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Background: BNT162b2 mRNA vaccine has been shown to be safe and effective in healthy subjects. The safety and efficacy of this vaccine in liver transplant (LT) recipients is still a subject of evaluation. The objective of this study was to assess the safety and efficacy of BNT162b2 mRNA vaccine among LT recipients. Methods: Immune response of two dose of BNT162b2 mRNA vaccine in 76 LT recipients was compared to 174 age-matched immunocompetent subjects with no exposure to SARS-CoV-2 infection. Postvaccination IgG antibodies against the RBD of SARS-CoV-2 IgG S-protein serology and neutralizing antibodies (NA) to the BNT162b2 mRNA vaccine were determined at least 14 days after the second dose of vaccine. AB titer ≥1.1 was considered protective. Side effects were monitored during study period. Results: Following the administration of the BNT162b2 mRNA two dose vaccines, LT recipients (median age 64 (range 22-83 years), 56.6% males) showed reduced immune response as compared with immunocompetent controls (72% vs. 94.2%, p<0.0001). The geometric mean of titer IgG antibody of SARS-CoV-2 and NA was significantly lower in LT recipients who received combine immunosuppression (combination of CNI and prednisone, and/or MMF and/or everolimus) vs CNI monotherapy 1.1±3.1 vs. 3.5±2.1, p<0.0001, 59.0±3.2 vs. 256.0±4.7, p=0.002. In multivariate analysis, the antibody response was reduced in LT recipients who received combined immunosuppression and in those with impaired renal function. Overall most self-reported side effects that were detected in 39 (51%) LT recipients were mild. The immune response did not correlate with more severe side effects. The side effects occurred more often in women than in men. Conclusion: Compared with immunocompetent subjects, liver transplant recipients had reduced immune response. Factors affecting serological antibodies response include renal function and type of immunosuppression used. Side effects were mild in most cases and more often in women. The durability of immune response to BNT162b2 mRNA vaccine among LT recipients needs further investigation.
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TOPIC: Chest Infections TYPE: Original Investigations PURPOSE: The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to challenge the world. Even though effective vaccines have been developed, new variants of concern continue to emerge. While there is evidence of higher transmissibility rates of the B.1.1.7 variant and other variants, concerns regarding disease severity of these variants have not yet been confirmed. Patients undergoing maintenance hemodialysis are at increased risk for infection, with several reports of COVID-19 outbreaks in hemodialysis centers. The clinical outcomes of the SARS-CoV-2 variant viruses have not been reported or compared to non-variant SARS-CoV-2 among this unique population. The goal of the study was to compare the clinical outcomes and related mortality of infection with variant SARS-CoV-2 in chronic hemodialysis patients, and to compare it with infection by previous, non-variant strains of the virus. METHODS: This is a retrospective observational study comparing COVID-19 outbreaks of variant and non-variant SARS-CoV-2 strains in 2 hemodialysis centers in Israel. In one dialysis center ("center 1") an outbreak of COVID-19 caused by variant SARS-CoV-2 occurred starting from 28 December 2020. Subjects from a second hemodialysis center ("center 2") infected by non-variant SARS-CoV-2 in an earlier outbreak of COVID-19 which occurred from April 2020 to July 2020 served as control group. Complete SARS-CoV-2 genomes were sequenced via next generation sequencing (NGS).Primary outcome measures were 30-days mortality rates and in-hospital mortality rates. Secondary outcomes included mortality rates during follow-up, disease severity (according to NIH guidelines), need for respiratory support, type of respiratory support and need for hemodynamic support. RESULTS: Baseline subjects' characteristics were comparable. Chronic hemodialysis patients infected with SARS-CoV-2 variants had more severe infection and required more respiratory support, such as NIV (p=0.05), HFOT (p=0.021) and mechanical ventilation (p=0.05), as well as more hemodynamic support (p=0.05). Among patients from center 1, who were infected with virus variants, 71% were classified as critical vs. 8% of patients from center 2 (non-variant, p=0.005). 30-day mortality was higher among patients from center 1 as compared to center 2 (57.1% vs. 7.7.%, odds ratio for 30-day mortality in center 1 was 16, with 95% confidence interval 2-128, p=0.003).Multivariate analysis model for predictors of all-cause mortality showed that infection with a variant was the most important predictor of mortality. CONCLUSIONS: Infection with variant SARS-CoV-2 among chronic hemodialysis patients was strongly related with severe disease and mortality. CLINICAL IMPLICATIONS: SARS-CoV-2 genetic variation may affect clinical outcomes. Vaccination of hemodialysis patients should be prioritized. DISCLOSURES: No relevant relationships by sydney Benchetrit, source=Web Response No relevant relationships by keren cohen, source=Web Response No relevant relationships by Ayman Fadeela, source=Web Response No relevant relationships by Orna Mor, source=Web Response no disclosure on file for Naomi Nacasch;No relevant relationships by ori wand, source=Web Response no disclosure on file for Neta Zuckerman;
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Late in 2020, two genetically-distinct clusters of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with mutations of biological concern were reported, one in the United Kingdom and one in South Africa. Using a combination of data from routine surveillance, genomic sequencing and international travel we track the international dispersal of lineages B.1.1.7 and B.1.351 (variant 501Y-V2). We account for potential biases in genomic surveillance efforts by including passenger volumes from location of where the lineage was first reported, London and South Africa respectively. Using the software tool grinch (global report investigating novel coronavirus haplotypes), we track the international spread of lineages of concern with automated daily reports, Further, we have built a custom tracking website (cov-lineages.org/global_report.html) which hosts this daily report and will continue to include novel SARS-CoV-2 lineages of concern as they are detected.
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Background: The ongoing outbreak of COVID-19 is associated with higher levels of morbidity and mortality among patients with comorbidities including the metabolic syndrome Liver impairment has been reported in up to 54% of hospitalized patients with COVID-19 The impact of COVID-19 on a preexisting chronic liver disease as well as the outcome of the chronic liver disease are scares The aim of the study was to determine the predictors of severity and outcome of liver injury among hospitalized patients with COVID-19 infection, including subgroup of patients with a preexisting liver disease and COVID-19 Methods: This single center retrospective cohort study, included all patients ≥18 years, admitted in Sheba Medical Center with confirmed COVID-19 infection Demographic, clinical and laboratory data were obtained using MDClone platform and rechecked after decryption data, using electronic health record Results: Of 382 patients with COVID-19, 66 4% had increased liver biochemistry Mild increase was observed in 76 7% Higher level of AST at admission was independently associated with higher mortality rate Preexisting liver disease was detected in 15 4% patients Most common etiology was NAFLD (78 7%) In hospital mortality of patients with preexisting liver disease was 16 7% compared to 6 8% in patients without preexisting liver disease (RR=2 792, p=0 01) In multivariate analysis liver disease adjusted to age and BMI was significantly associated with mortality Conclusion: Patients with preexisting chronic liver disease were at a higher risk of mortality AST level at admission was associated with worse prognosis These findings should be reevaluated in a larger cohort of patients.