Patients with cirrhosis of the liver who received the Pfizer or Moderna COVID-19 vaccine were less likely to experience COVID-19 infections and hospitalizations or death due to COVID-19, according to research published in JAMA Internal Medicine.
Researchers report that 0.6% of participants in phase 3 clinical trials for the Pfizer BNT162b2 mRNA and Moderna mRNA-1273 vaccines had liver disease, and immune dysregulation in cirrhosis is linked with vaccine hyporesponsiveness. They therefore investigated the effectiveness of the vaccines in a real-world setting with US veterans in the Veterans Outcomes and Costs Associated with Liver Disease (VOCAL) cohort.
Adult patients (n=20,037; median age, 69.1±8.4 years) with cirrhosis who had received care through the Veterans Affairs (VA) system and had received either vaccine from December 18, 2020, through March 17, 2021, were matched with control individuals (n=20,037; median age, 69 ± 8.8 years) who did not receive the vaccine. Individuals were matched based on risk factors for severe COVID-19 infection collected from health records within 90 days of December 18, 2020. The investigators matched the individuals 1:1 on age group, sex, race, Alcohol Use Disorders Identification Test-Concise (AUDIT-C), cirrhosis comorbidity score, and electronic Child-Turcotte-Pugh scores.
Nearly all (99.7%) individuals who received the first dose of either vaccine and had a follow-up period of at least 42 days received the second dose of the vaccine within the period recommended by the Centers for Disease Control and Prevention (CDC).
Twenty-eight days after administration of the first dose, receipt of 1 dose of either vaccine was linked with a 64.8% reduction in COVID-19 infections and a 100% reduction in hospitalizations (0 vaccinated individuals, 3 unvaccinated) and deaths (0 vaccinated, 2 unvaccinated). Seven days after the second dose of the vaccine, 3 patients in the vaccine group and 14 in the unvaccinated group developed COVID-19 infection (demonstrating a 78.6% reduction): 1 individual in the control group died and 2 were hospitalized. No vaccinated patient died or was hospitalized.
The investigators report a 100% reduction in hospitalizations and deaths among patients with compensated cirrhosis (n=16,895) or decompensated cirrhosis (n=3142) who received at least 1 dose of either vaccine compared with 1 hospitalization among control group individuals with decompensated cirrhosis and 2 hospitalizations and 1 death among control group individuals with compensated cirrhosis.
After 28 days, 1 dose of either vaccine was associated with a 50.3% reduction in COVID-19 infections among individuals with decompensated cirrhosis (1 vaccinated, 2 unvaccinated) and a 66.8% reduction in COVID-19 infections (5 vaccinated, 15 unvaccinated) among individuals with compensated cirrhosis.
After adjusting for age, diabetes diagnosis, tobacco use, AUDIT-C score, and Model For End-Stage Liver Disease-Serum Sodium (MELD-Na), individuals who received either vaccine had a 25% lower risk of COVID-19 infection or death from the time of vaccination (adjusted hazard ratio [aHR], 0.75; P =.008). The link was significant for patients with compensated cirrhosis (aHR 0.69; P =.005).
The study included 1144 women with cirrhosis. Multivariable analysis did not show a link between 1 dose of either vaccine and COVID-19 infection or death (aHR 0.53; P =.46).
Limitations of this study included possible residual confounding as a result of differences among cohorts, such as differential risk to COVID-19 exposure, and exclusion of any hospitalizations of study participants outside of the VA system.
John BV, Deng Y, Scheinberg A, et al. Association of BNT162b2 mRNA and mRNA-1273 vaccines with COVID-19 infection and hospitalization among patients with cirrhosis. JAMA Internal Med. 2021;181(10):1306-1314. doi:10.1001/jamainternmed.2021.4325