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Why Is the FDA Still Covering Up the Deadly Risks of mRNA Injections?
Dr. Carol Taccetta exposes how the FDA ignored clear evidence of lethal heart damage from mRNA shots—abandoning its duty to protect the public.

I sat down with Dr. Carol Taccetta—a physician with decades of experience in drug safety who contributed to the Surgeon General’s landmark report on smoking—to unpack why, despite overwhelming evidence of fatal myocarditis linked to the COVID-19 mRNA shots, the FDA continues to deny not only a market recall, but even the bare minimum: a black box warning.

Dr. Taccetta explains that a black box warning is the FDA’s most serious labeling requirement. It's reserved for risks that are fatal, life-threatening, or permanently disabling—and when proper warnings can reduce harm. The warning must be placed front and center on prescribing information, especially when the risk can be mitigated by monitoring, patient selection, or dose adjustment.

The question isn’t whether myocarditis qualifies—it clearly does—but why the FDA is refusing to act. ...

They ignored the 43,000+ serious adverse events she documented. They dismissed autopsy findings, CMR imaging studies showing persistent cardiac scarring, and even their own insurance claims data. The agency simply refused to act on the overwhelming body of evidence presented.

This is the same FDA that paused the Janssen vaccine for blood clots after just 54 cases. Yet now they claim no action is needed despite at least tens of thousands of serious heart injuries and deaths.

They admitted persistent cardiac injury in post-vaccine myocarditis cases. But they refused to include the terms death, heart failure, or arrhythmia risk—even though the study they cited links vaccine heart injury to sudden cardiac death...

Dr. Taccetta has spent countless hours trying to make a difference—submitting petitions, engaging the process, and writing directly to Dr. Peter Marks—all in an effort to fully inform the public about the risk of fatal heart damage.

But the FDA’s continued denial of black box warnings, even after confirming long-term cardiac injury, makes one thing clear: this agency has abandoned its duty to protect the public.

We don’t just need better labels—we need these shots off the market.

Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.

One expert put it bluntly—the FDA’s threshold for evidence “can’t go any lower because it’s already in the dirt.”

A system built on weak evidence
The findings were damning—73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.

Those four criteria—presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival—are supposed to be the bedrock of drug evaluation.

Yet only 28% of drugs met all four criteria—40 drugs met none.

These aren’t obscure technicalities—they are the most basic safeguards to protect patients from ineffective or dangerous treatments.

But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called “regulatory flexibility”.

FDA Commits Grave Betrayal: Fully Approves Deadly Genetic Injections for Infants

The FDA has committed a grave betrayal — putting millions of vulnerable infants, toddlers, and young children at risk of serious injury and death while cementing loss of trust.

With full approval, mRNA injections are now further embedded into our medical and public health systems — despite mounting evidence of catastrophic harm.

As detailed in our study, Review: Calls for Market Removal of COVID-19 Vaccines Intensify as Risks Far Outweigh Theoretical Benefits:

They ignored 81,000 physicians, scientists, and concerned citizens.
They ignored 240 elected officials and 17 public health organizations.
They ignored excess mortality, negative efficacy, and confirmed DNA contamination.

There is still time for RFK Jr. to act in accordance with “MAHA” values and denounce this disastrous decision. With a mass casualty event still unfolding, the time for playing politics is over.

Leadership demands courage — not silence.

One of the most powerful figures at the US Food and Drug Administration (FDA) has admitted she refused the Covid-19 mRNA vaccine while pregnant—even as her agency promoted it as “safe and effective” for all pregnant women.

Dr Sara Brenner’s explosive disclosure, made on 15 May 2025 at the MAHA Institute Round Table in Washington, DC, is as revealing as it is troubling.

A preventive medicine physician, Brenner has worked at the FDA since 2019. As the FDA’s Principal Deputy Commissioner—and briefly its Acting Commissioner—Brenner was at the centre of decision-making. ...

“Knowing what I knew—not only about nanotechnology, about medicine, about the medical countermeasures—but also having a very strong and firm grounding in bioethics…there were many things that were not right,” she told the audience.

That someone with her seniority and access to internal data privately rejected the vaccine, while her agency promoted it to millions of pregnant women, presents a profound ethical dilemma.

Brenner explained that her decision was driven by a lack of safety data, particularly around the biodistribution of the vaccine’s lipid nanoparticles (LNPs)—the tiny fat particles used to deliver the mRNA into cells.

“It was unknown at the time what the biodistribution patterns of those products were…That was my primary concern, and that exposure I was very concerned about,” said Brenner.