EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients

Abstract

According to a recent World Health Organization estimate, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, which originated in China in 2019, has spread globally, infecting nearly 100 million people worldwide by January 2021. Patients with chronic liver diseases (CLD), particularly cirrhosis, hepatobiliary malignancies, candidates for liver transplantation, and immunosuppressed individuals after liver transplantation appear to be at increased risk of infections in general, which in turn translates into increased mortality. This is also the case for SARS-CoV-2 infection, where patients with cirrhosis, in particular, are at high risk of a severe COVID-19 course. Therefore, vaccination against various pathogens including SARS-CoV-2, administered as early as possible in patients with CLD, is an important protective measure. However, due to impaired immune responses in these patients, the immediate and long-term protective response through immunisation may be incomplete. The current SARS-CoV-2 pandemic has led to the exceptionally fast development of several vaccine candidates. A small number of these SARS-CoV-2 vaccine candidates have already undergone phase III, placebocontrolled, clinical trials in healthy individuals with proof of short-term safety, immunogenicity and efficacy. However, although regulatory agencies in the US and Europe have already approved some of these vaccines for clinical use, information on immunogenicity, duration of protection and long-term safety in patients with CLD, cirrhosis, hepatobiliary cancer and liver transplant recipients has yet to be generated. This review summarises the data on vaccine safety, immunogenicity, and efficacy in this patient population in general and discusses the implications of this knowledge on the introduction of the new SARS-CoV-2 vaccines.

Protected or not protected, that is the question - First data on COVID-19 vaccine responses in patients with NAFLD and liver transplant recipients

“…The second study from Tel-Aviv Sourasky Medical Center, Israel, evaluated humoral antibody responses in 80 LTR and 25 healthy volunteers after vaccination with the mRNA vaccine BNT162b2 (BioNTech/Pfizer). The study confirmed the concern of lower immunogenicity of vaccination in transplant recipients (reviewed in [1]); antibodies were detectable in only 47.5% of patients compared to all 25 healthy controls and antibody titers were significantly lower in LTR (95.41 AU/mL vs. 200.5 AU/mL, p<0.001) [3]. Importantly, the authors reported no serious adverse events associated with the vaccine, and no event of graft rejection was observed.…”

“…Reported patients were rather young (median age 39 years) and only 3.7% had diabetes mellitus, a main risk factor for steatohepatitis and disease progression. This suggests that study participants had no advanced CLD and might explain why these findings are different to what is seen with other vaccines, such as influenza, where patients with advanced CLD elicit lower humoral immune responses [1]. More data on COVID-19 vaccination in patients with advanced CLD and with different vaccine types are eagerly awaited.…”

“…Immunocompromised and cancer patients were excluded from the phase III trials of current COVID-19 vaccines and data from very few study participants with chronic liver disease (CLD) were not reported in detail. This lead the European Association for the Study of the Liver (EASL) to publish a position paper guiding COVID-19 vaccination in patients with CLD, hepatobiliary cancer, and liver transplant recipients (LTR) [1]. In this issue, Wang et al [2] and Rabinowich et al [3] report first data on COVID-19 vaccination in patients with nonalcoholic fatty liver disease (NAFLD) and liver transplant recipients.…”

“…Phase I/II trails have shown that especially mRNA and viral vector COVID-19 vaccines elicit T cell responses that mightin addition to humoral responses -play a role in protection [8,9]. Vaccine efficacy in preventing symptomatic COVID-19 even in healthy individuals ranges between around 70 and 95%, depending on the type of vaccine (reviewed in [1]). Thus, it is expected that SARS-CoV-2 infection and cases of COVID-19 pneumonia will also occur in CLD or transplant recipients, as it has been reported in KTR, who were fully vaccinated with the BNT162b2 mRNA vaccine [10].…”

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

“…Coronavirus disease 2019 (COVID-19) has caused a devastating global pandemic since early 2020. 1 , 2 We read with interest the recent article by Cornberg et al. , 1 in which they summarized the data on vaccine safety, immunogenicity, and efficacy in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients.…”