Impact of Vaccination and Early Monoclonal Antibody Therapy on Coronavirus Disease 2019 (COVID-19) Outcomes in Organ Transplant Recipients During the Omicron Wave

In an organ transplant population, this prospective study shows that being vaccinated with >= 3 doses of mRNA vaccine and using monoclonal antibody within 7 days of symptom onset are protective of severe outcomes in patients with vaccine breakthrough coronavirus disease 2019 (COVID-19). Background Solid organ transplant (SOT) recipients are at high risk for complications from coronavirus disease 2019 (COVID-19) and vaccine breakthrough infections are common. We determined the effectiveness of >= 3 doses of mRNA vaccine and early monoclonal antibody therapy in reducing disease severity against the Omicron (B.1.1.529) variant. Methods Prospective cohort study of consecutive SOT recipients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection referred to our transplant center who were followed for at least 30 days. The primary outcome was supplemental oxygen requirement. Effectiveness of sotrovimab and >= 3 vaccine doses was estimated using adjusted risk ratios (RR). Results Three hundred adult organ transplant recipients were included. Seventy-one patients (24.1%) were hospitalized, 44 (14.9%) required supplemental oxygen, 19 (6.5%) were admitted to the intensive care unit (ICU), 15 (5.1%) required mechanical ventilation (MV), and 13 (4.4%) died. On multivariate analysis, age and multiple comorbidities were risk factors for oxygen requirement. Both receipt of >= 3 vaccine doses prior to SARS-CoV-2 infection and receipt of sotrovimab in the first 7 days of symptom onset was associated with a reduction in the need for supplemental oxygen (RR 0.30 [95% confidence interval {CI}: .17 to .54] and RR 0.24 (95% CI: .1 to .59), respectively]. For sotrovimab, the number needed to treat (NNT) to prevent one patient requiring oxygen was 6.64 (95% CI: 4.56-13.66). Both sotrovimab use and having received >= 3 vaccine doses were also associated with a shorter hospitalization length of stay. Conclusions In a cohort of SOT recipients with Omicron variant COVID-19 infection, prior receipt of >= 3 mRNA vaccine doses and early monoclonal antibody therapy were independently associated with significantly reduced disease severity.