Role of Vaccination in the COVID-19 Nationwide Cohort (N3C) of Solid Organ Transplant Recipients

ABSTRACT

Purpose: Immunosuppressed solid organ transplant (SOT) patients have been repeatedly challenged in the COVID-19 pandemic with significant morbidities and mortality following infection and a suppressed immune response to vaccination. The aim of this study was to assess the impact on COVID-19 morbidity and mortality in the presence and absence of vaccination. Method(s) We studied adult (>18 years) patients from across the United States identified using the National COVID Cohort Collaborative (N3C) Enclave from Dec 10, 2020-Oct 12, 2021. Using multivariable logistic regression, we determined the odds of developing COVID-19 infection in the 6 months after full vaccination (defined as a breakthrough (BT) infection) in SOT recipients relative to nonimmunosuppressed (non-IS) patients. In SOT patients with BT COVID-19 infection, we then used multivariable logistic regression to determine the association of full and partial vaccination status with major adverse cardiac events, mortality, and additional secondary outcomes in the 90 days following COVID-19 diagnosis relative to unvaccinated/unconfirmed vaccination status SOT recipients). Result(s) Over the study period, 16,075 SOT patients were diagnosed with COVID-19 (515 were partially vaccinated, and 1,868 were fully vaccinated). Relative to non- IS, SOT was associated with an increased odds of BT COVID-19 infection in the 6 months post vaccine, that varied by organ type (i.e. OR 1.97, 95% CI 1.75-2.25 for kidney;OR 2.30, 95% CI 1.70-3.06 for lung), Table 1. In SOT patients who experienced BT COVID-19, full vaccination was associated with a small reduction in adverse outcomes relative to unvaccinated/unconfirmed vaccination status (OR 0.91, 95% CI 0.89-0.93 for MARCE;OR 0.92, 95% CI 0.90-0.93 for death;OR 0.90, 95% CI 0.88-0.92 for hospitalization), Table 2. Conclusion(s) SOT patients are at a ~2-fold increased odds of BT COVID-19 infection after vaccination compared with non-IS patients. Vaccination in SOT patients, regardless of product, has a small but significant reduction in the risk of adverse outcomes after a diagnosis of COVID-19, however SOT recipients remain at high risk and should continue to use caution even after vaccination. (Table Presented).