Review
Copyright ©The Author(s) 2022.
World J Gastroenterol. Dec 28, 2022; 28(48): 6791-6810
Published online Dec 28, 2022. doi: 10.3748/wjg.v28.i48.6791
Table 1 Summary of coronavirus disease 2019 vaccines
Corporation
Vaccine
Mechanism
Vaccination Group: Number of cases/number of vaccinations (%)
Invaccination Group: Number of cases/number of vaccinations (%)
Efficacy % (95%CI)
Pfizer-BioNTech[18]BNT162b2mRNA8/21720 (0.037)162/21728 (0.746)95.0 (90.3-97.6)
Moderna[20]mRNA-1273mRNA11/15210 (0.072)185/15210 (1.216)94.1 (89.3-96.8)
Oxford-AstraZeneca[25]ChAdOx1 nCoV-19 (AZD122)Vector27/4440 (0.608)71/4455 (1.594)62.1 (41.0-75.7)
Johnson & Johnson[26]Ad26.COV2.SVector433/19113 (2.265)883/18924 (4.666)52.9 (47.1-58.1)
Sinovac Life Science[29]Corona VacInacctivated9/6559 (0.137)32/3470 (0.922)83.5 (65.4–92.1)
Table 2 Literature review of the efficacy and safety of coronavirus disease 2019 vaccines in patients with liver disease
Ref.
Design
Vaccine
Country/region
Number of participants
Value
Major findings (efficacy)
Major findings (safety)
Cirrhosis
John et al[45], 2021 Multicentre retrospective cohort studyBNT162b2 and mRNA-1273United StatesCirrhosis group (n = 20037); Control (n = 20037)Efficacy64.8% decrease in the development of COVID-19 infection after the first dose and a 78.6% decrease after the second doseNA
Thuluvath et al[46], 2021 Prospective cohort studyBNT162b2, mRNA-1273, and AZD1222United StatesLT (n = 62); Cirrhosis (n = 79); CLD (n = 92)ImmunogenicityAntibody was detectable in 82.2% of LT recipients, 96.2% of cirrhosis and 95.7% of CLD without cirrhosis. 61.3% of LT recipients and 24% CLD with/without cirrhosis had poor antibody responsesNo patient had any serious AEs
Ruether et al[47], 2022Prospective cohort studyBNT162b2, mRNA-1273, and AZD1222GermanyLT (n = 138); Cirrhosis (n = 48); Control (n = 52)ImmunogenicityImmunological response rates were 36.6%, 65.4%, and 100% in LT, cirrhosis, and controls, respectivelyNA
Willuweit et al[48], 2022Prospective cohort studyBNT162b2GermanyCirrhosis (n = 166); Control (n = 79)ImmunogenicityAntibody was detectable in 96% of cirrhosis and 99% of controls. The median SARS-CoV-2 IgG titer was significantly lower in cirrhosis compared to the controls (939 vs 1905 BAU/mL, P = 0.0001)NA
Wang et al[49], 2022Multicentre retrospective cohort studyInactivated vaccineChinaCompensated-cirrhosis (n = 388); Decompensated cirrhosis (n = 165)ImmunogenicityAntibodies were detectable in 71.6% and 66.1% in compensated-cirrhosis and decompensated-cirrhosisThe vaccines were well tolerated, most AEs were mild and transient
Ai et al[50], 2022 Multicentre prospective cohort studyInactivated vaccineChinaCLD (n = 284); Compensated cirrhosis (n = 123); Decompensated cirrhosis (n = 30)ImmunogenicityAntibody detection rates were 76.8% in noncirrhotic CLD group, 78.9% in compensated cirrhotic group, 76.7% in decompensated cirrhotic group, and 90.3% in controls (P = 0.008 vs CLD)There was no significant difference in AE among subgroups
Liver transplant recipients
Rabinowich et al[51], 2021 Multicentre retrospective cohort studyBNT162b2 mRNA vaccineIsraelLT patients (n = 80); Control (n = 25)ImmunogenicityImmunogenicity among LT recipients was significantly lower [47.5% (LT) vs 100% (control), P < 0.001]No patient had any serious AEs
Herrera et al[52], 2021Multicentre prospective cohort studymRNA-1273SpainLT recipients (n = 58)Immunogenicity93% of patients developed immunologic responses to mRNA-1273 vaccineNo serious AEs were reported in LT recipients
Strauss et al[53], 2021Multicentre retrospective cohort studyBNT162b2 and mRNA-1273United StatesLT recipients (n = 161)ImmunogenicityAntibody was detectable in 34% (95%CI: 27%-42%) of participants after first dose, and in 81% (95%CI: 74%-87%) after second doseNA
Nazaruk et al[54], 2021Retrospective cohort studyBNT162b2 mRNA vaccinePolandLT recipients (n = 65)ImmunogenicityAntibody detection rate was 88.9% in LT recipients after the second doseNA
Timmermann et al[55], 2021Retrospective cohort studymRNA vaccinesGermanyLT recipients (n = 118)ImmunogenicityThe seroconversion rate was 78.0% in LT recipients. MMF for immunosuppression was risk factors for seronegativityNA
D'Offizi et al[56], 2022Retrospective cohort studyBNT162b2 and mRNA-1273ItalyLT patients (n = 61); Control (n = 51)ImmunogenicityImmunological response rates 2 wk after 2nd dose were 47.5% (LT) and 100% (control) (P < 0.001)NA
John et al[57], 2022Multicentre retrospective cohort studyBNT162b2 and mRNA-1273United StatesLT patients (n = 1133); Control (n = 791)EfficacyVaccination with 2 doses of an mRNA vaccine was associated with a 64% decrease in COVID-19 infection and 87% decrease in COVID-19–related death in LT recipientsNA
Davidov et al[58], 2022Retrospective cohort studyBNT162b2 mRNA vaccineIsraelLT patients (n = 76); Control (n = 174)ImmunogenicityImmunological response rates 2 wk after 2nd dose were 72.0% (LT) and 94.2% (control) (P < 0.001)AEs were reported by 51% LT recipients. No serious events were reported
Sakai et al[59], 2022Retrospective cohort studyBNT162b2JapanLT patients (n = 56); Control (n = 42)ImmunogenicityLT recipients showed a lower seroconversion rate (44/56; 78.6%) than healthy controls (41/42; 97.6%)NA
Calleri et al[60], 2022Retrospective cohort studyBNT162b2 and mRNA-1273ItalyPre-LT patients (n = 89)ImmunogenicityIn the 89 pre-LT patients, seroconversion rate was 94.4% (23 d after vaccination), and 92.0% (68 d after vaccination) No serious AEs were reported in participants
Viral hepatitis and NAFLD
Xiang et al[61], 2021Retrospective cohort studyInactivated vaccineChinaCHB patients (n = 149)ImmunogenicityThe seroconversion rate was 87.2% in CHBNo serious AEs were reported in participants
He et al[62], 2022Cross-sectional observational studyInactivated vaccineChinaCHB patients (n = 362); Control (n = 87)ImmunogenicityThe seroconversion rates of SARS-CoV-2 antibodies were similar between CHB patients and healthy controlsThe incidence was similar between CHB patients and controls. No serious AE
Wang et al[63], 2021Multicentre retrospective cohort studyInactivated vaccineChinaNAFLD patients (n = 381)ImmunogenicityThe inactivated COVID-19 vaccine was good immunogenicity (95.5%) in patients with NAFLDAEs within 7 d and within 28 d totaled 95 (24.9%) and 112 (29.4%), respectively. No serious AEs were recorded
Autoimmune liver disease
Duengelhoef et al[64], 2022Prospective cohort studyBNT162b2, mRNA-1273, and AZD1222GermanyAIH (n = 103); PSC (n = 64); PBC (n = 61); Control (n = 95)ImmunogenicitySeroconversion was measurable in 97% of AIH and 99% of PBC/PSC patients, respectively. In 14% of AIH patients antibody levels were lower compared to PBC/PSC or controls NA
Schneider et al[65], 2022Prospective cohort studyBNT162b2 mRNA vaccineAustriaAIH (n = 12); Control (n = 24)ImmunogenicityPatients of AIH and healty controls acquired sufficient antibodies after third vaccinationNA
Table 3 Reported cases of liver injury following coronavirus disease 2019 vaccination
Ref.
Age/sex
Past history
Vaccine
Onset
AST/ALT (U/ L)
Total bilirubin (mg/ dL)
IgG
Antibody
Biopsy
Diagnose
Treatment
Outcome
Bril et al[87] 35/FThird month postpartumBNT162b27 d after the1st dose754/20014.8NormalANA: 1:1280Interface hepatitis, rosette formation, eosinophil infiltrationTypical for AIHPrednisone (20 mg/d)Improved
Lodato et al[88]43/FDyslipidemiaBNT162b215 d after the 1st dose52/5117.54NormalANA: negativeModerate portal inflammatory infiltrate with interface hepatitis, biliary injuryCompatible with AIHMethyl-prednisolone (1 mg/kg/d)Improved
Vuille-Lessard et al[89]76/FHashimoto's disease, urothelial carcinomamRNA-12733 d after the 1st dose811/5793.8IncreasedANA: 1:1280, AMA: 1:1280Interface hepatitis, plasma cells infiltration, pseudorosettesCompatible with AIHPrednisolone (40 mg/d) + azathioprineImproved
Londoño et al[90]41/FPremature ovarian failuremRNA-12737 d after the 2nd dose993/13122.3IncreasedANA: 1:80Interface hepatitis with a lymphoplasmacytic infiltrateTypical for AIHPrednisone (1 mg/kg)Improved
Rocco et al[91]80/FHashimoto's diseaseBNT162b27 d after the 3rd dose1401/118610.5IncreasedANA: 1:160Interface hepatitis with a lymphoplasmacytic infiltrateTypical for AIHPrednisoneImproved
McShane et al[92]71/FOsteoarthritismRNA-12734 d after the 1st dose-/106715.7IncreasedASMA: 1:2560Interface hepatitis, eosinophil infiltrationCompatible with AIHPrednisolone (40 mg/d)Improved
Clayton-Chubb et al[93]36/MHypertensionAZD122226 d after the 1st dose633/17749.9NormalANA: 1:160Interface hepatitisCompatible with AIHPrednisolone (60 mg/d)Improved
Tan et al[94]56/FNonemRNA-127335 d after the 1st dose1124/17015.9IncreasedANA: positive, ASMA: PositiveInterface hepatitis, rosette formation, eosinophil infiltrationCompatible with AIHBudesonideImproved
Ghielmetti et al[95]63/MType 2 diabetes, ischemic heart diseasemRNA-12737 d after the 1st dose1127/103811.9IncreasedANA: 1:640Inflammatory portal infiltrate with interface hepatitisTypical for AIHPrednisone (40 mg/d)Improved
Zhou et al[96]36/FUlcerative colitis, primary sclerosing cholangitismRNA-127311 d after the 1st dose581/5881.4IncreasedANA: 1:2560Interface hepatitis with a lymphoplasmacytic infiltrate, rosette, eosinophilCompatible with AIHPrednisone (50 mg/d)Improved
Garrido et al[97]65/FJAK2 V617F-positive polycythemiamRNA-127314 d after the 1st dose1056/10921.1IncreasedANA: 1:100Interface hepatitisCompatible with AIHPrednisolone (60 mg/d)Improved
Goulas et al[98]52/FNonemRNA-127314 d after the 1st dose350/936 9.06IncreasedANA: 1:320, ASMA: positivePortal, periportal inflammation, rosette formationTypical for AIHPrednisolone (50 mg/d) + azathioprineImproved
Rela et al[99]38/FHypothyroidismAZD122220 d after the 1st dose1101/102514.9IncreasedANA: positiveMultiacnar hepatic necrosis and periportal neocholangiolar proliferationCompatible with AIHPrednisolone (30 mg/d)Improved
Rela et al[99]62/MNoneAZD122213 d after the 2nd dose1361/109419.2NAANA: negativePortal neocholangiolar proliferation and mild to moderate inflammation Compatible with AIHPrednisolone (30 mg/d) + plasma exchangeDeath
Palla et al[100]40/FSarcoidosisBNT162b228 d after the 2nd dose4 times upper limit of normalNAIncreasedANA: 1:640Interface hepatitis with plasma cells infiltrationCompatible with AIHPrednisolone (40 mg/d)Improved
Mann et al[101]61/FIrritable bowel disease, cholecystectomyBNT162b29 d after the 2nd dose37/376.2NAANA: negativeScattered inflammatory cells consisting of lymphocyte and few eosinophilsDrug induced liver injuryConservative treatmentImproved
Avci et al[102]61/FHashimoto's disease, hypertensionBNT162b228 d after the 1st dose455/91311.8IncreasedANA: 1:100, ASMA: 1:100Interface hepatitisCompatible with AIHPrednisolone (40 mg/d) + azathioprineImproved
Torrente et al[103]46/FHypothyroidism, anemiaAZD122221 d after the 1st dose241/353NormalIncreasedANA: 1:160Lymphoplasmacytic portal infiltrateCompatible with AIHPrednisone (30 mg/d) + azathioprineImproved
Ghorbani et al[104]62/MNoneCorona Vac3 d after the 2nd dose722/4358NAANA: negative, ASMA: negativeInterface hepatitis, infiltration of lymphocytes and eosinophils in portal tractCompatible with AIHUrsodeoxycholic acidImproved
Kang et al[105]27/FNoneBNT162b27 d after the 2nd dose1004/14788.6IncreasedANA: 1:80Interface hepatitis with a lymphoplasmacytic infiltrate, rosette, eosinophilTypical for AIHPrednisolone (40 mg/d)Improved
Camacho-Domínguez et al[106]79/MNoneAZD122215 d after the 1st dose2003/199411.9IncreasedANA: 1:80Interface hepatitis with a lymphocytic infiltrate, eosinophilCompatible with AIHPrednisone (30 mg/d) + azathioprineImproved
Shahrani et al[107]59/FDyslipidemiaAZD122212 d after the 2nd dose962/11787.5IncreasedNALympho-plasmacellular portal infiltrateCompatible with AIHPrednisolone (40 mg/d)Improved
Shahrani et al[107]63/FUlcerative colitis, primary sclerosing cholangitisAZD122214 d after the 1st dose505/35418.6IncreasedANA: positiveInterface hepatitisCompatible with AIHPrednisolone (40 mg/d)Improved
Shahrani et al[107]72/FNoneBNT162b210 d after boostershot 1452/22801.7IncreasedANA: negative, AMA: positiveInfiltration of lymphocytes and plasma cells in portal tractCompatible with AIHPrednisolone (40 mg/d)Improved
Zin Tun et al[108]47/MNonemRNA-12733 d after the 1st dose; A few days after the 2nd doseNA/104811.3IncreasedANA: positiveInterface hepatitis with a lymphoplasmatic infiltrate, rosette, emperipolesisTypical for AIHPrednisolone (40 mg/d)Improved
Suzuki et al[109]80/FGastroesophageal reflux esophagitisBNT162b210 d after the 2nd dose995/9743.5IncreasedANA: 1:40Lymphoplasmacytic infiltration in the portal area, interface hepatitisCompatible with AIHPrednisone (0.8 mg/kg/d)Improved
Suzuki et al[109]75/FDyslipidemiaBNT162b24 d after the 2nd dose1085/82017.7IncreasedANA: 1:80Lymphoplasmacytic infiltration in the portal area, interface hepatitisCompatible with AIHPrednisone (1.0 mg/kg/d)Improved
Suzuki et al[109]78/FPrimary biliary cholangitisBNT162b27 d after the 1st dose401/5421.3IncreasedANA: 1:80Lymphoplasmacytic infiltration in the portal area, interface hepatitisCompatible with AIHPrednisone (0.6 mg/kg/d)Improved