Liver related adverse events reported after the use of COVID-19 vaccines: A descriptive study

Objectives: The present study focus on the liver-related adverse events (AEs) reported with COVID-19 vaccines in VigiBase, a database maintained by WHO for reporting adverse events. Materials and Methods: The data of liver-related adverse events following COVID-19 vaccination was acquired on a subscription basis from VigiBase. This study included all the suspected liverrelated adverse events reported in VigiBase after administering any of the three COVID-19 vaccines: Moderna, BNT162b2 Pfizer and 1222 AstraZeneca between December 15, 2020, and January 24, 2021. The MedDRA (Medical Dictionary for Regulatory Activities) and WHOART terminology- SOC (System Organ Class) and PT (Preferred Terms) were used for analysis. We extracted three SOCs - hepatobiliary disorders, gastrointestinal disorders and investigations. All the SOC were further cleaned to remove all PTs other than those related to the liver. Disproportionality analysis was reported in the form of IC025, Reporting Odds Ratio and Prevalence Odds Ratio. Results: A total of 103,954 AEs were reported for COVID-19 vaccines from 32,044 individuals, out of which only 51 (0.049%) AE from 32 patients was related to the liver. Most common liver-related AE reported were in the SOC ''investigations''- increase in alanine amino transferase (0.009%) followed by increased aspartate aminotransferase and increased bilirubin (0.006%). Based on the disproportionality analysis (IC025 values) none of them was vaccinerelated AE. Conclusion: COVID-19 vaccines are safe for liver and there was no increase in the events were associated with the use of vaccines. As these were early data of vaccine use, analysis based on recent data need to be done to ascertain it fully.

Liver related adverse events reported in WHO database with use of remdesivir in COVID-19

Objectives: Remdesivir was granted emergency approval for use in the management of COVID-19 though some studies exhibit concerns regarding its effectiveness, it is still being used for COVID-19 infection management in many parts of the globe. To date, limited data is available regarding its safety as it's a newer drug. Thus there is a need to observe and record its adverse events to aid future decisions. This study was designed with the aim of analyzing the liver-related adverse drug events (ADEs) reported in VigiBase, the WHO database for adverse event reporting. Materials and Methods: The analysis of all suspected adverse events related to remdesivir reported in the last 5 years to VigiBase®, i.e. from January 1, 2015, to July 19, 2020, was performed. We used SOC (System Organ Class) information and PT (Preferred Terms) for analysis in the present study. We extracted three SOCs - hepatobiliary disorders, gastrointestinal disorders, and investigations. Descriptive statistics were reported in the form of frequency and percentages. Results: The majority of ADEs were reported from males and the majority were serious in nature. A total of 1086 ADEs were reported from the 439 individuals up to July 19, 2020, in the VigiBase®, after exclusion of duplicates1004 ADE were analyzed. out of this 18.12% (182 of 1004), ADE was related to the liver from 142 subjects. The most common ADE were alternations in the liver enzymes with Alanine aminotransferase increased 4.98% (50 of 1004), 3.19% (32 pf 1004) of increase in Aspartate Aminotransferase, and increased in transaminase increased in 2. 39% (24 of 1004). Conclusion: Deterioration of liver functions was observed with the use of remdesivir in a few patients. A thorough review of cases and proportionality analysis should be done to ascertain the causality of these adverse events as COVID-19 infection may itself leads to an increase in liver enzymes.

Adverse events reported from the COVID-19 vaccines: a descriptive study based on the WHO database (VigiBaseR)

The emergency approval of a few COVID-19 vaccines provided a ray of hope to fight the deadly pandemic. However, their approval was solely based on limited data from the clinical trials in a short period, thereby imposing a demand for post-marketing surveillance studies to monitor beneficial and adverse events (AEs). This study focuses on observing the serious adverse events (SAEs) data reported in the World Health Organization database. The data from VigiBaseR was analyzed. The duplicates in the data were removed and analyzed based on age, gender, and SAEs at the system organ classification level and the individual preferred term level. A total of 103,954 AEs were reported. The majority of them were seen as females (80%), from Europe (83%), and were between 18 and 64 years (80.74%) of age. The most-reported AEs were of the nervous system (19.1%), musculoskeletal (11.2%), and elderly (>65 years) people. The reported SAEs from the COVID-19 vaccines were in line with the data published in the clinical trial reports. These SAEs to vaccines will need causality analysis and review of individual reports.