Exploring the ethical complexity of pediatric organ transplant candidates and COVID‐19 vaccination: Tensions between autonomy and beneficence, children and parents

Abstract

Background

POT is emotionally sensitive due to cohort vulnerability, their lack of decisional capacity, and waitlist mortality. The COVID‐19 pandemic has added complexity to the setting of pediatric transplantation, as well as living donation, due to tensions about COVID‐19 vaccination for recipients, donors, and parent‐caregivers.

Methods

In the context of COVID‐19 vaccination, two ethicists present four pediatric donation and transplant dilemmas for ethical exploration and offer guidance to clinical teams, noting that mandates are controversial, and there is no global harmonization regarding requirements.

Results

As with all vaccinations, they are a tool of organ stewardship aimed to optimize outcomes and, in the setting of pediatrics, ensure optimal caregiving for these vulnerable recipients. Current evidence supports the ethical permissibility of COVID‐19 vaccination mandates for transplant candidates aged 6 months and older.

Conclusion

Our guidance considers the tensions of autonomy and beneficence and the ethical duty of organ stewardship. The harms of being unvaccinated and risking the harms of COVID‐19 and long‐COVID post‐transplant support the ethical permissibility of vaccination mandates in countries where the vaccine has pediatric regulatory approval.

Abbreviations

JW

Jehovah's Witnesses

POT

Pediatric Organ Transplantation

SOT

Solid Organ Transplantation

UNOS

United Network for Organ Sharing

In January 2022, a Cyprus toddler was refused a life‐saving heart transplant due to the fact that his parents were refusing COVID‐19 vaccination (in the setting of requirements for legal guardians to be present and vaccinated as a condition of their child's surgery). ¹ Because Cyprus lacked a pediatric heart transplant program, the child was referred to hospitals in three other countries but all refused. The dilemma was eventually solved by a Greek hospital agreeing to place the child on their heart transplant waiting list; however, this case presents many dilemmas and tensions between autonomy and beneficence in the setting of the pediatric transplant journey and COVID‐19. In 2020, in USA, 1766 children received life‐saving solid organ transplants, matched from 860 pediatric organ donors. ² Currently, there are 1900 children on the USA transplant waiting list. More than 500 children waiting for a donor organ are between 1 and 5 years old. ³ Children awaiting heart transplantation experience the single highest waiting list mortality compared with all other age groups and all other solid organs. In USA, a 6‐year period study found 17% (533) of children with severe heart failure died, while on the heart transplant waiting list, 63% (1943) received a transplant, 8% (252) were removed from the waiting list due to recovery, and 370 (12%) remained alive on the waiting list at the time the study had finished. ⁴ POT is one of the most common therapies in the management of end‐stage medical diseases, improving survival and life expectancy in up to 80% of patients yet the shortfall of organs limits access. ⁵

From an ethics perspective, there is much precedence for parents not being allowed to refuse standard medical treatment for their young children. For example, JW, as a religious denomination, do not support blood transfusion; however, courts and physicians do not honor JW parental refusal of blood transfusion for their young children. ⁶ As indicated by the landmark 1944 USA case, Prince v Massachusetts, the beliefs of parents cannot be applied to young children to block their access to standard medical treatment, especially life‐saving treatment. ⁷ An interesting case arose recently in Italy whereby a child required cardiac surgery and the parents demanded the use of donor blood which had not been exposed to COVID‐19 vaccination. ⁸ In this case, the court refused to honor the parent's request and assigned temporary guardianship to ensure ongoing, best practice medical care for the child. ⁹ Noting that there are no legally or ethically supported religious/philosophical exemptions for child neglect, ¹⁰ the pediatric Cypriot case raises an interesting matter for exploration: what if parental refusal of their own, personal medical care impacts the health of their children? Could this also be a form of neglect? Admittedly, there is complexity in pediatric care, for the patient/child is often not able to make their own medical decisions and parent(s) and child together can form a decisional unit, with each having their own set of values and opinions. For very young children with unformed value sets, their parent(s) have strong influence on medical decisions which are, in fact, family decisions. Overall, parents in their carer roles need to make decisions in the best interest of their children's health and wellbeing.

1. VACCINATION AS STANDARD OF CARE IN TRANSPLANTATION

Many healthcare systems require several recommended vaccines, including COVID‐19 vaccine, and lifestyle behaviors for organ transplant candidates so as to create the best chance to optimize the patient's survival after transplantation; otherwise, they are not active on the waitlist. ¹¹ Several organ transplant professional societies (American Society of Transplantation, the International Society for Heart and Lung Transplantation, American Society of Transplant Surgeons) have written a joint statement ¹² regarding COVID‐19 vaccination in transplant candidates and recipients. As of 29 November 2021, they strongly recommend (but not mandate) that all eligible children (and adult) transplant candidates and recipients be vaccinated with a COVID‐19 vaccine. Further, they advise that all eligible household and close contacts of SOT recipients should be vaccinated against SARS‐CoV‐2 to minimize risks to the recipient. This optimization facilitates organ stewardship in the setting of a suppressed immune system post‐transplant. A 3Q2021 survey of US transplant centers showed that only 35.7% of hospitals have implemented a COVID‐19 vaccine mandate for transplant recipients. ¹³ The same study reported 42% of responding centers mandated vaccination for living organ donors. Notably, a COVID‐19 vaccine mandate for the transplant recipient's home caregiver/support person or cohabitants was rare (10% and 5%, respectively). Inequities, as well as pressure and concern about legal consequences were reported reasons for not implementing a COVID‐19 vaccine mandate. ¹³

COVID‐19 vaccination should be completed at least 2–4 weeks before the anticipated start of any transplant immunosuppression, as clinically feasible. ¹⁴ While attention has focused on SARS‐CoV‐2, pediatric transplant recipients are vulnerable to other infections as well. It remains imperative that patients receive routine (non‐COVID) vaccines pre‐transplant including diphtheria‐tetanus‐pertussis, inactivated poliovirus, and HPV, and this is best practice globally. ¹⁵ Combination vaccines, accelerated vaccine schedules, and vaccine pre‐planning include possible prioritization of vaccines (e.g., measles‐mumps‐rubella/MMR and varicella 4 weeks prior to transplant) ¹⁴ to optimize pre‐transplant vaccination strategies. If the patient cannot receive COVID‐19 vaccination before transplant, they should be reassessed for vaccination post‐transplant.

Kates et al. ¹⁶ argue “ethical arguments for [COVID‐19] vaccine mandates on the basis of maximizing net utility from transplantation are less robust in the pediatric context.” Ross and Opel ¹⁷ have also made arguments against pediatric COVID‐19 vaccination mandates for transplant. Yet, we do not believe that such mandates are ethically untenable, depending on the situation. Vaccination refusal based on emergency or other preliminary authorizations are no longer tenable arguments. This is because worldwide, more and more health regulatory agencies are approving COVID‐19 vaccines for pediatric use. Currently in USA, there are two approved COVID‐19 vaccines for pediatric use ¹⁸ and neither (Pfizer‐BioNTech nor Moderna COVID‐19 vaccine) are manufactured using cells from aborted fetuses—another potential argument for vaccine refusal. In USA, the Centers for Disease Control and Prevention recommends COVID‐19 vaccination for children ages 6 months and older, and boosters for everyone ages 5 years and older if eligible. ¹⁹ Accordingly, we pose four ethical dilemmas for exploration:

2. DILEMMA A: PARENT REFUSES VACCINATION FOR THEMSELVES

Parents, as adults and custodians of their children, are the legal decision‐makers for their young children and are obligated to make decisions in the child's best interest. Transplant is complex medical specialty which has many stakeholders, including the donor who gave the graft gift, and parents who remain carers ²⁰ on the child's post‐transplant journey. Parents (otherwise clinically eligible) who refuse COVID‐19 vaccination after education efforts willfully increase the clinical risk of the child both pre‐and post‐transplant. Pre‐transplant, children are vulnerable and need to maintain a level of clinical health that allows them access to transplant surgery. Post‐transplant, their immunocompromised status put them at increased risk of infection. Willfully unvaccinated parents are neglectful of these matters, and while they might be willing to have increased personal (themselves) risk of COVID‐19 infection, this places their already clinically fragile child in harm's way. Admittedly, there will be situations where parents could be clinically unable to receive COVID‐19 vaccination; however, these situations will be increasingly rare as there become more vaccine compounds available to accommodate clinical exclusions. In situations where a temporary clinical inability to vaccination would exist for a parent, risk mitigation could be implemented until vaccination was completed (e.g., alternate carers, masking, physical distancing). Denying pediatric transplant adds a burden to the child which is potentially greater than receiving transplant while concurrently being cared for by an unvaccinated parent(s). In the setting of willfully refusing parents, pediatric transplant should be permitted, with a parental behavior contract ²¹ , ²² for post‐transplant risk mitigation (e.g., parental use of masks; their physical isolation if SARS‐CoV2 positive; carer back‐up plan if SARS‐CoV2 positive), as well as on‐going parental counseling post‐transplant to encourage vaccination. Behavior contracts are common in transplantation even though they lack legal weight; this is because they can help to formally set ground rules for a therapeutic alliance promoting transplant success. Ultimately, there is precedence for courts to step in when parents are the blockers or otherwise an impedance for best‐practice medical care for their child. ⁷ , ⁹

3. DILEMMA B: PARENT REFUSES VACCINATION FOR THEIR CHILD

Pediatric shared decision‐making helps improve knowledge and lesson decisional conflict. ²³ Yet, the landmark 1944 USA case, Prince v Massachusetts, affirmed that the beliefs of parents cannot be applied to children to block their access to standard medical treatment. Children who require vaccination as part of routine, standard of care, should have access to such vaccinations. Young children might not understand the concept of vaccination (and might not be receptive to the idea), yet when best practice, vaccination should prevail, especially when it is adjunctive to transplantation. Ultimately, there is precedence for courts to step in when parents are the blockers or otherwise an impedance for best‐practice medical care for their child. ⁷ , ⁹ Some children might directly request their transplant vaccinations, and while they lack the legal capacity to provide informed consent as minors (in many jurisdictions), their wish, even in the setting of parental refusal, should be honored. In fact, in five states in USA (Alabama, California, Delaware, Illinois, and Vermont), minors (12 years or older) are allowed to consent to any medical intervention, including vaccines. ²⁴ , ²⁵

4. DILEMMA C: MATURE MINOR REFUSES VACCINATION

In some regions of the world, teenage children are permitted to make their own medical decisions, including refusing best practice medical care. In a famous case in USA, a 15‐year‐old liver transplant recipient (twice transplanted) was allowed to stop taking his prescribed immunosuppressants, facilitating organ rejection and his death. ²⁶ Ultimately, the court decided not to forcibly medicate the teenager and he was allowed to die at home in the presence of his family. Consider if a teenager approaches for transplant candidacy but willfully refuses COVID‐19 vaccination—should wait listing be denied? This dilemma is ripe for a clinical ethics consultation, ²⁷ as well as consultation by psychiatry, so as to understand the motivation and cognitive capacity of the child in the ethical context of treatment refusal. In this dilemma, informed refusal of COVID‐19 vaccination must be understood in the context of an informed refusal of transplant. Does the child and parent comprehend these matters (the risk of death by excluding transplant as a treatment)? Conservative (high aversion to risk) transplant hospitals might honor the refusing teen's wish, yet still place the child on the transplant waiting list in an effort to potentially prevent death. Indeed, Wightman et al. ²⁸ have argued it is likely that the risks of morbidity or mortality from SARS‐CoV‐2 infection for an unvaccinated pediatric transplant recipient are lower compared to unvaccinated adult recipients, but this is a broad, generalized statement that does not reflect on the evolving nature of the virus and the potential for its variants to effect cohorts differently. Also, COVID‐19 vaccination is a measure to prevent burdensome long‐COVID in immunocompromised transplant patients who are exposed to the immunomodulatory capacity of SARV‐CoV‐2. ²⁹ , ³⁰

Ethically, it is also foreseeable that some transplant hospitals would honor the refusing teen's wish and also in tandem refuse to place the child on the transplant waiting, viewing the mature minor as thereby giving informed refusal to both medical interventions (vaccination, transplant). The latter situation, while likely emotionally taxing for transplant teams, could be justifiable with clearance from psychiatry and the ethics consult service, as well as a legal determination by a court. Conversely, it is also foreseeable that a court could intervene and mandate vaccination and transplantation as well (viewing both as standard of care and in the best interest of a person who is still a child and without the maturity to make their own medical decisions).

5. DILEMMA D: UNVACCINATED LIVING DONOR

For some organ transplants such as liver, kidney, lung, pancreas, and intestine, there is the option of living donation, and parents/relatives often volunteer as donor candidates. What if the best match (or only volunteer) is also refusing COVID‐19 vaccination? Through a joint statement, ¹² several transplant professional societies have strongly recommended that living donors be vaccinated with a minimum of two doses of COVID‐19 vaccine, while also encouraging COVID‐19 vaccine boosters. This aim is to minimize risks for donor ³¹ (as well as viral spread to the recipient). Because living donor transplants are known to produce better outcomes than deceased donor transplants, ³² , ³³ efforts should be made to encourage vaccination and living donation, while also reflecting on the time factor (deceased donor waiting list volume, waiting times, vaccination intervals). In a life‐threatening situation in which the only option is living donation with an unvaccinated donor, preference to save the child via the donation should take precedence, with a donor behavior contract ²⁰ , ²¹ for post‐transplant risk‐mitigation (if the donor is a parent or relative residing with the child or otherwise with close contact with the child), as well as on‐going counseling post‐donation to encourage vaccination. Allowing the child to die on the deceased donation transplant waiting list would be ethically untenable when there is a living donor match available.

6. CONCLUSION

The four dilemmas presented show tension between autonomy and beneficence in pediatric transplantation when there is COVID‐19 vaccination refusal. Confounders include patient age, cognitive ability, clinical situation, dual parental role of caregiver and parent, transplant as a life‐saving intervention, and organs as a scarce resource. Added to these dilemmas is the situation of child and family privacy, litigation risk, and media reporting (which is viral via the Internet) which can impact the image of transplantation and hospitals.

Children are the world's future, and in the setting of organ failure, their future is at risk, savable via transplant, and the protective measure of COVID‐19 vaccination. As with all vaccinations, they are a tool of organ stewardship aimed to optimize outcomes and, in the setting of pediatrics, ensure optimal caregiving for these vulnerable recipients. The harms of being unvaccinated, and risking the harms of COVID‐19 (admitting this differs among virus variants) and long‐COVID post‐transplant, support the ethical permissibility of vaccination mandates in countries where the vaccine has pediatric regulatory approval, noting that there is some flexibility via the use of behavior contracts for unvaccinated parents, as well as vaccination delay when this is clinically appropriate. This paper does not take a legal position on abuse or neglect; however, it is ethically clear that parents who risk their caregiving responsibilities through willful harmful behaviors (i.e., willful vaccine refusal) are showing neglect toward their child needing organ transplant.

AUTHOR CONTRIBUTIONS

Both authors have participated in the conception and design of the paper, drafting and reviewing it, and giving the final approval before submitting to the journal.

FUNDING INFORMATION

No funding was received for this work.

CONFLICT OF INTEREST

Prof Bramstedt is a consultant transplant ethicist at Cedars Sinai Medical Centre (USA). She is also Global Head of Bioethics at Roche; however, this work was conducted prior to her employment at Roche.

Lara Carrion L, Bramstedt KA. Exploring the ethical complexity of pediatric organ transplant candidates and COVID‐19 vaccination: Tensions between autonomy and beneficence, children and parents. Pediatric Transplantation. 2023;27:e14408. doi: 10.1111/petr.14408

DATA AVAILABILITY STATEMENT

There is no data statement.