Introduction: Robert Emmet Moffit, PhD.

Government COVID-19 vaccine mandates, at the federal and state level, have taken center stage in America’s national debate. The imposition of such mandates has raised a series of thorny ethical, legal, and practical questions, including personal freedom and autonomy, the role of natural immunity, the legitimate reach of government power, and problems related to private business enforcement of a government program.

In healthcare settings where the stakes are life and death, the debate over mandates is even more urgent. One particularly striking real-life example of this urgency is recent COVID-19 vaccine requirements as a condition for a life-saving organ transplant.

In October 2021, the University of Colorado Health System (UCHealth) announced that it was denying organ transplants to patients who were not vaccinated against COVID-19 in “almost all situations” because such patients had a greater likelihood of mortality. Acting on that policy, the hospital denied a Colorado woman a kidney transplant. Hospital officials told her that if she did not get the coronavirus vaccine within a thirty-day period, she would be removed from the transplant list. The decision generated a political backlash.

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Other hospital systems have adopted a similar policy.

This policy has huge implications, considering the emergence of COVID-19 variants. According to the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services, there are more than 106,000 persons currently on the waiting list for an organ transplant. In 2020, however, only 39,000 persons secured a transplant, and seventeen people die each day while awaiting a transplant.

Kidney transplants, as in the Colorado case, are in the greatest demand.

Two specialists in bioethics address this question from both sides. Greg F. Burke, MD., is an internal medicine specialist, and an associate of the Geisinger Medical Center in Pennsylvania, where he serves on the hospital’s ethics committee. A graduate of Jefferson Medical College in Philadelphia, he has published numerous articles and essays on bioethics and is co-chairman of the ethics committee of the Catholic Medical Association. Emanuela Midolo, PhD, is an attorney specializing in human rights law, and a Research Fellow in Bioethics at the Italian National Center of Research. She is also a Visiting Scholar at the Kennedy Institute of Ethics at Georgetown University and was previously an adjunct professor of bioethics, history of medicine, professional ethics, and human rights at the Catholic University of the Sacred Heart in Rome.

First, we present a statement from Dr. Burke affirming the case in favor of vaccination requirements for organ transplant patients, and following it is Dr. Midolo’s rejoinder. Then we present Dr. Midolo’s statement arguing that COVID-19 vaccination should not be mandated for transplant patients, and we conclude with Dr. Burke’s rejoinder.

Dr. Greg Burke: Yes, there should be vaccination requirements for organ transplant patients.

Prior to the COVID-19 pandemic, vaccination as a requirement for transplantation was not a controversial subject. However, the pandemic seems to have altered the approach to several of medicine’s diagnostic and therapeutic decisions. Therefore, defending a COVID-19 vaccination “mandate” for those in need of organ transplant is best understood in relation to nonnegotiable first principles in medical ethics. The competing principles in this debate make a “necessary tension” inevitable.

In philosophic disputation, St. Thomas Aquinas tried to make his opponents’ arguments clearer and even more convincing than his opponents’ presentation of their own arguments. Though I would never claim to have such gifts, I will nonetheless try to articulate the opposing view.

So, here is that case: justice in healthcare requires that all patients be treated equally without prejudice. Moreover, a patient’s personal choices that lead to ill health or precarious risks should not diminish a clinician’s provision of care. Doctors are solemnly obligated to put aside their personal opinions of a patient’s health-related choices, or their differences in ideological judgments, and pursue the relief of their suffering and restoration of health. Based on these premises, a physician must care for any patient in need of treatment—regardless of vaccination status.

I certainly understand and endorse a patient’s right to assess the benefit and harm of any medical intervention, particularly out of respect for their personal values. This is one of the nonnegotiable first principles that I referenced.

Nonetheless, as a surgical colleague of mine recently stated: both the patient and physician have “veto power” over an elective surgical procedure. Indeed, the surgeon may remove the offer to proceed if certain requirements are not met ahead of time. For instance, the surgeon may refuse to perform a procedure if the patient refuses to follow the necessary pre- or post-operative care to obtain a successful outcome.

Therefore, a transplant surgeon or program reserves the ethical right to refuse to proceed with an organ transplant if criteria are not met for the best possible outcome. Cancer screening, psychological testing, and financial assessment are all part of the pre-transplant protocol. Some screening procedures come with risk but are required. For instance, both colonoscopy and cardiac catheterization are often pre-transplant necessities. Vaccination for common diseases is administered routinely as well and is frequently expected. Failure to comply with any one of these protocols can prohibit a patient from being listed for transplantation.

Donor organs are a profound gift, but unfortunately demand outstrips their supply. Transplant surgeons will rightfully argue they are ethically obligated to offer organs to be implanted with the greatest chance of long-term success. They owe it to the recipient, the donor, their program, and society to hold firm to this principle.

To be more specific, conscientious professional practice for physicians and all health care professionals is built upon the foundational tenet: “First do no harm.” If a physician objects to performing abortions or assisting in suicide, or even referring for these immoral acts, he or she can appeal to this tenet as the reason for conscientious objection.

In the case of organ transplants, the risk of harm is increased in organ recipients who are unvaccinated for COVID-19. Consequently, a transplant surgeon understands that unvaccinated organ recipients are at higher risk for death if infected with COVID-19 and therefore cannot approve of transplantation if another vaccinated patient of equal merit and suitability needs donation.

I realize some may not agree with the “science” of COVID-19 vaccination, but most clinicians agree that immunosuppressed patients have a poorer prognosis if infected with SARS CoV-2. Moreover, vaccination reduces the risk of death from COVID-19, and serious vaccine side effects are rare. My personal experience in medical practice confirms this statement to be factual.

Finally, the fundamental ethical argument that permits transplant surgeons to set criteria for patients receiving organ donation is based on conscience protections for the physician. The surgeon has inherent “liberty” to practice medicine according to evidence and professional experience.

Dr. Midolo’s Rejoinder:

Organ transplant is a sensitive topic both from a medical and ethical point of view. COVID-19 has highlighted the shortage of medical resources, which has produced a utilitarian approach to care. The utilitarian mentality calculates what medical decisions will be most convenient for society and the healthcare system—not what is best for the individual patient. Nor does it consider the patient’s point of view.

As evidenced by the Colorado case, this mentality leads to medical acts that decline a life-saving treatment to a terminally ill person; it abandons a human life. A physician’s autonomy of choice for whom to provide care is not unlimited. Physicians’ autonomy is limited by regulation, law, ethical rules, and deontological principles. Physicians cannot refuse to provide care to patients for reasons related to ethnic, racial, or religious affiliations.

We also don’t know how the COVID-19 vaccine will affect terminally ill patients in need of organ transplants. There is not enough scientific evidence to support the mandatory administration of this vaccine to this kind of patient. It cannot be equated with other common vaccinations in the immunity rules for organ transplant reception. In the Colorado case, the woman involved has a greater chance of dying from a refused organ transplant than from a COVID-19 infection.

If we analyze this case from an ethical point of view, it is not just a matter of patient or physician autonomy. Indeed, other principles must be satisfied in medical actions. These principles are principles of beneficence and not maleficence. If medical action is just an execution of the patient’s wishes, we lose all sense of the physician’s art. Physicians must also analyze and make the decision—based on science and conscience—for the patient’s best interest only. Here it is very clear that the patient’s best interest is not dying because she has not received an organ for which she has long been waiting. Indeed, the organ transplant will give the patient the possibility, without any doubt, to return to a healthy condition.

Dr. Emanuela Midolo: No, there should not be vaccination requirements for organ transplant patients.

In the State of Colorado, the University of Colorado Health System (UCHealth), among other American hospitals, has declared that it will deny transplants for patients who are not vaccinated against COVID-19, including patients who refuse to start vaccination from coronavirus before receiving the living organ. This denial includes patients already on the transplant list.

The UCHealth decision has generated a political backlash within the state. Colorado State Rep. Tim Geitner, a Republican, confirmed that the Colorado Health system denied a kidney transplant to a woman who is unvaccinated against COVID-19. Rep. Geitner also said that this woman will be “inactivated” from the transplant list if she will not start the vaccination process thirty days before receiving the organ transplant. In this case, the patient, Leilani Lutali, told the local television news station that she was worried about the effect of this type of vaccine, given her health condition.

American federal and state officials are imposing, or are trying to impose, COVID-19 vaccine mandates on public- and private-sector employees. Although politicians may debate the policy implications of various kinds of vaccine mandates, denying organs to patients in need has major ethical implications. In the Colorado case, it appears that clinical ethics were not applied. Four criteria are applicable in a clinical ethics evaluation: indications for medical intervention, patient’s preferences, quality of life, and contextual aspects.

Other considerations are part of the decision-making process, too, like the parameters for moral action, the double effect doctrine, patient autonomy, quality of life, the proportionality of treatment, the rule of prudence, and the practice of other moral virtues.

According to the criteria of clinical ethics, the urgency of Lutali’s medical condition clearly meets the prerequisites needed for medical intervention. Therefore, providing the patient a potentially life-saving treatment must be warranted, including for an unvaccinated patient.

Regarding the COVID-19 vaccines, we do not know how and if they will protect us from all the variants of the coronavirus. The recent data are indisputable: many vaccinated people are infected by the recent Delta and Omicron variants. In Ms. Lutali’s case, her preference as the patient—one of the four criteria of clinical ethics—is obviously that she receive a living transplant. Based on these factors, an organ transplant would give this patient the possibility of a good quality of life. Even if she were not vaccinated against coronavirus, her quality of life would still be high. The reason: the probability that Ms. Lutali will die from organ failure is far greater than the risk of death from COVID-19.

Ms. Lutali was included—before UCHealth’s new vaccine requirement for transplant patients—in a transplant list, and there were no other obstacles to her receipt of an organ transplant. A person’s unvaccinated status, under the weak state of evidence that we have right now, does not allow us to dispense with the primary rule of medical ethics: “First do no harm.” That solemn duty is inherent in the medical profession. From the standpoint of clinical ethics, therefore, the case of Ms. Lutali matches all criteria to be included in a transplant list and to receive a new organ.

Today, health care systems are increasingly pressured to consider the costs and benefits of providing medical care. Some bioethicists are debating the many protocols that during this pandemic are at odds with traditional medical ethics. For example, some propose using a so-called “life-years” concept as a standard for allocating transplantable organs. Of course, “life-years” is often used as a justification for medical providers to choose which persons deserve to live or not. The Organ Procurement and Transplant Network, however, explicitly rejected the use of “life-years” as the criterion of allocation for kidney transplants.

The COVID-19 pandemic has brought to light several ethical dilemmas related to the allocation of scarce medical resources. Moreover, we also have to consider the human rights implications of these decisions. Given the primacy of human life, it seems that “inactivating” a person on a transplant list or refusing life-saving treatment for a vulnerable patient constitutes a violation of human dignity.

Human dignity is the indelible hallmark of all human existence. For this reason, human beings must be treated as subjects and never as objects of medical science or medical practice. The principle of the inviolability of human life follows as a moral responsibility, especially for physicians. Human dignity is inherent and equal in every human being. Respecting it restores medicine and the health professions to their true and proper activity.

Dr. Burke’s Rejoinder:

I appreciate Dr. Midolo’s excellent piece favoring transplantation in unvaccinated patients. Without any argument, patients should not be discriminated against in any way in terms of effective therapeutics.

Yet a necessary tension exists in recognizing the rights of physicians to practice within their conscience and not cooperate in suboptimal care. Society would expect nothing less than a medical profession dedicated to the best scientific evidence that promotes the welfare of those for whom they care.

I would also point out that the three vaccines used in the United States are approved by the FDA and are not experimental. Every credible medical society and public health authority, without exception, has endorsed vaccination against COVID-19 for high-risk individuals.

For those with significant conscientious objections to vaccination, I support their right of refusal. However, a refusal may require extra efforts on their part to reduce the spread of disease and avoid acquiring infection. Recall that receiving a transplant means that another person in need of that organ is denied. A physician is obliged to make surgical decisions aimed at the best long-term outcome for all their patients.