South African Transplant Society

COVID-19 VACCINATION

Position Statement on COVID-19 Vaccination in South Africa

The South African Transplantation Society (SATS) recommends that all patients for organ transplantation, healthcare professionals in transplant teams, and family members be vaccinated against COVID-19.

We recognize and advocate for the use of vaccines in the prevention of COVID-19 infections. There is clear scientific evidence for the use of vaccinations to reduce the risk of both hospitalization and death in COVID-19 infections, with the benefit of vaccination far outweighing its risk.

The mortality rate for transplant recipients from COVID-19 is reported to be 20%, which is 10-fold higher than the general population (1), due to their need for lifelong immunosuppression medication.

With such a scarce resource such as organs for transplantation, there is an ethical obligation to ensure that the gift of donation is used in the best way possible and for maximum benefit. Given the ongoing extreme shortage of donors, transplant centers will consider COVID-19 positive deceased donors as potential donors given early favorable results of transplants from selected COVID-19 positive donors. (2)

As such, transplant centers require patients to demonstrate adherence to optimum medical therapy prior to surgery and that patients undertake to continue such therapy after transplantation. Adherence to best medical therapy (e.g., for diabetes and hypertension), being fully vaccinated including booster doses (e.g., against hepatitis B), abstinence from alcohol consumption (in cases of alcoholic liver cirrhosis) are already established as routine in a transplant assessment and work-up.

Transplant centers should appropriately counsel patients and their donors about their need for COVID-19 vaccination. They should play an active role in ensuring that misinformation and vaccine hesitancy are appropriately addressed as part of that work-up. For children receiving transplants, it is important that family members are also fully vaccinated.

Further information:

Currently in South Africa there are two SARS-CoV-2 vaccines being used in the national vaccine program: the Pfizer-BioNTech and the Johnson & Johnson vaccines. The Pfizer-BioNTech vaccine is an mRNA vaccine that is given as two doses separated by 21 days. The Johnson & Johnson vaccine is an adenovirus-vectored DNA vaccine given as a single dose.

Both were evaluated in randomized controlled trials involving over 40,000 participants to evaluate efficacy and safety before being used in vaccine programs. In these trials, the Pfizer-BioNTech vaccine resulted in a 95% reduction in COVID-19 infections (3). A similar reduction in cases of severe COVID-19 was observed. The Johnson and Johnson vaccine resulted in an 85% reduction in severe-critical COVID-19 (4). Even with the spread of the delta variant of the virus, both vaccines remain highly effective at preventing severe COVID-19 that results in hospital admission and death.

Mild side effects are common with all SARS-CoV-2 vaccines and reflect the immune system being stimulated by the vaccine. Severe side effects have been reported in a transparent manner during the trials and during programmatic use but are exceptionally rare. The overwhelming benefits of vaccination in terms of preventing death from COVID-19 far outweigh the risks of these rare severe side effects.

As a professional society, we therefore strongly recommend the use of vaccination for COVID-19 and would encourage all people (including transplant recipients) to be vaccinated and so help protect themselves and others.

References:

M. Alfishawy et al. Int J Org Transplant Med 2020; Vol. 11 (4): p145-162
Gupta G, Azhar A, Gungor A, Molnar MZ. Early Data on Utilization and Discard of Organs From COVID-19 – infected Donors: A US National Registry Analysis. 2022;00(00):19-21. doi:10.1097/TP.0000000000004091
Polack, Fernando P., et al. "Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine." New England Journal of Medicine (2020).
Sadoff, Jerald, et al. "Safety and efficacy of single-dose Ad26. COV2. S vaccine against Covid-19." New England Journal of Medicine 384.23 (2021): 2187-2201.

Kind regards,

Dr David Thomson - SATS President, on behalf of the EXECUTIVE COMMITTEE

11 July 2022

Dr David Thomson – SATS President, on behalf of the EXECUTIVE COMMITTEE

Downloadable Version

Blood Group Incompatible (ABOi) Transplantation

Statement of the South African Society of Transplantation

Date: 11 May 2023

Introduction and Context

There is a global organ shortage resulting in many patients dying on transplantation wait lists. This has resulted in the development of numerous alternative clinical techniques to increase the availability of donor organs. The use of blood group incompatible organs from both deceased donor and living donors is a well validated and safe method for improving both access to transplantation and the number of transplants to be performed. In the era of improved pharmacotherapies such as the availability of the CD-20 monoclonal antibody Rituximab, improvements in isoagglutinin control and testing, ABOi transplantation is safe and results in equivalent patient and graft survival when compared to blood group compatible transplantation.

Purpose of this statement

To inform the circumstances and contexts under which ABOi transplantation can be considered
To advise on best practice principles through which ABOi transplantation should be performed at transplant centres
To propose a centralised, national platform for the development of treatment protocols, the collection of data and the development of new methodologies, techniques, and pharmacotherapies as they pertain to ABOi transplantation to ensure that a standardised and consistent baseline for care is established in South Africa

Context and Clinical Circumstances under which ABOi should be considered

ABOi transplantation can be considered in the following circumstances, provided there is informed consent from the patient or their surrogate, and a standardised institutional protocol for ABOi transplantation exists:

In all solid organ recipients where there is the availability of a deceased donor ABOi organ, and when there is no better suited compatible recipient of the same blood group, and where the risk of denying access to transplantation is outweighed by the benefit to patient survival.
In the acute organ failure setting where a viable living donor option exists, and there is no viable or available ABO compatible living donor or deceased donor, and where the risk of denying access to transplantation is outweighed by the benefit to patient survival.
In the elective setting where there is no available ABO compatible living donor
Where the recipient has a viable and available ABOi donor where the treating clinical team deems there to be no clinical contraindications to treatment and the option of a paired exchange has been explored.

These options should also be considered in children and adolescents in centres who have experience with this.

ABOi transplantation should not be considered at this time in the following situations:

If the recipient has a viable and available deceased donor or living donor ABO compatible donor offer
In the setting of donation after circulatory death (DCD)
If the measured isoagglutinin titre using the dithiothreitol (DTT) treatment of plasma method is greater than 512 for the donor organ blood type
If there is not informed consent
If there is no standardised protocol for the management of ABOi transplantation at the institution offering the transplant

Protocol Development and Data Collection

Institutions must develop institutionally contextualised and agreed upon protocols for the management of ABOi transplantation in their centre in line with accepted international standards
Such protocols should be available for review
We recommend the establishment of a National ABOi solid organ patient database for improving access and quality of ABOi transplantation for the South African population.

Best Practice Principals

We recommend the use of a separate ABOi consenting process and form for recipients of ABOi organs which outlines the processes and risks associated with ABOi transplantation.
We recommend the use of both PBS and Dithiothreitol (DTT) validated isoagglutinin testing for the estimation of IgG and IgM anti-A and anti-B antibody titres in recipient plasma samples.
We recommend that institutional protocols utilise either plasmapheresis techniques and/or immunoadsorption columns for the pre- and post-operative control of isoagglutinin titres in recipients of ABOi solid organ transplants and that the safety and efficacy of the techniques in question must consider individual as well as institutional factors such as bleeding risk, haemodynamic compromise, cost and availability.
We recommend that the protocolised care of ABOi recipients include the use of the CD20 monoclonal antibody therapy Rituximab.
We do not recommend the routine use of splenectomy as a method to control isoagglutinin levels in recipients of ABOi solid organ transplantation.
Immunosuppression regimens and immunomodulatory techniques and protocols must be adaptable to the individual patient requirements and treatment runs.

Conclusion

ABOi transplantation is a viable alternative for solid organ recipients and must be performed by experienced and well-trained clinical teams. The use of ABOi organs is safe and results in improved access to and availability of transplantation.

References

Lee EC, Kim SH, Park S, Lee EC, Kim SH, Park S. Outcomes after liver transplantation in accordance with ABO compatibility: A systematic review and meta-analysis. 2017;23(35):6516–33.
Yadav DK, Hua YF, Bai X, Lou J, Que R, Gao S, et al. Review Article ABO-Incompatible Adult Living Donor Liver Transplantation in the Era of Rituximab: A Systematic Review and Meta-Analysis. 2019;2019.
Geyer M, Fischer KG, Drognitz O, Walz G, Pisarski P, Wilpert J. ABO-incompatible kidney transplantation with antigen-specific immunoadsorption and rituximab - Insights and uncertainties. Contrib Nephrol. 2009; 162:47–60.
de Magnée C, Brunée L, Tambucci R, Pire A, Scheers I, Sokal EM et al. Is ABO-Incompatible Living Donor Liver Transplantation Really a Good Alternative for Pediatric Recipients? Children. 2021;8(7):600.
Peruhova M, Georgieva V, Yurukova N, Sekulovska M, Panayotova G, Mihova A, et al. ABOnonidentical liver transplantation from a deceased donor and clinical outcomes following antibody rebound: A case report. World J Transplant. 2020;10(5):138–46.

Contact Information

Prof Mignon McCulloch
Tel: +27(0)827804097
Email: mignon.mcculloch@uct.ac.za
President of South African Transplant Association (SATS)