NOTTO Guidelines for Vaccine Induced Thrombotic Thrombocytopenia in Organ Donation and Transplantation.

From the context of organ donation, COVID-19 vaccine-induced thrombotic thrombocytopenia (VITT) is important as there is an ethical dilemma in utilizing versus discarding organs from potential donors succumbing to VITT. This consensus statement is an attempt by the National Organ and Tissue Transplant Organization (NOTTO) apex technical committees India to formulate the guidelines for deceased organ donation and transplantation in relation to VITT to help in appropriate decision making. VITT is a rare entity, but a meticulous approach should be taken by the Organ Procurement Organization's (OPO) team in screening such cases. All such cases must be strictly notified to the national authorities like NOTTO, as a resource for data collection and ensuring compliance withprotocols in the management of adverse events following immunization. Organs from any patient who developed thrombotic events up to 4 weeks after adenoviral vector-based vaccination should be linked to VITT and investigated appropriately. The viability of the organs must be thoroughly checked by the OPO, and the final decision in relation to organ use should be decided by the expert committee of the OPO team consisting of a virologist, a hematologist, and atreating team. Considering the organ shortage, in case of suspected/confirmed VITT, both clinicians and patients should consider the risk-benefit equationbased on available experience, and an appropriate written informed consent of potential recipients and family members should be obtained before transplantation of organs from suspected or proven VITT donors.

Update on Coronavirus 2019 Vaccine Guidelines for Transplant Recipients.

The coronavirus disease 2019 (COVID-19) vaccine and its utility in solid organ transplantation need to be timely revised and updated. These guidelines have been formalized by the experts-the apex technical committee members of the National Organ and Tissue Transplant Organization and the heads of transplant societies-for the guidance of transplant communities. We recommend that all personnel involved in organ transplantation should be vaccinated as early as possible and continue COVID-19-appropriate behavior despite a full course of vaccination. For specific guidelines of recipients, we suggest completing the full schedule before transplantation whenever the clinical condition permits. We also suggest a single dose, rather than proceeding unvaccinated for transplant, in case a complete course is not feasible. If vaccination is planned before surgery, we recommend a gap of at least 2 weeks between the last dose of vaccine and surgery. For those not vaccinated before transplant, we suggest waiting 4 to 12 weeks after transplant. For the potential living donors, we recommend the complete vaccination schedule before transplant. However, if this is not feasible, we suggest receiving at least a single dose of the vaccine 2 weeks before donation. We suggest that suitable transplant patients and those on the waiting list should accept a third dose of the vaccine when one is offered to them. We recommend that organs from a deceased donor with suspected/proven vaccine-induced thrombotic thrombocytopenia should be avoided and are justified only in cases of emergency situations with informed consent and counseling.

Organ Donation and Transplantation in India in 2019.

OBJECTIVES: In India, organ donation and transplant activities are managed under the National Organ and Tissue Transplant Organisation, established per the mandate of the Transplantation of Human Organs and Tissues Act 1994, as stipulated by World Health Organization guidelines. MATERIALS AND METHODS: The National Organ and Tissue Transplant Organisation reached out to various hospitals and concerned authorities at national, regional, and local levels through E-mails and telephone calls to gather and to analyze 2019 data regarding the World Health Organization-Global Observatory on Donation and Transplantation questionnaire. RESULTS: In 2019, India had 550 transplant centers registered with state-appropriate authorities and 140 nontransplant organ retrieval centers. Most living donors were kidney donors (8613) or liver donors (1993). Of all solid-organ transplants, most were kidney transplants, followed by liver, heart, lung, and pancreas. There were few heart and pancreas transplants in 2019, with higher percentage of female donors (65.4% and 54.3%, respectively, n = 5633 and 1084). Of transplant procedures, there were more living donor transplants (84%, n = 10 600) than deceased donor transplants (16%, n = 2023). Among all organs, wait lists for kidney transplants were higher than for other organs. CONCLUSIONS: Reporting on organ donation and transplant of 2019 from the National Organ and Tissue Transplant Organisation, India's national registry, continued in 2020 despite the challenges of COVID-19. India has been submitting organ donation and transplant data at the national level to the Global Observatory on Donation and Transplantation consistently from 2013 to 2019 and is the only country in the World Health Organization South-East Asia Region to have done so, providing information from all states and union territories in India.

NOTTO COVID-19 Vaccine Guidelines for Transplant Recipients.

In December 2019, novel coronavirus (SARS-CoV-2) infection started in Wuhan and resulted in a pandemic within a few weeks' time. Organ transplant recipients being at a risk for more severe COVID-19 if they get SARS CoV-2 viral infection, COVID-19 vaccine has a significant role in these patients. The vaccine is a safer way to help build protection and would either prevent COVID-19 infection or at least diminish the severity of the disease. It would also reduce the risk of the continuing transmission and enhance herd immunity. Immuno-compromised patients should not receive live vaccines as they can cause vaccine-related disease and hence the guidelines suggest that all transplant recipients should receive age-appropriate 'inactivated vaccine' as recommended for general population. Though trials have not been undertaken on transplant recipients, efficacy and safety of COVID-19 vaccine have been scientifically documented for few vaccines among the general population.

Benefit to Few Versus Risk to Many: An Ethical Dilemma During Coronavirus Disease 2019 Pandemic for Deceased-Donor Organ Transplant in a Resource-Limited Developing Country.

The tools in our armamentarium to prevent the transmission of coronavirus disease 2019, known as COVID-19, are social distancing; frequent handwashing; use of facial masks; preventing nonessential contacts/travel; nationwide lockdown; and testing, isolation, and contact tracing. However, the World Health Organization's suggestions to isolate, test, treat, and trace contacts are difficult to implement in the resourcelimited developing world. The points to weigh before performing deceased-donor organ transplant in developing countries are as follows: limitations in standard personal protective equipment (as approved by the World Health Organization), testing kits, asymptomatic infections, negative-pressure isolation rooms, intensive care unit beds, ventilator support, telehealth, availability of trained health care workers, hospital beds, the changing dynamic of this pandemic, the unwillingness of recipients, education updates, and additional burdens on the existing health care system. This pandemic has created ethical dilemmas on how to prioritize the use of our facilities, equipment, and supplies in the cash-strapped developing world. We believe that, at the present time, we should aim to resolve the COVID-19 pandemic that is affecting a large sector of the population by diverting efforts from deceased-donor organ transplant. Transplant units should conduct case-bycase evaluations when assessing the convenience of carrying out lifesaving deceased-donor organ transplant, appropriately balanced with the resources needed to address the current pandemic.

Deceased-Donor Organ Transplantation in India: Current Status, Challenges, and Solutions.

Tamil Nadu, Gujarat, Telangana, Maharashtra, Kerala, Chandigarh, Karnataka, National Capital Territory of Delhi, and Rajasthan are states and union territories having active deceased-donor organ transplant programs in India. Transplant data (2013-2018) have been collected by the National Organ and Tissue Transplant Organization from all states and union territories of India and submitted to the Global Observatory on Donation and Transplantation. From 2013 to 2018, 49155 transplants were reported in India, including 39000 living-donor organ recipients and 10 155 deceased-donor organ recipients. These transplants were for kidney (living donor = 32584, deceased donor = 5748), liver (living donor = 6416, deceased donor = 2967), heart (deceased donor = 895), lung (deceased donor = 459), pancreas (deceased donor = 78), and small bowel (deceased donor = 8). According to 2018 data, India was the second largest transplanting country in the world in terms of the absolute number of transplants. Here, we discuss the status, progress, challenges, and solutions for deceaseddonor organ transplantation. The plan to increase rates of organ donation in India include the following points: teamwork and focus by intensive care unit doctors; public education on organ donation using social media; professional education and family donation conversation programs for brain death declaration and donor management; organ procurement organizations; international collaboration and regular meetings and updates for organizations working in the field of organ transplantation; grief counseling and reporting of potential donation for families of recently deceased people; nonfinancial incentivization to families of potential organ donors; expert committees and standard operating protocols for use of marginal donor organs, donation after circulatory death programs, and machine perfusion; maintenance of transparency and ethics in organ donation, allocation, and transplantation as directed by governmental, nongovernmental, and intergovernmental entities; and regular audit of progress and registry data.