Various provincial and territorial health authorities received direction from the Public Health Agency of Canada (PHAC) to withdraw all COVID-19 XBB vaccines at the end of August in a move that is being done under the guise that it will lead to the imminent authorization of the latest KP.2 booster formulations.
The original notice from Ontario’s chief medical officer of health Dr. Kieran Moore goes on to say that the decision is part of the “regulatory submission of the Kp.2 formulations to Health Canada for the upcoming fall 2024 respiratory illness campaign” but the instruction to destroy the shots raises concern about underlying rationale.
“As a requirement of the regulator, Health Canada, the Ontario Ministry of Health is required to quarantine remaining supply of viable XBB vaccine starting on September 1, 2024, and follow local practices and process for the destruction of these vaccines,” the notice to vaccinators reads.
In the past, neither Health Canada nor the PHAC took such measures; instead, they made extensive efforts to keep what they termed life-saving products on the market by extending expiry dates and reducing storage and transportation requirements, rather than removing the novel injections.
Former regulatory drug pricing specialist and ex-pharmacy manager Maria Gutschi told Rebel news that the decision is clouded in mystery.
First of all, PHAC doesn’t have the mandate to make this order. Only Health Canada has the authority to authorize, approve or otherwise remove, food and drug products from the market.
This change in the standard operating procedure (SOP) signals a significant shift in the decision-making process at Health Canada and deserves scrutiny, especially given the lack of transparency seen by both agencies as it pertains to DNA contamination issues and the presence of concerning plasmids like the SV-40 promoter.
Furthermore, the notice explains that “Health Canada will remove the strain identifier (XBB / KP.2, etc.) from the naming convention of the COVID-19 vaccine products to enable the assignment of one drug identification number (DIN) for each presentation on an ongoing basis.”
Gutschi says that is a “bizarre” move that implies a single identifier for various doses, with all the old DINs being withdrawn.
The XBB vaccines originally had several different DINs to cover various combinations, including single-dose vs. multi-dose and age-specific dosages: 3 micrograms of mRNA for children 6 months to under 5 years, 10 micrograms for children 5 to under 12 years, and 30 micrograms for those 12 years and older.
The concern now is whether this change will reduce or eliminate vaccine options. This significant shift, coupled with the lack of a public statement from Health Canada, raises questions about the transparency and motivations behind the directive.
So what’s the real story behind this directive, and why are provinces like British Columbia defying it while ensuring vaccines remain available?
Rebel News contacted Health Canada to understand whether the order to destroy the XBB.1.5 vaccines came from the Public Health Agency of Canada or Health Canada, why the directive hasn’t been publicly released, and how this new approach differs from previous vaccine updates. Rebel also queried BC’s health ministry about the directive’s details, its public availability, and their reasons for not following it.
Neither agency responded.
If Health Canada continues with authorization of the latest variant formulation, it will follow in the footsteps of the US FDA which authorized the novel variant formulation based on hope rather than solid evidence, as mRNA inventor Robert Malone explained last week.
At this time last year, Health Canada was authorizing the Moderna Spikevax COVID-19 injection for the omicron XBB.1.5 subvariant, despite the ongoing Phase 2/3 study on its safety and efficacy in adults not being due for completion until November 2023. To date, the study results have not been published. When Rebel News inquired about how safety for those under 18 was being assessed, Health Canada directed questions back to the manufacturer.
Dr. Tam endorses new mRNA boosters authorized today by Health Canada for those 6 months and up.
— Tamara Ugolini 🇨🇦 (@TamaraUgo) September 12, 2023
The new formulation is “expected to better protect" against subvariants, unlike the "safe and effective" originals. https://t.co/kYRgPpFNxo pic.twitter.com/cxeJRdmQS7
The Ottawa Citizen recently reported that this decision stems from a contractual agreement between Health Canada and vaccine manufacturers.
Was this directive handed down by Health Canada or dictated by Big Pharma? And is Health Canada truly putting public health ahead of industry interests? The glaring lack of transparency only fuels suspicion that safety issues and contaminants from previous vaccine versions will not be addressed in the new KP.2 formulations.