mRNA vaccine yields modest cut in COVID-19 infection in veterans with cirrhosis
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A cohort of veterans with cirrhosis who received the mRNA COVID-19 vaccine had a delayed and modest decrease in infection, with an excellent decrease in hospitalizations or death.
“Patients with cirrhosis have immune dysregulation that is associated with vaccine hyporesponsiveness with several vaccines including hepatitis B and pneumococcal vaccines,” Binu V. John, MD, MPH, affiliate associate professor, University of Miami Miller School of Medicine, chief of hepatology, Bruce W Carter VA Medical Center, and colleagues wrote. “Therefore, the efficacy of the vaccine in patients with cirrhosis, particularly decompensated cirrhosis, is a significant knowledge gap.”
To fill that gap, John and colleagues conducted a retrospective study of 20,037 patients with cirrhosis who received at least one dose of either the Pfizer BNT162b2 mRNA (n = 10, 236) or Moderna mRNA-1273 COVID-19 vaccine (n = 9,801) at the Veterans Health Administration. Investigators matched the patients to 20,037 control participants to evaluate the correlations of vaccination with new COVID-19 infection and COVID-19 hospitalization and death. COVID-19 infection documented by a positive result by polymerase chain reaction, hospitalization and death due to COVID-19 infection served as the primary outcome.
Median patient age was 69.1 years; both the vaccinated and unvaccinated groups comprised 19,465 men, which is consistent with the U.S. veteran population. Most patients (99.7%) who received the first dose received a second dose of the vaccine with a follow-up of 42 days or more.
After the first dose, both cohorts had a similar number of COVID-19 infections in days 0 to 7, 7 to 14, 14 to 21, and 21 to 28. John and colleagues noted after 8 days, one dose of a mRNA vaccine correlated with a 64.8% decrease in COVID-19 infections. Further, they said the one dose had 100% protection against hospitalization or death to COVID-19 infection, according to researchers.
The correlation between reduced infections and one dose of an mRNA vaccine was lower in patients with decompensated cirrhosis (50.3%) than in patients with compensated cirrhosis (66.8%). After 7 days, a second dose of the vaccine correlated with a 78.6% decrease in COVID-19 infections and a 100% decrease in COVID-19–related hospitalization or death.
“These results were from patients who received vaccination until March 2021, so more studies are needed to assess if these results change with the emergence of the delta variant,” John said in an interview.
Perspective
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Omar Massoud, MD, PhD
Patients with cirrhosis have immune dysregulation. They are more susceptible to various infection and can have more severe forms of infection than normal healthy patients. In addition, their response to various vaccines can be sub-optimal. Patients with cirrhosis are generally, as those with many other chronic diseases, excluded from clinical trials. The clinical trials that demonstrated the efficacy of COVID-19 vaccines did not include patients with cirrhosis and other chronic conditions. There is a significant knowledge gap related to their response to vaccines. Although the current guidelines recommend COVID-19 vaccines for people with cirrhosis, these recommendations are based on expert opinion rather than clinical data.
To determine the vaccine efficacy, the researchers compared 20,037 patients with cirrhosis who received either Pfizer or Moderna mRNA vaccine through the Veterans Health Administration with 20,037 patients with cirrhosis who did not receive the vaccine. The researchers looked at the rate of infection, hospitalization and death from COVID-19.
Results of this study showed that receiving two doses of either the Pfizer or Moderna mRNA vaccine was associated with a 78% protection against infection and 100% protection against hospitalization or death.
There are two major limitations of this study. The cohort was predominantly men (97.2%) of older age (median age, 69.1 years) which raises questions about the generalizability of the results. The second important limitation is the short period of follow up (28 days after the first dose or 7 days after the second dose). Clearly longer follow-up is needed to assess if the reported response is sustained.
There are, however, many strengths in this study. It included a large cohort of well-characterized patients with cirrhosis who were not represented in the initial clinical trials that led to the approval of those vaccines. The study cohort was derived from patients throughout the United States. It includes more Black participants than the initial clinical trials (23% vs. 10%). The study was performed at a point of time where there were comparable numbers of vaccinated and unvaccinated patients. As more patients receive the vaccine, it will become difficult to have large enough number of controls in future studies.
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