Safety and Efficacy of COVID-19 Vaccination in Patients With Cirrhosis in United States: A Multicenter Study

Introduction: Cirrhosis is associated with high mortality in COVID-19. Although COVID-19 vaccines are now available and are being administered to the public, their safety and efficacy in patients with cirrhosis have not been studied. We aimed to study the efficacy and safety of Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines in patients with cirrhosis compared to patients without cirrhosis. Methods: We performed a retrospective cohort study utilizing TriNetx multi-institutional research network to analyze patients who received mRNA COVID-19 vaccines. Outcomes were compared between patients with and without diagnosis of cirrhosis. Cirrhosis and non-cirrhosis groups were also compared using 1:1 propensity-score matching (PSM). Cohorts were matched based on age, gender, ethnicity, BMI, and comorbid conditions including diabetes, chronic lower respiratory diseases, ischemic heart disease, heart failure, nicotine dependence, and chronic kidney disease. Results: A total of 402,202 patients with COVID-19 vaccination during the study period were identified, of which 3,063 patients were included in the cirrhosis cohort. After propensity score matched analysis, no significant difference was found between the cirrhosis and non-cirrhosis cohorts in the incidence of adverse events of special interest (RR 1.29, 95% CI 0.9-1.86) and new diagnosis of COVID-19 (RR 1.27, 95% CI 0.58-2.8) after COVID-19 vaccination. 30-day all cause hospitalization after COVID-19 vaccination was higher in patients with cirrhosis. Sub-group analysis revealed no difference in 30-day adverse events of special interest after COVID-19 vaccination in patients with decompensated cirrhosis (RR:1.23, 95% CI 0.74-2.05) or compensated cirrhosis (RR:1.48, 95% CI: 0.88-2.50) compared to patients without cirrhosis. < 10 patients in the decompensated cirrhosis and compensated cirrhosis subgroups received new diagnosis of COVID-19 after vaccination. Sub-group analysis revealed no difference in 30-day adverse events of special interest after COVID-19 vaccination in patients with decompensated cirrhosis (RR:1.23, 95% CI 0.74-2.05) or compensated cirrhosis (RR:1.48, 95% CI: 0.88-2.50) compared to patients without cirrhosis. Conclusion: Our study including a large cohort of patients who received COVID-19 mRNA vaccines in United States did not reveal any concerns regarding the safety and efficacy of these vaccines in patients with cirrhosis compared to general population.Table 1.: Vaccination related outcomes in study cohorts.