marty Makary provided a fairly strong indication this week that the change was coming.

Makary told Turning Point USA CEO Charlie Kirk that he would "love to see the evidence to show that giving young, healthy children another COVID-19 shot — you know, a sixth COVID booster — would help them, but that evidence does not exist, and so we're not going to rubber-stamp things at the FDA."

"I don't think you're going to see a push at the CDC to be pushing COVID shots in young, healthy children," continued Makary, adding that he expected an announcement on that front in the coming weeks.

Sources told the Journal that it would only be a matter of days.

At the time of publication, the CDC was still recommending that everyone ages 6 months and older get a COVID-19 vaccine.

'Connected to serious adverse events, including myocarditis and pericarditis, failed pregnancies, and deaths.'

The agency states on its website that getting the shot is especially important for individuals who have survived this long without one, geriatrics, pregnant women, those planning to conceive, and breastfeeding mothers. The agency urges parents to get their children 6 months to 4 years of age loaded up with two doses of the Moderna vaccine or three doses of the Pfizer vaccine if they were starting fresh.

As of April 26, 14.4% of pregnant women had received a 2024-25 COVID-19 vaccine and 13% of children 6 months to 17 years of age were up to date, CDC data shows.

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EKIN KIZILKAYA/iStock/Getty Images Plus

The CDC stuck with its recommendations until now despite credible warnings from Florida Surgeon General Dr. Joseph Ladapo and other experts; troubling scientific studies demonstrating the vaccines were not as safe and effective as advertised; glaring evidence that kids and teens were at low risk for COVID and could go without; and damning state-leveled allegations that one of the primary vaccine manufacturers sat on evidence that its COVID-19 vaccine "was connected to serious adverse events, including myocarditis and pericarditis, failed pregnancies, and deaths."

Just last month, a preprint study backed by the Florida Department of Health suggested that adults in the Sunshine State who received the Pfizer vaccine had "significantly higher risk of 12-month all-cause, cardiovascular, COVID-19, and non-COVID-19 mortality" than those who received the Moderna shot.

A study conducted by the Global COVID Vaccine Safety Project — a Global Vaccine Data Network initiative supported by both the CDC and the HHS — and published last year in the journal Vaccine detailed troubling links between the AstraZeneca, Moderna, and Pfizer vaccines and medical conditions such as Guillain-Barré syndrome, brain and spinal cord inflammation, Bell's palsy, and convulsions.

Another peer-reviewed study published last year in the pharmacotherapy journal Therapeutic Advances in Drug Safety indicated that "COVID-19 vaccination is strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death."

"COVID-19 vaccines induce an uncontrolled expression of potentially lethal SARS-CoV-2 spike protein within human cells, have a close temporal relationship of events, and are internally and externally consistent with emerging sources of clinical and peer-reviewed data supporting the conclusion that COVID-19 vaccines are deterministic for myocarditis, including fatal cases," said the study.

'The current risks of serious adverse events or deaths outweigh the benefits.'

Texas cardiologist Peter McCullough, a leading critic of the vaccines, said in a statement Thursday, "Two presidents, three HHS Secretaries, three FDA Commissioners, and nearly five years into the disastrous COVID-19 vaccine debacle, women and children receive long overdue yet welcome news. After record vaccine injuries, disabilities, and death, America is wondering will any of these leaders be held accountable?"

Dropping the recommendations appears to be a half measure, given that HHS Secretary Robert F. Kennedy Jr. previously fought to revoke authorization of COVID-19 vaccines altogether.

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Photographer: Al Drago/Bloomberg via Getty Images

In a petition he filed with the FDA on May 16, 2021, Kennedy said the agency should revoke all emergency use authorizations and refrain from approving future EUAs for any COVID vaccine for all demographic groups "because the current risks of serious adverse events or deaths outweigh the benefits, and because existing, approved drugs provide highly effective prophylaxis and treatment against COVID, mooting the EUAs."

Kennedy noted further that the agency should specifically spare children and pregnant women from the novel vaccines.

Kennedy's warnings and requests evidently fell on deaf ears.

In its final weeks, the Biden HHS extended liability protection to COVID-19 vaccine manufacturers and administrators through Dec. 31, 2029, precluding vaccine recipients who reportedly end up injured or their surviving family members from holding those responsible to account. This was the latest of several such extensions.

The reports of the HHS dropping the vaccine recommendations and other moves made in recent months by the Trump administration have elements of the medical establishment clutching pearls.

Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, told the New York Times, "I think that we are in the midst of watching the vaccine infrastructure being torn down bit by bit."

"I think everything is a target," said Tara Smith, an epidemiologist at Kent State University College of Public Health.

"Overturning the recommendation means that insurance companies will no longer have to cover these vaccines," Dorit Reiss, a law professor at UC Law San Francisco, complained to the health publication Stat.

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EPIC RANT: Dr. Fauci pardon is A DISGRACE



Former President Joe Biden issued a pre-emptive pardon to Dr. Anthony Fauci before handing the Oval Office over to Trump, leaving millions of Americans wondering why someone who apparently did nothing wrong would need one.

Alex Stein of “Prime Time with Alex Stein” — who tragically lost his mother during the pandemic due to improper medical care from America’s so-called trustworthy medical system — is one of them.

“For me, what was so frustrating is that Joe Biden gave a pre-emptive pardon to Dr. Fauci,” Alex Stein of “Prime Time with Alex Stein” says. “In theory, you’re thinking, ‘Oh well, he’s just trying to protect him from the political persecution that could come from Donald Trump.’”

However, why would someone who did nothing wrong need legal protection?


“But if he didn’t do anything illegal, he wouldn’t need that protection. So giving him that pardon justifies every single thing we said during the pandemic,” Stein says. “What’s so frustrating when it comes to Dr. Fauci is that we know that he was lying this whole entire time, and now he’s going to be protected.”

“People like my mom were not even given proper care because what they said is, ‘There are no applications for COVID other than the vaccine.’ Because the only way they can get an emergency use authorization was if there were no other remedies whatsoever,” he explains.

“Which is not true, because we’ve had pneumonia since the beginning of time. We’ve had respiratory illnesses forever, and we’ve been able to give people medicine,” he continues. “But because they were so dead set on this vaccine and helping Moderna and helping Pfizer, they had to make it so that there were no other remedies, when there are other remedies, and because of that, people like my mom died.”

“Yes, I’m happy Donald Trump is president. But Dr. Fauci can go out there and give false information in order to give us a free vaccine, somehow that’s free, every other medical s*** costs a billion dollars, but somehow the vaccine is not only free, but you get a cheeseburger with it,” he adds.

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Post-DEI America: a profitable future unfolds



Has the time come for corporate DEI to die? It would seem so, as businesses are rediscovering profitability by refocusing on their customers rather than black squares or woke packaging.

“We’re seeing more and more changes going this way,” Stu Burguiere of “Stu Does America” comments, adding, “We don’t know what the reasoning is exactly, but we can all kind of take a little bit of a guess.”

One of the most recent examples is American Airlines, which a judge says has violated federal law through its ESG investing strategy. In a 70-page ruling following a four-day, non-jury trial, Judge Reed O’Connor of the North District of Texas ruled that the airline violated its fiduciary duty of loyalty by letting asset manager BlackRock weigh environmental factors and 401k funds.

“A federal judge in one of the country’s foremost conservative district courts ruled Friday that American Airlines unlawfully incorporated environmental and sustainable governance — ESG factors — into its employee retirement plan,” Stu explains, adding, “You can’t just do that, and now they’re getting slapped down in court.”


But American Airlines isn’t the only one, as Pfizer must also face a lawsuit over a diversity fellowship program.

On Friday, a U.S. appeals court revived a lawsuit by a conservative group opposed to diversity initiatives in medicine that challenged a Pfizer fellowship program that was designed to boost the pipeline of black, Latino, and Native American people in leadership positions at the pharmaceutical company.

“Basically, they just admitted a pretty large mistake in their ruling and revised it,” Stu explains, noting that the incoming inauguration of Donald Trump may be having an effect on these companies as well.

“We’ll see if these things wind up having a shelf life beyond the inauguration,” he says. “And that’s another potential explanation for all of this. Look, Donald Trump is coming into power, he’s threatened a lot of these companies, ‘Get your act together or I’m coming after you,’ and so they’re quote unquote ‘getting their act together’ whether they mean it or not.”

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