Pfizer Secretly Studied a Heart Damage Marker In 2021
We warned that there was proof that the Pfizer BNT162b2 mRNA COVID vaccine caused heart damage in teens and young adults, as early as May of 2021
As more information surfaces from the court-mandated release of Pfizer clinical trial documents by the FDA, and via FOIA’d emails, the CDC’s cover-up of evidence of COVID-19 mRNA vaccine-associated myocarditis in minors, becomes increasingly serious.
Myocarditis is inflammation of the myocardium, resulting in tissue degeneration or necrosis.
For example, during the same time period that the Centers for Disease Control and Prevention (CDC) was repeatedly advising parents to get their children vaccinated against COVID-19, Pfizer was secretly testing for markers of heart damage in vaccinated kids.
They looked for Troponin I in minors. When heart damage occurs, troponin I, a protein, gets released into the bloodstream.
While the CDC was urging parents to vaccinate their kids, Pfizer was studying how badly its mRNA COVID vaccine damaged children’s hearts.
Pfizer ran a study called ‘Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing.’ The study, which started in September 2021, was “…carried out in 2 age groups in order to collect blood samples for potential troponin I testing.
The younger age group (5 to <12 years of age) will be placebo-controlled meaning you will receive either active vaccine or placebo. The older age group (12 to <16 years of age) will be open-label meaning everyone will receive active vaccine.”
Shortly after the initial release of Pfizer documents, in April 2022 I wrote my first report, which presented compelling evidence that Pfizer and the Food and Drug Administration (FDA) were both aware of the myocarditis-causing potential of the emergency use authorization (EUA) mRNA COVID vaccine.
Subsequent research by the late German pathologist Dr. Arne Burkhardt confirmed that myocarditis was caused by the mRNA injection: he revealed the presence of spike protein in the myocardium of autopsied patients who had ‘died suddenly,’ as well as revealing scarring as a result of autoimmune effects.
Who Knew What, and When?
It became clear by February 2021 that a myocarditis safety signal was in the data and in scientific research ‘in press’ – meaning, scientific research which had passed peer review and been accepted for publication but that was not in print.
In fact, the Israeli Ministry of Health alerted the CDC to a myocarditis safety signal on February 28, 2021.
My previously mentioned ‘Report 11: Pfizer Vaccine – FDA Fails to Mention Risk of Heart Damage in Teens‘ clarified that the committees reviewing the vaccine rollout had received information from the Pfizer Post-Marketing Experience 5.3.6 document, released in full in Spring 2021, and from other publicly available information that showed 35 cases of myocarditis in children within one week after receiving the second dose of the Pfizer mRNA vaccine.
In April 2021, Israel began examining an unexpected incidence of myocarditis primarily linked to the second dose of the mRNA COVID vaccine.[https://www.reuters.com/world/middle-east/israel-examining-heart-inflammation-cases-people-who-received-pfizer-covid-shot-2021-04-25/]
This finding was contrary to prevailing message at that time that COVID infection caused myocarditis. In June 2021, Israel reported a link between a second shot of the Pfizer mRNA COVID vaccine and heart problems in males under the age of 30.
Emails between the CDC and the White House, obtained through FOIA by Ed Berkovich and reported by Amy Kelly, show that the White House and other top health agencies were aware of this information, and sought to cover it up.
These emails reveal the panic within the White House and public health agencies, that unfolded even as the agencies directed consistent media promotion that the vaccine was “safe and effective.”
The FOIA-produced emails, despite being heavily redacted, contain revealing information. As Ms. Kelly reported, “Astonishingly, the emails reveal that the most senior leaders, up to the White House, knew about heart damage linked to mRNA vaccines yet colluded behind the scenes to conceal this side effect from the American people.”
(For a comprehensive description and analysis of the FOIA’d emails, please refer to Amy Kelly’s article.)
As noted above, at first the public health agencies’ messaging – and thus the general fear – was that myocarditis might result from COVID-19 infection. This message prompted public health entities and medical professionals to advocate for COVID vaccination.
On May 23, 2021,Demetre Daskalakis, MD, COVID CDC Response Role: Senior Lead, Equity in COVID Data and Engagement and Director of CDC Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, sent a slide deck with the filename ‘Myocarditis update deck 5232021 Final’ to Henry Walke, MD, MPH, CDC Director of the Office of Readiness and Response (the FOIA’d version is almost completely redacted).
This event prompted a flurry of also-mostly-redacted emails between CDC personnel and others.
Thus, the CDC knew by then that COVID vaccine-related myocarditis occurred, yet the agency worked hard publicly to minimize the seriousness of that risk, and to conceal that possible cause and effect.
The October 2023 Pfizer documents released by the FDA revealed Federal-level U.S. health agencies’ awareness of vaccine-induced myocarditis.
Indeed, they knew this, in part, because Pfizer attempted to address these very concerns in the pediatric clinical trial documentation.
These documents contain protocols and information ‘assent’ sheets for a Spring 2021 pediatric clinical trial in which Pfizer orchestrated ACTIVE FOLLOW-UP – i.e., in clinic and telephone follow-up with participants at four days, one month, and six months – to assess the degree of heart damage from the vaccine.
(The ‘assent’ sheet reflects an effort to enable the minor to understand, to the degree they are capable of, what their participation in the decision-making process would involve.) Pfizer was specifically looking for myocarditis.
The first document, in comic book format and dated 15 February 2021, is tailored for younger children. The second document is for older children to assent – i.e., agree to the ability they are able to as minors – participation in the trial.
The cynicism of a corporation’s employees handing children comic books in order to secure their agreement to a test of possibly life-threatening heart damage, needs no emphasis.
In the October 2023 Pfizer documents, a pediatric informed consent study template (ICD Version Date 10 September 2021), for “Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (all age groups) September 13, 2021,” was discussed in a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting presentation on October 26, 2021.
While the FDA and Vaccines and Related Biological Products Advisory Committee (VRBPAC) acknowledged myocarditis as an important identified risk, this is a discussion about five- to 11-year-olds, a demographic not at naturally risk for such a heart condition.
In VRBPAC’s October 26, 2021, presentation entitled, “FDA Review of Effectiveness and Safety of Pfizer-BioNTech COVID-19 Vaccine in Children 5 through 11 Years of Age Emergency Use Authorization Amendment,” the FDA/Center for Biologics Evaluation and Research (CBER) indicated monitoring for the following identified safety concerns for 5- to 11-year-olds:
https://www.fda.gov/media/153510/download, p. 31.
According to the prevailing narrative at that time, vaccine-related myocarditis occurred in male teens and young adults, not young children. By testing the younger age group, Pfizer had two aims:
- To show that any ‘vaccine-induced’ myocardial damage, as shown by raised troponin I levels, was mild and temporary – i.e., in alignment with the company’s and public health’s prevailing message.
- To show the vaccine was not causing myocarditis, as it was not detected in the younger population, which, again, aligned with Big Pharma and public health’s talking points.
Myocarditis is normally a very rare event among in five- to 11-year-old children and would typically be caused by a viral infective agent.
The CDC was concerned about young children potentially getting COVID-induced myocarditis but did not understand that the mRNA COVID vaccines were causing the immune-mediated heart damage in the children, which would manifest after the short trial, not during it.
Additionally, this study involved Comirnaty™, which was not publicly available in the United States. Therefore, it seems European children, not American children, participated in it. (Reference the second bullet in the screenshot below.
In active surveillance, scientists actively seek out cases of disease.) The question arises: Was a study of only Comirnaty™ done to keep information away from the American public?
https://www.fda.gov/media/153510/download, p. 31.
Pfizer reported in the five- to 11-year-old pediatric trial that there were no cases of myocarditis. However, the company only conducted two months of follow-up, and there was a small number of vaccinated subjects (3,109).
While myocarditis may present soon after vaccination, particularly after a second dose, it can take much longer than one to two months to become symptomatic to the point where the patient becomes aware there is a medical issue occurring.
As a result of both the brevity of the study and the small sample, the absence of evidence of myocarditis in the study lacks significance.
https://www.fda.gov/media/153510/download, p. 30.
What Information Was Conveyed to the Parents of Children in the Trial?
Pfizer-BioNTech’s informed consent form for “Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing” advised parents of trial participants that myocarditis and pericarditis are known adverse events associated with Pfizer’s mRNA COVID vaccine and that they should seek medical attention should their child suffer from chest pain, shortness of breath, of fast-beating, fluttering, or pounding heart.
Pfizer-BioNTech also explained that the troponin I protein can be an early indicator of myocarditis or pericarditis and that their child would take part in troponin I blood testing to that end.
M5_c4591007-p2-3-parent-troponin-icd.pdf
(019736_S488_M5_c4591007-p2-3-parent-troponin-icd.pdf, p. 8)
By perpetuating ongoing ACTIVE SURVEILLANCE and testing for troponin I levels, Pfizer acknowledged the risk of vaccine-induced myocarditis and pericarditis and thereby appropriately tested for potential disease.
However, it is crucial to keep in mind that this coincided with CDC Director Dr. Walensky repeatedly promoting the allegedly “safe and effective” Pfizer mRNA COVID vaccine for children and indicating that “the CDC hasn’t identified any concerns with the temporary heart inflammation known as myocarditis.” [https://abcnews.go.com/Health/cdc-director-rochelle-walensky-concerns-myocarditis-million-children/story?id=81659883]
So, Who Bears Responsibility for Myocarditis Not Being Highlighted as a Legitimate Post-Vaccination Concern in Children?
While Pfizer eventually conducted active surveillance for early myocarditis signs following the widespread reporting of the disease following vaccination, it did so belatedly — especially given that the Israeli Ministry of Health raised the alarm about post-vaccination myocarditis as early as February 2021 and that, once pediatric COVID vaccines gained approval, people worldwide watched mRNA COVID-vaccinated children collapse, and even die, during normal exercise.
The CDC and the mainstream media concealed that myocarditis was a vaccine-related concern, and the Biden Administration, working with social media companies, actively censored or canceled people who shared myocarditis findings.
The Twitter Files demonstrated how Twitter, with help from the White House, rigged the COVID debate [https://legalinsurrection.com/2022/12/twitter-files-covid-edition-how-twitter-rigged-the-covid-debate-with-help-from-the-white-house/], while YouTube, also with help from Joe Biden’s White House, censored vaccine ‘misinformation,’ which turned out to be factual.
Most reprehensible is the cover-up by the CDC and the FDA, including the then CDC Director Dr. Rochelle Walensky.
Americans entrusted these US government employees to protect them and their families from medication-related harms.
They failed in that responsibility.
See more here substack.com
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Tom
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The fizer drug death machine has been invisible for the last 70 years. It hasn’t always been named fizer. The companies to come out of mergers were already dealing in death by drugs.
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Anapat
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First damage, then study the damage. Reminds me of Joseph Mengele.
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