Discussion about this post

User's avatar
Ad Nausica's avatar

Yes. I agree wholeheartedly with this. I too have had a career in risk management and risk management processes, including safety-of-life risks, mission risks, project risks, business risks, financial risks.

One thing I would start with is the Government of Canada's own vaccine risk management plan, which is actually quite reasonable, if followed. The first thing about it to note is that the vaccines have not been approved due to proof of long-term safety, but rather an overall "accepted risk" based on the demonstrated efficacy of the vaccines. The GoC explanation is, "predicated on the Minister's determination that the evidence provided supports the conclusion that the benefits outweigh the risks associated with the drug, taking into account the uncertainties related to the benefits and risks, as well as the urgent public health need caused by COVID-19.”

That is, they are tentatively approved in an overall risk-benefit analysis so that people in general can use them, but the risks are not zero and this is not the same thing as a case-by-case analysis of whether any specific individual should use them.

For that, the GoC also has a risk mitigation plan. Each approved vaccine has a Health Canada analysis with stated risks and risk mitigation. They state, “One limitation of the data at this time is the lack of information on the long-term safety and efficacy of the vaccine. The identified limitations are managed through labelling and the Risk Management Plan. The Phase 3 Study is ongoing and will continue to collect information on the long-term safety and efficacy of the vaccine.”

"Labelling" means providing the risk information to medical professionals and patients for their informed consent. This approach mitigates risk by acknowledging the risks exist and allowing each person to decide for themselves, along with their doctor, on whether to take the vaccine based on their individual risk-benefit calculation. The Risk Management Plan describes monitoring public outcomes, after the fact, and keeping the vaccine monographs updated with known and unknown risks.

For example, the vaccine monographs, Section 7.1, state the following: "The safety and efficacy of [the vaccine] in pregnant women have not yet been established; It is unknown whether [the vaccine] is excreted in human milk. A risk to the newborns/infants cannot be excluded.”

They also list known risks in Section 7 and recommendations for who should probably not take the vaccines as decided between the patient and the doctor doing their own risk-benefit analysis.

The science is also clear that people with prior COVID-19 infection appear to as good or better immunity, meaning that vaccines still have the risks of unknowns but lack much benefit value for such people, and the known risks vary with age, probably the square of age given that the risks of COVID-19 are very low in the young and high in the old, and long-term unknown risk of vaccine are small for the old (who have less time left) than the young. This includes potential risks to reproductive processes such as described above, so there are also gender-specific risks.

This is why I am concerned about the emergence of vaccine mandates, coercion, and fear-mongering that undermines the well designed GoC risk mitigation plan, including coming from our own Prime Ministers and provincial leaders. What is their replacement for this risk mitigation plan if they are coercing people to get vaccinated and even chose between their jobs and health?

They seem to be making classic risk management mistakes of confusing the overall risk-benefit approval so that people can take the vaccines with individual risk-benefit calculations on whether an individual should, and confusing the absence of evidence of harm with evidence of evidence of harm. These mistakes destroyed two space shuttles, contributed to Chernobyl, and caused the Thalidomide tragedy.

This is why I sub-titled my own writing on this issue as "A lesson in how to learn nothing about risk management, ever.": https://adnausica.substack.com/p/a-canadian-behavioral-study-of-obedience

References to the GoC risk mitigation process mentioned above are available there as well.

Expand full comment
Kathy Sykes's avatar

So beautifully presented, thank you for this.

Expand full comment
10 more comments...

No posts