A Current View of SARS-CoV-2 Vaccine Policies Amongst Pediatric Renal Transplant Centers and Relationships to State Policy

Despite the slight downtrend over the last 10 years, over 800 children were diagnosed with incident end stage renal disease (ESRD) in 2020. ¹ A more pronounced decrease has been seen in first year mortality, with the lowest rates amongst those undergoing renal transplantation. However, even with the >700 pediatric renal transplants per year in the US, the median time on the kidney alone transplant list was 204 days in 2019.^1,2 Traditionally, eligible candidates adhere to the widely accepted CDC recommended immunization schedule leading up to the time of transplant. Post-operatively, the recipients are instructed to abstain from live-virus vaccinations due to their immunocompromised state.

With the onset of the novel SARS-CoV-2 pandemic in early 2020, government agencies implemented extensive isolation procedures to contain the spread while industry leaders sought to develop a successful vaccine. In December 2020, the FDA released its initial Emergency Use Authorization (EUA) for the Pfizer^© mRNA vaccine for use in adults >18 years of age. With further clinical trials, subsequent EUAs were released to include adolescents 12-15 (May 2021) and further extended to include children as young as 6 months (June 2022). However, despite promising data showing a favorable adverse effect profile and similar effectiveness to that of their adult counterparts, significant skepticism remained among parents.

According to their 2021 survey respondents, Hippen et al. demonstrated that 35.7% of US solid organ transplant centers enforced a COVID-19 vaccine requirement prior to transplantation. ³ Beginning in October 2021, the dynamic climate of the pandemic took another turn when multiple states enacted articles of legislation banning vaccination mandates for specific populations. With this, news reports began to arise regarding patients’ dismay when they were denied waitlisting for organ transplantation based on their vaccination status.

Given their vulnerability and inability to consent, children in need of a life-preserving transplant have garnered specific interest. Here, we set out to describe the current landscape of the institutional specific vaccination policies at US pediatric renal transplant centers. Furthermore, we set out to illustrate the relationship of each center’s policy to vaccination regulations set forth by the center’s state government.

In order to obtain information regarding institutional specific vaccination policies, we utilized the Scientific Registry of Transplant Recipients to identify US centers that performed at least one pediatric renal transplant during the January-December 2021 reporting period. Our search included both deceased and living donors. After our cohort was identified, each center’s solid organ transplantation department was individually contacted via phone call and interviewed after verbal consent was obtained. Interviewees included transplant coordinators, attending transplant surgeons, and attending pediatric nephrologists. Each center was encouraged to provide their institutional COVID-19 vaccination requirement policies for eligible pediatric renal transplant candidates. If vaccination was required prior to transplant, centers were further asked to elaborate on vaccine requirements and organ listing status decisions.

Utilizing both The National Academy for State Health Policy^© and the National Conference of State Legislatures^© online databases, state specific legislation regarding COVID-19 policies were recorded, including detailed population (students, state employees, public workers, etc.) vaccine mandates and statewide mandate bans.

Of the 100 identified pediatric renal transplant centers, thirty-six institutions provided their individual policies. Seven (19.4%) centers required eligible candidates to complete a full vaccination series prior to listing, while six (16.7%) centers stated that candidates may be placed on the inactive waiting list with transition to active status upon vaccination. Conversely, most respondents (23, 63.9%) declared no vaccination requirement for transplantation.

As of September 2022, seventeen states had an act of legislation that actively prohibited proof of vaccination as a means of access to governments services. Interestingly, over half (65.2%) of the aforementioned centers without a vaccination requirement were located outside states that prohibited proof of vaccination for access to public government services (Figure 1). This finding suggests that government policy is not the main influential factor when developing institutional policy in our ever-changing climate since the COVID-19 pandemic.

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Figure 1.

Variation of institutional pediatric renal transplant COVID-19 vaccine policies and the relationship to state legislation banning proof of vaccination. 17 total states with bans against proof of vaccination mandates—for receipt of government services (shaded tan) and for customers of local government/business (striped tan). Location of respondent transplant centers with policies denoted by color—vaccination requirement prior to transplantation but allow inactive listing (blue), vaccination requirement prior to listing (red), and those without vaccination requirements (green).

We recognize that our study is limited in multiple facets and fails to illustrate a comprehensive view of the current environment. First, our decreased response rate represents only about one-third of the transplant centers in the country which is likely due to the polarizing nature of the topic. Second, unlike Hippen et al, centers without vaccination requirements were not asked to denote their reasoning for electing to forgo a mandate. Lastly, although our initial search criteria for identification of transplant centers included both deceased and living donors, we did not delineate whether each center’s policies differed based on donor type.

Given their inability to consent, children are fully reliant on their parents/caregivers to make sound medical decisions on their behalf. Those in need of organ transplantation represent an especially vulnerable population, and the long-standing parental hesitancy/medical mistrust surrounding vaccination has been placed in the spotlight over the last 1-2 years. With the introduction of legislations banning vaccination as a requirement to certain services, issues of litigation against transplant centers based on their policies have arisen. In conjunction with the United Network of Organ Sharing, these transplant centers are tasked with responsibly and judiciously allocating limited, life-preserving gifts to help ensure the greatest good.

Limited data currently exists to illustrate the vaccine effectiveness and graft outcomes in pediatric renal transplant recipients, which provides little support for or against vaccination mandates in eligible candidates. In a state of numerous uncertainties and opposing arguments, some have turned to previously established precedents for guidance. Wightman et al. thoroughly describe a vaccine mandate comparison to alcohol abstinence policies with liver transplantation, similarities to the practices of mandatory Hepatitis B immunity in hemodialysis clinics, and wide spanning public school vaccination mandates. ⁴ Here, we have shown the lack of current standardized practice across the country. Although differing policies may preserve autonomy for parents to seek care based on their own morals/preferences, we fear that inequities may be unduly created for those without sufficient resources, such as location, transportation, and finances. While the updated 2014 Organ Procurement and Transplant Network Kidney Allocation System increased eligibility for ESRD patients by including time on dialysis as part of waitlist time upon active listing, vaccine resistant parents with means may be provoked to travel extensive distances for transplantation. However, those in states with substantial social disparities, such as Mississippi, are unable to afford the financial and lifestyle burdens necessitated by ongoing continuity of care.