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Pfizer and the Centers for Disease Control and Prevention (CDC) withheld evidence that COVID-19 vaccinations were causing myocarditis, according documents obtained by Children’s Health Defense via a Freedom of Information Act request to the CDC, and documents leaked this week to Project Veritas.
Pfizer and the Centers for Disease Control and Prevention (CDC) withheld evidence that COVID-19 vaccinations led to an increased risk of myocarditis, especially in young males, according to two sets of documents made public this week.
Confidential Pfizer documents leaked Thursday by Project Veritas show the company had “evidence that suggests patients who receive a COVID-19 vaccine are at an increased risk of myocarditis.”
And heavily redacted CDC documents obtained by Children’s Health Defense (CHD) via a Freedom of Information Act (FOIA) request indicate the agency provided an undercounted figure of post-COVID-19-vaccination myocarditis cases to Israel’s Ministry of Health in early 2021.
The latest revelations come as Germany, Japan and other governments are raising questions about the significant numbers of severe adverse events recorded in individuals following administration of the COVID-19 vaccines.
According to researchers at the National Organization for Rare Disorders, myocarditis can result from infections, or it may result directly from a toxic effect such as a toxin or a virus.
“More commonly the myocarditis is a result of the body’s immune reaction to the initial heart damage,” researchers said.
Severe myocarditis can permanently damage the heart muscle, possibly causing heart failure.
Internal documents contradict Pfizer claim of ‘low incidence of myocarditis’
An internal Pfizer document leaked to Project Veritas on Thursday, updated Feb. 11, 2022, and authored by eight scientists in Pfizer’s Drug Safety Research & Development division, indicates that the drugmaker was aware of a connection between mRNA COVID-19 vaccines and higher incidence rates of myocarditis within two weeks of vaccination — particularly following the second dose of the primary series.
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Although Pfizer couldn’t identify a “clear mechanism” behind the increased risk in males, it did identify several possibilities.
These included direct cardiotoxicity, acute/active viral infection, genetic predisposition and pre-existing conditions, a prior history of myocarditis, immune-mediated mechanisms and vaccine-associated autoimmunity, molecular mimicry to the spike protein and sex-related effects.
These cases occurred, according to the document, despite a claimed low incidence of myocarditis during the clinical trials for the mRNA COVID-19 vaccines.
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Based on these incidences of myocarditis, the document states the product labels for the Pfizer COVID-19 vaccine were updated to state:
“Post marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose of the 2-dose primary series.
“The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age.”
This change had already been made as of August 2021, according to a document released as part of the so-called “Pfizer documents” — documents pertaining to the U.S. Food and Drug Administration’s (FDA) issuance of Emergency Use Authorization (EUA) to the Pfizer-BioNTech COVID-19 vaccine.
The “Pfizer documents” were released last year by court order following a FOIA request filed by Public Health and Medical Professionals for Transparency.
Another internal Pfizer document from these same “Pfizer documents” states that on July 13, 2021, it was suggested that myocarditis and pericarditis be added “to the PVP” (pharmacovigilance plan).
This addition appears to have taken place.
The Pfizer pharmacovigilance plan of July 28, 2021 — also contained within the “Pfizer documents” release — lists myocarditis and pericarditis as “important identified risk[s]” identified in Pfizer’s safety database on June 18, 2021.
A pharmacovigilance plan “proposes activities to better characterize and assess the risks during the lifecycle of a medicine. (e.g., to investigate frequency, severity, seriousness and outcome of a risk under normal conditions of use, and/or which populations are particularly at risk).”
Pfizer’s July 28, 2021 pharmacovigilance plan stated that two serious adverse events of pericarditis were reported during the C4591001 clinical trial, although “both [were] deemed not related to study treatment by the Investigator.”
The document also refers to data from Pfizer’s safety database, stating that among people 16 and older, “490 cases reported events related to myocarditis and 371 cases reported events related to pericarditis (in 38 of these 823 cases, the subjects developed both myocarditis and pericarditis related events).”
Of these 490 cases, 26 were later definitively rejected as not being myocarditis, leaving 464 cases ranging from “definitive case” to “reported event.” From there, 459 were listed as “serious,” 337 required hospitalization, and 14 resulted in death.
Nearly 71% of these cases were recorded in males.
Of 371 reported pericarditis cases in individuals 16 and over, all but one was listed as “serious,” 206 required hospitalization, and 3 resulted in death.
Pfizer, in the same pharmacovigilance plan, claimed that no myocarditis or pericarditis cases were recorded in C4591001 trial participants ages 12 to 15.
However, its safety database recorded 11 possible cases of myocarditis — all but one among males, 10 of which were “serious” and nine of which required hospitalization.
Four cases of pericarditis among males between the ages of 12 and 15 also were recorded in the safety database, three of which were considered serious and one of which required hospitalization.
However, in the July 28, 2021 pharmacovigilance plan, Pfizer told the FDA:
“Considering the low rates of myocarditis and pericarditis reported following vaccination, balanced with the risk of death and illness (including myocarditis) caused by SARS-CoV-2, the public health impact of post-vaccination myocarditis and pericarditis is minimal.”
Nevertheless, in another leaked document publicized by Project Veritas, dated May 2022, further confirms Pfizer was aware of the increased incidence of myocarditis.
According to the leaked document:
“Adverse events (AEs) following COVID-19 vaccination are of high clinical importance: even adverse events with small incidence may be seen in appreciable numbers given the massive scope of the vaccination effort.
“There is evidence that suggests patients who received a COVID-19 vaccine are at an increased risk of myocarditis.”
CDC undercounted myocarditis cases in 2021
Documents provided by the CDC in response to an Oct. 12, 2022 FOIA request submitted by CHD reveal the agency provided an undercounted number of recorded myocarditis cases following COVID-19 vaccination to the Israeli Ministry of Health.
The FOIA request asked the CDC to “provide all emails sent by any of the relevant individuals or received by any of the relevant individuals (whether directly or via cc or bcc) containing the search word ‘myocarditis’” between Oct. 1, 2020 and April 30, 2021.
“There has been considerable public discussion of and controversy about how to weigh
the risk of myocarditis that is associated with COVID-19 vaccines,” the request stated. “The public has a significant interest in having a full understanding of how U.S. public health agencies have addressed this issue.”
Following a response by the CDC, CHD on Nov. 17, 2022, narrowed down its request to include only documentation containing the term “myocarditis” within 25 words of “(covid or report* or child* or adolescent* or young*or teen* or male or fatal* or death* or die* or serious or severe or hospital*).”
The heavily redacted 985-page tranche of documents provided to CHD included a Feb. 28, 2021 request, on page 692, from Israel’s Ministry of Health. The request, logged on that date by CDC’s internal task tracking system, stated:
“We are seeing a large number of myocarditis and pericarditis cases in young individuals soon after Pfizer COVID-19 vaccine. We would like to discuss the issue with a relevant expert at CDC.”
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Via https://childrenshealthdefense.org/defender/myocarditis-pfizer-covid-vaccine/
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