Canada’s Health Minister ignores science, pushes unproven vaccine guidance instead

Holland's post links to the National Advisory Committee on Immunization (NACI), which has recently updated its vaccine recommendations. Among these, the committee continues to endorse the simultaneous administration of COVID-19 and flu vaccines for those aged six months and older. NACI’s guidance states that this concurrent dosing is meant to “reduce barriers to the provision of routine childhood immunizations and seasonal influenza immunization,” and calls the data backing up the recommendation “reassuring.”

NACI's vague assurances that the simultaneous injections are “reassuring” and “safe” aren’t grounded in evidence-based science. While the advisory body claims no “established safety issues” with concurrent vaccine administration, they also acknowledge that some studies show an increase in reactogenicity (side effects) when the vaccines are given together, which is okay because it’s “comparable to COVID-19 vaccination alone.”

These are the same vaccinations that Minister Holland called “remarkably safe” and “miracles of science” last year.

Canada’s Health Minister Mark Holland deems the mRNA vaccine's new formulation "remarkably safe," urging everyone to get their shots, even as Phase 2/3 clinical trials to assess safety, reactogenicity, and immunogenicity remain ongoing.https://t.co/Pi3CfkFYMg pic.twitter.com/A0hUNwbbln

At least NACI’s guidance document refers to informed consent.

“Informed consent should include a discussion of the benefits and risks given the limited data available on administration of COVID-19 vaccines at the same time as, or shortly before or after, other vaccines,” it reads. Arguably, this discussion is best centered around the package insert, or the product monograph, which is a factual, scientific document on a drug product.

For example, Moderna’s SPIKEVAX product monograph for the new Omicron KP.2 variant explicitly states that the safety and efficacy of the vaccine in pregnant and breastfeeding women have not been established. It also makes clear that “no interaction studies have been performed,” leaving an alarming gap in the data about how this vaccine interacts with others. Yet, Health Canada and NACI continue to recommend concurrent vaccination without acknowledging these significant unknowns.

Disturbingly the product monograph makes it sound as though no safety or efficacy studies have been conducted for Moderna's new SPIKEVAX injection. Rather, its safety and effectiveness are "inferred" from previous studies of its previous formulations, which were only recently posted and have questionable results. Notably, the Phase Three trial data for the original formulation showed concerning adverse event rates, including 39.5% of participants experiencing moderately debilitating reactions (Grade 2), 19.7% experiencing severely debilitating reactions (Grade 3), and 14 participants experiencing life-threatening reactions (Grade 4) — nearly five-fold higher than the placebo group. Given these troubling results, relying on inferred safety for new formulations seems unsubstantiated and reckless.

Similarly, Pfizer’s product monograph for their Omicron formulation, COMIRNATY, states that there is “no data” available regarding its use in pregnant or breastfeeding women, or whether it is excreted in human milk. Much like Moderna’s monograph, Pfizer relies on “inferred” data from earlier studies to justify the new vaccine’s safety and efficacy. While Pfizer has attempted to study concurrent administration of their COVID-19 vaccine with the seasonal flu shot, they inferred effectiveness from a non-inferiority trial involving just over 1,100 healthy participants aged 18 to 64, who were only followed for seven days to a month, making the results far from long-term.

With such gaps in the evidence, it’s troubling to see these formulations promoted as safe for widespread use without clear, thorough testing.

The lack of concrete scientific evidence supporting concurrent vaccine administration is troubling, especially when it involves the health of vulnerable populations, including pregnant women, children, and the elderly. Health Minister Mark Holland and Canadian health authorities appear to be prioritizing expedience over thorough, evidence-based decision-making. Instead of waiting for robust data, they are relying on speculative conclusions drawn from limited studies, potentially putting millions at risk.

Informed consent should be at the core of all medical decisions, yet Canadians are being urged to accept vague assurances without the full picture, for political convenience rather than best practices.

When health and wellbeing are involved, it’s crucial to ensure public health policies are grounded in solid science — not vague inferences and half-baked assumptions. It is time for a more cautious, rigorous approach to vaccine guidance that truly prioritizes the health and safety of Canadians.

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