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Real-World Effectiveness and Immunogenicity of BNT162b2 and mRNA-1273 SARS-CoV-2 Vaccines in Patients on Hemodialysis
Journal of the American Society of Nephrology ( IF 13.6 ) Pub Date : 2022-01-01 , DOI: 10.1681/asn.2021060778
Scott Sibbel 1 , Katherine McKeon 1 , Jiacong Luo 1 , Karl Wendt 1 , Adam G Walker 1 , Tara Kelley 1 , Rachael Lazar 2 , Meredith L Zywno 2 , Jeffrey J Connaire 1 , Francesca Tentori 1 , Amy Young 1 , Steven M Brunelli 1
Affiliation  

Background

Patients on hemodialysis have an elevated risk for COVID-19 but were not included in efficacy trials of SARS-CoV-2 vaccines.

Methods

We conducted a retrospective, observational study to estimate the real-world effectiveness and immunogenicity of two mRNA SARS-CoV-2 vaccines in a large, representative population of adult hemodialysis patients in the United States. In separate, parallel analyses, patients who began a vaccination series with BNT162b2 or mRNA-1273 in January and February 2021 were matched with unvaccinated patients and risk for outcomes were compared for days 1-21, 22-42, and ≥43 after first dose. In a subset of consented patients, blood samples were collected approximately 28 days after the second dose and anti–SARS-CoV-2 immunoglobulin G was measured.

Results

A total of 12,169 patients received the BNT162b2 vaccine (matched with 44,377 unvaccinated controls); 23,037 patients received the mRNA-1273 vaccine (matched with 63,243 unvaccinated controls). Compared with controls, vaccinated patients’ risk of being diagnosed with COVID-19 postvaccination became progressively lower during the study period (hazard ratio and 95% confidence interval for BNT162b2 was 0.21 [0.13, 0.35] and for mRNA-1273 was 0.27 [0.17, 0.42] for days ≥43). After a COVID-19 diagnosis, vaccinated patients were significantly less likely than unvaccinated patients to be hospitalized (for BNT162b2, 28.0% versus 43.4%; for mRNA-1273, 37.2% versus 45.6%) and significantly less likely to die (for BNT162b2, 4.0% versus 12.1%; for mRNA-1273, 5.6% versus 14.5%). Antibodies were detected in 98.1% (309/315) and 96.0% (308/321) of BNT162b2 and mRNA-1273 patients, respectively.

Conclusions

In patients on hemodialysis, vaccination with BNT162b2 or mRNA-1273 was associated with a lower risk of COVID-19 diagnosis and lower risk of hospitalization or death among those diagnosed with COVID-19. SARS-CoV-2 antibodies were detected in nearly all patients after vaccination. These findings support the use of these vaccines in this population.



中文翻译:

BNT162b2 和 mRNA-1273 SARS-CoV-2 疫苗在血液透析患者中​​的真实世界有效性和免疫原性

背景

接受血液透析的患者感染 COVID-19 的风险较高,但未被纳入 SARS-CoV-2 疫苗的功效试验。

方法

我们进行了一项回顾性观察性研究,以评估两种 mRNA SARS-CoV-2 疫苗在美国大量有代表性的成年血液透析患者中​​的真实有效性和免疫原性。在单独的平行分析中,将在 2021 年 1 月和 2021 年 2 月开始 BNT162b2 或 mRNA-1273 疫苗接种系列的患者与未接种疫苗的患者进行匹配,并比较首次接种后第 1-21 天、第 22-42 天和≥43 天的结果风险. 在同意的患者子集中,在第二次给药后约 28 天收集血样,并测量抗 SARS-CoV-2 免疫球蛋白 G。

结果

共有 12,169 名患者接种了 BNT162b2 疫苗(与 44,377 名未接种疫苗的对照相匹配);23,037 名患者接种了 mRNA-1273 疫苗(与 63,243 名未接种疫苗的对照相匹配)。与对照组相比,接种疫苗的患者在接种疫苗后被诊断为 COVID-19 的风险在研究期间逐渐降低(BNT162b2 的风险比和 95% 置信区间为 0.21 [0.13, 0.35],而 mRNA-1273 的风险比和 95% 置信区间为 0.27 [0.17, 0.42] ≥ 43 天)。在确诊 COVID-19 后,接种疫苗的患者住院的可能性明显低于未接种疫苗的患者(对于 BNT162b2,分别为 28.0% 和 43.4%;对于 mRNA-1273,分别为 37.2% 和 45.6%),并且死亡的可能性也明显更低(对于 BNT162b2, 4.0% 对 12.1%;对于 mRNA-1273,5.6% 对 14.5%)。在 98.1% (309/315) 和 96 中检测到抗体。

结论

在接受血液透析的患者中,接种 BNT162b2 或 mRNA-1273 疫苗与较低的 COVID-19 诊断风险和较低的 COVID-19 住院或死亡风险相关。接种疫苗后,几乎所有患者都检测到了 SARS-CoV-2 抗体。这些发现支持在该人群中使用这些疫苗。

更新日期:2021-12-31
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