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Real-world evidence of autoimmune hepatitis following COVID-19 vaccination: A population-based pharmacovigilance

Congqin Chen1, Danfei Xie2, Jie Xiao1

  • 1Department of Pharmacy, Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China.

Frontiers in Pharmacology
|May 1, 2023
PubMed

Insights

Autoimmune hepatitis (AIH) reports after Coronavirus Disease 2019 (COVID-19) vaccination were investigated. The study found no increased risk of AIH following COVID-19 vaccination, indicating no safety concern at this time.

Area of Science:

  • Immunology
  • Vaccinology
  • Hepatology

Background:

  • Autoimmune hepatitis (AIH) is a rare liver disease.
  • Reports of AIH following Coronavirus Disease 2019 (COVID-19) vaccination have emerged.
  • The safety profile of COVID-19 vaccines requires ongoing monitoring.

Purpose of the Study:

  • To determine the incidence rate of AIH post-COVID-19 vaccination.
  • To assess if COVID-19 vaccination disproportionately increases AIH risk.
  • To evaluate AIH reporting trends in the Vaccines Adverse Event Reporting System (VAERS).

Main Methods:

  • Utilized CDC COVID Data Tracker and VAERS data from December 2020 to March 2022.
  • Calculated AIH incidence rates per million vaccinated individuals.
  • Employed reporting odds ratio (ROR) and empirical Bayes geometric mean (EBGM) to detect disproportionality.

Main Results:

  • Identified 53 AIH reports post-COVID-19 vaccination.
  • Reported AIH rate was 0.21 per million people.
  • No statistically significant disproportionality of AIH reporting was found for COVID-19 vaccines (mRNA or virus vector).

Conclusions:

  • COVID-19 vaccination does not appear to elevate the risk of developing AIH.
  • Current VAERS data does not indicate a vaccine-attributable safety concern for AIH.
  • Further post-marketing surveillance is essential for vaccine safety monitoring.

Keywords:
CDC COVID data trackerCOVID-19 vaccineVAERSautoimmune hepatitisdisproportionality analysis

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