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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
Efficacy and safety of COVID-19 vaccination in patients with cirrhosis
Vladimir Ivashkin, Albina Ismailova, Ksenia Dmitrieva, Roman Maslennikov, Maria Zharkova, Salekh Aliev, Vyacheslav Bakhitov, Vadim Marcinkevich
Vladimir Ivashkin, Albina Ismailova, Ksenia Dmitrieva, Roman Maslennikov, Maria Zharkova, Department of Internal Medicine, Gastroenterology and Hepatology, Sechenov University, Moscow 119435, Russia
Ksenia Dmitrieva, Roman Maslennikov, Department of Internal Diseases, Consultative and Diagnostic Center № 2 of Department of Health, Moscow 107764, Russia
Salekh Aliev, Vyacheslav Bakhitov, Vadim Marcinkevich, Administration, Consultative and Diagnostic Center № 2 of Department of Health, Moscow 107764, Russia
Salekh Aliev, The First Hospital Surgery Department, Pirogov Russian National Research Medical University, Moscow 117997, Russia
Author contributions: Ivashkin V, Ismailova A, and Maslennikov R designed the research; all authors performed the research and analyzed the data; Ivashkin V, Ismailova A, Dmitrieva K, and Roman Maslennikov R wrote the paper.
Institutional review board statement: This study was approved by the Ethics Committee of Sechenov University (Protocol 20-11) in accordance with the Helsinki Declaration.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: There are no conflicts of interest to report.
Data sharing statement: Data can be provided upon request to the corresponding author.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Roman Maslennikov, MD, PhD, Assistant Professor, Department of Internal Medicine, Gastroenterology and Hepatology, Sechenov University, Pogodinskaya 1-1, Moscow 119435, Russia. mmmm00@yandex.ru
Received: February 23, 2022
Peer-review started: February 23, 2022
First decision: April 5, 2022
Revised: April 19, 2022
Accepted: June 16, 2022
Article in press: June 16, 2022
Published online: July 27, 2022
ARTICLE HIGHLIGHTS
Research background
Patients with cirrhosis have a high risk of poor prognosis when developing novel coronavirus disease 2019 (COVID-19).
Research motivation
The clinical efficacy and safety of vaccination against the COVID-19 in patients with cirrhosis have not been evaluated yet.
Research objectives
To evaluate clinical efficacy and safety of vaccination against COVID-19 in patients with cirrhosis.
Research methods
This was a retrospective cohort study of patients with cirrhosis. The first cohort included patients vaccinated with Gam-COVID-Vac (Sputnik V); the second one consisted of unvaccinated controls.
Research results
There were 4 cases of COVID-19 in the vaccinated group and 24 cases in the unvaccinated group (P = 0.035). No severe cases of COVID-19 were revealed in the vaccinated group, while there were 12 ones in the unvaccinated group (P = 0.012) with 10 deaths detected (P = 0.012). The vaccine efficacy was 69.5% (95%CI: 18.5%-94.4%) against symptomatic cases of COVID-19, 100% (95%CI: 25.1%-100.0%) against severe cases, and 100% (95%CI: 1.6%-100.0%) against death associated with COVID-19. There was no significant difference in liver-related mortality, or the incidence of liver decompensation, bleeding esophageal varices, and vascular events between the two groups of patients.
Research conclusions
Vaccination against COVID-19 in patients with cirrhosis is effective and safe.
Research perspectives
The effectiveness of vaccinating patients with cirrhosis against COVID-19 with different vaccines should be compared.
