International Practices on COVID-19 Vaccine Mandates for Transplant Candidates

Purpose: The coronavirus disease 2019 (COVID-19) pandemic has created unprecedented challenges and there are practice differences for solid organ transplant programs worldwide. We sought to assess an international perspective on COVID-19 vaccine mandates and rationales for or against a mandate policy. Method(s): We administered an electronic survey instrument to staff at transplant programs outside the United States (October-November 2021) that comprised of 23 questions addressing the reasons cited by centers for or against implementing a vaccine mandate. Each responding transplant program was represented once in the analysis. Result(s): Respondents (n=63) represented 19 countries on 5 continents. More than half (52.6%) of centers reported implementing a vaccine mandate, however 37.2% reported that their center has not considered (27.1%) or unsure (10.2%) on vaccination requirement. The main rationale for centers not implementing a vaccine mandate were concerns for undue pressure to transplant candidates, equity and legal considerations. (Fig. 1) The main rationale for centers with a vaccine mandate were efficacy of pre-transplant vaccination then post-transplant, importance for public health and minimizing exposure of other patients. (Fig. 2) The majority (79%) of the centers mandate vaccine regardless of prior SARS-CoV-2 infection status, and regardless of pre-vaccination spike-protein antibody titer or other markers or prior infection. Only 24.4% of centers with a vaccine mandate for transplant candidates also extended a vaccine requirement to potential living donors. Conclusion(s): The approach to pre-transplant COVID-19 vaccination mandate is heterogeneous across different countries and centers. More than one third of centers are reluctant to consider vaccine mandates for a varies of reasons including ethical, legal and equity concerns. (Figure Presented).

On the way to mandate booster vaccine dose of coronavirus disease 2019 for transplant recipients: A narrative review of literature

Coronavirus disease 2019 (COVID-19) vaccine efficacy, especially against severe disease is known to wane over time. We examined current knowledge of COVID-19 vaccine booster dose in solid organ transplant recipients (SOTR). We have systematically searched PubMed, EMBASE, MEDLINE, Scopus and Google Scholar with the following MeSH terms: 'SARS-CoV-2 vaccine,' or 'COVID-19 vaccine,' and 'organ transplantation' and 'booster' or 'third dose.' This review article examines a number of studies including guidelines from professional societies examining the safety as well as increased immunogenicity of a booster dose among SOTR. Equitable distribution of vaccines across the globe is the need of the hour. While some countries are well into the booster dose phase, the lower-income countries are languishing behind with primary doses for their health workers. Available reports suggest less efficacy of COVID-19 vaccine in SOTR suggesting booster dose for them. Several studies highlighted the safety and efficacy of COVID-19 vaccines booster dose among SOTR. SOTR should also continue to adhere to all safety and COVID-19 appropriate behaviors. There is a growing need for alternative strategies to improve protection. As Omicron cases rise around the world, India announced that COVID-19 vaccination for children aged 15-18 years and 'precautionary (booster) doses' would be administered to healthcare and frontline workers and people above 60 years of age with comorbidities from January 2022. In near future, with increased availability of vaccinations, all SOTR will have access to booster dose in a phased manner.

Consensus statement on organ donation from COVID-positive deceased donors-Indian Society of Organ Transplantation, Liver Transplant Society of India and Indian Society for Heart and Lung Transplantation

COVID has drastically impacted organ donation across the world, leading to untold misery for thousands of patients who have been waiting for organs. Early rules on the use of organs from COVID positive or affected donors were stringent due to the fear of spread of disease or thrombotic complications in patients who received these organs. However much has changed in the past two years. Most of our adult population has either been infected with COVID, or has received two doses of vaccine, or both. The current variant, despite being more infective, is associated with mild disease, especially in those who have been vaccinated Our armamentarium against severe COVID has improved dramatically in the past year- we have effective vaccines, monoclonal antibodies for treatment of mild COVID in high risk patients and post exposure and antiviral prophylaxis and treatment which can substantially reduce the risk of severe COVID requiring ICU admission. The risk of transmission of COVID infection has to be balanced against the risk of patients dying with end organ disease. We will have to learn to live with COVID- this also means investigating whether organs from donors who are, or have been COVID positive can be used with acceptable risk -benefit in selected patients with end stage organ failure. This document is a summary of evidence and information regarding donor screening for SARS-CoV-2 and considerations for organ acceptance from donors with a history of COVID-19.

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 (NOTTO) as a resource for data collection and ensuring compliance with protocols 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 considered to 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 a treating team. Considering the organ shortage, in case of suspected/confirmed VITT, both clinicians and patients should consider the riskbenefit equation based on limited experience. An appropriate written informed consent of potential recipients and family members should be obtained before the transplantation of organs from suspected or proven VITT donors.

Role of telemedicine in kidney transplant recipient in COVID 19 era

Introduction: Telemedicine represents an innovative but untested approach to maintain patient care and reduce the risk of COVID-19 exposure to patients, health-care workers, and the public. In this study, we evaluated the applicability and efficacy of telemedicine in a kidney transplant recipient (KTR) cohort in COVID 19 era. Materials and Methods: An observational cohort study was conducted at a tertiary-care public-sector kidney disease institute in western India between March and September 2020. We evaluated the reasons, modes, and outcomes of patient contacts by telemedicine in the KTR cohort. We also evaluated the utility of telemedicine across three age groups. Results: Of 840 participants, whose mean age was 38.78 ± 12.39 years, male to female ratio was 4:1. The most common mode of communication was WhatsApp (653, 77.7%) followed by in-person surrogates (126, 15%). Acceptability of telemedicine was significantly better in younger and middle-age groups (P < 0.00001) compared to the elderly. Request for drug delivery (n = 756) was the most common reason for contact overall and managed through postal parcels. KTRs (n = 200) and donors (n = 75) were evaluated for medical illnesses. The most common medical reasons for contact were for febrile illness (n = 120) and graft dysfunction (n = 60). COVID-19-related disease was diagnosed and managed in 80 KTRs and 2 donors. COVID-19 updates were given to all contacts. Conclusion: Telemedicine is underutilized in the care of the KTR cohort. Telemedicine can be used across all ages although it's best suited for young and middle age groups. The impact of telemedicine on short- and long-term patient outcomes is unclear and warrants further study.

Multisystem inflammatory syndrome in an adult associated with coronavirus disease-19 in a renal transplant recipient - A case report

Coronavirus disease (COVID-19) caused by novel coronavirus (SARS-CoV-2) infection is still incompletely understood in transplantation, and there have been a few reports of multisystem inflammatory syndrome in adults (MIS-A) like illness in transplant patients. Herein, we report a case of MIS-A in a renal transplant that ultimately was successfully managed. The case was a 32-year-old man, transplanted 3 years ago, with chronic graft dysfunction and no other comorbidities. He presented with a 3-day history of fever and abdominal pain with no respiratory complaints. The patient had multi-organ involvement in the form of acute pancreatitis, severe diarrhea, acute kidney injury, and shock. Inflammatory markers including D-dimer and C-reactive protein were elevated. Chest radiology showed bilateral haziness on admission. The patient had two consecutive SARS CoV 2 reverse transcription-polymerase chain reaction (RT PCR) tests negative initially but eventually SARS CoV 2 antibody test came positive. The patient was managed initially with broad-spectrum antibiotics, and after confirmation of MIS-A, steroids, intravenous immunoglobulin, and anticoagulation were administered. The patient survived and was discharged on the 29 th day of admission. Our reports highlight that MIS-A should be suspected in atypical cases irrespective of COVID-19 tests and should be confirmed with repeated RT-PCR and SARS-CoV-2 antibody tests. © 2021 Wolters Kluwer Medknow Publications. All rights reserved.

Live kidney donor with a history of COVID-19 infection: When to go for transplant? - A case report

Transplant in COVID era is a challenging task given a paucity of data and limited experience worldwide. A 35-year-old male patient with chronic kidney disease on dialysis for the past 9 months underwent successful living-related donor transplant with his father (aged 64 years) as donor at our center. In this case, donor was diagnosed with reverse-transcription polymerase chain reaction (RT-PCR)-confirmed COVID-19 during evaluation, and he was managed with supportive care and comprehensive social distancing at home. Donor was asymptomatic throughout this period. Interval from positive to negative RT-PCR for nasopharyngeal swab test was 37 days. Interval from negative RT-PCR to kidney transplant was 33 days. Later, recipient and donor were discharged with negative RT-PCR posttransplant. At 71 days of follow-up, both recipient and donor have stable kidney function with normal urinalysis. Hence, prospective donor with a history of COVID-19 infection can be taken for transplant after thorough pretransplant evaluation and having two negative RT-PCR reports after infection, normal imaging, and additional preprocedural negative RT-PCR testing. © 2021 Wolters Kluwer Medknow Publications. All rights reserved.

SOT Consensus Statement for the Kidney Transplant Recipient and Living Donor with a Previous Diagnosis of COVID-19

The National Organ and Tissue Transplant Organization (NOTTO) has previously published transplant-specific guidelines with reference to COVID-19.([1]) The mortality is higher in dialysis patients with COVID-19 (12%-30%) than posttransplant COVID-19 patients (11.3%) and both are higher than the general population (<2%) in India.([2-5]) With the resumption of the kidney transplant program in various parts of India, new issues are expected to occur. There is uncertainty, regarding the safety of performing kidney,([ 6-8]) liver,([9-12]) and lunge([13]) transplantation in a recipient recently recovered from COVID-19. At present, we have limited evidence-based information about safety and feasibility of kidney transplantation from living donors, who have recovered from COVID-19.([4]) Recently, Indian Multi-center cohort studies have reported successful kidney transplantation in recipients from living donors with a previous diagnosis of COVID-19.([15, 16])

Challenges of COVID-19 vaccination in the context of transplantation - A narrative review

Coronavirus disease 19 (COVID-19) vaccination is imperative for preventing disease transmission and combating the associated mortality. Vaccination in the setting of transplantation is a complex issue. Owing to the chronic immunocompromised state in a transplant recipient, the immunogenicity of the vaccines is expected to be attenuated. Immunizing pretransplant patients will also be a challenge, as chronic kidney disease is also an immunocompromised state causing a lower seroconversion rate. The protective immune response generated is also expected to fade earlier. Enumerable psychosocial barriers exist regarding vaccine acceptance and a tender bond between health care providers and patients is essential for the smooth conduct of the vaccination program. The tolerability and safety profile of different available vaccines are reassuring in the general population but more data are needed in transplant communities. In addition, the efficacy data of COVID-19 vaccines are derived from the general population and preliminary reports in transplant patients have shown weakened immune response to vaccination. As of May 2021, Indian government advisories have approved three vaccines: COVIDSHIELD, COVAXIN, and Sputnik. Hence, research on vaccine efficacy with different vaccine constituents, dosing, and intervals is necessary for an effective protocol for vaccination in transplantation. © 2021 Wolters Kluwer Medknow Publications. All rights reserved.

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.

NOTTO COVID-19 vaccine guidelines for transplant recipients

In December 2019 Novel corona virus (SARS-CoV-2) infection started in Wuhan and resulted in a pandemic within 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 atleast 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. © 2021 Indian Journal of Transplantation ;Published by Wolters Kluwer - Medknow.