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.
Very well written (both yours and Sabrina's). I also did a risk benefit analysis which is why I got the vaccine. I am healthy but in the higher age bracket. I will not judge young people who are at a very low risk for covid 19 for not getting the vaccine. I completely understand their concerns about reactions like myocarditis(1 in 42,000 for young men). This vaccine mandate is just wrong on so many levels. I'm disheartened at where our country has gone with these mandates. Even more disheartened by the apathy of everyday Canadians in this level of coercion and fear-mongering.
I'm hesitant to reply to a comment that brings up thalidomide, but you do have a point.
Meeting Ontario's latest vax target (90% of eligible people) will require substantial uptake among 12-20 year-olds, despite Covid's extremely low risk to this age group. Looking further out, there's growing agreement on the need to vaccinate *children under 12* too, although their Covid risk is even lower — bordering on negligible.
While the vaccines are generally quite safe, risk varies based on individual circumstances. For some, there is a threshold where the vaccines' small risk outweighs an even smaller benefit. Who's in the best position to judge this? Parents & children themselves.
But by de facto mandating Covid vaccines for any kind of participation in society, governments are putting a thumb on the scale. They are treating young people as mere means in the service of larger ends, like reduced community spread.
Depending on your ethical views, this may be justifiable. Perhaps it is OK to expose certain people to a small risk of serious injury, against their wishes, for some greater good. But at least be clear about what we're doing here. This is not "protecting" young people in any sense of the word. If anything, it is yet another way of subjugating the young to the needs of the old.
I think I agree with most of what you've said in terms of what "we" are really trying to do versus the political narrative.
What you are describing is a form of the Trolley Problem in moral philosophy. Five workers are on a track and a runaway trolley is about to kill them. You can shift the Trolley to a different track by pushing a buttom but it will kill one person there. Would you do it. I believe something like 70% say they would.
In a second version, you have to push a largr person on the track to save the 5 others, and only about 30% say they would do that. (My numbers may be way off, but the majority shift is there.)
The underlying issues are trading off pure numbers (utilitarian morality) for responsibility. Five killed by a runaway trolley is tragic, but you didn't cause them. Killing one person by your intentional makes you responsible.
In this case, it is more complicated. We're trying to minimize COVID deaths, but they are mostly elderly, and to save them the other track is filled with young people, and the trolley may miss them.
We don't know the long-term risks of the vaccines, but we do know young people are both least at risk from COVID and most at risk from unknown long-term risks. That has significant moral consequences.
But, it requires recognizong that we don't know the long-term risks. That's where I am curious about your statements that the vaccines are "quite safe" and "small risk". Neither the approvals nor the manufacturer monographs make that claim. The approvals are based on short-term side effect safety and the emergency situation.
In fact they say quote the opposite. The interim approvals explicitly say “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.”
The manufacturer monographs Section 7.1 say "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.”
That is the latest, up-to-date information as required to be maintained by the Risk Management Plans.
What are you basing your statements on?
I suspect this is why you are hesitant about the mention of Thalidomide, suggesting that we know that these vaccines can't possibly be that tragic of outcomes. Based on what? The best risk data of the formal process says we don't know those risks at all. And, in 1961 the best rat test data on Thalidomide said it wasn't a risk either. Frances Kelsey blocked it 6 times, requiring long-term (Phase 3) data leading to the very standards that we now use and data we lack on these vaccines.
Putting these together, it looks to me like we have what is called in game theory a partial Prisoners Dilemma with unequal payoffs. For the elderly, it is both personal best interest to get the Vax and for others to as well. For the young, and female, and post-COVID immune, it is better if everybody *else* gets it, but not personally.
So a better coercion plan is to force everybody over, say, 50, to get it, then work down in age to 40ish, then just younger men and women who can't have (more) children, then teens last.
Each step monitor the outbreak rates. This process spread out over a couple of years gives time to gather more data and puts the most at risk from vaccine unknowns last while protecting them from COVID too by maximizing the vaccines of everybody else first. That ignores the rights issues, but does it more reasonably.
Sorry, I meant confusing "absence of evidence" with "evidence of absence" related to harms. I hope that was clearer. That confusion is what brought down Space Shuttle Challenger and caused the Thalidomide tragedy. It contributed to Space Shuttle Columbia disaster, but that was compounded by the mistake of confusing the overall a priori "accepted risk" of foam impacts with case-specific "not-a-safety-of-flight risk", which occurs here between the overall vaccine risk-benefit approval versus individual case-by-case which are very different calculations.
Bravo! I'm not sure if my cranky comments were part of the constructive feedback mentioned, but my objections are fully addressed by this.
A financial services analyst also has to work in a field too complicated to accurately model; it's a "dismal science" allied to economics. A better choice than a physicist to cover this material!
But, honestly, The Line would still benefit from a regular contributor with a BSc instead of BA (much less journalism 'schools' so sharply nailed by Tom Patterson in his "Informing the News".)
Failing that, I hope Sabrina gets involved and is handed anything touching on sci/tech to review and edit in future.
Very good article. I am watching the numbers in Ontario daily. With three straight days now with cases in the 500s, I wonder if this is just a lull before another spike in cases after the labor day long weekend, or if this was the 4th wave. Ultimately, I agree with the notion put forth that we need to be provided with more context to just the graph showing such a wide range of outcomes, but with no context.
The role of the science table is to provide modeling data to the health table group of experts. The audience is not supposed to be the general public, which probably explains some of the confusion.
Loved the piece. When we are in the throws of fear our limbic system is in charge, running on feelings. Rational thought is blocked so no matter how beautiful we think the math, until we assuage the flight or fight mechanism, we just ain't listening. Your point is well taken on the communications failure, perhaps we need to add experts in the science of communication into the mix of those well versed in the science of math.
As a side note not entirely unrelated, I would love to see the Line Editors tackle media culpability real, perceived or overstated in the next prep for the dispatch video. You start this article with hey we received respectful criticism and here is the answer to that.
On the heels of "the did the gravel hit you" question and to a lesser degree the REBEL smackdown clip, to what degree is criticism of the media reasonable and is there a real case for media bias in covering the election. The obvious partisan condemnations aside, it feels like their is a patronizing pat on the head for those who do criticize. Maybe it is too broad in scope but to what extent does media bias exist, is there too much focus on pursuing agendas, when is criticism valid and when is it not. And when should journos respond and is there really a Santa Claus.
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.
Very well written (both yours and Sabrina's). I also did a risk benefit analysis which is why I got the vaccine. I am healthy but in the higher age bracket. I will not judge young people who are at a very low risk for covid 19 for not getting the vaccine. I completely understand their concerns about reactions like myocarditis(1 in 42,000 for young men). This vaccine mandate is just wrong on so many levels. I'm disheartened at where our country has gone with these mandates. Even more disheartened by the apathy of everyday Canadians in this level of coercion and fear-mongering.
I'm hesitant to reply to a comment that brings up thalidomide, but you do have a point.
Meeting Ontario's latest vax target (90% of eligible people) will require substantial uptake among 12-20 year-olds, despite Covid's extremely low risk to this age group. Looking further out, there's growing agreement on the need to vaccinate *children under 12* too, although their Covid risk is even lower — bordering on negligible.
While the vaccines are generally quite safe, risk varies based on individual circumstances. For some, there is a threshold where the vaccines' small risk outweighs an even smaller benefit. Who's in the best position to judge this? Parents & children themselves.
But by de facto mandating Covid vaccines for any kind of participation in society, governments are putting a thumb on the scale. They are treating young people as mere means in the service of larger ends, like reduced community spread.
Depending on your ethical views, this may be justifiable. Perhaps it is OK to expose certain people to a small risk of serious injury, against their wishes, for some greater good. But at least be clear about what we're doing here. This is not "protecting" young people in any sense of the word. If anything, it is yet another way of subjugating the young to the needs of the old.
I think I agree with most of what you've said in terms of what "we" are really trying to do versus the political narrative.
What you are describing is a form of the Trolley Problem in moral philosophy. Five workers are on a track and a runaway trolley is about to kill them. You can shift the Trolley to a different track by pushing a buttom but it will kill one person there. Would you do it. I believe something like 70% say they would.
In a second version, you have to push a largr person on the track to save the 5 others, and only about 30% say they would do that. (My numbers may be way off, but the majority shift is there.)
The underlying issues are trading off pure numbers (utilitarian morality) for responsibility. Five killed by a runaway trolley is tragic, but you didn't cause them. Killing one person by your intentional makes you responsible.
In this case, it is more complicated. We're trying to minimize COVID deaths, but they are mostly elderly, and to save them the other track is filled with young people, and the trolley may miss them.
We don't know the long-term risks of the vaccines, but we do know young people are both least at risk from COVID and most at risk from unknown long-term risks. That has significant moral consequences.
But, it requires recognizong that we don't know the long-term risks. That's where I am curious about your statements that the vaccines are "quite safe" and "small risk". Neither the approvals nor the manufacturer monographs make that claim. The approvals are based on short-term side effect safety and the emergency situation.
In fact they say quote the opposite. The interim approvals explicitly say “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.”
The manufacturer monographs Section 7.1 say "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.”
That is the latest, up-to-date information as required to be maintained by the Risk Management Plans.
What are you basing your statements on?
I suspect this is why you are hesitant about the mention of Thalidomide, suggesting that we know that these vaccines can't possibly be that tragic of outcomes. Based on what? The best risk data of the formal process says we don't know those risks at all. And, in 1961 the best rat test data on Thalidomide said it wasn't a risk either. Frances Kelsey blocked it 6 times, requiring long-term (Phase 3) data leading to the very standards that we now use and data we lack on these vaccines.
Putting these together, it looks to me like we have what is called in game theory a partial Prisoners Dilemma with unequal payoffs. For the elderly, it is both personal best interest to get the Vax and for others to as well. For the young, and female, and post-COVID immune, it is better if everybody *else* gets it, but not personally.
So a better coercion plan is to force everybody over, say, 50, to get it, then work down in age to 40ish, then just younger men and women who can't have (more) children, then teens last.
Each step monitor the outbreak rates. This process spread out over a couple of years gives time to gather more data and puts the most at risk from vaccine unknowns last while protecting them from COVID too by maximizing the vaccines of everybody else first. That ignores the rights issues, but does it more reasonably.
Sorry, I meant confusing "absence of evidence" with "evidence of absence" related to harms. I hope that was clearer. That confusion is what brought down Space Shuttle Challenger and caused the Thalidomide tragedy. It contributed to Space Shuttle Columbia disaster, but that was compounded by the mistake of confusing the overall a priori "accepted risk" of foam impacts with case-specific "not-a-safety-of-flight risk", which occurs here between the overall vaccine risk-benefit approval versus individual case-by-case which are very different calculations.
So beautifully presented, thank you for this.
Bravo! I'm not sure if my cranky comments were part of the constructive feedback mentioned, but my objections are fully addressed by this.
A financial services analyst also has to work in a field too complicated to accurately model; it's a "dismal science" allied to economics. A better choice than a physicist to cover this material!
But, honestly, The Line would still benefit from a regular contributor with a BSc instead of BA (much less journalism 'schools' so sharply nailed by Tom Patterson in his "Informing the News".)
Failing that, I hope Sabrina gets involved and is handed anything touching on sci/tech to review and edit in future.
Very good article. I am watching the numbers in Ontario daily. With three straight days now with cases in the 500s, I wonder if this is just a lull before another spike in cases after the labor day long weekend, or if this was the 4th wave. Ultimately, I agree with the notion put forth that we need to be provided with more context to just the graph showing such a wide range of outcomes, but with no context.
Lovely writing - many thanks to The Line for publishing Sabrina's article. The narrative is the persuader, not the data itself.
The role of the science table is to provide modeling data to the health table group of experts. The audience is not supposed to be the general public, which probably explains some of the confusion.
Loved the piece. When we are in the throws of fear our limbic system is in charge, running on feelings. Rational thought is blocked so no matter how beautiful we think the math, until we assuage the flight or fight mechanism, we just ain't listening. Your point is well taken on the communications failure, perhaps we need to add experts in the science of communication into the mix of those well versed in the science of math.
As a side note not entirely unrelated, I would love to see the Line Editors tackle media culpability real, perceived or overstated in the next prep for the dispatch video. You start this article with hey we received respectful criticism and here is the answer to that.
On the heels of "the did the gravel hit you" question and to a lesser degree the REBEL smackdown clip, to what degree is criticism of the media reasonable and is there a real case for media bias in covering the election. The obvious partisan condemnations aside, it feels like their is a patronizing pat on the head for those who do criticize. Maybe it is too broad in scope but to what extent does media bias exist, is there too much focus on pursuing agendas, when is criticism valid and when is it not. And when should journos respond and is there really a Santa Claus.
Well done!