FDA Announces New Safety Warning on All mRNA COVID Vaccines — Cites “Extremely High” Risk of Myocarditis and Long-Term Heart Damage in Young Men

The U.S. Food and Drug Administration (FDA) under the Trump administration has formally updated the safety labeling on all mRNA COVID-19 vaccines to reflect what many Americans have been warning about for years: a disturbingly high risk of myocarditis—particularly in young men—and the possibility of long-term, irreversible heart damage.

The revised warnings apply to both Pfizer’s Comirnaty and Moderna’s Spikevax vaccines and follow months of mounting pressure over transparency and accountability regarding the true risks of these experimental injections.

The update stems from new studies and data showing persistent cardiac abnormalities months after vaccination—especially among males aged 12 to 24.

During a presentation of the new FDA safety data on Tuesday, Dr. Vinay Prasad, Director, Center for Biologics Evaluation & Research Chief Medical and Scientific Officer, walked the public through the harrowing evidence behind the label change.

Prasad detailed how FDA data reveals a myocarditis rate of 27 per million in young men—a figure that experts say is significantly underreported due to passive surveillance methods and political suppression of adverse event reports.

More troubling, Dr. Prasad cited late gadolinium enhancement (LGE) on cardiac MRIs as proof of sustained, potentially irreversible myocardial injury. According to Prasad, in one FDA-funded study, 60% of patients who suffered post-vaccine myocarditis still showed signs of LGE five months later.

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Pfizer’s Delayed Myocarditis Study

This headline has garnered so much attention on social media that I was asked to participate in an interview last night to discuss the topic. First, I had to clarify that I cannot be interviewed about ACIP issues without prior clearance from HHS Communications. Once that was understood, at 6:00 PM (dinner time!) I dialed in via Zoom, and we talked on the record. No, I do not know if or when the interview will be aired. Before the interview, as usual, I did the necessary diligence to avoid embarrassing myself due to ignorance, keeping in mind the first rule of social media.

It is often better to stay quiet and have people wonder if you are ignorant than to tweet and remove all doubt.

Let’s dive into the details. I think that this particular situation provides a great example of how bias, combined with insufficient background and subject matter experience, can lead to unjustified clickbait headlines. This is a chronic problem on both sides of the mRNA “vaccine” safety debate, one which makes it so, so much harder to get to the bottom of all of this.

I will try to explain so that most can understand, but it may get a little technical. The nuances of clinical research study design and implementation are complicated. Please try to stick it out, if for no other reason than it does lead back to some statements from CDC’s Captain Dr. Sarah Meyer (CDC/NCEZID) during her recent presentation titled “COVID-19 safety update” regarding long-term outcomes from COVID-19 mRNA product myocarditis. Consider that an embedded easter egg.

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Nearly 10,000 Claims Pending as COVID Vaccine Injury Compensation Program Faces Possible Budget Cut

A government-run COVID-19 vaccine injury compensation program with nearly 10,000 pending claims faces the threat of a budget cut for the 2026 fiscal year.

The Trump administration’s proposed budget would eliminate funding for the Countermeasures Injury Compensation Program (CICP), TrialSite News reported last week. If approved, the program would be forced to operate on “carryover funds” — or unspent funds from previous years.

According to TrialSite News:

“With no civil court recourse under the PREP Act, downgrading CICP funding leaves injured individuals with limited legal avenues and uncertain financial relief. This undermines public trust in vaccine policy, risks fueling hesitancy, and may deter future claim filings altogether.

“The decision to drop new CICP funding was hidden in budget pages — no public announcements or detailed breakdown of carryover metrics. How much carryover exists? How long will it last? What if claim volume increases?”

CICP was established under the Public Readiness and Emergency Preparedness Act (PREP Act) of 2005.

Under a PREP Act declaration, issued during an official public health emergency such as the COVID-19 pandemic, manufacturers of vaccines and other countermeasures associated with a health emergency are exempt from liability for serious injuries or death caused by their products — except in cases of willful misconduct.

That means people who believe they were injured by one of these products can’t sue the manufacturer. Instead, they can apply to the CICP for compensation.

However, even if successful, claimants often receive limited compensation from CICP. By law, the program can reimburse only those medical expenses not compensated by insurance or other programs.

It can also reimburse for lost employment income (capped at $50,000 per year) and a one-time benefit of $370,000 for deaths.

The program does not reimburse legal fees or provide compensation for pain and suffering.

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More Fetal Losses Than Expected After Pfizer COVID-19 Vaccination In Israel: Study

A higher-than-expected number of miscarriages and other forms of fetal loss were associated with COVID-19 vaccinations in Israel, a new study has revealed.

Researchers found 13 fetal losses—four more than the nine expected—for every 100 pregnant women who received a COVID-19 vaccine during weeks eight to 13 in pregnancy, according to the study, which was published as a preprint on the medRxiv server.

Most people in Israel, including pregnant women, received the Pfizer-BioNTech COVID-19 vaccine.

Pfizer did not respond by publication time to a request for comment.

The team behind the study includes Retsef Levi, a Massachusetts Institute of Technology researcher who was recently named to the committee that advises the Centers for Disease Control and Prevention on vaccines, and Dr. Tracy Hoeg, who works for the Food and Drug Administration.

The researchers analyzed electronic health records from Maccabi Healthcare Services, one of four organizations that provide health care to Israelis. They looked at 226,395 pregnancies that occurred between March 1, 2016, and Feb. 28, 2022. The primary analysis looked at fetal loss for pregnant women after dose one or dose three of a COVID-19 vaccine, with fetal loss including miscarriage, abortion, and stillbirth.

The researchers came up with an expected number of fetal losses based on a model that drew from data before the COVID-19 pandemic, then compared the expected number of fetal losses with those that occurred from week eight of pregnancy onward.

They identified 13,214 fetal losses after the COVID-19 pandemic started, compared with 12,846 fetal losses in the reference period, finding that women who received a COVID-19 vaccine during weeks eight to 13 in pregnancy experienced a higher-than-expected number of fetal losses.

“If you believe this result … every 100 women that you would vaccinate during weeks eight to 13, you are going to see close to four additional fetal losses,” Levi told The Epoch Times.

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SARS-CoV-2 Vaccination and the Multi-Hit Hypothesis of Oncogenesis

Cancer is a complex and dynamic disease. The “hallmarks of cancer” were proposed by Hanahan and Weinberg (2000) as a group of biological competencies that human cells attain as they progress from normalcy to neoplastic transformation. These competencies include self-sufficiency in proliferative signaling, insensitivity to growth-suppressive signals and immune surveillance, the ability to evade cell death, enabling replicative immortality, reprogramming energy metabolism, inducing angiogenesis, and activating tissue invasion and metastasis. Underlying these competencies are genome instability, which expedites their acquisition, and inflammation, which fosters their function(s). Additionally, cancer exhibits another dimension of complexity: a heterogeneous repertoire of infiltrating and resident host cells, secreted factors, and extracellular matrix, known as the tumor microenvironment, that through a dynamic and reciprocal relationship with cancer cells supports immortality, local invasion, and metastatic dissemination. This staggering intricacy calls for caution when advising all people with cancer (or a previous history of cancer) to receive the COVID-19 primary vaccine series plus additional booster doses. Moreover, because these patients were not included in the pivotal clinical trials, considerable uncertainty remains regarding vaccine efficacy, safety, and the risk of interactions with anticancer therapies, which could reduce the value and innocuity of either medical treatment.

After reviewing the available literature, we are particularly concerned that certain COVID-19 vaccines may generate a pro-tumorigenic milieu (i.e., a specific environment that could lead to neoplastic transformation) that predisposes some (stable) oncologic patients and survivors to cancer progression, recurrence, and/or metastasis. This hypothesis is based on biological plausibility and fulfillment of the multi-hit hypothesis of oncogenesis (i.e., induction of lymphopenia and inflammation, downregulation of angiotensin-converting enzyme 2 (ACE2) expression, activation of oncogenic cascades, sequestration of tumor suppressor proteins, dysregulation of the RNA-G quadruplex-protein binding system, alteration of type I interferon responses, unsilencing of retrotransposable elements, etc.) together with growing evidence and safety reports filed to Vaccine Adverse Effects Report System (VAERS) suggesting that some cancer patients experienced disease exacerbation or recurrence following COVID-19 vaccination. In light of the above and because some of these concerns (i.e., alteration of oncogenic pathways, promotion of inflammatory cascades, and dysregulation of the renin-angiotensin system) also apply to cancer patients infected with SARS-CoV-2, we encourage the scientific and medical community to urgently evaluate the impact of both COVID-19 and COVID-19 vaccination on cancer biology and tumor registries, adjusting public health recommendations accordingly.

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The Hidden Tragedy of Neurological Vaccine Injuries

From birth, we are taught that vaccines were one of the most remarkable discoveries in history, and were so safe and effective that many now unimaginable plagues vanished with few to no side effects occurring in the process. In truth, give or take, every part of that mythology is false, and remarkably similar vaccine disasters occur every few decades.

Much of this results from the fact that it is very difficult to produce safe vaccines due to both their mode of action and the methods used in their production. As such, the best “solution” which could be found to this problem was to insist in lockstep that vaccines were safe and erase any memory that vaccine disasters had in fact occurred, thereby making it possible to gaslight anyone who was severely injured by a vaccine and claim their injury was just anecdotal or a product of anti-vaccine hysteria.

For example, recently I discussed how vaccines cause autism, and focused on a central argument used to debunk the link between the two—that the only reason people believe vaccines cause autism is because a disgraced British doctor published a fraudulent 1998 study claiming they did and then made everyone start hallucinating that vaccine injuries were occurring.

This mythology however, ignores that brain injuries were a longstanding problem of vaccination. For example, a 1982 NBC news program revealed that many parents were having children develop “post-pertussis encephalopathy” after taking the DPT vaccine, that most doctors refused to report this.

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Rates of successful conceptions according to COVID-19 vaccination status: Data from the Czech Republic

Abstract

Background

Adverse effects of COVID-19 vaccination on human menstrual cycle characteristics have been observed, but limited data are available on the relationship between COVID-19 vaccination status and birth rates.

Objectives

Therefore, we used nationwide data from the Czech Republic to examine rates of successful conceptions (SCs), that is, conceptions leading to live births 9 months later, for women who were either vaccinated or unvaccinated against COVID-19 before SC.

Methods

Summary monthly COVID-19 vaccination and birth data for women in the Czech Republic aged 18–39 years were retrieved for the period from January 2021 to December 2023. The numbers of SCs per month per 1000 women were calculated for preconception-vaccinated or unvaccinated women, respectively, as well as the number of SCs per month per 1000 women for all women aged 18–39 years.

Results

During the study period, there were approximately 1,300,000 women aged 18–39 years in the Czech Republic, and the proportion of COVID-19-vaccinated women increased from January 2021 until reaching a steady state of around 70% by the end of 2021. At least from June 2021, SCs per 1000 women were considerably lower for women who were vaccinated, compared to those that were unvaccinated, before SC. Furthermore, SC rates for the vaccinated group were much lower than expected based on their proportion of the total population.

Conclusions

In the Czech Republic, SC rates were substantially lower for women vaccinated against COVID-19 before SC than for those who were not vaccinated. These hypothesis-generating and preliminary results call for further studies of the potential influence of COVID-19 vaccination on human fecundability and fertility.

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FDA, CDC advisers say lost pregnancies higher than expected following early mRNA vaccination

President Trump’s second-term agenda has been careful not to cast doubt on his signature first-term achievement, the development of COVID-19 vaccines through Operation Warp Speed, which congressional Republicans continue to laud and even claim was sabotaged by Pfizer to deny Trump a consecutive term despite his base souring on the therapeutics.

A new preprint study on mRNA COVID vaccines in early pregnancy, coauthored by top advisers to Trump’s Food and Drug Administration and Centers for Disease Control and Prevention, may fuel the splintering of the Make America Healthy Again movement as the jabs’ opponents ramp up pressure on Health and Human Services Secretary Robert F. Kennedy Jr. to ban them.

Not yet peer-reviewed, the study analyzed hundreds of thousands of Israeli medical records on pregnant women in the three years before and after SARS-CoV-2 emerged in China, finding 43% more “observed-to-expected” fetal losses per 100 pregnancies — 13 instead of nine — when the first mRNA dose is taken between 8-13 weeks’ pregnancy.

Pregnant women who took a booster between 8-13 weeks lost an additional two pregnancies per 100, a “potential dose-response relationship,” the study said.

By using pregnant women who got flu vaccines between 8-27 weeks and women who received either vaccine before their pregnancy as “comparative controls,” the authors said they were able to show the association is unique to COVID vaccines. 

The former had a “consistently lower-than-expected observed number of fetal losses, likely the result of healthy vaccinee bias” – in which people with overall better health tend to have higher vaccination rates – while the latter had “according-to-expected or lower-than-expected numbers of fetal losses,” the study found.

It said “almost all” mRNA doses were made by Pfizer, whose own 2021 report to the FDA – which the agency hid for 16 months until a court made it public – shows 44% of women in Pfizer’s clinical trial lost their pregnancies.

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Did Head of CDC Vaccine Safety Office Delete COVID Vaccine Injury Records?

A key official at the Centers for Disease Control and Prevention (CDC) responsible for monitoring vaccine safety and reports of vaccine injuries may have mishandled or deleted official records subpoenaed by Congress, Sen. Ron Johnson (R-Wis.) alleged earlier this week. The New York Post first reported the story on Thursday.

Dr. Tom Shimabukuro, director of the CDC Immunization Safety Office, maintained the records in question. Shimabukuro previously authored a key paper and participated in public messaging claiming the COVID-19 vaccines were safe and effective for pregnant women.

Johnson, chairman of the U.S. Senate Permanent Subcommittee on Investigations, requested the records in a subpoena sent in January to the U.S. Department of Health and Human Services (HHS). The subpoena pertained to an investigation into internal COVID-19 vaccine safety communications.

According to the New York Post, the subpoena led HHS to discover “potential discrepancies” in the emails maintained by Shimabukuro.

“HHS officials recently informed me that Dr. Shimabukuro’s records remain lost and, potentially, removed from HHS’s email system altogether,” Johnson wrote in a letter he sent earlier this week to U.S. Attorney General Pam Bondi, FBI Director Kash Patel and HHS Principal Deputy Inspector General Juliet Hodgkins.

Johnson called Shimabukuro’s possible mishandling of his official records “highly concerning.”

Journalist Paul D. Thacker, a former U.S. Senate investigator, said, “Every American should be concerned about government scientists deleting or hiding federal information to shape a political agenda. That information belongs to the taxpayers.”

Nebraska chiropractor Ben Tapper, whose questioning of the COVID-19 vaccines led the Center for Countering Digital Hate to add him in 2021 to its “Disinformation Dozen” list of the “leading online anti-vaxxers,” said he was “not surprised” by Johnson’s allegations.

“For years, I’ve seen patterns like this before regarding vaccine safety data. The public health establishment often prioritizes profits over people and continuously seems to protect the lies over the truth. The idea that critical records might vanish — whether through negligence or intent — fits a familiar playbook,” Tapper said.

California attorney Rick Jaffe said Johnson’s allegations are “troubling, but not surprising, given longstanding concerns about transparency at the CDC.”

In response to a Freedom of Information Act (FOIA) request last year, the CDC told Children’s Health Defense the agency has no records of certain internal email communications relating to the agency’s follow-up investigation of safety signals associated with COVID-19 vaccines.

HHS, CDC and Johnson’s office did not respond to requests for comment.

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Vindication For The Unvaccinated?

At a recent family gathering, I sat at the dinner table with a group of loved ones for the first time since the Covid-19 fiasco. Most of the cheerful discussion focused on the spectacular event of the week: my mother’s 100th birthday. 

I was the only person at the table who hadn’t had any form of flu for many years, while all of the guests had been ill to one degree or another. Almost everyone had tested positive for Covid at least once over the last few years with accompanying flu symptoms. Although no one in my family was hospitalized or died during the so-called pandemic; they all had been vaccinated repeatedly. As far as I know, my wife and I were the only ones in our families who didn’t get any Covid shot, and I haven’t been inoculated for anything in the last seventy years. 

On this happy occasion, the fear, masks, lockdowns, and accusations of the recent past had been mostly forgotten. It was not because the signs and symptoms of the disease had ended, nor that the call for vaccination or testing had been silenced. No one understood why they were still occasionally feeling unwell, with some continuing to report they’d been diagnosed with Covid. 

My view of healthcare has always been outside of the box, having practiced Traditional Chinese Medicine for many decades. I’d worked closely with medical doctors in treating some of their patients and also served as the chief medical officer of a volunteer fire department, appreciating life-saving emergency procedures of modern biomedicine. Through a range of experiences, I gained some knowledge of the causes and cures for suffering and illness.

Before the Covid fiasco, my alternative approach to illness had been respected; I’d shared my knowledge with whoever might ask. My medical perspective was no secret from friends and family. When my daughters were young, they weren’t vaccinated as there were no threats of deadly or debilitating diseases. This was in a place and time when vaccination for infants could be considered and refused, not done by rote. There was reasonable dialogue about the topic — and non-compliance certainly did not elicit threats of excommunication. 

As the specter of a pandemic arose, my opinion about vaccination became dangerous and irrelevant. 

From the outset, it was apparent that the claimed benefits of the new vaccines did not outweigh their risks. I openly said and wrote that the technology remained untested — though never advised anyone to refrain from inoculation — only counseling those who listened to remain fully informed.

It wasn’t complicated. Using genetic-based technology in developing a new drug that attempted to manipulate the magnificent complexity of the human immune system was at a minimum, a gamble. As easily demonstrated, this new technology embraced the bold assumption that human design was flawed and could be improved. It was premature to declare that this experimental treatment was safe and effective. We still don’t know the actual long-term effects — particularly over generations.

This simple and logical evaluation was considered preposterous by those who responded to the seemingly new disease with unbridled fear. The danger of the Covid flu was deemed sufficient to quell all reasonable responses about the risks of the vaccines. Suddenly, there was an eclipse of medical autonomy, and debate was scorned. The actions and motives of corrupted government agencies and their profit-oriented allies in Big Pharma were blessed by devious leaders, who deemed them altruistic and unquestionable. 

This atmosphere, developed and enforced in a haze of authoritarian dictates, created an unprecedented climate of hostility that infected all relationships. Because of my views and unvaccinated status, I rapidly became a pariah to my family.

Early on, when the fear tactics were in high gear, my cousin, who is an attorney involved in healthcare issues, sent a blistering email, condemning one of my first articles skewering the pandemic response. He left no room for dialogue and writing, it is the height of irresponsibility to add to the disinformation that is everywhere about the Covid vaccine. He concluded…

I am really upset that you have chosen to use your talents and thoughtful manner to give credence to the kind of wrongheaded rhetoric and conspiracy theories that feed the mass hysteria over accepting the reality that if we are to beat this pandemic, we need to not just take the vaccine if we want to, but take it on a societal level whether certain individuals want to or not. Your call for “transparency” just further feeds a certain, huge segment of the populations’ belief that they know better than the experts on this issue. They do not. You do not. I do not. But every reputable researcher and medical professional who has reviewed this data agree – it is safe, it is effective, and it is critical.

The venom exuded in response to my unwillingness to join in the mass delusion supporting vaccination was palpable. My crime was unforgivable.

Although we had been very close, all contact ended. However, it was not his unconscious, misdirected anger that troubled me, rather that he shared his views and wrath with my daughters, supporting their inclination to distance themselves from me because of my independent views. This wound with my cousin may never heal.

My mother, who had cordially disagreed with me on vaccination, balanced his bias with sound advice to her granddaughters. She urged them not to be harsh, suggesting that whatever differences they see, these were not worthy of destroying their relationship with their father. Thanks to her wise counsel, the love my daughters and I share has survived.

This and similar events had been left smoldering. In the spring of 2025, at this happy gathering celebrating my mom’s longevity, to my surprise, the topic turned to Covid. (My cousin was not there.) Conversation comprised mostly of personal accounts of suffering and confessions of a lack of understanding of why the virus persisted. 

My sister said she’d attended a lecture at a local college on the history of the social response to mass infection. She described the common human responses and behaviors to past epidemics and pandemics, including how scapegoating was a dominant and destructive response. 

Managing to remain quiet until all had acknowledged these horrors of the past, I spoke up, voicing a simple question: Did the recent Covid pandemic fit this pattern?

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