tetano
Editor, Senior Moderator
J Pharm Pharm Sci
. 2023 Jun 30;26:11453.
doi: 10.3389/jpps.2023.11453. eCollection 2023. COVID-19 mRNA vaccination is associated with IgA nephropathy: an analysis of the Japanese adverse drug event report database
Hiroka Nakao[SUP] 1 [/SUP], Takenao Koseki[SUP] 2 [/SUP], Koki Kato[SUP] 2 [/SUP], Shigeki Yamada[SUP] 2 [/SUP], Naotake Tsuboi[SUP] 3 [/SUP], Kazuo Takahashi[SUP] 1 [/SUP], Tomohiro Mizuno[SUP] 2 [/SUP]
Affiliations
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.
. 2023 Jun 30;26:11453.
doi: 10.3389/jpps.2023.11453. eCollection 2023. COVID-19 mRNA vaccination is associated with IgA nephropathy: an analysis of the Japanese adverse drug event report database
Hiroka Nakao[SUP] 1 [/SUP], Takenao Koseki[SUP] 2 [/SUP], Koki Kato[SUP] 2 [/SUP], Shigeki Yamada[SUP] 2 [/SUP], Naotake Tsuboi[SUP] 3 [/SUP], Kazuo Takahashi[SUP] 1 [/SUP], Tomohiro Mizuno[SUP] 2 [/SUP]
Affiliations
- PMID: 37456806
- PMCID: PMC10348063
- DOI: 10.3389/jpps.2023.11453
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.