Department of Microbiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Neurochemistry and Biological Markers Unit, 1(st) Department of Neurology, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Vaccine. 2023 Nov 22;41(48):7176-7182. doi: 10.1016/j.vaccine.2023.10.030. Epub 2023 Oct 26.
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.
本研究旨在评估 COVID-19 疫苗接种后在欧洲经济区（EEA）和美国发生急性肾损伤（AKI）和肾衰竭（RF）的报告率（RR）。
我们检索并分析了自 2020 年第 52 周至 2022 年第 52 周或 2023 年第 1 周期间，在欧洲警戒系统（EudraVigilance）和疫苗不良事件报告系统（VAERS）报告的疑似 AKI 和 RF 病例以及与 COVID-19 疫苗接种相关的死亡病例的药物警戒数据。根据每百万接种疫苗剂量计算报告率及其 95%置信区间。
在研究期间，在 EudraVigilance（1692 例 AKI/971 例 RF）和 VAERS（2552 例 AKI/586 例 RF）共报告了 4244 例 AKI 和 1557 例 RF 疑似病例，接种的 COVID-19 疫苗剂量超过 16 亿剂（EEA：970934453，美国：666511603）。总的 AKI 和 RF 报告率分别为每百万接种疫苗剂量 3.03（95%CI：2.94-3.12）和 1.11（95%CI：1.06-1.17）。在≥65 岁的人群中，与 18-64 岁人群相比，AKI 的风险指数（OR）显著升高（AKI：OR=7.23，95%CI：6.63-7.88，p=0.000；RF：OR=4.74，95%CI：3.99-5.63，p<0.001），RF 也发现了统计学上显著增加的风险。美国 AKI 报告率较高，而欧洲 RF 报告率较高。与 mRNA 疫苗相比，载体疫苗接种后 AKI 和 RF 的风险更高，美国 AD26.COV2.S 接种后 AKI 的报告率最高（AKI：RR=12.24，95%CI：10.66-13.81；RF：RR=3.17，95%CI：2.36-3.97）。与 AKI 可能相关的 1312 例死亡（RR=0.94，95%CI：0.89-0.99）和与 RF 可能相关的 460 例死亡（RR=0.33，95%CI：0.30-0.36）每百万接种疫苗剂量。欧洲的死亡率低于美国（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）。
接种 COVID-19 疫苗后可能会很少观察到 AKI 和 RF。需要进一步的研究来证实这些发现，并揭示潜在的病理生理机制。
