Sunday, Nov 16, 2025

FDA Warns of Cardiac Risk with Covid Vaccines

 

Explosive Senate Report Says Health Agencies Ignored Evidence of Heart Damage

 

 

 

The era of unquestioned pharmaceutical authority may finally be unraveling.

The first cracks in the once-impregnable vaccine empire appeared last week, as the FDA announced it was preparing to halt mRNA Covid vaccinations for children, teenagers, and pregnant women—an unthinkable move just months ago.

Then, newly confirmed HHS Commissioner Robert F. Kennedy Jr. appeared before Congress and declared a seismic shift in vaccine policy—vowing that never again would a vaccine be licensed by the FDA without first undergoing rigorous, placebo-controlled efficacy trials.

For decades, new flu or Covid vaccines, as well as new children’s vaccines, relied on the older approved versions, the side effects for which were often improperly monitored.

Now, “safe and effective” would be applied only to drugs that passed robust clinical trials, RFK pledged.

On the heels of this stunning reversal, a fresh blow hit leading vaccine makers last week; the FDA is forcing Pfizer and Moderna to use expanded warning labels about the risks of heart damage from Pfizer and Moderna Covid vaccines — especially for teenage boys and men between the ages of 6 to 25.

Studies show this group is the most susceptible to vaccine-related heart inflammation. The most conservative estimates assessing the risk at 39 cases out of a million doses, with some estimates claiming significantly higher rates.

In real world numbers, the government’s own monitoring system, VAERS, tells a frightening story:

Between Dec. 14, 2020, and Sept. 16, 2022—a nine-month period—23,926 cases of myocarditis and pericarditis were reported to the CDC’s Vaccine Adverse Event Reporting System (VAERS).

The cardiovascular adverse events on VAERS for the nine-month period are broken down as follows: 150 children dead; 445 permanently disabled; 8176 children injured.

Historically, as VAERS relies on self-reporting and many family members of the vaccine-injured, as well as hospitals, do not follow through on making reports, adverse events have been shown to be vastly underreported—some say by about 30 percent.

There is no indication these numbers triggered in the Biden administration and federal public health leaders the slightest pause in their determination to see every American fully vaccinated.

 

Health Agencies Downplayed Risks of Heart Damage

 

On the heels of the FDA directive to vaccine manufacturers to expand the warnings of myocarditis and pericarditis risks on vaccine labels came another bombshell: The Senate Homeland Security Subcommittee on Investigations released a scathing interim report called “The Failure to Warn; The Corruption of the Federal Public Health Agencies.”

The investigation was chaired by Sen. Ron Johnson, R-Wis, a fierce critic of the pandemic response under the Biden administration who has spearheaded multiple probes into its disastrous decisions.

The latest report is based on 2,473 pages of records obtained through a subpoena from the HHS under its new director, RFK. It argues that U.S. health agencies knew about the risks of myocarditis associated with mRNA Covid-19 vaccines but purposely downplayed them.

Sen. Johnson, who has sent over 70 oversight letters since 2021—many of which he claims were simply ignored —argues that this delay in transparency jeopardized public health and likely caused injury and even death.

The report chronicles how early warning signs for myocarditis and pericarditis — inflammation of the heart muscle or heart lining — were first communicated to the CDC and FDA in February 2021 by Israeli health authorities. Mounting reports of vaccine injury among teenage boys and young men had sparked alarm among Israeli public health experts.

An Israeli research team, headed by Dr. Dror Mevorach, head of internal medicine at the Hadassah University Medical Center, announced in 2021 that “myocarditis has disproportionately struck older boys and young men who received the shots,” reported Science.

“The rate of myocarditis events among those vaccinated was found to be somewhere between five and 25 times the baseline rate,” the article said.

Another article by Jeniffer-Couzin Frankel in Science Insider reported that vaccine-induced myocarditis is thought to be triggered by an immune reaction following the Covid-19 shot.

It quoted a study from Germany published in The New England Journal of Medicine that suggested the disease “may be driven by an inflammatory response associated with the Covid spike protein, which the mRNA vaccines coax the body to produce.”

“This [side effect] is thought to occur particularly after the second booster dose of mRNA vaccines…These are important safety concerns,” noted the British Medical Journal (BMJ).

Investigators learned from the agencies’ internal documents that in the face of clear danger signals, the Biden administration downplayed Israel’s concerns, minimizing the documented risks and continuing to push Americans to get fully vaccinated.

 

Months of Stalling

 

Documents show the directors of the FDA and CDC dithering back and forth for weeks over whether they should publicize the data about myocarditis risks, and if so, how to formulate the warning language on the vaccine labels and on the CDC website.

The FDA was the most intractable on the subject, continually putting the brakes on any plan to warn Americans of the myocarditis risk. The agencies delayed taking any action at all until late May 2021.

“Even though CDC and FDA officials were well aware of the risk of myocarditis following Covid -19 vaccination, the Biden administration opted to withhold issuing a formal warning to the public for months about the safety concerns, jeopardizing the health of young Americans,” the 54-page interim report said.

Among the officials named in the report is former senior FDA official Peter Marks, who was instrumental in having Covid-19 shots added to the childhood vaccine schedule. Marks and longtime FDA official Janet Woodcock took the lead in discouraging the CDC from issuing a formal warning in May 2021, the Senate report alleges.

The documents show that Woodcock and Marks even prompted the CDC to “walk back” planned language for its website about the need to restrict exercise after myocarditis or pericarditis.

Experts say this warning could have saved an unknown number of lives but it was scrubbed from the CDC’s draft for the label’s warning.

Under increasing pressure, the FDA on June 25, 2021, finally updated the labels on the Pfizer and Moderna vaccines to note the risk of myocarditis and similar complications.

However, rather than issue a Health Alert Network (HAN) advisory to promptly inform healthcare professionals, the CDC chose a more passive approach—quietly posting a notice on its website that “increased cases of myocarditis and pericarditis” had been reported following Covid-19 mRNA vaccination.

Despite the mounting concerns, the agency continued to recommend immunization for ages 12 and up, the interim report said.

Janet Woodcock stepped down in 2024. Peter Marks was fired last month.

“Died Suddenly” Showed Athletes Collapsing on the Field

Many will remember shocking reports about an unprecedented wave of professional athletes—required to be vaccinated as a condition of play—suddenly collapsing on the field, often from cardiac arrests that turned out to be fatal.

The disturbing pattern gave rise to a number of viral videos titled Died Suddenly that captured these devastating moments of otherwise healthy young men alive one moment and dead the next. They fueled growing alarm about suspected side effects of the Covid vaccines.

During a Senate subcommittee hearing last week titled “The Failure to Warn and the Corruption of the Federal Public Health Agencies,” cardiologist Dr. Peter McCullough offered an explanation for the bizarre phenomenon behind “died suddenly” reports.

“When the heart muscle has sustained some degree of damage, the normal adrenalin surge produced by the body during strenuous exercise can trigger cardiac arrest,” he said.

“There is no heart damage that is ‘mild’ or inconsequential,” he added, echoing the same position he espoused back in 2022 when such a statement, running counter to the government’s narrative, was deemed controversial.

At the time, American parents were being subjected to enormous pressure to have their children vaccinated. In many communities including religious ones, local leaders echoed the government line that vaccination stopped the spread of the virus, even though this claim had been proven false as early as 2021.

In the same vein, community leaders were urging all their people to get vaccinated, claiming “studies had shown the vaccine was ‘safe and effective’ even for pregnant women.”

Since pregnant women were excluded from Pfizer’s Covid vaccine drug trials for traditional safety reasons, the claim that Covid vaccines had been proven safe for this group was a complete fabrication.

In a sole exception to the rule of “no pregnant women in clinical drug trials,” pregnant   healthcare workers were prioritized for admittance to Pfizer’s post-rollout drug trials.

To everyone’s shock, the outcome for their pregnancies, recorded by the drug company itself, was disastrous in terms of stillbirths and miscarriages. Similarly, the overall record of adverse effects from the vaccine painted such a dismal picture, Pfizer sought to keep the records sealed for 75 years.

Concerned civil rights activists, scientists and doctors from all over the country joined ranks in a major lawsuit, demanding the drug manufacture’s information, obtained through Americans’ taxpayer money.

Texas-based Judge Mark Pittman ruled against the drug giant in January 2022, and ordered all the records –hundreds of thousands of pages—released over the next 8 months.

 

Raising Critical Awareness

 

In light of the conflicting messaging surrounding Covid vaccines, Yated editor Rabbi Pinchos Lipschutz felt a responsibility to raise awareness of the fuller picture—one that included some of the documented risks of vaccine-induced myocarditis and potential reproductive complications.

To this writer’s knowledge, this information was not being carried by any other publication or news outlet in the Torah community.

A Jan. 2022 Yated article (Pfizer Ordered to Expedite Release of Vaccine Trial Data) shed light on pregnancy complications from the vaccine that Pfizer sought to keep hidden.

A November 2022 article “(Are the Kids Okay?”) discussed various aspects of vaccine-caused myocarditis.

The myocarditis article quoted Dr. McCullough’s warning that “any form of heart damage causes scarring,” including the subclinical form.

Are the Kids Okay?” explained that subclinical myocarditis may be present in or around the heart without symptoms. This condition—dismissed as “mild” by the CDC—should not be taken lightly, cardiologists say, as it can develop down the line into an abnormal heart rhythm that has the potential to lead to heart failure.”

At the May 14 Senate hearing, Dr. McCullough cited the case of two teenagers from Pennsylvania who died suddenly shortly after getting their Covid shots. One of them was 16-year-old Ernesto Ramirez Jr., who died of cardiac arrest five days after taking the injection, without prior noticeable symptoms.

“Autopsies were performed on the children,” Dr. McCullough testified, “and the findings were crystal clear. The deaths were caused by the vaccine which caused massive heart inflammation.”

 

 

**

 

Drug Companies Push for Covid Vaccine Uptake

 

As a result of the erosion of public trust in federal health agencies—coupled with the emergence of milder Covid strains—vaccine uptake in the U.S. has plummeted. Only 23% of adults and even fewer children received a shot as of last month, according to CDC data.

A glance at some recent headlines reveals a coordinated push by pharmaceutical companies and their media allies to revive faltering interest in vaccines—resorting to “scare tactics” to persuade Americans to roll up their sleeves for a Covid booster.

–New Covid Variant Spreads Rapidly, Experts Warn (CNN).

–Limiting Covid Vaccines Endangers Everyone (Boston Globe)

–Why are More Than 300 people in the US Dying of Covid Every Week?” (ABC News)

In addition to fear-mongering, the vaccine manufacturers employ robust financial incentives to motivate organizations, institutions, physicians and health agencies to promote Covid vaccines to all Americans.

 

Pfizer Donated Thousands to Groups Who Lobbied for Vax Mandates

Pfizer quietly funded groups lobbying for vaccine mandates during the coronavirus pandemic, a Newsmax article reported, quoting Twitter Files journalist Lee Fang.

The drug giant doled out tens of thousands of dollars to medical and civil rights groups, doctors, and public health organizations supporting government-backed Covid-19 vaccine mandates, according to a lengthy list of contributions from fiscal year 2021.

Dr. Aaron Kheriaty, an expert in bioethics, said Pfizer engaged in a “form of market manipulation by pushing mandates via organizations that present themselves as scientifically credible, or acting purely in the public interest.”

All the while, these organizations lobbied for government forced mandates, creating a hugely profitable market for the company’s products, while earning tens of thousands of dollars from Pfizer for their efforts.

In just a partial listing, these organizations include The American Pharmacists Association, American College of Preventive Medicine, Academy of Managed Care Pharmacy, American Society for Clinical Pathology and the American College of Emergency Physicians.

They all signed a letter in support of the Biden administration mandate to require employers with 100 or more employees to require employees to be fully vaccinated. The organizations all received individual grants from Pfizer.

The arrangement was enormously profitable for all sides, especially Pfizer. The drug maker in 2021 raked in over $36.7 billion in sales from the vaccine, making it one of the most profitable medical products in history, Newsmax attested.

A look at the list of medical organizations that accepted Pfizer grants in exchange for lobbying for vaccine mandates leaves little mystery as to why the medical establishment so staunchly supported Covid vaccines and mandates.

They did so even in the face of overwhelming real-world evidence that the shots fell far short of their promised effectiveness and, in many cases, caused real harm.

*****

A Toxic Culprit

During the May 21 Senate Subcommittee hearing, chairman Sen. Ron Johnson asked expert witnesses Dr. McCullough and Dr. Jordan Vaughn to explain in layman’s terms what happens in the human body when spike protein from the Covid vaccine is injected.

“To start with, mRNA was chemically modified by Pfizer and Moderna to make the spike protein—the damaging part of the virus—unassailable. Meaning it was made to resist being broken down by enzymes in the body,” Dr. McCullough explained.

“Three recent studies show spike protein circulating in the blood of some people six to nine months after vaccination,” the expert went on. “This is a pathogen. It’s a killer protein potentially causing blood clots, damage to blood vessels, ovaries, testes and other organs.

“Autopsies show it’s been found in the human heart and the brain after death; it’s been found everywhere in the body.”

But what of the claims that the vaccine saved millions of lives, McCullough was asked.

“That is a false drug claim,” he said. “There has never been a single randomized, double-blinded study showing that covid vaccines reduce mortality or hospitalization. There hasn’t even been a non-randomized study.”

“Thankfully, Covid infection began lessening around the same time as the vaccine rollout—even prior to that—for three reasons,” the cardiologist elaborated.

“First, almost all of us got infected which led to population natural immunity; second, we began to treat patients with drug protocols [such as steroids, monoclonal antibodies, ivermectin and other compounds] that kept them out of the ER and enabled recovery at home.

“Lastly, the viruses mutated to much milder forms, more infectious but less severe,” McCullough noted.

 

Institutional Failure

 

Another witness at the Senate hearing, Dr. Jordan Vaughn, an Alabama-based internist and expert in microvascular disease, runs a clinic focused on “Long Covid” and vaccine injury.

Vaughn said the CDC, by failing to acknowledge the myocarditis signal in vaccinated people as early as the spring of 2021, failed in its key mission.

“By then, a clear safety signal had emerged: the Department of Defense confirmed cases of rare heart inflammation. And autopsy findings have confirmed fatal vaccine-induced myocarditis.”

“Yet, federal authorities accelerated licensing and mandates, sidelining these concerns.”

“Spike protein is not a benign substance,” the internist noted. “It’s toxic. It impairs oxygen delivery, damages blood vessels and causes pathologies in many people that manifest as persistent symptoms of heart racing, brain fog, shortness of breath, and malaise.”

“It was heralded as the solution but what it does in the body is it injects a blueprint for uncontrolled spike protein for an unknown duration,” Vaughn said. “We don’t know when it will be expelled, if at all. These are not abstract theories; they are the lived realities of my patients in Alabama and beyond.”

“I could fill the room with photos of people who died or were seriously injured from Covid vaccines,” added Senate subcommittee chairman Sen. Johnson. “They are being gaslit, ignored and denied. The government has shown them no compassion.”

 

 

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