SPECIAL ARTICLE

Year : 2021  |  Volume : 15  |  Issue : 1  |  Page : 1-3

NOTTO COVID-19 vaccine guidelines for transplant recipients

Vivek Kute¹, Sanjay K Agarwal², Jai Prakash³, Sandeep Guleria⁴, Sunil Shroff⁵, Ashish Sharma⁶, Prem Varma⁷, Narayan Prasad⁸, Manisha Sahay⁹, Subhash Gupta¹⁰, S Sudhindran¹¹, Kewal Krishan¹², Vasanthi Ramesh¹³, Sunil Kumar^14
1 Department of Nephrology, Institute of Kidney Diseases and Research Center; Dr. H L Trivedi Institute of Transplantation Sciences (IKDRC-ITS), Ahmedabad, Gujarat; Secretary, Indian Society of Organ Transplantation (ISOT), Delhi, India
² Department of Nephrology, All India Institute of Medical Sciences, Delhi, India
³ Former Professor and Head Nephrology, Banaras Hindu University, Varanasi, Uttar Pradesh; President, Indian Society of Organ Transplantation (ISOT), Delhi, India
⁴ Department of Transplantation Surgery, Apollo Hospital; Past President, Indian Society of Organ Transplantation (ISOT), Delhi, India
⁵ Managing Trustee, MOHAN Foundation, Chennai, Tamil Nadu; President-Elect, Indian Society of Organ Transplantation (ISOT), Delhi, India
⁶ Department of Transplant Surgery, The Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India
⁷ Department of Nephrology, Venkateshwar Hospital, Delhi, India
⁸ Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
⁹ Department of Nephrology, Osmania Medical College, Hyderabad, Telangana, India
¹⁰ Department of Liver Transplant Surgery, Max Center of Liver and Biliary Sciences at Max Hospital, Saket, Delhi; Past President, Liver Transplant Society of India (LTSI), Kochi, Kerala, India
¹¹ Clinical Professor in Transplantation and Gastrointestinal Surgery, Amrita Institute of Medical Sciences and Research Centre, Kochi, Kerala; President, Department of Cardiovascular Surgery Max Super Specialty Hospital, Saket, New Delhi, India
¹² Department of Cardiovascular Surgery Max Super Specialty Hospital, Saket, New Delhi; President, Indian Society for Heart and Lung Transplantation, Delhi, India
¹³ Director, National Organ and Tissue Transplant Organization, Delhi, India
¹⁴ Director General of Health Services, Delhi, India

Correspondence Address:
Dr. Vasanthi Ramesh
Director, National Organ and Tissue Transplant Organization, 4^th Floor, National Institute of Pathology, NIOP Building, Safdarjung Hospital Campus, New Delhi - 110 029
India

Source of Support: None, Conflict of Interest: None

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.

Keywords: NOTTO, COVID 19 vaccine, Guidelines, transplant recipients

Introduction

1. Risk of acquiring COVID-19 infection goes down substantially
2. Risk of having severe COVID disease even if one acquires the infection is substantially reduced
3. The risk of continuing transmission to others will decrease
4. Vaccine will help in the faster development of herd immunity.

Rationale and General Principle for the Vaccination

1. Patients with immunosuppression may have reduced response to vaccination because of altered T-lymphocyte functions. These patients may have lower antibody responses compared to the general population. Antibody response usually correlates with the degree of immunosuppression
2. In general, in immunocompromised patients, live vaccines can cause vaccine-related disease; therefore, patients with organ transplants should not receive live vaccines.^{[10],[11],[12]} Kidney Disease: Improving Global Outcomes and American Society of Transplantation-Infectious Disease Community of Practice guidelines suggest that all transplant recipients should receive age-appropriate “inactivated vaccine” as recommended for the general population^[13],[14]
3. Efficacy and safety of COVID-19 vaccine have been scientifically documented only for few vaccines and many are still under clinical trial.^{[15],[16],[17],[18]} Initial trial of COVID-19 vaccine had included healthy volunteers, and patients with comorbidity but trials on transplant recipients have not been done till the publication of these guidelines
4. Participating recipients can have minor side effects as seen in many other vaccines such as vaccine site pain, fever, fatigue, muscle and joint pain, and headache after administration of COVID-19 vaccine. These side effects do not mean vaccines are unsafe. Severe or long-lasting side effects are extremely rare. In addition, COVID-19 vaccines are continuously being monitored for safety in postmarketing surveys to detect rare adverse events
5. In cases of any adverse event, the transplant patient is required to report to health-care providers for appropriate management. After the completion of COVID-19 schedule, routine antibody testing is not required to confirm seroconversion. If needed for research, antibody testing can be done after 14 days of the second dose
6. More studies are required to document energy, duration of immunity, and requirement of a booster dose in case no antibodies develop. [Table 1] shows details of few common regulatory bodies' approved COVID-19 vaccine.

Table 1: Types of COVID-19 vaccines Click here to view

COVID-19 Vaccine Guidelines

1. We recommend that all transplant team members should support and encourage appropriate uptake of vaccine by counseling transplant recipients and addressing vaccine hesitancy
2. We recommend using virtual platforms for information related to COVID-19 vaccine for all transplant team members, who are a major source of information for the transplant recipient community
3. Based on other vaccine guidelines for solid organ transplant recipients,^{[11],[12],[13],[14],[15]} we suggest that transplant recipients and their household members should get vaccinated against any COVID-19 vaccine that is authorized or approved by their health regulators/agencies. Transplant recipients scheduled for transplantation should be given vaccine 2 weeks prior to surgery or 1 to 6 month posttransplant.^[13],[14] Even after vaccination, COVID-19 appropriate behaviors such as wearing face mask, hand hygiene, cough etiquettes, and social distancing should be continued by all recipients
4. Transplant recipients who have previous COVID-19 infection and or have antibodies against COVID-19 are also required to be vaccinated. There is no need of testing for antibodies against coronavirus before giving COVID-19 vaccination. Transplant recipients should undergo an entire schedule of vaccination with only one type of vaccine and different COVID-19 vaccines should not be used in the same patient. In case, a transplant recipient misses the second dose of COVID-19 vaccine at the scheduled time, then the second dose is to be given as early as possible. Revaccination is not required
5. Transplant patients with suspected or active SARS-Cov2 infection should not get the vaccination. Vaccination should be deferred for 4–8 weeks after symptom resolution
6. Please see the details of COVID-19 vaccine operational guidelines updated as of December 28, 2020.^[2],[3],[22]

References

1.	Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html. [Last accessed on 2021 Jan 14].
2.	Available from: https://www.mohfw.gov.in/pdf/COVID19VaccineOG111 Chapter 16.pdf. [Last accessed on 2021 Jan 14].
3.	Available from: https://www.mohfw.gov.in/pdf/Covid19Communication Strategy2020.pdf. [Last accessed on 2021 Jan 14].
4.	American Society of Transplantation, Transplant Capacity and Early Vaccine Recommendations. Available from: https://www.myast.org/sites/default/files/2020%2012%2008%20COVID19%20VACCINE%20FAQS_FINAL.pdf. [Last accessed on 2021 Jan 14].
5.	COVID-19 Vaccination for Adult Patients with Kidney Disease: A Position Statement from the UK Renal Community. Available from: https://britishrenal.org/covid-19-vaccination-for-adult-patients-with-kidney-disease/. [Last accessed on 2021 Jan 14].
6.	Guidance from the International Society of Heart and Lung Transplantation Regarding the SARS CoV-2 Pandemic. Available from: https://ishlt.org/ishlt/media/documents/SARS-CoV-2_Guidance-for-Cardiothoracic-Transplant-and-VAD-center.pdf. [Last accessed on 2021 Jan 14].
7.	Taking Immunosuppressants? Fauci Says Get the COVID-19 Vaccine. Available from: https://www.ajmc.com/view/taking-immunosuppressants-fauci-says-get-the-covid-19-vaccine. [Last accessed on 2021 Jan 14].
8.	Kute VB, Bhalla AK, Guleria S, Ray DS, Bahadur MM, Shingare A, et al. Clinical profile and outcome of COVID-19 in 250 kidney transplant recipients: A multicenter cohort study from India. Transplantation 2020;Publish Ahead of Print. doi: 10.1097/TP.0000000000003593. Online ahead of print.
9.	Raja MA, Mendoza MA, Villavicencio A, Anjan S, Reynolds JM, Kittipibul V, et al. COVID-19 in solid organ transplant recipients: A systematic review and meta-analysis of current literature. Transplant Rev (Orlando) 2021;35:100588.
10.	Craig-Schapiro R, Salinas T, Lubetzky M, Abel BT, Sultan S, Lee JR, et al. COVID-19 outcomes in patients waitlisted for kidney transplantation and kidney transplant recipients. Am J Transplant 2020. doi: 10.1111/ajt.16351. Epub ahead of print. PMID: 33043597; PMCID: PMC7675359.
11.	Guidelines for vaccination in kidney transplant recipients. Indian J Nephrol 2016;26 Suppl S1:19-25.
12.	Stucchi RSB, Lopes MH, Kumar D, Manuel O. Vaccine recommendations for solid-organ transplant recipients and donors. Transplantation 2018;102:S72-80.
13.	Cordonnier C, Einarsdottir S, Cesaro S, Di Blasi R, Mikulska M, Rieger C, et al. Vaccination of haemopoietic stem cell transplant recipients: Guidelines of the 2017 European Conference on Infections in Leukaemia (ECIL 7). Lancet Infect Dis 2019;19:e200-12.
14.	Summary of Recommendation for Vaccination in Kidney Transplants. Available from: https://kdigo.org/wp-content/uploads/2018/08/KDIGO-Txp-Candidate-GL-FINAL.pdf. [Last accessed on 2021 Jan 14].
15.	Danziger-Isakov L, Kumar D, AST ID Community of Practice. Vaccination of solid organ transplant candidates and recipients: Guidelines from the American society of transplantation infectious diseases community of practice. Clin Transplant 2019;33:e13563.
16.	Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med 2020;383:2603-15.
17.	Safety and Immunogenicity Clinical Trial of an Inactivated SARS-CoV-2 Vaccine, BBV152. Available from: https://clinicaltrials.gov/ct2/show/NCT04471519. [Last accessed on 2021 Jan 14].
18.	Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): A single-blind, randomised, controlled, phase 2/3 trial. Lancet 2021;396:1979-93.
19.	The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020. Available from: https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e1.htm. [Last accessed on 2021 Jan 14].
20.	Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency Approval of COVID-19 Virus Vaccine. Available from: https://pib.gov.in/PressReleseDetail.aspx?PRID=1685761. [Last accessed on 2021 Jan 14].
21.	Ministry of Health and Family Welfare Guidelines for Vaccination in COVID19. Available from: https://www.mohfw.gov.in. [Last accessed on 2021 Jan 14].
22.	Available from: https://www.mohfw.gov.in/pdf/LetterfromAddlSecy MoHFWregContraindicationsandFactsheet forCOVID19vaccines.pdf. [Last accessed on 2021 Jan 16].