Maxwell Smith and Diego Silva analyze the case for the imposition of risk via vaccine mandates.

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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.

Photo Credit: Nataliya Vaitkevich/pexels. Image Description: COVID-19 vaccine vials and syringes on pink background.

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.

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

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

This commentary was originally published in Healthy Debate