In October 2021, news broke that a Colorado woman had been denied a transplant because she was not vaccinated against COVID-19. The woman, a patient suffering from stage 5 chronic kidney disease and registered with the Aurora, Colorado-based UCHealth system, had been months away from receiving a new kidney from a living donor, who had also not received the vaccine. According to media coverage, the patient perceived too many unknowns about the vaccine and the donor had declined it for religious reasons.
The patient had reached out to the media after receiving a letter from UCHealth indicating that, since she had not received the COVID-19 vaccine, her waiting list status was considered inactive. It went on to say that if she did not commence the vaccination series within 30 days, she would be removed from the kidney transplant list. She is reportedly now seeking a transplant center that will perform the procedure even though she and the donor are unvaccinated. Thus far, she has been unsuccessful in her efforts.
The intense media coverage of the incident has prompted questions about transplant rules in instances of unvaccinated individuals. In a public statement on Twitter, UCHealth posted the following: “Transplant centers across the nation, including the UCHealth Transplant Center, have specific requirements in place to protect patients both during and after surgery. Patients and living donors may be required to receive vaccinations including hepatitis B, MMR, and others, and to avoid alcohol, stop smoking, or prove that they will be able to continue taking their anti-rejection medications long after transplant surgery. Several weeks ago, COVID-19 vaccination was added to this list because of the significant risk the virus poses to transplant recipients.”
More Than a Push
“It should be a no-brainer that we do it,” says Douglas Norman, MD, medical director of the Oregon Health & Science University (OHSU) Kidney Transplant Program in Portland, who reports that 15 of the program’s patients have died of COVID-19 post transplant. Dr. Norman emphasizes that immunosuppressed patients who have not been vaccinated do very poorly if they get COVID-19. Indeed, a multicenter collaborative study of 482 solid organ transplant recipients in the prevaccine era found a 20.5%, 28-day mortality rate in patients hospitalized for COVID-19.
While researchers continue to study the impact of vaccination on COVID-19 mortality in transplant recipients, it has become clear that immunosuppressed transplant recipients have a blunted antibody response to vaccination. Transplant centers have therefore pushed for pretransplant vaccination to optimize the immune response to vaccination that can last through their transplant and provide protection during the period of greatest immunosuppression: right after transplant surgery.
KEY POINTS.
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COVID-19 poses a significant risk to transplant recipients.
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In some transplant centers, patients who refuse COVID-19 vaccination are no longer permitted to remain waitlisted.
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Explicit vaccination requirements benefit patients because they increase transparency in the waitlisting decision-making process.
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Although some patients may seek a religious exemption from vaccination, the Oregon Health & Sciences University’s legal department determined that no religious doctrine expressly bans vaccines.
To underscore its policy, OHSU has sent a letter to all patients stating that they need to be vaccinated by November 9th to remain on the waitlist. Dr. Norman notes that OHSU will consider patients who have valid medical reasons not to be vaccinated but specifies that the OHSU legal department has determined that “no religions, as part of their doctrines, actually ban vaccines.” In short, OHSU does not accept “religious reasons” as an allowable exemption for vaccination.
Olivia S. Kates, MD, a transplant and oncology infectious diseases attending at Johns Hopkins University in Baltimore, and a lead investigator of the multicenter study on COVID-19 in transplant recipients, states that although her center currently does not have a COVID-19 vaccine policy, one has been proposed and is under development. She points out that prior to COVID-19, most centers had not issued explicit policies requiring vaccination. One 2013 study of pediatric transplant centers found that only 5 of 195 pediatric solid organ transplantation programs had written policies regarding parental refusal of vaccination.
Optimizing a Vaccine Policy
Transplant centers must serve as reliable stewards of donor organs, and they are given a lot of leeway to do so. Candidates undergo comprehensive pretransplant evaluations to determine their overall health, ability to withstand surgery, likelihood of a successful transplant, and even the availability of caregivers and social supports to assist them through the transplant journey. Depending on the transplant center, vaccination status may or may not be addressed in detail during the pretransplant evaluation, a process that can be opaque for patients. Dr. Kates believes that the new, explicit vaccination requirements benefit patients because they increase transparency in the process.
“The goal is never to deny or prevent a transplant,” says Dr. Kates, but she adds that, “the goal is [also] to get candidates vaccinated so that they can undergo a transplant safely.” She encourages transplant centers to focus on this objective and partner with social workers and others on the transplant team to ensure that centers considering vaccine mandates are also prepared to help patients receive their vaccine.
Of course, the decision to mandate vaccinations itself has been controversial. “In 2019, not everyone agreed that there should be a vaccination requirement,” acknowledges Dr. Kates, referencing the intense disagreement in the transplant community prior to the pandemic. She documented this discussion in an article calling for a uniform national policy addressing vaccine refusal among transplant recipients.3
In large part, the internal controversy surrounding mandatory vaccination has revolved around a concern that transplant inequity would be further exacerbated. Black Americans, for example, have historically experienced disparities in transplant also and, according to Dr. Kates, their reluctance to be vaccinated may be based on authentic personal and community histories of medical abuse and surreptitious experimentation. She suggests that such reluctance be given special consideration so that vaccine policy does not disproportionately and unfairly prevent these patients from accessing transplant. She also cautions that rapid adoption of new vaccine policies may not allow for appropriate consideration of the effect of vaccine requirements on racial equity and calls for better data to predict and track the impact of vaccine mandates on equity, as well as national-level guidance on the use of vaccination as criteria.
Tipping Point for Requirements
“COVID has really been a tipping point for this issue of vaccination for transplantation,” says Dr. Kates, pointing out that over the past weeks, dozens of centers have begun to develop and refine COVID-19 vaccine requirements. She expects that transplant centers will now mandate non–COVID-19 vaccinations as well, and feels that net utility weighs in favor of vaccine mandates in general. A vaccination requirement, believes Dr. Kates, is reasonable from a risk mitigation perspective, and less difficult to achieve than, say, requirements for a 24-hour caregiver or abstinence from substance use. “The burden on most patients to get vaccinated is pretty low,” she says.
As a medical ethicist, Dr. Kates contends that not only do vaccinations protect a scarce resource, but they can also be seen as an example of adherence to medical recommendations and a good faith effort to contribute to the social contract. Such a contract underlies organ transplantation such that candidates for organ transplantation are petitioning to benefit from a limited resource that must be shared among individuals in need. Vaccination is not only beneficial for individual candidates, it is beneficial for the entire community: fellow candidates, organ donors, and donor families. An explanation of the social contract may be helpful for individuals who argue against vaccines based on a firm belief in patient autonomy. The truth is, when it comes to sharing scarce resources and honoring a social contract, intrusions on autonomy are naturally expected, and, as Dr. Kates sees it, vaccination is the perfect example of this.
