DaVita Clinical Research, Minneapolis, Minnesota.
DaVita Inc., Denver, Colorado.
J Am Soc Nephrol. 2022 Jan;33(1):49-57. doi: 10.1681/ASN.2021060778. Epub 2021 Nov 17.
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.
背景：接受血液透析的患者感染 COVID-19 的风险较高，但他们并未被纳入 SARS-CoV-2 疫苗的疗效试验。
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 21 在美国的代表性成人血液透析患者中，疫苗在真实世界中的有效性和免疫原性。在单独的平行分析中，2021 年 1 月和 2 月开始接受 BNT162b2 或 mRNA-1273 疫苗系列接种的患者与未接种疫苗的患者进行了匹配，并比较了首次接种后 1-21 天、22-42 天和≥43 天的结局风险。在同意的患者亚组中，大约在第二次接种后 28 天采集血样，并测量抗 SARS-CoV-2 免疫球蛋白 G。
结果：共有 12169 名患者接受了 BNT162b2 疫苗接种（与 44377 名未接种疫苗的对照组相匹配）；23037 名患者接受了 mRNA-1273 疫苗接种（与 63243 名未接种疫苗的对照组相匹配）。与对照组相比，接种疫苗的患者在研究期间发生 COVID-19 诊断后的风险逐渐降低（BNT162b2 的风险比和 95%置信区间为 0.21 [0.13，0.35]，mRNA-1273 为 0.27 [0.17，0.42]）≥43 天）。在 COVID-19 诊断后，接种疫苗的患者与未接种疫苗的患者相比，住院的可能性明显降低（BNT162b2 为 28.0%对 43.4%；mRNA-1273 为 37.2%对 45.6%），死亡的可能性明显降低（BNT162b2 为 4.0%对 12.1%；mRNA-1273 为 5.6%对 14.5%）。在 BNT162b2 和 mRNA-1273 患者中，分别有 98.1%（309/315）和 96.0%（308/321）的患者检测到抗体。
结论：在接受血液透析的患者中，接种 BNT162b2 或 mRNA-1273 与 COVID-19 诊断风险降低以及 COVID-19 诊断后住院或死亡风险降低相关。接种疫苗后，几乎所有患者都检测到 SARS-CoV-2 抗体。这些发现支持在该人群中使用这些疫苗。
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