Adverse events of acute nephrotoxicity reported to EudraVigilance and VAERS after COVID-19 vaccination

• Published in: Vaccine Vol. 41; no. 48; pp. 7176 - 7182
• Main Authors: Anastassopoulou, Cleo, Boufidou, Fotini, Hatziantoniou, Sophia, Vasileiou, Konstantinos, Spanakis, Nikolaos, Tsakris, Athanasios
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 22.11.2023; Elsevier Limited
• Subjects: acute kidney injury; Acute kidney injury (AKI); Acute Kidney Injury - chemically induced; Acute Kidney Injury - epidemiology; Ad26COVS1; Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Aged; Allergy and Immunology; Case reports; COVID-19; COVID-19 - prevention & control; COVID-19 infection; COVID-19 vaccines; COVID-19 Vaccines - adverse effects; Disease; Economic analysis; EudraVigilance; Europe; Fatalities; Female; Humans; Immunization; Kidneys; Licenses; Male; Middle Aged; Mortality; mRNA; mRNA vaccines; nephrotoxicity; Pharmacovigilance; Renal failure; Side effects; Statistical analysis; United States - epidemiology; vaccination; Vaccination - adverse effects; Vaccines; VAERS; Vectored vaccines; Young Adult; United States; United States > US; Europe; mRNA vaccines; VAERS; Vectored vaccines; EudraVigilance; Acute kidney injury (AKI); Renal failure
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2023.10.030

The present study aimed to estimate the reporting rates (RRs) of acute kidney injury (AKI) and renal failure (RF) after COVID-19 vaccination in the European Economic Area (EEA) and the United States. We retrieved and analyzed pharmacovigilance data on suspected AKI and RF cases and fatalities post COVID-19 vaccination with licensed vaccines reported to EudraVigilance and VAERS between week 52/2020 and week 52/2022 or week 1/2023, respectively. Reporting rates with 95% confidence intervals were estimated per million administered vaccine doses. In total, 4,244 AKI and 1,557 RF suspected cases were notified to EudraVigilance (1,692 AKI/971 RF) and VAERS (2,552 AKI/586 RF) during the study period following the administration of >1.6 billion COVID-19 vaccine doses (EEA: 970,934,453/US: 666,511,603). The overall RRs were 3.03 (95 % CI: 2.94–3.12) for AKI and 1.11 (95 % CI: 1.06–1.17) for RF per million administered vaccine doses. Indices for statistically significant increased risks were found in subjects, especially males, ≥65 years compared to 18–64 years old (AKI: OR = 7.23, 95 % CI: 6.63–7.88, p = 0.000, and RF: OR = 4.74, 95 % CI: 3.99–5.63, p < 0.001). AKI reporting rates were higher in the US, while RF reporting rates were higher in Europe. Both potential side effects were elevated following vectored rather than mRNA vaccines, with the highest reporting rates post AD26.COV2.S vaccination in the US (AKI: RR = 12.24, 95 % CI: 10.66–13.81; RF: RR = 3.17, 95 % CI: 2.36–3.97). There were 1,312 deaths possibly associated with AKI (RR = 0.94, 95 % CI: 0.89–0.99) and 460 deaths possibly associated with RF (RR = 0.33, 95 % CI: 0.30–0.36) per million vaccine doses. Fatalities were lower in Europe than in the US (AKI: OR = 0.25, 95 % CI: 0.22–0.28, p < 0.001; RF: OR = 0.82, 95 % CI: 0.69–0.99, p = 0.036). AKI and RF may be observed rarely following vaccination against COVID-19. Further studies are warranted to confirm these findings and uncover the underlying pathophysiological mechanism.