A Colorado kidney transplant candidate who was bumped to inactive status for failing to get vaccinated against Covid-19 has become the most public example of an argument roiling the country's more than 250 organ transplant centers.
Across the country, growing numbers of transplant programs have chosen to either bar patients who refuse to take the widely available Covid vaccines from receiving transplants or to give them lower priority on crowded organ waitlists. Other programs, however, say they plan no such restrictions — for now.
At issue is whether transplant patients who refuse the jabs are not only putting themselves at greater risk for serious illness and death from Covid infections, but also squandering scarce organs that could benefit others. The argument echoes the demands that smokers quit cigarettes for six months before they receive lung transplants or that addicts refrain from alcohol and drugs before they receive new livers.
"It is a matter of active debate," said Dr. Deepali Kumar, an expert in transplant infectious diseases at the University of Toronto and president-elect of the American Society of Transplantation. "It's really an individual program decision. In many programs, it's in flux."
Leilani Lutali, 56, a late-stage kidney disease patient from Colorado Springs, Colorado, learned in a Sept. 28 letter from UCHealth in Denver that if she didn't begin a Covid vaccine series within 30 days, she would lose her spot on the transplant waiting list. Both she and her donor, Jaimee Fougner, 45, of Peyton, Colorado, refused to get vaccinated, citing religious objections and uncertainty about the safety and effectiveness of the vaccines.
"I have too many questions that remain unanswered at this point. I feel like I'm being coerced into not being able to wait and see and that I have to take the shot if I want this lifesaving transplant," Lutali said.
She said she offered to be tested for Covid before the surgery or to sign a waiver absolving the hospital of legal risk for her refusal of a vaccine. "At what point do you no longer become a partner in your own care regardless of your own concerns?" she said.
Lutali now hopes to take her transplant quest to Texas, where several hospitals, including Houston Methodist and Baylor University Medical Center in Dallas, said they don't require Covid vaccinations to approve active candidates for the national waiting list.
The difference between policies in Denver and Texas — and elsewhere — underscores a tense national divide. As of late April, fewer than 7 percent of transplant programs nationwide reported having inactivated patients who were unvaccinated or were partly vaccinated against Covid, according to research by Dr. Krista Lentine, a nephrologist at the Saint Louis University School of Medicine.
But that was just a snapshot in late spring, and like all Covid-related practices, it's "rapidly changing," Lentine said.
UCHealth in Denver began requiring Covid vaccinations for transplant patients in late August, citing the American Society of Transplantation's recommendation in August that "all solid organ transplant recipients should be vaccinated against SARS-CoV-2," the formal name of the coronavirus that causes Covid-19.
The immune systems of patients who undergo transplant surgery are artificially suppressed during recovery, to keep their bodies from rejecting the new organs. That puts unvaccinated transplant patients at "extreme risk" of severe illness if they are infected by the coronavirus, with mortality rates estimated at 20 percent to 30 percent, depending on the study, said Dan Weaver, a spokesperson for UCHealth. For the same reason, transplant patients who receive Covid vaccines after surgery may fail to mount strong immune responses, research has found.
We mandate hepatitis and influenza vaccines, and nobody has an issue with that.
UW Medicine in Seattle began mandating Covid vaccinations this summer, said Dr. Ajit Limaye, director of the solid organ transplant infectious diseases program. Patients were already required to meet other stringent criteria to be considered for transplantation, including receiving inoculations against several illnesses, such as hepatitis B and influenza.
"For anyone who does not have a medical contraindication, basically we're requiring it," he said. "There's a very strong sense to make it a requirement, like all the other hoops, straight up."
By contrast, Northwestern Medicine in Chicago, where doctors performed the first double-lung transplant on a Covid patient in June 2020, is encouraging — but not requiring — vaccination against Covid-19.
"We don't decline care of transplant based on vaccine status," said Jenny Nowatzke, Northwestern's manager of national media relations. "The patient also doesn't get any lower scores."
The lack of consistent practice across programs sends a mixed message to the public, said Dr. Kapilkumar Patel, director of the lung transplant program at Tampa General Hospital in Florida, where Covid vaccinations aren't required.
"We mandate hepatitis and influenza vaccines, and nobody has an issue with that," he said. "And now we have this one vaccination that can save lives and make an impact on the post-transplant recovery phase. And we have this huge uproar from the public."
Nearly 107,000 candidates are waiting for organs in the U.S.; dozens die every day still waiting. Transplant centers evaluate which patients are allowed to be placed on the national list, taking into account medical criteria and other factors, such as financial means and social support to ensure that donor organs won't fail.
"We really make all kinds of selective value judgments," said Dr. David Weill, former director of Stanford University Medical Center's lung and heart-lung transplant program, who now works as a consultant. "When we're selecting in the committee room, I hear the most subjective, value-based judgments about people's lives. This is just another thing."
The centers can choose to place candidates on inactive status for a variety of reasons, including medical noncompliance, according to data from the United Network for Organ Sharing, or UNOS, which oversees transplants. As of Sept. 30, that category accounted for 738 of more than 47,000 registrants waiting in inactive status, although it's not clear how many of the inactive statuses are tied to vaccination status.
A particularly thorny question involves unvaccinated people who need transplants specifically because Covid infections destroyed their organs. As of late last month, more than 200 lungs, as well as at least six hearts and two heart-lung combinations, had been transplanted for Covid-related reasons in the U.S., according to UNOS data.
Many of the organs were transplanted earlier in the pandemic, before any Covid vaccine was widely available. That's no longer the case, Weill said. "If you're just now getting vaccinated, you've done it at gunpoint, actually," he said. "It's not just a personal choice. They're making some kind of a statement."
Such patients are usually younger and healthier than other transplant candidates, aside from the Covid-related damage, and they're often acutely ill enough to go to the top of any transplant list. "The sick Covid patient might go ahead of the stable cystic fibrosis patient," Weill said.
Patel of Tampa General said he performed a lung transplant on a patient who was transferred to Florida after having been delisted at another center because he wasn't vaccinated for Covid. "I mandated with him basically on a handshake that he will get his vaccine post-transplant," Patel said. "But his family? They haven't agreed."
Patel said he thanks that, eventually, nearly all transplant programs will mandate Covid vaccinations, largely because transplant centers are evaluated on the longer-term survival of their patients.
"I think it's going to spread like wildfire across the country," he said. "If you start losing patients in a year due to Covid, it will be mandated sooner rather than later."