Mandating COVID-19 vaccination prior to kidney transplantation in the United States: No solutions, only decisions
Benjamin Hippen
Abstract
The question of whether transplant clinicians should mandate COVID-19 vaccination as a condition of transplant candidacy is complex. A vaccine mandate may be defensible on the grounds that transplant clinicians are obligated to ensure transplantation is conducted safely, and in a manner that entails the best use of a scarce public good. However, mandate proponents will inexorably predicate their arguments on contingent clinical judgments that meliorate rather than resolve core value disagreements. Vaccine mandates are conceivably defensible on narrow grounds, but may prove to be purchased at the expense of an attenuation of shared decision-making, proffering claims of risk reduction from a vaccine mandate beyond what the current evidence base supports, and unintentionally exacerbating durable inequities in access to transplantation. The question of whether transplant clinicians should mandate COVID-19 vaccination as a condition of transplant candidacy is complex. A vaccine mandate may be defensible on the grounds that transplant clinicians are obligated to ensure transplantation is conducted safely, and in a manner that entails the best use of a scarce public good. However, mandate proponents will inexorably predicate their arguments on contingent clinical judgments that meliorate rather than resolve core value disagreements. Vaccine mandates are conceivably defensible on narrow grounds, but may prove to be purchased at the expense of an attenuation of shared decision-making, proffering claims of risk reduction from a vaccine mandate beyond what the current evidence base supports, and unintentionally exacerbating durable inequities in access to transplantation. The COVID-19 pandemic has extinguished the lives of more than 745,000 Americans and counting.1Johns Hopkins University and Medicine Coronavirus Research Center. Mortality analyses. https://coronavirus.jhu.edu/data/mortality. Accessed November 22, 2021.Google Scholar An mRNA-derived vaccine against the virus has proven to be highly effective against the duration and severity of infection. Hospital systems and health care workers have been pushed to the breaking point,2Baker M. ‘Their Crisis’ Is ‘Our Problem’: Washington Grapples With Idaho Covid Cases. The New York Times; 2021:A1.Google Scholar overwhelmed by infected patients, the vast majority of whom are unvaccinated. Patients with chronic kidney disease, end-stage kidney disease, and kidney transplants are all more vulnerable to severe infections. Despite widespread availability of the vaccine, and widespread promulgation of the social costs of unchecked spread, vaccination rates in the United States remain relatively static. More than a third of our fellow citizens remain unvaccinated, and in some states, more than 50% of citizens are unvaccinated. In the midst of this global public health crisis, focusing on how vaccine mandates affect a narrow category of patients with kidney disease seeking a transplant may seem parochial. Furthermore, for many public health professionals, the prima facie case in favor of a vaccine mandate for immunosuppressed transplant recipients may be so widely held and painfully obvious as to render doubts on some spectrum between tedious and exasperating. But, the ethical tensions and challenges at work for transplant centers currently considering a vaccine mandate for patients with kidney disease underscores an existing tension between practicing clinicians and public health professionals: Unlike public health authorities, whose decisions affect large populations, clinicians make judgments and decisions about the care of individual patients, and clinician leaders are primarily responsible for making sound medical judgments and decisions for health care institutions that provide care to local communities. While the ends of public health professionals and clinicians are typically aligned, the particular obligations of clinicians to individual patients (or to local communities) require additional circumspection when considering the exclusion of certain categories of patients from life-extending therapies such as kidney transplantation. In enacting a vaccine mandate policy, transplant center leaders render value-laden clinical judgments, contingent on an incomplete and evolving evidence base which offers directional but not dispositive guidance regarding the relative risk reduction afforded by a mandate. Mandate proponents relying on the obligation to promote “safe” transplant practices do so not by “balancing” competing obligations to promote shared decision-making, but by enacting exceptions to the “shared” part of decision-making in this instance, demarcating where the respect for patient autonomy ends and the policy-making authority of center leaders begins. Unintentionally, a vaccine mandate may exacerbate longstanding inequities in access to transplantation, and may entail extending policy authority in novel, intrusive, and tendentious ways. In each of these circumstances, mandate proponents test the durability of the public consensus from which their policy-making authority is derived. Elucidating how these competing ethical obligations on clinicians work in the case of kidney transplant candidates may illuminate how clinicians should proceed in analogous circumstances. Kidney transplantation generally conveys both a longer duration and better quality of life for most patients with end stage kidney disease, making transplantation the preferred treatment for advanced kidney disease or end-stage kidney disease. However, the availability of kidney transplantation is limited by both an insufficient supply of organs and an array of clinical strictures and requirements necessary for successful post-transplant management. All transplant centers in the United States have written clinical criteria for accepting a patient as a candidate for transplantation. However, no list of selection criteria is all-encompassing, so in many instances the sound application of selection criteria is a matter of exercising clinical judgment. Judgment, by definition, is a process of inductive reasoning: The exercise of clinical judgment is a matter of inference and decision, often under conditions of empirical uncertainty, employing an amalgam of observation, past experiences, and reference to germane empirical data, ultimately culminating in a decision. Clinical judgments are subject to framing and bias,3Kahneman D. Thinking Fast and Slow. Farrar, Straus, and Giroux, 2011Google Scholar and thereby, to criticism. But, they are also ubiquitous, and often necessary to function in a clinical setting. Properly deployed,4Goodman KW Goodman KS. Ethics and Evidence-Based Medicine: Fallibility and Responsibility in Clinical Science. Cambridge University Press, 2003Google Scholar the use of clinical judgment to form and execute a decision fuses the didactic and inductive expertise of the clinician with the ethical responsibilities and prerogatives of being entrusted with the care of individual patients, and with the responsibility for guidance and oversight of institutions delivering clinical care for entire communities. Clinicians entrusted with the oversight of kidney transplant programs are obliged to make individual and programmatic clinical judgments that inexorably privilege some competing values and obligations over others. There is no method available for a grand ethical synthesis that definitively resolves intractable ethical disagreements.5Engelhardt HT. The Foundations of Bioethics.2nd ed. Oxford University Press, 1996Google Scholar Instead, what is typically available is a modus vivendi, an agreement which permits peaceful co-existence in the face of unwavering disagreement, rather than the harmony of robust moral agreement. This point is worth remembering, given the durability of beliefs among vaccine refusers.6Blake A. Some striking numbers on the unvaccinated among us. The Washington Post; 2021.Google Scholar The stakes of exercising judgment poorly, unwisely, or arrogantly include an erosion of the social support for investing that authority in clinicians, which from time to time will cause other sources of authority to step in.7deSante J Caplan A Hippen B et al.Was Sarah Murnaghan treated justly?.Pediatrics. 2014; 134: 155-162Crossref PubMed Scopus (14) Google Scholar Transplant clinicians have a fiduciary obligation, mirrored in Federal law,842 CFR § 121.8 - Allocation of organs. https://www.law.cornell.edu/cfr/text/42/121.8. Accessed November 22, 2021.Google Scholar to ensure that organ transplantation is conducted in a manner that is “safe” for patients, and that organs are allocated in a manner that comprises the “best” use of a public good. “Safe” and “best” are judgments. Some judgments of safety are minimally controversial: Administering global T-cell immunosuppression to a patient with an active bacterial or tubercular infection is generally understood to be unsafe. The fact that this or that patient in that circumstance might survive unscathed does not undercut the soundness of the judgment or the reasoning behind avoiding these clinical scenarios. Judgments of safety are sometimes expanded to cover matters where the cause-and-effect relationship with unsafe practices or bad outcomes is less clear, or even inconsistent with other accepted and extant practices and policies. Translating this fiduciary obligation into public policy, centers are routinely held to objectively measured and publicly reported standards (such as patient and graft survival rates), and are held to account if they fall short. Transplant center leaders have agency, and are not obligated to cooperate with requests for non-emergency care they judge to be outside their endorsed standards for safety and quality.9Hippen B. Professional obligation and supererogation with reference to the transplant tourist.Am J Bioeth. 2010; 10: 14-16Crossref PubMed Scopus (6) Google Scholar (I stipulate that, given the widespread availability of dialysis, the need for a kidney transplant does not constitute a medical emergency.) Therefore, if center leaders are accountable for the outcomes of the patients they transplant and care for, and there are no regulatory or clinical best-practice exceptions to this standard for candidates who elect not to be vaccinated prior to transplant and then suffer a COVID-19 related adverse outcome, then center leaders could be justified in declining to list and transplant candidates who elect not to be vaccinated. By extension, if center leaders judge that the accommodations in care delivery for an unvaccinated transplant patient, to avoid exposing the patient to COVID-19 in the hospital or clinic, or exposing other patients, family members, and staff to COVID-19 from an unvaccinated and infected patient, are either too onerous or are likely to fall below the center’s standards of care delivery, then the center could also be justified on these grounds to decline to list or transplant an unvaccinated candidate. Too, instituting a vaccine mandate for transplant candidates may prove to be a necessary (if not sufficient) condition for avoiding tort liability.10Congressional Research Service. COVID-19 Liability: tort, workplace safety, and securities law. https://crsreports.congress.gov/product/pdf/R/R46540. Published September 24, 2020. Accessed November 22, 2021.Google Scholar However, centers contemplating this approach should be prepared to address the obvious counterfactual: In the United States, after a brief pause early in the pandemic, and prior to the availability of COVID-19 vaccines, organ transplant rates returned to previous levels, and in the case of kidney transplantation, actually exceeded pre-pandemic levels,11United Network for Organ Sharing. U.S. on pace to top 40,000 transplants in a single year for first time. https://unos.org/news/on-pace-for-40000-transplants-record/. Published August 5, 2021. Accessed November 22, 2021.Google Scholar indicating an evolved consensus on the safety of transplantation during the pandemic. Transplantation has continued during the availability and use of COVID-19 vaccines, despite a preponderance of evidence showing that most transplanted patients on immunosuppression have either a negligible or reduced response12Bertrand D Hamzaoui M Lemée V et al.Antibody and T cell response to SARS-CoV-2 messenger RNA BNT162b2 vaccine in kidney transplant recipients and hemodialysis patients.J Am Soc Nephrol. 2021; 32: 2147-2152Crossref PubMed Scopus (114) Google Scholar to a two-dose regiment of the vaccine. So, if transplanting unvaccinated patients is outside the standards of quality and safety now, why wasn’t it also outside those same standards prior to the availability of the vaccine? One answer might be that the assessment of the risks and benefits of continued dialysis versus receiving a transplant prior to the availability of a vaccine are now different with the wide availability of a vaccine. With demonstrated evidence of safety and efficacy (sometimes after more than two vaccine doses), the appropriate consideration has shifted to comparing risks and benefits with or without clinically sufficient vaccination. The skeptic has recourse to the argument that the infection fatality rate for SARS-CoV-2 infection in kidney transplant recipients is not known, because the total number of SARS-CoV-2 cases is not known, since an unknown number of patients develop infection without ever being tested. (Infection fatality rates require knowledge of the total number of patients infected; Case fatality rates use confirmed total cases as a denominator.13Mortality risk of COVID-19 our world in data. https://ourworldindata.org/mortality-risk-covid. Accessed November 1, 2021.Google Scholar) Reports of a high risk of morbidity and mortality in infected kidney transplant recipients are limited only to patients requiring hospitalization, rather than all infected (tested or otherwise) recipients.14Ajaimy M Liriano-Ward L Graham J et al.Risks and benefits of kidney transplantation during the COVID-19 pandemic: transplant or not transplant?.Kidney360. 2021; 2: 1179-1187Crossref PubMed Google Scholar Furthermore, both the infection fatality rate and case fatality rate for SARS-CoV-2 infection will vary by location and over time, and both will likely decrease as prevalent vaccination rates and primary infection rates converge. The pro-mandate contingent may rejoin that pre-vaccination norms are not desirable norms for running a transplant program in the vaccine era, the widespread availability of vaccines, the very low adverse event rate from vaccination, and the high efficacy of vaccination to prevent serious complications from infection limits the appeal of the skeptic’s concerns, and so on. Center leaders may well decide to institute a vaccine mandate as a binary choice, without room for clinical exception, based on the low risk of receiving a COVID-19 vaccine combined with the likely benefit of lowering the risk (albeit from an unknowable baseline risk) of a severe infection. Center leaders choosing this “binary” path should offer clear justifications for their approach, and they should consider suggesting evidence-based conditions under which the policy should either be revisited or optionally modulated by clinical judgment in individuated circumstances. Ultimately, vaccine mandate proponents must inexorably contend with limits on their ability to quantify the risk reduction realized by a vaccine mandate, whereas skeptics must contend with the extent to which their insistence on evidentiary scrupulousness requires a high threshold of empirical proof rarely available in any facet of clinical medicine. While the responsibilities for safety and quality placed upon center leaders provide wide latitude for acting on considered clinical judgments made in service to those responsibilities, center leaders should anticipate and be prepared to respond to questions and criticism from dissenters asking after data to justify more restrictive measures. Again, the terminus of this back and forth will not be a of disagreement, but only a policy decision more or less by those with the authority to HT. The Foundations of Bioethics.2nd ed. Oxford University Press, 1996Google Scholar to be by with the authority to make these decisions is contingent in part on exercising clinical judgment with and is to an of the of with to and of Scholar answer for center leaders to a vaccine mandate policy, in the of or of the COVID-19 vaccine to the question of whether such a patient the risks of et limits of an ethical of organ transplantation and vaccine J 2021; PubMed Scopus Google Scholar from the risks of COVID-19 infection. the in this for a patient may in a patient that the requirements for transplant immunosuppression also is not with their considered and or at a tension in the values worth A shared decision-making approach should not be the decision not to offer transplantation to an unvaccinated patient should not be a a center’s considered policy is not to transplant unvaccinated patients, there is no decision-making to in this Clinicians practicing in a center with a vaccine for transplant should a values and how they with the requirements of transplantation without a that the of that will to in the center’s for a policy should care to narrow their clinical judgments to a decisions about whether or not to the vaccine, and the for that narrow policy with judgments about the of values that a decision to decline a vaccine. a center a vaccine the policy should be and to the clinical of the patient in This may entail not a vaccine but also require sufficient vaccine to a high or some other evidence-based of clinical in patients with end stage kidney disease a of to B A et patients a highly response after COVID-19 vaccination with 2021; PubMed Scopus Google et al.Antibody response to SARS-CoV-2 vaccine in organ transplant 2021; PubMed Scopus Google Scholar more suggesting more to the M et of a messenger vaccine against SARS-CoV-2 in chronic dialysis 2021; PubMed Scopus Google et response to SARS-CoV-2 infection and vaccination in patients receiving kidney 2021; PubMed Scopus Google Scholar Furthermore, there have been regarding the of clinical of both the and of as well as Is to COVID-19 Accessed November 1, Scholar some patients with advanced chronic kidney disease or end stage kidney disease are on such as or which reduced to the COVID-19 vaccine, and may require vaccine to clinically et of response after two-dose SARS-CoV-2 messenger RNA vaccination in patients with and a case 2021; PubMed Scopus Google D. of on response to COVID-19 vaccine and in patients with 2021; PubMed Scopus (6) Google Scholar policy be to account for all clinical but and support to a center’s arguments in favor of a under the of clinical While is it that a vaccine has more against severe COVID-19 infection to no vaccination to T-cell centers with a vaccine mandate should whether the mandate requires that transplant candidates threshold (or some other of after vaccination, to an organ from vaccine requirements additional challenges for center from of the COVID-19 vaccine has been for adverse reported after COVID-19 vaccination. November 2021. Accessed November 22, 2021.Google Scholar Center leaders a vaccine mandate, but to transplant candidates with clinical to additional vaccine will need to between these patients and patients who are after a two-dose centers reasoning under the of category of patient should organ from vaccine such as a some hospital systems have COVID-19 an to September 2021. Accessed November 22, 2021.Google Scholar in the or of is outside the and authority of or other of vaccination does not an obligation on center clinicians, the narrow of to candidates who The beyond the patient as as most centers require that transplant candidates have a to the patient on a after centers for a policy will need to consider extending a vaccine to the a vaccine the could not any of the for the candidate. a candidate who with a vaccine mandate, but is without a to be be as a transplant candidate. requirements for a and other social support criteria have been a of since the early of dialysis, as a for social worth in in University Press, Scholar for candidates based on the of social support might be but it is by the fact that of social support with being a of have that candidates to on a to a often do not and are and V et and health systems patient access to kidney PubMed Scopus (14) Google Scholar Kidney disease vulnerable and in the United States, and the A by and a of access to kidney transplantation among Americans and those in the which has for two A et to access to kidney transplantation over two in the United Am Soc Nephrol. 2021; 32: PubMed Scopus Google Scholar the high rate of among these populations, and the of of disease, and vaccine of are for access to COVID-19 2021; PubMed Scopus (14) Google Scholar that it is likely that a policy will at not in durable health in access to transplantation among these that centers that to a vaccine mandate are to these and But, centers choosing to a vaccine mandate on and of grounds are not from these may unintentionally patients that have been subject to durable inequities in access to kidney transplantation. Center leaders about the extent to which patients may be from access to transplantation as a of to a of will be with either an ethical argument or which is more in accepting patients and or a vaccine mandate policy to the of practices for will from others. arguments are vulnerable to core about the very of of in arguments and must with the with which these be to justify regarding the of argument over competing and the extent to which such reasoning in or on HT. The Foundations of Bioethics.2nd ed. Oxford University Press, 1996Google Scholar of what for should be with the of some vaccination combined with and social is our best path of the pandemic of our Transplant professionals are to be about the clinical of transplanting unvaccinated patients, both for the of the patient for other transplant patients and and for the safety of the at or not a center to a vaccine mandate policy, the of patients and to vaccinated is not in enacting a vaccine mandate may be justified in but a mandate will not be will test an modus in our will at some expense to shared decision-making, will have to a of exceptions and for may entail extending vaccine requirements to and may existing inequities in access to transplantation, and should be for and as the evidence base leaders should the of their decisions with in the face of questions and and a of the justifications and of their policy there is a to the modus vivendi, it is by showing our that are sometimes to it