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Are COVID-19 mRNA vaccines associated with decrease in COVID-19 infections and death in a real-world setting among patients with cirrhosis of the liver?
In this retrospective cohort study of US veterans with cirrhosis that compared 20 037 patients who received either a Pfizer BNT162b2 mRNA or a Moderna mRNA-1273 COVID-19 vaccine with 20 037 propensity score matched controls, receipt of 1 dose of either vaccine was associated with a 64.8% reduction in COVID-19 infections and 100% reduction in hospitalization or death due to COVID-19 infection after 28 days.
This cohort study found that mRNA vaccines against COVID-19 were associated with reduced COVID-19 infections in individuals with cirrhosis, despite hyporesponsiveness to other vaccines.
Two mRNA-based vaccines against coronavirus disease 2019 (COVID-19) were found to be highly efficacious in phase 3 clinical trials in the US. However, patients with chronic illnesses, including cirrhosis, were excluded from clinical trials. Patients with cirrhosis have immune dysregulation that is associated with vaccine hyporesponsiveness.
To study the association of receipt of the Pfizer BNT162b2 mRNA or the Moderna mRNA-1273 vaccines in patients with cirrhosis compared with a propensity-matched control group of patients at similar risk of infection and severe disease from COVID-19.
Design, Setting, and Participants
We performed a retrospective cohort study of patients with cirrhosis who received at least 1 dose of a COVID-19 mRNA vaccine at the Veterans Health Administration. Patients who received at least 1 dose of the vaccine (n = 20 037) were propensity matched with 20 037 controls to assess the associations of vaccination with new COVID-19 infection and COVID-19 hospitalization and death.
Receipt of at least 1 dose of the BNT162b2 mRNA or the mRNA-1273 vaccines between December 18, 2020, and March 17, 2021.
Main Outcomes and Measures
COVID-19 infection as documented by a positive result for COVID-19 by polymerase chain reaction, hospitalization, and death due to COVID-19 infection.
The median (interquartile range) age of the vaccinated individuals in the study cohort was 69.1 (8.4) years and 19 465 (97.2%) of the participants in each of the vaccinated and unvaccinated groups were male, consistent with a US veteran population. The mRNA-1273 vaccine was administered in 10 236 (51%) and the BNT162b2 mRNA in 9801 (49%) patients. Approximately 99.7% of patients who received the first dose of either vaccine with a follow-up of 42 days or more received a second dose. The number of COVID-19 infections in the vaccine recipients was similar to the control group in days 0 to 7, 7 to 14, 14 to 21, and 21 to 28 after the first dose. After 28 days, receipt of 1 dose of an mRNA vaccine was associated with a 64.8% reduction in COVID-19 infections and 100% protection against hospitalization or death due to COVID-19 infection. The association of reduced COVID-19 infections after the first dose was lower among patients with decompensated (50.3%) compared with compensated cirrhosis (66.8%).Receipt of a second dose was associated with a 78.6% reduction in COVID-19 infections and 100% reduction in COVID-19–related hospitalization or death after 7 days.
Conclusions and Relevance
This cohort study of US veterans found that mRNA vaccine administration was associated with a delayed but modest reduction in COVID-19 infection but an excellent reduction in COVID-19–related hospitalization or death in patients with cirrhosis.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: June 21, 2021.
Published Online: July 13, 2021. doi:10.1001/jamainternmed.2021.4325
Corresponding Author: Binu V. John, MD, MPH, Affiliate Associate Professor, University of Miami Miller School of Medicine, Chief of Hepatology, Bruce W Carter VA Medical Center, 1201 NW 16th St, Miami, FL 33125 (firstname.lastname@example.org).
Author Contributions: Drs John and Dahman had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: John, Deng, Mahmud, Dahman.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: John, Deng, Dahman.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: John, Deng, Mahmud, Kaplan, Dahman.
Obtained funding: John, Dahman.
Administrative, technical, or material support: John, Scheinberg, Taddei, Kaplan, Labrada, Dahman.
Supervision: John, Dahman.
Conflict of Interest Disclosures: None reported.
Funding/Support: Services supporting the analysis and interpretation of the data of this research project were generated by the VCU Massey Cancer Center Biostatistics Shared Resource, supported, in part, with funding from NIH-NCI Cancer Center Support Grant P30 CA016059.
Role of the Funder/Sponsor: The VCU Massey Cancer Center Biostatistics Shared Resource had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The authors prepared this work in their personal capacity. The opinions expressed in this article are the author's own and do not reflect the view of the Department of Veterans Affairs or the US government.
Additional Contributions: We acknowledge data and support from the VA COVID-19 shared data resource.
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