SARS-CoV-2 Vaccine Mandates for Patients on the Kidney Transplant Waitlist

Respect for Autonomy

An individual has the fundamental right to accept or deny any medical treatment—including vaccination (2). Autonomy is the basis of informed consent and so fundamental to modern medicine that some regard this principle most important (5). As coercion invalidates consent (4), insisting that patients be vaccinated against SARS-CoV-2 or else be denied transplantation infringes on their right to autonomy.

However, an individual’s right to autonomy is not absolute, especially when personal decisions may result in harm to others (2). During a pandemic that has killed >5 million people, personal autonomy may be superseded by interests of the majority. This tension between personal autonomy and the greater good has led to the current chaos, with heated—often violent—disputes between opponents of mandatory public health measures and those imposing them. Some rightfully contend that when personal freedoms are restricted in favor of public health, the burden of proof must lie with those advocating them (3). Imposed measures must be safe, effective, transparent, and without less restrictive alternatives (6). When masking and social distancing were initially imposed in early 2020, this burden of proof was easier to meet: the benefits to public health in preventing total collapse of the health care system due to COVID-19 were enormous, while the nontrivial restrictions to personal freedoms were thought to be safer, easily reversible, and temporary. What about now? Do pretransplant vaccine mandates effectively protect the well-being of the majority? Although unvaccinated patients may pose risks to health care workers and other patients during transplant surgery, denying transplantation does not eliminate risks because these patients still require health care, including dialysis. In regions with herd immunity and/or low COVID-19 prevalence, it is difficult to argue that an individual’s right to refuse vaccination is superseded by the need to protect others, especially when social distancing and masking are maintained.

Importantly, any restrictions to personal autonomy must be deemed proportionate to the threats to public health averted by those restrictions (proportionality) (3). Consider an unvaccinated woman who has complied with all previous pretransplant requirements and waited her “turn” for years. Is her removal from the waiting list a just and proportionate response to the public health benefits derived from removing her? Are risks to her health of remaining on dialysis greater than the risk she poses to the public in not being vaccinated? Ultimatums to accept vaccination or be denied kidney transplantation in this context are ethically questionable, yet they have been used even in life-threatening circumstances (7).

Nonmaleficence and Beneficence

This means that all medical treatments should aim to minimize patient harm and maximize patient benefit (2,4). Kidney transplantation carries substantial health benefits over dialysis, but potential recipients undergo extensive workup and treatment of underlying conditions to reduce adverse events post-transplantation. Unvaccinated kidney transplant recipients who develop COVID-19 have a mortality of 20%–40% (8), and SARS-CoV-2 vaccination is far less effective after kidney transplantation than during dialysis (9). To offer kidney transplantation without SARS-CoV-2 vaccination is akin to boating in rough waters without a life jacket, and vaccine mandates have thus garnered support in some centers.

Do vaccine mandates have harms? If vaccination causes death, even infrequently, denying patients’ rights to equal health care unless they accept risks they may otherwise refuse is problematic. Fortunately, serious side effects after SARS-CoV-2 vaccination are rare and less than the risk of dying from COVID-19 while immunosuppressed (8). Immune sensitization after vaccination is also considered improbable.

Rather, the potential harm lies in forcing patients who refuse vaccination to remain on dialysis, denying them the opportunity for improved health that a kidney transplant offers. Unless being unvaccinated irrefutably results in high risk of personal harm (as with active cancer or infection), it cannot be reasonably considered an absolute contraindication to transplantation. Nonmaleficence and beneficence require global consideration of risk-benefit (2), and therefore, an individual’s risk of acquiring and dying from COVID-19 or other conditions while unvaccinated post-transplantation must be weighed against the morbidity and mortality risk of remaining on dialysis also unvaccinated. This deliberation becomes crucial as local virus prevalence falls, as effective treatments for COVID-19 are developed, and as continued vaccine efficacy against emerging SARS-CoV-2 variants, such as omicron, is unknown. Risk-benefit is neither static nor uniform, and its proper assessment requires flexibility for repeated and individualized evaluation, similar to evaluation processes for non–COVID-19 risks. Such flexibility runs contrary to vaccine mandates. Vaccine mandates also become harmful when they undermine patients’ trust in providers, compromising care. When vaccine politicization leads providers to pass vicious judgments on unvaccinated patients on social media, these harms are compounded.

Justice

Justice commonly concerns the equitable distribution of scarce resources to optimize population health or health maximization (3). Given their scarcity, donor kidneys are allocated to patients with the best chances of graft and overall survival. Medication nonadherence contraindicates transplantation as without immunosuppression, graft loss is almost certain. Kidney graft loss from COVID-19–related complications could theoretically be minimized by mandatory SARS-CoV-2 vaccination, maximizing population health. Although valid, this reasoning is only applicable if viral transmission rates are high, if vaccines are effective, if no effective COVID-19 treatments exist, and if appraised against loss of autonomy. Vaccine refusal is thus not the same as medication nonadherence unless risks of graft loss are comparable.

Justice also denotes minimizing health inequities so that no one is unfairly disadvantaged (3). People of color, indigenous populations, and those from low socioeconomic groups experience reduced access to kidney transplantation compared with others, and also have lower vaccine uptake (10,11). Vaccine mandates may further restrict these groups’ access to transplantation, making them unjust. Health inequity may be promoted when only some centers impose vaccine mandates, as those patients with means can relocate and seek transplantation elsewhere. Vaccine mandates are also not possible in low- to middle-income countries with variable supply.

Disclosures

L. Gunaratnam reports consultancy agreements with Novartis Pharma Canada Inc. and Paladin Labs Inc.; honoraria from Novartis Pharma Canada Inc. and Paladin Labs Inc.; and serving in an advisory or leadership role for the Trillium Gift of Life Network and Canadian Blood Services. R.S. Suri reports honoraria from Amgen, Otsuka, and AstraZeneca and serving in an advisory or leadership role for the Canadian Institutes of Health Research Institute of Circulatory and Respiratory Health and the Canadian Society of Nephrology. The remaining author has nothing to disclose.

Funding

None.

Author Contributions

R.S. Suri and L. Gunaratnam conceptualized the work; F. Tallaa, L. Gunaratnam, and R.S. Suri performed literature and media article review; R.S. Suri provided supervision; R.S. Suri and F. Tallaa wrote the original draft; and L. Gunaratnam, R.S. Suri, and F. Tallaa reviewed and edited the manuscript.