Quick Tips and Considerations for COVID-19 Vaccination in Heart Failure and Transplant Patients
- Patients with heart failure and heart transplantation may be at increased risk of mortality from COVID-19 due to co-morbidities and immunosuppression.
- Based on available data, there does not appear to be safety concerns for the administration of the SARS-CoV-2 mRNA vaccines in transplant recipients.
- While data is forthcoming, the efficacy of the SARS-CoV-2 vaccines may be reduced based on historical experience of vaccines in transplant recipients but given the risk of COVID-19 morbidity and mortality, it is recommended transplant recipients receive a SARS-CoV-2 mRNA vaccine.
It has been nearly a year since the World Health Organization declared SARS-CoV-2/COVID-19 as a global pandemic on March 11, 2020. While a large number of SARS-CoV-2 infections result in mild symptoms, the overall death toll is staggering with nearly 2.9 million deaths worldwide and over 500,000 deaths in the United States alone as of February 27th, 2021.1 Underlying co-morbidities such as diabetes, hypertension, and cardiac or pulmonary disease, significantly increase the risk of death due to COVID-19. In fact, an early systematic review and meta-analysis found a case fatality rate (CFR) of 12-14% for patients with two to five co-morbidities, nearly double the baseline CFR of 7%.2
Patients with heart failure and those who have undergone heart transplantation may be at increased risk of mortality from COVID-19 due to co-morbidities and immunosuppression.3 As vaccines for COVID-19 have recently become available, many providers are receiving questions regarding vaccine recommendations for this population. The International Society for Heart and Lung Transplantation (ISHLT) and the American Society for Transplantation (AST) have both released guidance regarding COVID-19 vaccination in patients with chronic heart or lung failure and those who have undergone thoracic transplantation.3,4
- There are two available COVID-19 vaccines available in the United States, the Moderna and Pfizer-BioNTech mRNA vaccines, with other vaccines in various stages of development and review. While recipients of organ transplants were excluded, the mRNA vaccine trials otherwise showed 94-95% overall efficacy with efficacy of ≥86% (Moderna) and ≥92% (Pfizer-BioNTech) observed across age, sex, race, and ethnicity categories and among persons with underlying medical conditions. No specific safety concerns were identified in subgroup analyses by age, race, ethnicity, underlying medical conditions, or previous SARS-CoV-2 infection.5,6
- As transplant recipients were not included in the large vaccine trials, there is currently little data on efficacy, safety, or durability in this population. Preliminary data from an observational study of 187 transplant recipients having received the first dose of the Pfizer-BioNTech or Moderna mRNA vaccine showed rates of adverse events expected with vaccine reactogenicity such as injection-site pain (61%), fatigue (38%), headache (32%), myalgias (15%), and fever/chills (4%/9%). Importantly, in the initial short-term follow up there were no reported cases of acute rejection, neurological diagnoses (Guillain-Barré syndrome, Bell's Palsy, or neuropathy) or allergic reactions requiring epinephrine.7 Further data, including post-vaccine antibody production, will be forthcoming from this observational study.
- The risk of COVID-19 morbidity and mortality is high in transplant recipients and the risks of COVID-19 vaccination appear to be low despite likely reduced vaccine efficacy, thus the AST and ISHLT have recommended vaccination of both patients with heart failure as well as heart transplant recipients.3,4
- The ISHLT and AST recommend that patients receive the COVID-19 vaccine prior to transplantation when possible. While it is preferred that patients would complete the vaccine series 2 weeks or more prior to transplantation, transplantation should not be routinely delayed.3,4 If patients with heart failure undergo heart transplantation and have only received one vaccine of the series, there is no data regarding optimal timing to receive the second vaccine after transplantation. Similar to post-transplant vaccine timing, it is currently recommended patients receive the second vaccine at least 1 month after transplantation.3,4
- Current recommendations suggest transplant recipients should wait at least 1 month after transplant surgery to receive the COVID-19 vaccine, keeping in line with recommendations for other vaccines. This allows for routine reduction of immunosuppression after transplantation to hopefully allow for improved efficacy of the vaccine. However, COVID-19 vaccination should be postponed for 3-6 months following T-cell or B-cell depleting therapies (such as anti-thymocyte globulin, rituximab, etc.), whether given for induction immunosuppression or as treatment for rejection.3,4
- Similar to the general population, patients with heart failure or heart transplant recipients who have had COVID-19 should still proceed with receiving the vaccine once they have recovered from the acute infection.
- COVID-19 Projections (Institute for Health Metrics and Evaluation website). 2021. Available at: https://covid19.healthdata.org/global?view=total-deaths&tab=trend. Accessed 02/27/2021.
- Mahumud RA, Kamara JK, Renzaho AMN. The epidemiological burden and overall distribution of chronic comorbidities in coronavirus disease-2019 among 202,005 infected patients: evidence from a systematic review and meta-analysis. Infection 2020;Aug 19:[Epub ahead of print].
- Guidance from the International Society for Heart and Lung Transplantation regarding the SARS CoV-2 pandemic (ISHLT website). 2021. Available at: https://ishlt.org/ishlt/media/documents/SARS-CoV-2_Guidance-for-Cardiothoracic-Transplant-and-VAD-center.pdf. Accessed 02/01/2021.
- COVID-19 Vaccine FAQ Sheet (myast.org). 2021. Available at: https://www.myast.org/sites/default/files/2021%2001%2025%20COVID19%20VACCINE%20FAQS_update%20v%203.pdf. Accessed 01/25/2021.
- Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices' interim recommendation for use of Moderna COVID-19 vaccine — United States, December 2020. MMWR Morb Mortal Wkly Rep 2021;69:1653-56.
- Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices' interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine — United States, December 2020. MMWR Morb Mortal Wkly Rep 2020;69:1922-24.
- Boyarsky BJ, Ou MT, Greenberg RS, et al. Safety of the first dose of SARS-CoV-2 vaccination in solid organ transplant recipients. Transplantation 2021;Feb 04:[Epub ahead of print].
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Heart Transplant, Hypertension
Keywords: Heart Failure, COVID-19, Antilymphocyte Serum, Transplantation, Ethnic Groups, Pandemics, Antibody Formation, RNA, Messenger, Follow-Up Studies, Heart Transplantation, Organ Transplantation, Lung Transplantation, Immunosuppression, Vaccination, Morbidity, Diabetes Mellitus, Hypertension, Headache, Hypersensitivity, Fatigue, World Health Organization, Epinephrine, B-Lymphocytes, T-Lymphocytes
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