背景:COVID-19大流行对全球卫生系统构成了重大挑战。有效的公共卫生应对措施需要快速,安全地收集健康数据,以提高对SARS-CoV-2的了解,并检查新型COVID-19疫苗的疫苗有效性(VE)和药物安全性。
目的:这项研究(针对16年以上接种疫苗和未接种疫苗的受试者的COVID-19研究;eCOV研究)旨在(1)通过数字参与式监测工具评估COVID-19疫苗的现实世界有效性,以及(2)评估自我报告数据用于监测德国COVID-19大流行关键参数的潜力。
方法:使用数字研究Web应用程序,我们收集了2021年5月1日至2022年8月1日之间的自我报告数据,以评估VE,测试阳性率,COVID-19发病率,和COVID-19疫苗接种后的不良事件。我们的主要结果指标是SARS-CoV-2疫苗对实验室确认的SARS-CoV-2感染的VE。次要结果指标包括针对住院的VE和不同的SARS-CoV-2变体,接种疫苗后的不良事件,和感染期间的症状。在初次疫苗接种系列和第三剂疫苗接种后,使用校正混杂因素的Logistic回归模型来估计VE4至48周。未接种疫苗的参与者与年龄和性别匹配的参与者进行比较,这些参与者接受了2剂BNT162b2(Pfizer-BioNTech)和接受了3剂BNT162b2并且在最后一次疫苗接种之前未感染。为了评估自我报告的数字数据的潜力,将这些数据与公共卫生当局的官方数据进行了比较。
结果:我们招募了10,077名参与者(年龄≥16岁),他们贡献了44,786项测试和5530项症状。在这个年轻的,主要是女性,和数字识字队列,第二剂BNT162b2后第4周,针对任何严重程度的感染的VE从91.2%(95%CI70.4%-97.4%)下降到第48周的37.2%(95%CI23.5%-48.5%)。第三剂BNT162b2在4周后将VE增加至67.6%(95%CI50.3%-78.8%)。报告的住院次数少限制了我们计算住院VE的能力。疫苗接种后的不良事件与先前发表的研究一致。与国家传染病监测系统的官方数字相比,七天的发病率和测试阳性率反映了德国大流行的过程。
结论:我们的数据表明,COVID-19疫苗接种是安全有效的,和第三剂疫苗接种部分恢复对SARS-CoV-2感染的保护。该研究展示了在德国成功使用数字研究网络应用进行COVID-19监测和持续监测VE,强调其加速公共卫生决策的潜力。解决数字数据收集中的偏见对于确保数字解决方案作为公共卫生工具的准确性和可靠性至关重要。
BACKGROUND: The COVID-19 pandemic posed significant challenges to global health systems. Efficient public health responses required a rapid and secure collection of health data to improve the understanding of SARS-CoV-2 and examine the vaccine effectiveness (VE) and drug safety of the novel COVID-19 vaccines.
OBJECTIVE: This study (COVID-19 study on vaccinated and unvaccinated subjects over 16 years; eCOV study) aims to (1) evaluate the real-world effectiveness of COVID-19 vaccines through a digital participatory surveillance tool and (2) assess the potential of self-reported data for monitoring key parameters of the COVID-19 pandemic in Germany.
METHODS: Using a digital study web application, we collected self-reported data between May 1, 2021, and August 1, 2022, to assess VE, test positivity rates, COVID-19 incidence rates, and adverse events after COVID-19 vaccination. Our primary outcome measure was the VE of SARS-CoV-2 vaccines against laboratory-confirmed SARS-CoV-2 infection. The secondary outcome measures included VE against hospitalization and across different SARS-CoV-2 variants, adverse events after vaccination, and symptoms during infection. Logistic regression models adjusted for confounders were used to estimate VE 4 to 48 weeks after the primary vaccination series and after third-dose vaccination. Unvaccinated participants were compared with age- and gender-matched participants who had received 2 doses of BNT162b2 (Pfizer-BioNTech) and those who had received 3 doses of BNT162b2 and were not infected before the last vaccination. To assess the potential of self-reported digital data, the data were compared with official data from public health authorities.
RESULTS: We enrolled 10,077 participants (aged ≥16 y) who contributed 44,786 tests and 5530 symptoms. In this young, primarily female, and digital-literate cohort, VE against infections of any severity waned from 91.2% (95% CI 70.4%-97.4%) at week 4 to 37.2% (95% CI 23.5%-48.5%) at week 48 after the second dose of BNT162b2. A third dose of BNT162b2 increased VE to 67.6% (95% CI 50.3%-78.8%) after 4 weeks. The low number of reported hospitalizations limited our ability to calculate VE against hospitalization. Adverse events after vaccination were consistent with previously published research. Seven-day incidences and test positivity rates reflected the course of the pandemic in Germany when compared with official numbers from the national infectious disease surveillance system.
CONCLUSIONS: Our data indicate that COVID-19 vaccinations are safe and effective, and third-dose vaccinations partially restore protection against SARS-CoV-2 infection. The study showcased the successful use of a digital study web application for COVID-19 surveillance and continuous monitoring of VE in Germany, highlighting its potential to accelerate public health decision-making. Addressing biases in digital data collection is vital to ensure the accuracy and reliability of digital solutions as public health tools.