Risk of acute liver injury following the mRNA (BNT162b2) and inactivated (CoronaVac) COVID-19 vaccines

Carlos King Ho Wong; Lung Yi Mak; Ivan Chi Ho Au; Francisco Tsz Tsun Lai; Xue Li; Eric Yuk Fai Wan; Celine Sze Ling Chui; Esther Wai Yin Chan; Wing Yiu Cheng; Franco Wing Tak Cheng; Man Fung Yuen; Ian Chi Kei Wong

doi:10.1016/j.jhep.2022.06.032

Risk of acute liver injury following the mRNA (BNT162b2) and inactivated (CoronaVac) COVID-19 vaccines

J Hepatol. 2022 Nov;77(5):1339-1348. doi: 10.1016/j.jhep.2022.06.032. Epub 2022 Jul 9.

Affiliations

¹ Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; Department of Family Medicine and Primary Care, School of Clinical Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; Laboratory of Data Discovery for Health (D(2)4H), Hong Kong Science and Technology Park, Hong Kong SAR, China.
² Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong SAR, China.
³ Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.
⁴ Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; Laboratory of Data Discovery for Health (D(2)4H), Hong Kong Science and Technology Park, Hong Kong SAR, China.
⁵ Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; Laboratory of Data Discovery for Health (D(2)4H), Hong Kong Science and Technology Park, Hong Kong SAR, China; Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.
⁶ Laboratory of Data Discovery for Health (D(2)4H), Hong Kong Science and Technology Park, Hong Kong SAR, China; School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.
⁷ School of Biomedical Sciences, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.
⁸ Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China; Laboratory of Data Discovery for Health (D(2)4H), Hong Kong Science and Technology Park, Hong Kong SAR, China; Research Department of Practice and Policy, UCL School of Pharmacy, University College London, London, UK; Aston School of Pharmacy, Aston University, Birmingham, UK. Electronic address: wongick@hku.hk.

Abstract

Background & aims: Case reports of severe acute liver injury (ALI) following COVID-19 vaccination have recently been published. We evaluated the risks of ALI following COVID-19 vaccination (BNT162b2 or CoronaVac).

Methods: We conducted a modified self-controlled case series analysis using the vaccination records in Hong Kong with data linkage to electronic medical records from a territory-wide healthcare database. Incidence rate ratios (IRRs) for ALI outcome in the 56-day period following first and second doses of COVID-19 vaccines in comparison to the non-exposure period were estimated and compared to the ALI risk in patients with SARS-CoV-2 infection.

Results: Among 2,343,288 COVID-19 vaccine recipients who were at risk, 4,677 patients developed ALI for the first time between 23^rd February 2021 to 30^th September 2021. The number of ALI cases within 56 days after the first and second dose of vaccination were 307 and 521 (335 and 334 per 100,000 person-years) for BNT162b2, and 304 and 474 (358 and 403 per 100,000 person-years) for CoronaVac, respectively, compared to 32,997 ALI cases per 100,000 person-years among patients within 56 days of SARS-CoV-2 infection. Compared to the non-exposure period, no increased risk was observed in the 56-day risk period for first (IRR 0.800; 95% CI 0.680-0.942) and second (IRR 0.944; 95% CI 0.816-1.091) dose of BNT162b2, or first (IRR 0.689; 95% CI 0.588-0.807) and second (IRR 0.905; 95% CI 0.781-1.048) dose of CoronaVac. There were no severe or fatal cases of ALI following COVID-19 vaccination.

Conclusion: There was no evidence of an increased risk of ALI associated with BNT162b2 or CoronaVac vaccination. Based on all current available evidence from previous studies and our study, the benefit of mass vaccination far outweighs the ALI risk from vaccination.

Lay summary: There have been some recent reports that COVID-19 vaccination could be associated with acute liver injury. In our study, we found no evidence that COVID-19 vaccination increased the risk of acute liver injury, which was much more common after SARS-CoV-2 infection than after vaccination. Hence, our study provides further data indicating that the benefits of mass COVID-19 vaccination outweigh the potential risks.

Keywords: Acute liver injury; BNT162b2; COVID-19 vaccine; CoronaVac; case series.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Anthraquinones
BNT162 Vaccine
COVID-19 Vaccines* / adverse effects
COVID-19* / epidemiology
COVID-19* / prevention & control
Humans
Liver / injuries
Pyrazoles
RNA, Messenger
SARS-CoV-2

Substances

Anthraquinones
BNT162 Vaccine
COVID-19 Vaccines
piroxantrone
Pyrazoles
RNA, Messenger