Last week, Rebel News reported a concerning lack of data available to justify the recent endorsement of Moderna’s latest novel mRNA booster SPIKEVAX XBB.1.5 by Health Canada and its pharmaceutical aficionados. In what appears to be an attempt to save face, the agency has once again responded to a media request seeking clarification.
Mark Johnson, manager and media relations at Health Canada and the Public Health Agency of Canada, who participates in media briefings with Canada’s chief public health officer Dr. Theresa Tam, replied with the following:
As indicated in the Regulatory Decision Summary for Spikevax XBB.1.5, 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). Therefore, a total of 101 participants were included in study mRNA-1273-P205 Part J.
The two groups were randomized and additional information regarding the study design for this clinical trial can be found here.
The 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). These include tens of thousands of participants who were administered the original COVID-19 vaccine and many hundreds of participants who received variant-adapted COVID-19 vaccines. The benefit-risk profile of previously authorized mRNA COVID-19 vaccines is well established as these vaccines have been administered to hundreds of millions of people. Consistent with the totality of the evidence and input from Health Canada’s scientists, the Spikevax XBB.1.5 COVID-19 vaccine has been updated to include a monovalent component that corresponds to the Omicron variant XBB.1.5. The percentage change in the spike protein between the Spikevax original and the Spikevax XBB.1.5 COVID-19 vaccines is approximately 3%. The benefit of having an mRNA vaccine is that it is easily adaptable to new variants, as it only requires a change in the variants, while keeping everything else (all other components including the formulation) in the vaccine consistent.
The estimated study completion date is November 2023 with a final report to be submitted by the sponsor thereafter.
The Terms and Conditions issued with the authorization of Spikevax XBB.1.5, includes provision of interim analyses and the final Clinical Study Report for Study mRNA-1273-P205 Part J as soon as the data become available.
As background, please also note that Health Canada has a rigorous scientific review system in place to ensure vaccines are safe and effective throughout their lifecycle, from clinical trials to post-market surveillance. While Health Canada is expediting the approval process for COVID-19 drugs and vaccines, the Department only authorizes a vaccine once the data has demonstrated that the vaccine’s benefits outweigh its risks for Canadians.
But the risks for Canadians are real and they include death.
According to Health Canada itself, as of May 26, 2023 there have been a total of 442 reports of death following COVID-19 vaccination. Health Canada previously stonewalled efforts to streamline vaccine adverse event reporting after massive confusion, wherein deputy minister of Health Canada Celia Lourenco admitted that vaccine adverse events underreporting is a well-known fact.
Of those 442 reports of death following COVID-19 vaccination, it “was not possible to assess causality for 115 reports due to missing information.”
Furthermore, 165 reports of death were unclassifiable due to lack of available information, 106 were unlikely to be linked to the vaccine, 52 were indeterminate, and only four were consistent with a causal association to the vaccine.
That’s 75% of deaths with missing information.
It seems that there is a lot of missing information at Health Canada, which is oddly the exact same style of messaging that the Privy Council Office was tasked with studying to ensure nothing compromised the safe and effective pharma-centric narrative.
How can the data demonstrate that the vaccine’s benefits outweigh its risks for Canadians when there are no placebo controls?
The study in question had 101 participants, with no placebo arm, in a trial that is not set to conclude for more than two months. And was never tested on anyone under the age of 18.
According to the own study inclusion criteria, female participants of childbearing potential had to have a negative pregnancy test, adequate contraception or abstain from all activities that could result in pregnancy for at least 28 days prior to day one of the study, including an agreement to continue adequate contraception or abstinence through three months following the vaccination, and not currently be breastfeeding.
As posted by the Canadian COVID Care Alliance, the European Society of Cardiology published a peer-reviewed study earlier this year that showed myocardial damage in 1 in 35 recipients of a Moderna booster.
Similarly, various health agencies gave preferential treatment to Pfizer over Moderna two years ago after an increase of myocarditis and pericarditis following the novel mRNA injection, especially in young males.
As is the case with the other product monographs, the SPIKEVAX XBB.1.5 package insert states that this injection was never studied for its carcinogenicity, genotoxicity, or reproductive or developmental toxicology. Additionally, no drug interaction studies have been performed. To further drive that point home, it says that there is limited information on the use of SPIKEVAX with other vaccines.
Yet Health Canada asserts that “people 6 months of age and older can get their COVID-19 vaccine at the same time as, or at any time before or after, other recommended vaccines. This includes the flu shot.”
How can Health Canada justify continuing to make these claims without the data, science and/or evidence to substantiate their advice?