Transplant and vaccination access a concern for renal patients

Challenges in maintaining the transplantation programme and timing of access to Covid-19 vaccination for end-stage kidney disease patients are being highlighted by advocates and clinicians. Catherine Reilly reports

During 2020, the national kidney transplant programme at Beaumont Hospital, Dublin, was “paused” due to the Covid-19 pandemic. End of year figures (to 28 December) show there were 30 fewer kidney transplants conducted last year compared to 2019 (123 vs 153).

A fall in transplantations is reflected across the national transplant programmes in the Republic. There were nine heart transplants (15 in 2019), 16 lung transplants (38 in 2019), and 37 liver transplants (66 in 2019). While there was a small increase in pancreas transplants (five vs two), this programme had declined some potential donations in 2019 due to manpower deficits.

There were 90 donors (62 deceased and 28 living) in 2020, compared with 110 donors in 2019 (85 deceased and 25 living).

Seven kidney transplants have proceeded in the first 13 days of 2021, according to Dr Colm Magee, Consultant Nephrologist and Co-Director, Transplantation, Urology and Nephrology Directorate, Beaumont Hospital. The transplants were from deceased donors

“For many reasons, it is very difficult to continue a deceased donor and living donor kidney transplant programme during a Covid-19 pandemic,” Dr Magee informed the Medical Independent (MI) on 13 January. “I am pleased to say that the national kidney transplant programme is continuing to perform kidney transplants in situations where the risks are judged to be low – obviously each potential case must be very carefully assessed and discussed with the potential recipient before proceeding.”

Northern experience

Last year, the renal transplant programme in Northern Ireland achieved 101 transplants in 101 days, working from a designated non-Covid-19 hospital (the renal transplant unit at Belfast City Hospital having transferred to Royal Victoria Hospital for these purposes). A greater number of organs became available to the Belfast programme due to reduced activity at other centres in the UK.

Initially, transplanted kidneys came from standard criteria donors, due to the pressures on critical care, but kidneys from extended criteria donors were utilised subsequently.

“We closed down in March for about three weeks, then we realised that actually we were probably okay to keep going, so we opened up again and became the busiest transplant programme in Europe,” Consultant Transplant Surgeon Mr Tim Brown, a strong advocate for north-south collaboration in healthcare, told MI. “We did our first transplant after [the onset of] Covid on 17 April and after that, we did 101 transplants in 101 days.”

Some 159 kidney transplants in total were conducted in 2020. Overall, the patients have done “extremely well”, stated Mr Brown. There was one mortality in the cohort due to community-acquired Covid-19. But, as in the South, the programme has been impacted by surges of SARS-CoV-2 infections in the community. As of mid-January, the Belfast programme was transplanting high priority cases only.

“There are a number of patients on the list, who are very difficult to transplant or highly sensitised, which the list has remained open for,” explained Mr Brown.

“The living donor programme closed last March – but they allowed it to open for paediatric patients as well as the paired exchange scheme – and it still remains closed as far as that is concerned. All elective surgery in Belfast, including cancer surgery, has now stopped.”

Mr Brown said “our hope is that we open our programme fully at the very, very first opportunity that logistics will allow”.

At the Irish Kidney Association (IKA), National Projects Manager Mr Colin White said increasing pressures on intensive care units will affect kidney transplant activity over the coming period.

“It is a time of great anxiety for those who are active on the pool because as long as you have that hope of the phone ringing and getting the call – that sometimes can be what gets the person through a tough time,” he commented.

Approximately 550 people are active on the kidney transplant pool, while over 2,000 people are on dialysis. The number requiring dialysis is rising. In December, the HSE National Renal Office (NRO) stated that a number of patients who have had Covid-19 infection developed end stage kidney disease (ESKD). Most of these patients had pre-existing chronic kidney disease. Combined with the decreased transplant activity, this had led to a 6 per cent increase number of patients requiring renal replacement therapy in the form of dialysis.

Mr White said ESKD is “difficult to come to terms with” due to its significant illness burden. The regular provision of dialysis, its associated fatigue and wider personal impact, mean that removing the hope of a transplant is “obviously tough”. However, feedback from patients is that they generally understand the constraints and safety considerations.

Vaccination

Currently the IKA is strongly advocating for ESKD patients to be re-prioritised for Covid-19 vaccination. The “provisional vaccine allocation groups”, published on 8 December by the Department of Health, designated “people aged 18-64 with certain medical conditions” as the seventh-placed category. Increasingly, patient organisations and clinicians are questioning this level of priority.

The HSE NRO has advocated a heightened priority status for ESKD patients. In particular, the NRO has stated that in-centre haemodialysis patients should be considered on par with the first-ranked priority group (over-65s living in nursing homes).

Shock is the word used quite frequently, in people I have spoken with, when the provisional list was first published

These patients, who are “extremely medically vulnerable and have a very high mortality risk”, cannot cocoon as they must attend hospital facilities for dialysis treatment three times per week. “Published data indicates that the case mortality rate in this patient group is similar to that of residents of long-term care facilities averaging between 20 and 25 per cent,” according to the NRO.

At Beaumont, Dr Magee agrees that in-centre haemodialysis patients “are at increased risk of acquiring severe Covid-19 infection and therefore should be high on the priority list for receiving the Covid-19 vaccine”. As to effectiveness of Covid-19 vaccination in kidney transplant recipients and dialysis patients, there is minimal data as they were not included in the trials. However, Dr Magee stated that he was “optimistic” efficacy will be high based on all the subgroups studied.

He also confirmed it is not yet known if a ‘booster’ injection to the standard schedules may be worthwhile for dialysis patients and transplant recipients. The safety data for the three vaccines currently (or imminently) available to Ireland (Pfizer/BioNTech, Moderna, and AstraZeneca, the latter awaiting European regulatory approval) have been very reassuring, according to Dr Magee. He said he is “strongly advising all my transplant patients to get the vaccine as soon as possible”

However, as these are new vaccines, “we will monitor transplant recipients appropriately”. Ideally, people on the kidney waiting list would be vaccinated before transplant “and we are working on this”, stated the nephrologist.

Commenting on vaccine access, Mr Brown would consider the vulnerability of in-centre haemodialysis patients as akin to over-80s, who are second on the UK vaccination priority list alongside frontline health and social care workers. Organ recipients and dialysis patients are in the fourth category, as people who are “clinically extremely vulnerable”, alongside over-70s.

“The thing is the over-80s are vulnerable, yes, but they are able to shield,” Mr Brown noted. “Dialysis patients are not able to shield by virtue of the fact they are in hospital three times a week dialysing. So they are super vulnerable, but also super exposed.”

In the Republic, many at-risk patients are confused and concerned about the provisional vaccination priority list, according to Mr White at the IKA. In December, a submission led by the Irish Platform for Patient Organisations, Science and Industry (IPPOSI) stated that people with chronic and/or rare diseases, of all ages, should be treated as the highest priority in determining early vaccine recipients. It also called for urgent dialogue and input from patient organisations to be accommodated.

“I have had a number of interesting phone calls from patients, and not only kidney patients, in the last few days,” said Mr White, who was speaking to MI on 13 January. “The common thread from each of those calls was ‘we were on a par with the over-70s when it came to cocooning, but when it comes to vaccination, for some reason we have been dropped way down the priority list’.”

Having cocooned for the best part of a year, feelings were stirred by the publication of the vaccination list. “The emotions are starting to build in relation to this. Shock is the word used quite frequently, in people I have spoken with, when the provisional list was first published,” said Mr White.

He said a number of patients are keenly aware of international data indicating a mortality rate of around 21 per cent for transplant recipients and 25 per cent for people on dialysis, when infected with Covid-19.

“From our perspective it is very encouraging that the National Renal Office have been very unambiguous in their statement, saying renal patients need to be the same level of priority as nursing home residents.

“But equally, if we look outside the country, the American Society of Nephrology is saying the same thing, the British Transplantation Society is saying the same thing. The general feeling from the medical fraternity is, it makes sense to give priority to this particular group, it is not just a patient organisation feeling, ‘well our people are the most special.’ It is the medically-qualified people saying ‘there is a very strong reason’.” for reprioritisation.

A Department spokesperson told MI on 12 January: “The priority is to first vaccinate and protect directly the most vulnerable amongst us, that is, those most likely to have a poor outcome if they contract the virus.

“The priority is to directly use vaccines to save lives and reduce serious illness, hence the focus on the over-65-year-old cohort in long-term residential care facilities, and healthcare workers in frontline services often caring for the most vulnerable. 

“All of the groups will be covered as further vaccine supplies become available and the immunisation programme is rolled out nationally.
“The evidence will be kept under review and the allocation groups may be updated, where necessary, in light of new evidence.”