Health Canada misjudged media criticism as they discussed authorization of Pfizer’s COVID vaccine for kids

Canada’s drug regulator expected media scrutiny when expediting Pfizer’s COVID-19 mRNA shots for children aged 12 – 15, citing the robustness (or lack thereof) of the clinical data used to support the safety and efficacy of the novel injection.

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Health Canada was preparing to field media scrutiny when it authorized Pfizer’s novel COVID-19 mRNA injection in youth in the spring of 2021.

In a highly anticipated Health Canada release package obtained after a three-year-long investigation into the risk versus benefit calculation justifying the authorization of Pfizer’s novel COVID-19 mRNA injection in adolescents – the agency noted that Canada was the first country to roll these shots out for kids, and wanted to prepare for media to scrutinize the clinical trial data (or lack thereof).

A “Biologics and Genetic Therapies Directorate” details the preparations sought by the agency to field media criticism that never came.

The person responsible for authorizing these injections, Celia Lourenco (director general at Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate) included the directorate in an email to Leo Bouthillier (manager at the office of clinical trial data at Health Canada) on May 5, 2021.

“Is there reason to anticipate media interest or a negative impact for the department, when the clinical data package is released on the Public Release of Clinical Information (PRCI) Portal?” a generic question box asks.

“YES,” it is checked, followed by “See Release of Information on the PRCI Portal section below for considerations leading to this opinion.”

The release of information section says:

“There will likely be media interest. There may be questions regarding the strength of the clinical information provided to support the safety and effectiveness of the vaccine in the adolescent population as Canada was the first country to approve it. There may also be questions whether the sponsor appropriately addressed the requirements for an Issuance under section 5 of the Interim Order.”

Section 5 of the now archived interim order, which became a permanent piece of the authorization process through “regulatory amendments” on February 22, 2023, says the following, under Issuance:

The Minister must issue the authorization for importation or sale if the following requirements are met:
a) the applicant has submitted an application to the Minister that meets the requirements set out in subsection 4‍(1)….. and, if applicable, subsection 4‍(2)….;
b) the applicant has submitted to the Minister all additional information or material, including samples, requested under section 9;
c) the Minister has sufficient evidence to support the conclusion that the benefits associated with the COVID-19 medical device outweigh the risks, having regard to the uncertainties relating to the benefits and risks and the urgent public health need; and
d) the Minister determines that the health or safety of patients, users or other persons will not be unduly affected.

Rebel News has been on a quest to determine point C – how the supposed benefits outweigh the unknown risks – since May of 2021.

Health Canada’s anticipation of media criticism starkly contrasted with what unfolded in real time.

The government-funded mainstream media wasn’t interested in anything other than cheerleading the novel injection into the arms of Canadian children and youth, with headlines at the time like, “Making history, 1st NWT teen gets COVID-19 vaccine” and the disturbing promotion of minors getting the injection without parental consent.

Even more concerning headlines would follow a month later, such as “SickKids reports handful of ‘rare' heart inflammation cases following COVID-19 vaccine.”

According to the directorate mentioned above, the efficacy of Pfizer’s injection was solidified when “there were 0 confirmed COVID-19 cases identified in the vaccine group and 16 in the placebo group, evaluated 7 days after Dose 2. The efficacy of the vaccine was therefore 100%.”

That’s right, the injection is 100% effective based on a laughable seven-day follow-up!

Rebel News continues to dissect the contents of these exclusive documents.

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