COVID-19 mRNA vaccination is associated with IgA nephropathy: an analysis of the Japanese adverse drug event report database

Hiroka Nakao; Takenao Koseki; Koki Kato; Shigeki Yamada; Naotake Tsuboi; Kazuo Takahashi; Tomohiro Mizuno

doi:10.3389/jpps.2023.11453

COVID-19 mRNA vaccination is associated with IgA nephropathy: an analysis of the Japanese adverse drug event report database

J Pharm Pharm Sci. 2023 Jun 30:26:11453. doi: 10.3389/jpps.2023.11453. eCollection 2023.

Authors

Hiroka Nakao¹, Takenao Koseki², Koki Kato², Shigeki Yamada², Naotake Tsuboi³, Kazuo Takahashi¹, Tomohiro Mizuno²

Affiliations

¹ Department of Biomedical Molecular Sciences, School of Medicine, Fujita Health University, Toyoake, Japan.
² Department of Pharmacotherapeutics and Informatics, School of Medicine, Fujita Health University, Toyoake, Japan.
³ Department of Nephrology, School of Medicine, Fujita Health University, Toyoake, Japan.

Abstract

Purpose: Coronavirus disease 2019 (COVID-19) mRNA vaccines are used worldwide to prevent severe symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. IgA nephropathy (IgAN) is the most common form of glomerular injury after COVID-19 vaccination; however, because of the low frequency of such events, only a few reports have been published. A large pharmacovigilance database of real-world spontaneous adverse event (AE) reports is essential for evaluating the drug-associated safety signals regarding rare AEs. Herein, we aimed to investigate the frequency of IgAN after the COVID-19 vaccination, using the Japanese Adverse Drug Event Report (JADER) database. Methods: Data on drug-associated AEs reported between April 2004 and May 2022 were obtained from the JADER database on the Pharmaceuticals and Medical Devices Agency website. To evaluate the safety signals for the targeted AEs, reporting odds ratios (RORs), information components (ICs), and their 95% confidence intervals (CIs) were calculated using two-by-two contingency tables. Results: A total of 697,885 cases were included in the analysis. Safety signals were detected for IgAN (ROR: 6.49, 95% CI: 4.38-9.61; IC: 2.27, 95% CI: 1.70-2.83). Of 30 cases for IgAN associated with COVID-19 mRNA vaccines, 16 had information available on time to onset. Of the 16 cases, 11 occurred ≤2 days after vaccination, and two occurred >28 days after vaccination. Conclusion: These results suggest that, compared with other drugs, COVID-19 vaccination is associated with a higher frequency of IgAN. Monitoring of gross hematuria following COVID-19 vaccination should be needed.

Keywords: COVID-19; IgA nephropathy; Japanese adverse drug event report; mRNA vaccine; reporting odds ratio.

Publication types

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

MeSH terms

Adverse Drug Reaction Reporting Systems
COVID-19 Vaccines / adverse effects
COVID-19* / prevention & control
Drug-Related Side Effects and Adverse Reactions*
East Asian People
Glomerulonephritis, IGA* / genetics
Humans
SARS-CoV-2 / genetics
Vaccination / adverse effects
mRNA Vaccines

Substances

COVID-19 Vaccines
mRNA Vaccines

Grants and funding

This work was supported by Otsuka Pharmaceutical Factory, Inc. for English editing and article publication through scholarship donations. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.