Immunogenicity of COVID-19 mRNA Vaccines in Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome (preprint)

Immunocompromised patients are particularly susceptible to serious complications from infection with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Two mRNA vaccines, BNT162b2 and mRNA-1273, have been shown to have excellent clinical efficacy in immunocompetent adults, but diminished activity in immunocompromised patients. In this study, we measured anti-spike SARS-CoV-2 antibody response, avidity, and surrogate neutralizing antibody activity in Coronavirus Disease 2019 (COVID-19) vaccinated patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Anti-spike SARS-CoV-2 antibody was present in 89% of AML and 88% of MDS patients, but median antibody levels for were lower than in healthy controls (p=0.001 and p=0.04, respectively). SARS-CoV-2 antibody avidity and neutralizing antibody activity from AML patients were significantly lower than controls (p=0.028 and p=0.002, respectively). There was a trend toward higher anti-spike SARS-CoV-2 antibody levels after mRNA-1273 vaccination. Antibody avidity was greater in patients after mRNA-1273 versus BNT162b2 (p=0.01) and there was a trend toward greater neutralizing antibody activity after mRNA-1273 versus BNT162b2 vaccination.

Social and Clinical Determinants of COVID-19 Outcomes: Modeling Real-World Data from a Pandemic Epicenter (preprint)

IMPORTANCE: As the United States continues to accumulate COVID-19 cases and deaths, and disparities persist, defining the impact of risk factors for poor outcomes across patient groups is imperative. OBJECTIVE: Our objective is to use real-world healthcare data to quantify the impact of demographic, clinical, and social determinants of health associated with severe COVID-19 outcomes. We sought to identify high-risk scenarios and characterize dynamics of risk among racial and ethnic groups. DESIGN: A retrospective cohort of COVID-19 patients diagnosed between March 1 and August 20, 2020. Fully adjusted logistical regression models for hospitalization, severe disease and mortality outcomes across 1-the entire cohort and 2- nested within self-reported race/ethnicity groups. SETTING: Three NewYork-Presbyterian health care system that draw patients across all five boroughs of New York City. Data was obtained through automated abstraction of real-world data from electronic medical records. PARTICIPANTS: During the study timeframe, 110,498 individuals were tested for SARS-CoV-2 in the NewYork-Presbyterian health care system; 11,930 patients were confirmed for COVID-19 by RT-PCR or covid-19 clinical diagnosis. MAIN OUTCOMES AND MEASURES: The primary predictor of interest was patient race/ethnicity, and study covariates included demographics, clinical comorbidity, and zip code-based neighborhood socio-economic status. The primary outcomes of interest were COVID-19 hospitalization, severe disease, and death. RESULTS: Of the patients who tested positive for COVID-19, 4,895 were hospitalized; of those, 1,070 developed severe disease. 1,654 patients suffered COVID-19 related death. Certain risk factors only showed an impact in specific race groups and varied among outcome models. Clinical factors were more significant than demographic or social determinants. In our all-patients models, hypertension conveyed the highest risk of hospitalization (OR=1.89, 89p=1.26x10 -1020), while Type 2 Diabetes was significantly associated with all three outcomes (hospitalization: OR=1.4848, p=1.39x10-04394; severe disease: OR=1.466, p=44.47x10-099; mortality: OR=1.27, p=0.001). In race-nested models, COPD increased risk of hospitalization only in Non-Hispanic (NH)-White patients (OR=2.707, p=0.009). Obesity (BMI 30+) was associated with severe disease among hospitalized NH-White (OR=1.48, p=0.038) and NH-Black (OR=1.77, p=0.025). Cancer was the only significant mortality risk factor in Hispanic patients (OR=1.9797, p=0.04343), and heart failure was associated with mortality only in NH-Asian patients (OR=2.62, p=0.001). CONCLUSIONS AND RELEVANCE. We found that clinical comorbidity, more than social determinants, was associated with COVID-19 outcomes, suggesting clinical factors are more predictive of risk than social factors.