Bernardo Ana Paula, Carioni Paola, Stuard Stefano, Kotanko Peter, Usvyat Len A, Kovarova Vratislava, Arkossy Otto, Bellocchio Francesco, Tupputi Antonio, Gervasoni Federica, Winter Anke, Zhang Yan, Zhang Hanjie, Ponce Pedro, Neri Luca
Fresenius Medical Care Portugal / Nephrocare Portugal, Vila Nova de Gaia, Portugal.
Unit for Multidisciplinary Research in Biomedicine (UMIB), Institute of Biomedical Sciences Abel Salazar (ICBAS), Porto University, Oporto, Portugal.
Front Nephrol. 2022 Nov 15;2:1037754. doi: 10.3389/fneph.2022.1037754. eCollection 2022.
Hemodialysis patients have high-risk of severe SARS-CoV-2 infection but were unrepresented in randomized controlled trials evaluating the safety and efficacy of COVID-19 vaccines. We estimated the real-world effectiveness of COVID-19 vaccines in a large international cohort of hemodialysis patients.
In this historical, 1:1 matched cohort study, we included adult hemodialysis patients receiving treatment from December 1, 2020, to May 31, 2021. For each vaccinated patient, an unvaccinated control was selected among patients registered in the same country and attending a dialysis session around the first vaccination date. Matching was based on demographics, clinical characteristics, past COVID-19 infections and a risk score representing the local background risk of infection at vaccination dates. We estimated the effectiveness of mRNA and viral-carrier COVID-19 vaccines in preventing infection and mortality rates from a time-dependent Cox regression stratified by country.
In the effectiveness analysis concerning mRNA vaccines, we observed 850 SARS-CoV-2 infections and 201 COVID-19 related deaths among the 28110 patients during a mean follow up of 44 ± 40 days. In the effectiveness analysis concerning viral-carrier vaccines, we observed 297 SARS-CoV-2 infections and 64 COVID-19 related deaths among 12888 patients during a mean follow up of 48 ± 32 days. We observed 18.5/100-patient-year and 8.5/100-patient-year fewer infections and 5.4/100-patient-year and 5.2/100-patient-year fewer COVID-19 related deaths among patients vaccinated with mRNA and viral-carrier vaccines respectively, compared to matched unvaccinated controls. Estimated vaccine effectiveness at days 15, 30, 60 and 90 after the first dose of a mRNA vaccine was: for infection, 41.3%, 54.5%, 72.6% and 83.5% and, for death, 33.1%, 55.4%, 80.1% and 91.2%. Estimated vaccine effectiveness after the first dose of a viral-carrier vaccine was: for infection, 38.3% without increasing over time and, for death, 56.6%, 75.3%, 92.0% and 97.4%.
In this large, real-world cohort of hemodialyzed patients, mRNA and viral-carrier COVID-19 vaccines were associated with reduced COVID-19 related mortality. Additionally, we observed a strong reduction of SARS-CoV-2 infection in hemodialysis patients receiving mRNA vaccines.
血液透析患者感染严重SARS-CoV-2的风险很高，但在评估新冠疫苗安全性和有效性的随机对照试验中却没有他们的身影。我们估计了新冠疫苗在一个大型国际血液透析患者队列中的实际效果。
在这项历史性的1:1匹配队列研究中，我们纳入了2020年12月1日至2021年5月31日期间接受治疗的成年血液透析患者。对于每一位接种疫苗的患者，在同一国家登记且在首次接种日期前后参加透析治疗的患者中选择一名未接种疫苗的对照。匹配基于人口统计学、临床特征、既往新冠病毒感染情况以及一个代表接种日期当地感染背景风险的风险评分。我们通过按国家分层的时间依赖性Cox回归估计了mRNA和病毒载体新冠疫苗在预防感染和死亡率方面的有效性。
在关于mRNA疫苗的有效性分析中，在平均44±40天的随访期间，我们在28110名患者中观察到850例SARS-CoV-2感染和201例与新冠病毒相关的死亡。在关于病毒载体疫苗的有效性分析中，在平均48±32天的随访期间，我们在12888名患者中观察到297例SARS-CoV-2感染和64例与新冠病毒相关的死亡。与匹配的未接种疫苗对照组相比，我们分别观察到接种mRNA和病毒载体疫苗的患者每100患者年的感染减少了18.5例和8.5例，与新冠病毒相关的死亡减少了5.4例和5.2例。在接种第一剂mRNA疫苗后第15、30、60和90天的估计疫苗有效性为：对于感染，分别为41.3%、54.5%、72.6%和83.5%；对于死亡，分别为33.1%、55.4%、80.1%和91.2%。接种第一剂病毒载体疫苗后的估计疫苗有效性为：对于感染，为38.3%，且未随时间增加；对于死亡，分别为56.6%、75.3%、92.0%和97.4%。
在这个大型的血液透析患者真实队列中，mRNA和病毒载体新冠疫苗与降低新冠病毒相关死亡率有关。此外，我们观察到接受mRNA疫苗的血液透析患者中SARS-CoV-2感染大幅减少。
