All current guidance and responses are based on opinions of the ASTCT/ASH COVID-19 Vaccine expert panel. This FAQ will be updated periodically as new data become available. However, despite the scarcity of data, the high level of protection afforded to those vaccinated in the clinical trials, and the overall safety of the vaccine in clinical trials and post-EUA experience, ASTCT and ASH strongly support vaccination of this vulnerable patient population, along with their caregivers, family, and household contacts. Responses to COVID-19 vaccines are likely to be blunted in HCT, or CAR T cell recipients compared with healthy individuals. The overall lower efficacy was thought to be due to the newly emerging SARS-CoV-2 variant arising from South Africa (20H/501Y.V2 variant ), which was the predominant strain circulating in South Africa at the time of the clinical trial, and accounted for 95 percent of the sequenced isolates. The single-dose recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector-based vaccine ( Johnson & Johnson/Janssen) reduced the incidence of symptomatic COVID-19 with a reported efficacy of 66.1 percent (72% in the United States) based on data from the phase III clinical trial. The BNT162b2 (Pfizer/BioNTech) and the mRNA-1273 (Moderna) COVID-19 vaccines have both been shown in large phase III clinical trials to be more than 90 percent effective at preventing lab-confirmed COVID-19 illness and severe infections. Food and Drug Administration (FDA) or are approved under the FDA’s Emergency Use Authorization (EUA). In the United States, two novel messenger RNA (mRNA) vaccines and one novel adenovirus vector–based vaccine have been either formally approved by the U.S. These patients also face other comorbidities associated with COVID-19–related mortality, including older age, cardiovascular disease, renal dysfunction, and high-level immunosuppression, among many others that further deepen and drive worse outcomes. Hematopoietic cell transplant (HCT) and chimeric antigen receptor T (CAR T) cell recipients are at higher risk for serious complications from the virus, including hospitalization, intensive care unit admission, and death from COVID-19. The SARS-CoV-2 pandemic continues to cause excess morbidity and mortality in the United States and worldwide. Updated recommendations regarding vaccination timing in patients who have received monoclonal antibodies for prevention or treatment of COVID-19.Updated vaccination schedule for immunocompromised patients in alignment with the new recommendations from CDC for this specific population.The American Society of Transplantation and Cellular Therapy (ASTCT), the National Marrow Donor Program (NMDP), and the American Society of Hematology (ASH) have continued to engage with the Centers for Disease Control and Prevention (CDC) to better understand, communicate, and implement these changes. However, COVID-19 vaccines remain the cornerstone for prevention of severe illness, hospitalization, and death from SARS-CoV-2. Advances in therapeutics such as monoclonal antibodies for prevention and treatment of COVID-19 have become available and can be given irrespective of vaccination status. Our understanding of vaccine responses in immunocompromised patients has improved, leading to revised schedules and changes in the number of doses needed. The changes reflect the access to new data the need to optimize vaccination uptake and timeline during new surges and the spread of new variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the need to better protect vulnerable populations. Vaccination recommendations have been attuned since the first COVID-19 vaccines became available. Hohl, MD, PhD Mini Kamboj, MD Michael Boeckh, MD, PhD and Genovefa Papanicolaou, MD. Pergam, MD, MPH John Wingard, MD Jeffery Auletta, MD Zeinab El Boghdadly, MBBCh Maheen Abidi, MD Alpana Waghmare, MD Zainab Shahid, MD Laura Michaels, MD Joshua Hill, MD Tobias M. Chemaly, MD, MPH Sanjeet Dadwal, MD Steven A. (Version 5.0 last updated March 22, 2022)
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