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COVID-19 Vaccine Efficacy and Safety in patients with Vascular Liver Disease

Apr 15, 2021

Vascular liver diseases (VLD) are a group of rare liver disorders consequence of alterations in the liver venous tree and of unknown etiology.

SARS-CoV-2 pandemic has led to a huge number of research studies in patients with liver disease that have demonstrated an increased risk of severe disease and death in patients with chronic liver disease (CLD). However, data on COVID-19 susceptibility, thrombotic risk and outcome in patients with VLD is not totally known.

In the last months, the Pfizer/BioNTech® BNT162b2 mRNA, Moderna® mRNA-1273, and the AstraZeneca®/University of Oxford ChAdOx1-nCoV-19 chimpanzee adenovirus vector vaccines have each reported excellent safety profiles have all gained rapid regulatory approval.

Due to the impact of SARS-CoV-2 in patients with CLD and the safe profile of vaccines, the European Reference Network (ERN) for hepatological disorders recommend and encourage vaccination of patients with rare liver disorders, including (VLD) (https://rare-liver.eu).

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Aims

To better understand the profile and impact of SARS-CoV-2 vaccination in patients with VLD we propose to create a VALDIG-ERN registry to include VLD patients receiving COVID-19 vaccines with the aim of evaluating:

  1. Vaccine Efficacy
    • frequency of post-vaccination SARS-CoV-2 infection
  2. Patient response (when available)
    • anti-spike IgG antibodies and spike-specific CD4+ and CD8+ T cells
  3. Adverse events
  4. Liver-related complication and decompensation
  5. Due to the enhance thrombotic risk in patients with VLD, special interest will be paid on coagulation parameters and thrombotic events (both splanchnic and systemic)

The international nature of the study and the different vaccination policies in the participating countries, will allow to evaluate the impact of vaccine type. Moreover, having a big sample size will allow to group patients based on VLD phenotype and underlying disease.

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