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

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/m2 (IQR 23.8-28.1 kg/m2). 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.

Comparison of the community-acquired pneumonia and COVID-19 at the early stage: findings from two cohort studies.

BACKGROUND: The current focus is largely on whole course medical management of coronavirus disease-19 (COVID-19) with real-time polymerase chain reaction (RT-PCR) and radiological features, while the mild cases are usually missed. Thus, combination of multiple diagnostic methods is urgent to understand COVID-19 fully and to monitor the progression of COVID-19. METHODS: laboratory variables of 40 mild COVID-19 patients, 30 patients with community-acquired pneumonia (CAP) and 32 healthy individuals were analyzed by principal component analysis (PCA), Kruskal test, Procrustes test, the vegan package in R, CCA package and receiver operating characteristic to investigate the characteristics of the laboratory variables and their relationships in COVID-19. RESULTS: The correlations between the laboratory variables presented a variety of intricate linkages in the COVID-19 group compared with the healthy group and CAP patient group. The prediction probability of the combination of lymphocyte count (LY), eosinophil (EO) and platelets (PLT) was 0.847, 0.854 for the combination of lactate (LDH), creatine kinase isoenzyme (CK-MB), and C-reactive protein (CRP), 0.740 for the combination of EO, white blood cell count (WBC) and neutrophil count (NEUT) and 0.872 for the combination of CK-MB and P. CONCLUSIONS: The correlations between the laboratory variables in the COVID-19 group could be a unique characteristic showing promise as a method for COVID-19 prediction and monitoring progression of COVID-19 infection.