American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease

Fix, Oren K.; Blumberg, Emily A.; Chang, Kyong–Mi; Chu, Jaime; Chung, Raymond T.; Goacher, Elizabeth; Hameed, Bilal; Kaul, Daniel; Kulik, Laura; Kwok, Ryan M.; McGuire, Brendan M.; Mulligan, David C.; Price, Jennifer; Reau, Nancy; Reddy, K. Rajender; Reynolds, Andrew; Rosen, Hugo R.; Russo, Mark W.; Schilsky, Michael L.; Verna, Elizabeth C.; Ward, John W.; Fontana, Robert J.

doi:10.1002/hep.31751

Cited by 145 publications

(243 citation statements)

References 48 publications

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“… [3] , [4] , [5] Despite the large number of clinical trials of COVID-19 vaccines, only a few participants with pre-existing liver diseases were included. 1 , 6 Concerns have been raised recently about SARS-CoV-2 vaccine responses in the large population of patients with non-alcoholic fatty liver disease (NAFLD), 1 , 6 , 7 who may be uniquely susceptible to COVID-19 infection and disease progression. [8] , [9] , [10] The study aimed to explore the safety and immunogenicity of COVID-19 vaccination in patients with NAFLD in a large Chinese cohort.…”

Section: Introductionmentioning

confidence: 99%

Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study

Wang

Hou

Liu

et al. 2021

Journal of Hepatology

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Background & Aims The development of COVID-19 vaccines has progressed with encouraging safety and efficacy data. Concerns have been raised about SARS-CoV-2 vaccine responses in the large population of patients with non-alcoholic fatty liver disease (NAFLD). The study aimed to explore the safety and immunogenicity of COVID-19 vaccination in NAFLD. Methods This multicenter study included patients with NAFLD without a history of SARS-CoV-2 infection. All patients were vaccinated with 2 doses of inactivated vaccine against SARS-CoV-2. The primary safety outcome was the incidence of adverse reactions within 7 days after each injection and overall incidence of adverse reactions within 28 days, and the primary immunogenicity outcome was neutralizing antibody response at least 14 days after the whole-course vaccination. Results A total of 381 patients with pre-existing NAFLD were included from 11 designated centers in China. The median age was 39.0 years (IQR 33.0–48.0 years) and 179 (47.0%) were male. The median BMI was 26.1 kg/m 2 (IQR 23.8–28.1 kg/m 2 ). The number of adverse reactions within 7 days after each injection and adverse reactions within 28 days totaled 95 (24.9%) and 112 (29.4%), respectively. The most common adverse reactions were injection site pain in 70 (18.4%), followed by muscle pain in 21 (5.5%), and headache in 20 (5.2%). All adverse reactions were mild and self-limiting, and no grade 3 adverse reactions were recorded. Notably, neutralizing antibodies against SARS-CoV-2 were detected in 364 (95.5%) patients with NAFLD. The median neutralizing antibody titer was 32 (IQR 8-64), and the neutralizing antibody titers were maintained. Conclusions The inactivated COVID-19 vaccine appears to be safe with good immunogenicity in patients with NAFLD. Lay summary The development of vaccines against coronavirus disease 2019 (COVID-19) has progressed rapidly, with encouraging safety and efficacy data. This study now shows that the inactivated COVID-19 vaccine appears to be safe with good immunogenicity in the large population of patients with non-alcoholic fatty liver disease.

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Section: Introductionmentioning

confidence: 99%

Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study

Wang

Hou

Liu

et al. 2021

Journal of Hepatology

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“…A related consequence of the alterations in immune system in cirrhosis is vaccine hypo responsiveness to non-COVID vaccines. Immunogenicity to hepatitis A virus (HAV) and hepatitis B virus (HBV) vaccines decreases with increasing severity of cirrhosis and can be addressed by administering higher vaccine doses 3 .…”

Section: Risk Of Sars-cov-2 Infection In Chronic Liver Diseasementioning

confidence: 99%

“…mRNA based vaccines involve delivery of synthetic mRNA into the cytoplasm of the host which uses the host ribosomes to translate into antigenic proteins which induce immunity against the virus 3 . Pfizer BioNTech vaccine (BNT162b2) and Moderna vaccine (mRNA-1273) belong to this class and contain mRNA that codes for the spike protein used by the virus to gain entry into the host.…”

Section: Covid Vaccines Under Developmentmentioning

confidence: 99%

COVID-19 Vaccines in Patients With Chronic Liver Disease

Sharma

Patnaik

Kumar

et al. 2021

Journal of Clinical and Experimental Hepatology

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The COVID 19 pandemic has caused mayhem globally since the beginning of 2020. Due to the immune dysfunction inherent to cirrhosis and the poor general condition, patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Recently a number of vaccines against SARS-Cov-2 have been granted approval for emergency use around the globe. Although the phase 2/3 trials of these vaccines show them to be safe and effective in the general population, data in patients with CLD is scarce. The number of patients with CLD enrolled into these trials is small; no liver related adverse effects have been reported yet. Various liver societies have come up with guidelines on vaccination in this population and recommend vaccination on a priority basis. Trials to assess the safety and efficacy of the COVID vaccines are under way and are likely to provide valuable insight into this matter.

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“…While some trials included a small number of patients with pre-existing liver diseases, patients with advanced liver diseases were still excluded and no subgroup analysis was performed to assess outcomes or adverse events specifically in patients with liver diseases. 63 Thus, it is not clear at this moment how safe and effective these vaccines would be, in standard doses, for patients with AIH, especially while on immunosuppressive medications. Extrapolating from the experience with vaccination for other diseases in patients with liver diseases, [64][65][66] in patients on immunosuppression, 67 and specifically in AIH, 68 the likely efficacy of the Considering the high risk of poor outcomes due to COV-ID-19 infection in patients with liver diseases 18 and patients with immunosuppression, 69 the benefits of vaccination may outweigh the risks.…”

Section: Vaccinationmentioning

confidence: 99%

“…Extrapolating from the experience with vaccination for other diseases in patients with liver diseases, [64][65][66] in patients on immunosuppression, 67 and specifically in AIH, 68 the likely efficacy of the Considering the high risk of poor outcomes due to COV-ID-19 infection in patients with liver diseases 18 and patients with immunosuppression, 69 the benefits of vaccination may outweigh the risks. COVID-19 vaccination is being suggested in patients with chronic liver disease and solid organ transplant recipients on immunosuppression by various international societies, including AASLD 63 and European Association for Study of Liver (EASL). 70 Till further data on safety and efficacy are available, COVID-19 vaccines need to be administered at standard doses, unless other contraindications are present.…”

Section: Vaccinationmentioning

confidence: 99%

Special Considerations in the Management of Autoimmune Hepatitis in COVID-19 Hotspots: A Review

Madhu¹,

Sharma²,

Agarwal³

et al. 2021

Journal of Clinical and Translational Hepatology

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The ongoing coronavirus disease-2019 (COVID-19) pandemic has necessitated special considerations in the management of diseases. The way presence of pre-existing diseases or treatment for it predisposes to, alters course of, and changes the management of COVID-19, is of relevance and is being extensively studied. Autoimmune hepatitis (AIH) is unique in that it is an autoimmune disease mandating treatment with immunosuppressive drugs, as well as a liver disease with potential for varying degrees of underlying fibrosis. The use of immunosuppressive drugs could alter the risk of acquiring COVID-19, the clinical course and severity of COVID-19 and the degree of underlying liver fibrosis could alter the clinical outcomes of patients with COVID-19. In this review, we try to summarize key areas relevant in understanding and improving the clinical care of patients with AIH in the current pandemic. Special considerations required in the management of patients with AIH in COVID-19 hotspots have been outlined based on the current evidence.

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American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease

Cited by 145 publications

References 48 publications

Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study

Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study

COVID-19 Vaccines in Patients With Chronic Liver Disease

Special Considerations in the Management of Autoimmune Hepatitis in COVID-19 Hotspots: A Review

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