INVESTIGATIVE REPORT: Health Canada, the FDA, and the Pfizer-BioNTech COMIRNATY Deception? - Part One
Health Canada, New Drugs, and Division 8 of the Food and Drug Regulations
This is Part One of a three part Investigative Report, as follows:
Reviews published claims by Health Canada that the Pfizer-BioNTech COMIRNATY Covid-19 vaccine had been “approved” and “proven safe and effective”.
Provides details of the Health Canada - Regulatory Decision Summary - to authorize the use of the Pfizer-BioNTech COMIRNATY Covid-19 vaccine.
Outlines specifics on the regulatory classification assigned to the Pfizer-BioNTech COMIRNATY Covid-19 vaccine by the Government of Canada, and how this classification is defined in the governing statute.
Provides the definition of “Fraud” in the Criminal Code of Canada, and
Presents an analysis conducted by researchers at Columbia University on “COVID vaccination and age-stratified all-cause mortality risk” (Oct 2021).
Part Two and Three of this Investigative Report have been published separately but concurrently.
Part Two documents how Canadian regulators can rely on a “foreign regulatory authority” in the Pre-positioning of Designated COVID-19 Drugs. It then outlines the content and implications of two (2) separate letters the US FDA (“the FDA”) wrote to Pfizer Inc., and to BioNTech GmbH on August 23, 2021, with respect to the authorization and licensing of the BioNTech and COMIRNATY Covid-19 vaccines.
Part Three provides a overview of the known Epidemiology of Covid-19, versus The Covid Scare.
PART ONE – Health Canada, New Drugs, and Division 8
As with its essentially identical (while legally distinct - see Part Two) predecessor, the Pfizer-BioNTech COMIRNATY Covid vaccine is currently only "authorized" for use in Canada.
This has significant implications for parents given Health Canada’s decision to '‘approve” the COMIRNATY vaccine for children age 5 and older, as well as for employers who have imposed vaccine mandates on workers as a condition of employment. For details, please review the following three (3) screenshots and related documents found in the hyper-links.
1) Below is a screenshot of a Health Canada webpage concerning the Pfizer-BioNTech COMIRNATY COVID-19 vaccine, wherein Health Canada declares that:
All COVID-19 vaccines authorized in Canada "“are proven safe and effective”,
The Status of the Pfizer-BioNTech COMIRNATY COVID-19 is: “Approved by Health Canada”, and
It has been “Approved for: Age 5 and older”.
Figure 1: Government of Canada “ALL COVID-19 vaccines in Canada are proven safe, effective”
2) However, in the screenshot shown below taken from Health Canada’s Regulatory Decision Summary - COMIRNATY — we can clearly see that it states that this Covid-19 vaccine has (only) been “authorized”, under and in accordance with an obscure section of the 1,154 page Food and Drug Regulations – Division 8.
To what does Division 8 of the Food and Drug Regulations relate? Read on.
Figure 2: Regulatory Decision Summary - COMIRNATY - Health Canada (Divison 8)
… that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug.
Figure 3: Division 8 of the Food and Drug Regulations - New Drugs
Division 8 of the Food a Drug Regulations goes on to define a “designated Covid-19 Drug" as:
a new drug for which the purpose and conditions of use recommended by the manufacturer relate to COVID-19;
Health Canada’s published claims that the Pfizer-BioNTech COMIRNATY COVID-19 vaccine has been “approved” and “proven safe and effective” appear to be in direct conflict with the drugs regulatory status.
In fact, we can clearly see that COMIRNATY appears to have been authorized for use secondary to its classification under Division 8 of the Food and Drug Regulation as a “New Drug” — meaning, by definition, that the safety and efficacy of COMIRNATY has not been established.1 To claim otherwise, elsewhere, appears misleading, at best.
So what in the Sam Hill might be going on here? Have Canadians been deceived by their governments so that Proof of Vaccination edicts could be imposed, vaccine "mandates" deployed, and this New Drug even marketed to children?
If we were to attempt to unravel these questions we might begin by asking: would Pfizer’s liability shield (see Part Two) be at risk if fraud is found? After all, fraud, for which Big Pharma has plead guilty in the past, eviscerates all contracts. Pfizer itself has paid out Billions in civil lawsuits.
This is an especially salient question given that the FDA, now joined by Pfizer, is currently in a US Federal Court trying to prevent a group of public health officials and medical professionals from having access to the FDA's Pfizer Covid-19 vaccine licensing records. An issue that the senior editor of the British Medical Journal2 weighed-in on in a recent editorial: Covid-19 vaccines and treatments: we must have raw data, now
Section 380 of the Criminal Code of Canada — Fraud, states:
(1) Every one who, by deceit, falsehood or other fraudulent means, whether or not it is a false pretence within the meaning of this Act, defrauds the public or any person, whether ascertained or not, of any property, money or valuable security or any service,
(a) is guilty of an indictable offence and liable to a term of imprisonment not exceeding fourteen years, where the subject-matter of the offence is a testamentary instrument or the value of the subject-matter of the offence exceeds five thousand dollars; or
(2) Affecting public market
Every one who, by deceit, falsehood or other fraudulent means, whether or not it is a false pretence within the meaning of this Act, with intent to defraud, affects the public market price of stocks, shares, merchandise or anything that is offered for sale to the public is guilty of an indictable offence and liable to imprisonment for a term not exceeding fourteen years.
In an analysis published in October 2021 by researchers at Columbia University — COVID vaccination and age-stratified all-cause mortality risk — the authors stated:
Accurate estimates of COVID vaccine-induced severe adverse event and death rates are critical for risk-benefit ratio analyses of vaccination and boosters against SARS-CoV-2 coronavirus in different age groups. However, existing surveillance studies are not designed to reliably estimate life-threatening events or vaccine-induced fatality rates (VFR).
According to the authors:
Comparing our age-stratified VFRs [vaccine-induced fatality rates] with published age-stratified coronavirus infection fatality rates (IFR) suggests the risks of COVID vaccines and boosters outweigh the benefits in children, young adults and older adults with low occupational risk or previous coronavirus exposure.
We discuss implications for public health policies related to boosters, school and workplace mandates, and the urgent need to identify, develop and disseminate diagnostics and treatments for life-altering vaccine injuries.
If “existing surveillance studies are not designed to reliably estimate life-threatening events or vaccine-induced fatality rates”, is it not disingenuous for public health officials to claim that “no safety issues were detected” with respect to the administration of these “New Drugs”?
See below “Model-estimated deaths attributed to Covid Vaccination” in the US for Jan-Aug 2021, from the analysis conducted by researchers at Columbia University. Please, note the highlighted boxes and the Totals column.
Figure 4: from COVID vaccination and age-stratified all-cause mortality risk (October 2021)
"With the knowledge we have today, with a low risk for serious disease for kids, we don't see any clear benefit with vaccinating them," a Sweden Health Agency official told a news conference.
As noted in the preamble, in Part Two of this Investigative Report — The FDA, a foreign regulatory authority in Canada? — we will review the section of Division 8 of the Food and Drug Regulations that allows Health Canada, in the Pre-positioning of Designated COVID-19 Drugs, to rely on:
an application (that) has been submitted to a foreign regulatory authority to authorize the sale of the designated COVID-19 drug.
Which will be followed by a detailed analysis of the FDA’s authorization and licensing of the COMIRNATY Covid-19 vaccine, in response to a submission by Pfizer-BioNTech of a Biologic License Application (BLA) for this Covid-19 drug.
My dictionary defines “established” in the present context as: shown to be true or certain by determining the facts, and “proven” as: demonstrated by evidence to be true. In other words, these are synonyms; they mean the same thing.
The British Medical Journal (BMJ) is a weekly peer-reviewed medical trade journal published by the trade union of the British Medical Association. It is one of the world’s oldest general medical journals, having been founded in 1840, and has editorial freedom from the British Medical Association. In an editorial published on January 19, 2022 the BMJ called for the release of the raw data from the trials used to first authorize the Covid-19 vaccines for (emergency) use, and now mandate vaccine uptake.
Excerpt from the BMJ editorial:
“Today, despite the global rollout of COVID-19 vaccines and treatments, the anonymized participant-level data underlying the trials (used by governments to first authorize the use of the vaccines and now increasingly mandate their uptake) for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come,”
“This is morally indefensible for all trials, but especially for those involving major public health interventions.”
BMJ also accused pharmaceutical companies of “reaping vast profits without adequate independent scrutiny of their scientific claims,” pointing to Pfizer, whose COVID vaccine trial was “funded by the company and designed, run, analyzed, and authored by Pfizer employees.”
New York-headquartered Pfizer still holds that trial data and has indicated that it won’t begin considering requests for such data until May 2025 – 24 months after the primary study completion date of May 15, 2023, which is listed on ClinicalTrials.gov as well as Part Two of this report.
Meanwhile, The Food and Drug Administration (FDA) had asked a judge to give it 75 years to produce all the data concerning the Pfizer and BioNTech vaccine.
However, a judge earlier this month ordered that the FDA make public 12,000 pages of the data it used to make decisions regarding approvals for the Pfizer/BioNTech COVID-19 vaccine by the end of the month. The FDA must also release Pfizer’s vaccine data at a rate of 55,000 pages a month until all of the requested pages are public.
“We are left with publications but no access to the underlying data on reasonable request,” BMJ said.
“This is worrying for trial participants, researchers, clinicians, journal editors, policymakers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymized individual participant data from clinical trials must be made available for independent scrutiny.”
BMJ added that regulators are not there to “dance to the tune of rich global corporations and enrich them further” but to protect the general public’s health and for that reason, they said, we need “complete data transparency for all studies, we need it in the public interest, and we need it now.”
In December, the Centers for Disease Control and Prevention (CDC) was also sued by the Informed Consent Action Network (ICAN) over claims that it is improperly withholding COVID-19 vaccine safety data from the American public.
ICAN is asking the CDC to provide de-identified post-licensure safety data for the COVID-19 vaccines in the CDC’s v-safe system so as to assure transparency with the general public regarding claims by both the CDC and the Biden administration that COVID-19 vaccines are “safe and effective.”