Public safety is at risk as Health Canada greenlights new COVID-19 booster with incomplete data

Tamara Ugolini
  |   September 13, 2023

Health Canada announced that they have authorized the new Moderna Spikevax COVID-19 injection targeting the omicron XBB1.5 subvariant for those aged 6 months and up after five masked and socially distanced health overlords took centre stage on September 12.

In its regulatory decision to authorize Spikevax XBB.1.5, the Government of Canada states the following:

"The dose and dosing regimen for Spikevax XBB.1.5 has been updated to reflect an internationally agreed upon simplified schedule. The recommended dosing regimen is proposed to be 2 doses for children aged 6 months to 4 years who were not previously immunized and one dose in children who have been immunized. Individuals over 5 years receive one dose regardless of immunization status at an interval of at least 6 months following last dose… The safety, reactogenicity, and immunogenicity of Spikevax XBB.1.5 are evaluated in an ongoing Phase 2/3 open-label study in participants 18 years of age and older.”

So how was this injection studied for safety and efficacy in those under 18?

Well, it wasn’t.

The government website continues to clarify:

“[T]he safety and effectiveness of Spikevax XBB.1.5 for individuals 6 months of age and older is inferred from studies of a primary series and booster dose of Spikevax Bivalent (Original/Omicron BA.1) in individuals 6 months to 5 years of age, a booster dose of Spikevax Bivalent (Original/Omicron BA.1) in individuals >18 years of age, as well as data from studies which evaluated the primary series and booster vaccination with Spikevax (original)… In study mRNA-1273-P205 Part J, 50 participants received a 50 mcg dose of Spikevax XBB.1.5, and 51 participants received a dose of an investigational bivalent vaccine (XBB.1.5/Omicron BA.4/5)."

This means that a total of 101 participants were injected — 50 with the Spikevax XBB.1.5 shot and 51 with another “investigational” shot.

According to the National Institute of Health’s clinical trial data website, this study is not estimated to be complete until November 17, 2023. That’s nearly 12 weeks from the time of authorization.

So how can Health Canada make the above safety claims and recommendations?

Surely something has to be missing.

Rebel News reached out to inquire about study mRNA-1273-P205 Part J with Health Canada, asking if it was a randomized, placebo-controlled safety study. And if not, how can Health Canada make safety or efficacy assertions to Canadians? Additionally, we inquired about the estimated completion date and when the agency expects to receive that data.

Displaying shocking ineptitude, Health Canada responded with the following:

“Hello,

Please review: Health Canada authorizes Moderna COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant.

This page Regulatory Decision Summary for Spikevax XBB.1.5 is the extent of what Health Canada can share on this review.

You can contact the manufacturer for any follow-up questions.

Enjoy the rest of your day!”

A follow-up e-mail was immediately sent thanking the agency for their time and confirming that the links provided were already reviewed to formulate the above-mentioned questions, which were reiterated.

An additional question was posed: If the federal health department responsible for this authorization is not able to answer the above questions, how does this affect the confidence of Canadians in your capabilities and competency?

Crickets ensued from Health Canada.

This is the same agency that claims to have reviewed safety data months before it was released. The media line told Rebel News that they were sending a request for clarification all the way up to Minister Duclos office, but he never responded.

And a follow-up question just a few weeks ago fell on deaf ears too.

A year ago, Rebel News reported that scientific inconsistencies abound within the agency and its affiliates at the Public Health Agency of Canada and National Advisory Committee on Immunization (NACI), when they told Canadians that COVID vaccines could be administered “concurrently” which directly contradicted the manufacturers own product monographs.

Yet just yesterday, Canada’s chief public health officer Dr. Theresa Tam endorsed the new mRNA booster for those aged six months and up during the announcement.

When pressed as to why the panel did not mention the word ‘booster,’ Chief Medical Advisor at Health Canada Supriya Sharma confirms that is because of a global effort to standardize and simplify the terms around the now seasonal shots.

Sharma also warned Canadians to be mindful of their sources of information, which she says can be false and exaggerated.

And it appears the sources that she refers to are her own agencies.

Tamara Ugolini

Senior Editor

Tamara Ugolini is an informed choice advocate turned journalist whose journey into motherhood sparked her passion for parental rights and the importance of true informed consent. She critically examines the shortcomings of "Big Policy" and its impact on individuals, while challenging mainstream narratives to empower others in their decision-making.

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