Opinion

Vaccine risk vs. vaccine mandates

COVID-19 mRNA vaccination involves a degree of risk, including a risk of myocarditis. But should this preclude governments or institutions from making COVID-19 vaccination mandatory? We argue the mere existence of risk should not, and in reality, cannot, preclude government or institutional action, including mandates.

The view that risk should never be imposed on others ignores that inaction also imposes risk, assumes that a moral difference exists between doing and allowing harm, and would in effect preclude governments or institutions from doing virtually anything.

Estimates of myocarditis following COVID-19 mRNA vaccination vary across studies. A recent systematic review and meta-analysis found the overall incidence of myopericarditis to be 33.3 cases per million doses. The highest published rate we are aware of is 299.5 cases of myocarditis or pericarditis per million doses, observed among males aged 18-24 following mRNA-1273 as a second dose. Characterization of the health impacts from vaccine-associated myocarditis also varies. A recent study found that after at least 90 days since onset of myocarditis following COVID-19 mRNA vaccination, most individuals (81 per cent) in a cohort of patients aged 12-29 were considered recovered by health-care providers and that quality of life measures were comparable to those in pre-pandemic and early pandemic populations of a similar age.

So, how should we think about the ethics of a policy that imposes this sort of risk? Most will appreciate that information about risk represents just one side of the equation, in which benefit occupies the other. One way to evaluate such a policy would therefore be to conduct a risk-benefit analysis. Some may be inclined to think that so long as the risk-benefit ratio is favourable, the policy could be ethically justified unless additional ethical reasons exist to render it unjustified. Yet, others will think that while interventions carrying risk can be offered or recommended by governments or institutions, they should not be imposed. In other words, individuals should always have a choice whether to accept risks to their health.

Such a belief does not stand up to scrutiny for two reasons.

First, it is erroneous to believe governments and institutions impose risk through actions like vaccination policies but do not impose risk through inaction, such as by choosing not to introduce vaccination policies. Failures of governments or institutions to act can create or increase risks that may not be possible to avoid or mitigate on one’s own. Stated simply, failures to act can also impose risk.

Failures to act can also impose risk.

One may concede it is possible to impose risk through inaction but argue that harms resulting from inaction are more acceptable than those resulting from action. However, such a belief reflects an omission bias, whereby omissions are favoured over commissions, especially when either might cause harm. This view ignores ethical and legal obligations that governments and institutions have to reduce risk associated with infectious diseases; it assumes a moral difference exists between doing and allowing harm – an assumption that should not be taken for granted. It also problematically assumes the moral responsibility of governments or institutions is attenuated for omissive acts. If the risk associated with COVID-19 vaccination causes us to ask whether governments or institutions should be precluded from imposing that risk via vaccination mandates, we should just as well ask the opposite – whether the risk associated with doing nothing should preclude governments or institutions from imposing that risk by doing nothing.

Second, even if it were granted that a morally relevant distinction exists between actions that impose risk and inactions that impose risk, the view that risk should never actively be imposed would render most government or institutional activities out of the question. For example, seatbelt laws save lives at the expense of certain injuries specific to seatbelt use, including neck and chest injuries in less than five per cent of patients. Fluoridation of the public water supply, as another example, is considered one of the greatest achievements in public health but carries a risk of dental fluorosis – a condition found to be prevalent among 23 per cent of Americans aged 6-49 in 1999-2004. Banning toxic substances like asbestos or polyvinyl chloride for the sake of human health can have profound impacts on businesses and entire industries. And so forth. The existence of a risk associated with an intervention should not on its own preclude governments or institutions from imposing that intervention lest we think governments or institutions can never require anything.

One might concede that governments or institutions can impose interventions that carry a risk but argue they should never impose medical interventions that do so. This distinction rests on an objection not to risk per se but to the imposition of a type of intervention, such as an objection to interferences with bodily autonomy. Hence, the mere existence of a risk – vaccine-associated myocarditis – would not constitute a sufficient reason to rule out mandatory vaccination in the same way it is not sufficient to rule out the imposition of other government or institutional interventions. A separate reason, such as an objection to imposing medical interventions in particular, would be required.

Hence, the fact that COVID-19 mRNA vaccination involves a rare risk of myocarditis should not on its own preclude governments or institutions from making COVID-19 vaccination mandatory. This does not mean vaccination mandates are ethically justified or should be used, but simply that the existence of risk should not rule them out. The ethical evaluation of risk imposition necessitates a more complicated analysis that engages considerations including the nature of the risk, the nature of the benefits, who bears the risk and who benefits, and the strength of the justification grounded in promotion of the common good.

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8 Comments
  • Chris Packe says:

    This article is full of strawman components that render mandatory COVID vaccination arguments moot. The COVID example is not actually a vaccine conferring sterilizing immunity and capable of stopping spread, ending a pandemic or eradicating a disease. And myopericarditis is not the only adverse event that can occur (GBS, VITT, etc.). And sub-clinical myocarditis occurs at rates greater than clinical.

    The mandatory examples used are not comparable to vaccination. Seat belts are not mandatory if one wishes to pay fines, one can avoid fluoridated tap water by using bottled water or a fluoride filter. And no distinction is made between age groups. Car crashes kill equally, whereas COVID risks are significantly lower in the young (under age 50) while cardiac vaccine events significantly higher (especially under 30).

    For smallpox or polio one can postulate the ethics of mandatory vaccination. For a less perilous respiratory coronavirus constantly varying, outpacing immunity and vaccines that have the highest adverse events in history – one just might be inclined to conclude mandates are unethical.

  • COLIN FLETCHER says:

    Trudeau, please STOP with the mandates…stop controlling people. Let people make their own choices, and live.

  • rickk says:

    What happened to the epidemiology of those at risk of suffering a bad outcome from covid? That all went away – ie. male 50-59y, healthy, normal weight, normal BP, no underlying medical issues has a 99.5% chance of recovering from covid if he gets covid – so the ‘vaccine’ is perhaps providing 0.5?% benefit of not dying or having a hospital admitting course? Please…we knew by summer of 2020 those at high risk and those not – yet everyone was expected to take a jab for a very, very slight increase in ‘protection’? BTW why did the CDC have to change the definition of vaccine in 2021 – the definition that stood for some 100+ years prior? I know so many rhetorical questions, so few answers

  • Adelaide, Science Teacher says:

    Teresa and Vanessa, you both hit it on the nail, and very eloquently express the underlying reasons for NOT imposing a vaccine mandate. Anecdotally we all know the truth from what we have seen: Covid-19 vaccines were ineffective, and the science was very poorly done. Infused with bias and conflict of interest, the public have been exposed to a massive smokescreen… and have bought it. Astonishing. This entire pandemic has vilified the intelligent, the educated – and not given them a voice. Lastly, MY BODY IS MY BODY. I know best what it requires, and I have better ways of preventing illness, which have worked far better so far than any jab in the arm. I wanted to travel this year, and was forced to finally get a jab. I felt violated, and instantly had an ALLERGIC reaction to the PEG nanoparticles (not the antigen, as they would have people believe). Do you think I really want to go back again and risk a full anaphylactic reaction and possibly death?? I think not! Yet, my adverse reaction was reported to the CDC, and still does not allow me exemption. What kind of sick society have we become? LET’S GET THE SCIENCE RIGHT FOR A CHANGE!!

  • Teresa Longobardi, PhD says:

    If the government and regulatory agencies of pharmaceuticals and medical associations did not have a conflict of interest and did not have legal immunity I would engage in the debate. But as it stands, void of using independent sources of data, computed longterm risks of the COVID-19 jab and the longterm adverse events are incomplete. In the presence of uncertainty, I side with the precautionary principle and oppose mandates outright. Resources employed to provide valuable information would be better used than to expense resources in policing mandates. Human Rights Commissions or ethics commissions are not prepared to adjudicate based on scientific data because they do not employ independent expertise.

  • Vanessa Acheson says:

    I thank the author for his efforts, but am puzzled on several levels at the rationale that “ risks” to public protection trumps risks to individuals.
    Not only does this defy the fundamentals of informed consent, but the authors endorsement of mandates overlook key limitations ( and risks ) of covid vaccines that sets a slippery slope towards an authoritarian state.

    The authors believe that public risks overrule vaccine risks, rights, and bodily autonomy of those who decline a covid vaccine. However, their argument was isolated to the concerning risk of myocarditis …. what about the significant limitations of covid vaccines themselves ? In other words, what’s the threshold to remove rights ?

    Consider, the CDC changed the very definition of a Vaccine because of the inability of covid vaccines to provide immunity ; covid vaccines do not prevent transmission; they offer unpredictable protection in light of the shifting nature of this virus and provide a fleeting duration of protection (as little as two months) = Never has such a vaccine schedule been tested for safety in humans.
    Furthermore, covid vaccines trials never found they reduced serious illness. Indeed, there has been no pivotal randomized trial, and no one can claim COVID-19 vaccines reduce hospitalization and death.  In fact, the shortest section on the FDA Pfizer Fact Sheet is the “Benefits” section!  This is given with the consent form and makes no claims about severity, hospitalization, and death.
    Covid vaccines are associated with many more risks than just myocarditis, and we are not yet aware of long term risks associated with this novel vaccine. Even more shocking, the bivalent boosters which failed in animal studies to stop Omicron, have never been tested for safety or efficacy in human RCTs with clinical outcomes. 

    In times of censorship and maligning with name calling like “ anti vax” sentiments like mine are erased from arguments around mandates. But I do ask that everyone take a breath and consider the implications of removing fundamental rights. With these authors logic of prevention of public “risk” above all , then we also must mandate citizens to maintain a healthy weight ( obesity a major risk factor of covid hospitalization ) , stop smoking and to exercise etc etc
    Remember, there are numerous ways to protect ourselves and others against infectious diseases.A vaccine ( new definition and all ) is but only one of them

    https://swprs.org/covid-vaccine-adverse-events/

    https://www.theepochtimes.com/mkt_breakingnews/cdc-changed-definition-of-vaccine-because-of-covid-19-vaccines-emails_4083638.html?utm_source=newsnoe&utm_medium=email2&utm_campaign=breaking-2021-11-03-1&mktids=aad4291dd26bc1faef5c4c15f72787d9&est=M54bQiEnUXb1YfNvPyI0s2uLtr4sMjliT%2FWn46IYZJGeC%2Fk%2FaefI%2FsMY%2BesdNLXw8cvBjciZwQM%3D

    https://petermcculloughmd.substack.com/p/false-and-misleading-efficacy-claimswhat?utm_source=substack&utm_medium=email

  • Doug Pederson AKA SpectateSwamp says:

    As a medicine man… and follower of past herbalists….
    Elderberry was Hippocrates go to herb
    Shen Nung the father of chinese medicine listed nearly 100 ailments that responded well to Ma, Pot, Weed
    There are a myriad of other natural remedies, Hot toddies, mustard plasters, loving care…
    This isn’t a debate until the total disrespect for traditional cures is addressed.
    Colloidal silver I make it and give it out…. steady.
    When I was a Kid I had a bad flu..
    I was in her bed with lots of quilts.
    I was forced to drink steaming hot over proof rum toddie. with honey and butter and yucky
    Get under the covers and don’t stick your head out till morning..
    As Her and Grandma talked and chatted in the kitchen.
    I knew it was serious… AND had the best healers of all time on my side.

    I have endless stories from trusted elders…

Authors

Maxwell Smith

Contributor

Maxwell Smith, PhD, is a bioethicist and Assistant Professor in the School of Health Studies, Faculty of Health Sciences, and Associate Director of the Rotman Institute of Philosophy, at Western University.

maxwell.smith@uwo.ca

Diego Silva

Contributor

Diego Silva, PhD, is a Senior Lecturer at Sydney Health Ethics, in the Sydney School of Public Health, at the University of Sydney.

diego.silva@sydney.edu.au
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