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In May, the US Food and Drug Administration ordered Pfizer and Moderna to expand the warning labels on their covid-19 vaccines to include a heightened risk of heart inflammation, specifically myocarditis and pericarditis, in males aged 16 to 25.
Although the FDA has not characterised it as such, others have noted that the risk of myocarditis is a potential “ticking time bomb” because of its often-symptomless nature.
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Last month, Michel Chossudovsky shared an article published by Slay News in May, adding an introduction to it. Commenting on Chossudovsky’s article, Denis Rancourt said, “Wow. Just wow. This is social engineering repair, referred to as ‘cooling the mark out’ in criminal psychology. It is also the repair or return towards some democracy, in a period of runaway totalitarianism.”
The following are the “wow” articles Rancourt was referring to. We are sharing these articles belatedly because, although Americans may be aware, the rest of the world may not. At the end, we have added a section on what the product information for these so-called “vaccines” now states. Read the information and do some research before you allow anyone to inject you.
FDA Orders COVID ‘Vaccine’ Makers Pfizer and Moderna to Warn Public About Heart Damage Risk
Table of Contents
Introductory Note
By Michel Chossudovsky, 7 August 2025
“The United States Food and Drug Administration (FDA)has ordered pharmaceutical giants Pfizer and Moderna to issue warnings that their covid mRNA “vaccines” [May 2025] carry a high risk of heart damage, particularly for young men. The new guidance highlights the deadly risk of myocarditis from mRNA injections.”—Frank Bergman (see article below)
That deadly risk was known to the FDA and the CDC from the very outset. They failed to act. The mRNA vaccine was fully endorsed and imposed, nationally and internationally.
The Pfizer mRNA vaccine was launched in mid-December 2020.
Pfizer had commissioned a Confidential Classified study focusing on the impacts of its vaccine over a period of two and a half months (from mid-December 2020 to the End of February 2021). That report – which was subsequently made public in October 2021 under Freedom of Information (“FoI”) – confirmed the deadly nature of the mRNA injection (mortality and morbidity).
That Pfizer report was available to the FDA in early March 2021.
By the end of February 2021, “Pfizer had already received more than 1,200 reports of deaths allegedly caused by the vaccine and tens of thousands of reported adverse events, including 23 cases of spontaneous abortions out of 270 pregnancies and more than 2,000 reports of cardiac disorders.”
Click HERE to read the full Pfizer report.
These results were known to the FDA and the Centres for Disease Control (“CDC”). They closed their eyes. The mRNA vaccine was launched and distributed worldwide, resulting in millions of deaths and adverse events. This has been amply documented in numerous studies.
More than 75% of the world’s population of 8+ billion have been vaccinated.
This Confidential Pfizer Report provided data on deaths and adverse events recorded by Pfizer from the outset of the vaccine project in December 2020 to the end of February 2021, namely a very short period (at most two and a half months).
The data from mid-December 2020 to the end of February 2021 unequivocally confirms homicide (“manslaughter”).
If the FDA had acted at the outset to prevent the marketing of this deadly “vaccine,” millions of lives would have been saved.
Based on the evidence confirmed by its classified study, Pfizer had the responsibility to immediately cancel and withdraw the “vaccine.” That decision was not implemented.
The FDA was complicit. It was fully aware that the Pfizer-BioNTech mRNA covid injection would result in an upward trend in mortality and morbidity.
Pfizer’s worldwide marketing and distribution of the covid-19 “vaccine” beyond 28 February 2021 was no longer an “Act of Manslaughter” (involuntary homicide).
Murder, as opposed to manslaughter, implies “criminal intent.” They were fully aware from their own study that the mRNA vaccine would result in mortality. All of this is amply documented. Numerous peer-reviewed reports confirm the nature of the so-called “vaccine.”
Pfizer’s covid-19 vaccine constitutes a criminal act. From a legal standpoint, it is an“act of murder” applied worldwide to a target population of 8 billion people.
Click HERE to read the full Pfizer report.
What is required at this stage is the unconditionalcancellation of the mRNA vaccine, which has resulted in mortality and morbidity at the level of the entire planet. An inquiry should also be launched.
From the outset of the covid crisis, Global Research has posted hundreds of reports regarding the impacts of the mRNA “vaccine.”
The corporate media had the responsibility to inform the public. Censorship was applied. Scientists and medical doctors who revealed the truth were targeted.
Of relevance, did the US health authorities advise the public that Pfizer has a criminal record with the US Department of Justice (2009)? It is the only Big Pharma company which has a criminal record in the US.
That was not a civil lawsuit. Pfizer was put on probation.
To consult the Department of Justice’s historic decision, click HERE.
Our thanks to Frank Bergman for this outstanding article.
FDA Orders Covid ‘Vaccine’ Makers Pfizer and Moderna to Warn Public About Heart Damage Risk
by Frank Bergman, as published by Slay News on 25 May 2025
The United States Food and Drug Administration (“FDA”) has ordered pharmaceutical giants Pfizer and Moderna to issue warnings that their covid mRNA “vaccines” carry a high risk of heart damage, particularly for young men.
The new guidance highlights the deadly risk of myocarditis from mRNA injections.
Myocarditis is an immune-driven inflammation of the heart muscle, called the myocardium. The condition can reduce the heart’s ability to pump blood. Myocarditis can cause blood clots, strokes, cardiac arrest and, ultimately, sudden death.
Doctors have been warning for some time that myocarditis acts as a ticking time bomb, as it’s often symptomless, meaning sufferers may not be aware that they have the condition until it’s too late.
The new ruling from the FDA has sparked renewed scrutiny over covid “vaccine” safety policies.
According to a report from CBS News, the new guidelines signal growing federal scrutiny of covid “vaccine” safety.
The FDA has now formally requested that Moderna and Pfizer-BioNTech expand age-based warnings about heart damage caused by their mRNA vaccines.
In letters to the Big Pharma companies, the FDA cited recent data on myocarditis and pericarditis (another form of heart inflammation) that link to these conditions to mRNA injections.
Both manufacturers have been ordered to update product labels to reflect increased risk in males ages 16 to 25, up from the current ranges of 12 to 17 (Pfizer) and 18 to 24 (Moderna).
The letters were signed by Richard Forshee, acting director of the FDA’s Office of Biostatistics and Pharmacovigilance under the Centre for Biologics Evaluation and Research.
The agency’s move follows a 2024 FDA-funded study showing surging myocarditis cases following the second vaccine dose in young males. The FDA-backed study, published in The Lancet, shows continued abnormalities in heart scans in some patients months after experiencing myocarditis post-vaccination.
The data cited by Forshee shows that nearly 60 per cent of patients in a 333-person cohort still exhibited myocardial injury markers five months post-diagnosis. “The clinical and prognostic significance of these findings is not known,” he wrote.
The new directive requires the vaccine makers to inform patients that the long-term significance of these MRI findings is unknown. However, the heart abnormalities could reflect unresolved cardiac injury.
The department also emphasised that public awareness of these adverse events must be prioritised across both Pfizer and Moderna mRNA products.
In a statement, a Department of Health and Human Services spokesperson said: “Americans deserve radical transparency around the safety and efficacy of covid vaccines, and the FDA is delivering on its promise to do just that.”
The immune-driven condition has prompted fierce debate.
The scale of the crisis was amplified by a recent Senate hearing on “vaccine” safety and dissenting voices within the agency.
Meanwhile, FDA CommissionerDr. Marty Makary and vaccine policy leadDr. Vinay Prasad announced this week that Covid “booster” recommendations will now be limited to individuals over 65 or those with high-risk conditions.
The new rules continue to further shift the “vaccine” policy landscape.
Warnings Are Now Part of the Vaccine’s Product Information – in the US
According to a report by Cardiovascular Business at the end of June, the product information for the Comirnaty vaccine from Pfizer and the Spikevax vaccine from Moderna is now required to include the following text:
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.
Follow-up information on cardiovascular outcomes in hospitalised 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 before 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.
The Comirnaty product information does indeed include the updated warning – for residents in the US. It doesn’t seem to be the case everywhere else.
In its product information, the European Medicines Agency (“EMA”) downplays the risk of heart inflammation. Section 4.4 of the agency’s product information, first published on 12 January 2021 and last updated on 14 August 2025, states:
There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed.
Annexe I: Summary of Product Characteristics, EMA
In section 4.8, EMA states:
Myocarditis and pericarditis
The increased risk of myocarditis after vaccination with Comirnaty is highest in younger males (see section 4.4).
Two large European pharmacoepidemiological studies have estimated the excess risk in younger males following the second dose of Comirnaty. One study showed that in a period of 7 days after the second dose there were about 0.265 (95% CI: 0.255 – 0.275) extra cases of myocarditis in 12-29 year old males per 10,000 compared to unexposed persons. In another study, in a period of 28 days after the second dose there were 0.56 (95% CI: 0.37 – 0.74) extra cases of myocarditis in 16-24 year old males per 10,000 compared to unexposed persons.
Limited data indicate that the risk of myocarditis and pericarditis after vaccination with Comirnaty in children aged 5 to 11 years seems lower than in ages 12 to 17 years.
Annexe I: Summary of Product Characteristics, EMA
While Pfizer has been forced to slap additional warnings in the US, the EMA is recommending Comirnaty vaccines to target new covid variants. Even though on its “Comirnaty” page, EMA states, “Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) may occur in up to 1 in 10,000 people … The safety of the adapted vaccines is similar to that of the originally authorised Comirnaty vaccine.”
Inflammation of the heart in “up to 1 in 10,000” is a lot more than claimed in the product information: “about 0.265” and “0.56 … extra cases” per 10,000. We can conclude that EMA’s product information is, at best, spin and, at worst, part of the propaganda machine.
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Categories: Breaking News, World News
In the article:
“More than 75% of the world’s population of 8+ billion have been vaccinated.”
So, that is 6000000000 people vaccinated ?
We are told there are 8 billion people in the world, but I don’t think we really know. We have been lied to our entire lives. And the 75% figure is also suspect. But based on my personal knowledge, a majority of people have taken the shot where I live. And a lot of people who did are dead or very ill with heart issues, cancer, nerve damage, etc. All the sick people I know are unfortunately in denial that it was caused by the shot(s) they willingly took. You can’t even have a conversation with them about it because they get hostile. I guess they can’t admit they were duped…but unless they do, they will never be healed because standard medicine will keep them sick to continue preying on them and making huge sums of money off of them. It is sad to watch my friends and family go down this dark path. We need to pray to Jesus that these misled folks will wake up and come into the light. Thanks for considering my comments and peace to you.
Can we imagine any other product that was maiming or killing people being able to just use the “benefits outweigh the risk” argument and just list the deaths and injuries as a “cost of doing business?” 5 people get the runs from a bad head of lettuce and recalls are done immediately across the nation. I pray people continue to wake up to the whole “vaccine” myth, but a friend in Boston couldn’t wait to tell me that she was going for her “Flu” “vaccine” today. I had to really bite my tongue. The cult members consider it a badge of honor to have synthetic and foreign ingredients injected into them in the *hope* that it may keep them from getting sick. Unfortunately, my friend gets sicker than heck every year but refuses to point to the dangerous flu “vaccine”. Always using the “just think how much worse it would have been” line. We have our work cut out for us.