Adverse events of acute nephrotoxicity reported to EudraVigilance and VAERS after COVID-19 vaccination
Copyright © 2023 Elsevier Ltd. All rights reserved..
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
|---|---|
| Enthalten in: |
Vaccine - 41(2023), 48 vom: 22. Nov., Seite 7176-7182 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Anastassopoulou, Cleo [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Acute kidney injury (AKI) |
|---|
| Anmerkungen: |
Date Completed 22.11.2023 Date Revised 09.04.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.vaccine.2023.10.030 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM363831061 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM363831061 | ||
| 003 | DE-627 | ||
| 005 | 20240410232243.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.vaccine.2023.10.030 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1371.xml |
| 035 | |a (DE-627)NLM363831061 | ||
| 035 | |a (NLM)37891048 | ||
| 035 | |a (PII)S0264-410X(23)01214-8 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Anastassopoulou, Cleo |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Adverse events of acute nephrotoxicity reported to EudraVigilance and VAERS after COVID-19 vaccination |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 22.11.2023 | ||
| 500 | |a Date Revised 09.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Elsevier Ltd. All rights reserved. | ||
| 520 | |a OBJECTIVES: 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 | ||
| 520 | |a METHODS: 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 | ||
| 520 | |a RESULTS: 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) | ||
| 520 | |a CONCLUSIONS: 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Acute kidney injury (AKI) | |
| 650 | 4 | |a EudraVigilance | |
| 650 | 4 | |a Renal failure | |
| 650 | 4 | |a VAERS | |
| 650 | 4 | |a Vectored vaccines | |
| 650 | 4 | |a mRNA vaccines | |
| 650 | 7 | |a Ad26COVS1 |2 NLM | |
| 650 | 7 | |a JT2NS6183B |2 NLM | |
| 650 | 7 | |a COVID-19 Vaccines |2 NLM | |
| 700 | 1 | |a Boufidou, Fotini |e verfasserin |4 aut | |
| 700 | 1 | |a Hatziantoniou, Sophia |e verfasserin |4 aut | |
| 700 | 1 | |a Vasileiou, Konstantinos |e verfasserin |4 aut | |
| 700 | 1 | |a Spanakis, Nikolaos |e verfasserin |4 aut | |
| 700 | 1 | |a Tsakris, Athanasios |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Vaccine |d 1985 |g 41(2023), 48 vom: 22. Nov., Seite 7176-7182 |w (DE-627)NLM012600105 |x 1873-2518 |7 nnns |
| 773 | 1 | 8 | |g volume:41 |g year:2023 |g number:48 |g day:22 |g month:11 |g pages:7176-7182 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.vaccine.2023.10.030 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 41 |j 2023 |e 48 |b 22 |c 11 |h 7176-7182 | ||