Evaluating influenza, SARS-CoV-2, and other respiratory virus vaccine effectiveness in prevention of acute illness in Washington state 2022-2027

摘要 作为目前美国流感疫苗有效性（US Flu VE）网络网站之一，我们建议继续 我们对季节性流感、COVID-19和其他呼吸道病毒的疫苗有效性（VE）的研究， 2022年至2027年在华盛顿州预防急性呼吸道疾病（ARI）（A部分）。三月以来 于二零二零年，COVID-19大流行已导致超过8，000万人感染及约100万美国人死亡。直到 在大流行期间，季节性影响公共卫生的主要呼吸道病毒是流感。在美国，高达5% 的人口在严重流行病期间寻求门诊治疗，典型的流行病造成数十人死亡。 数千人死亡，数十万人住院。2019冠状病毒病大流行迅速催化了 采用远程医疗保健，特别是对轻度至中度ARI患者， 门诊访视，以最大限度地减少对COVID-19的医疗暴露。目前，流感和COVID-19 接种疫苗是减少呼吸道病毒负担和维持人口的最佳工具 免疫力疫苗接种计划是一项重大的公共卫生投资。考虑到这件事的严重性 投资和呼吸道病毒对公共卫生的动态影响，决策者需要准确，及时， 以及代表真实世界VE的相关数据，以监测对美国呼吸系统疾病负担的影响 人口。未来5年对美国人群呼吸道疾病的监测至关重要， 说明呼吸道病毒负荷的变化。美国流感VE网络有能力，基础设施， 研究方法和标本采集经验，以监测美国卫生保健中的任何呼吸道病毒。 从2022年到2027年，我们计划招募约6000名KPWA婴儿，儿童和成人，包括老年人， 紧急护理诊所，采集呼吸道和血液标本，完成入组和入组后 调查问卷，与实验室服务合作，对样本进行类型和基因测序，整理和 管理EHR数据，在网络中与组件A站点协作，与网络共享数据 协调中心（组件B），与现场领导组件E共享样本，参与网络 研究活动，包括传播，并开发新的方法，估计和推理VE。我们 实现美国流感VE网络目标的具体目标是：目标1。建立虚拟价值评估平台 季节性流感和COVID-19疫苗预防呼吸道病毒性疾病， 在门诊就诊的儿童和患有轻度或中度疾病的成人中确诊的疾病 （目标1）;目标2。建立一个方案，以获得流感和SARS-CoV-2病毒序列， 在拟议的门诊网络中的受感染参与者中收集的标本（目标2）;目标3。 描述KPWA中可用的容量和诊断测试方法以及获得COVID-19的方法 流感季节以外的疫苗接种数据（目标3）。目标4。提高阴性试验设计的精度 采用两阶段抽样方法（方法目的）。

ABSTRACT As one of the current US Influenza Vaccine Effectiveness (US Flu VE) Network sites, we propose continuing our studies of vaccine effectiveness (VE) for seasonal influenza, COVID-19, and other respiratory viruses to prevent acute respiratory illness (ARI) in Washington state from 2022 to 2027 (Component A). Since March 2020, the COVID-19 pandemic has resulted in >80 million infections and ~1 million US deaths. Until the pandemic, the dominant respiratory virus impacting public health seasonally was influenza. In the US, up to 5% of the population sought outpatient care during a severe epidemic, and a typical epidemic caused tens of thousands of deaths and hundreds of thousands of hospitalizations. The COVID-19 pandemic catalyzed rapid adoption of telehealth care, in particular for patients with mild to moderate ARI, shifting patients from ambulatory visits to minimize healthcare exposure to COVID-19. Currently, influenza and COVID-19 vaccinations are the best available tools for reducing the respiratory virus burden and maintaining population immunity. Vaccination programs represent a substantial public health investment. Given the magnitude of this investment and the dynamic impact of respiratory viruses on public health, policymakers need accurate, timely, and relevant data representing real-world VE to monitor the impact on respiratory illness burden in US populations. The next 5 years of surveillance of respiratory illness in US populations will be critical in accounting for changes in respiratory virus burden. The US Flu VE Network has the capacity, infrastructure, research methods, and specimen collection experience to monitor any respiratory virus within US health care. From 2022-2027, we propose to enroll ~6000 KPWA infants, children, and adults including older adults in urgent care clinics, collect respiratory and blood specimens, complete enrollment and post-enrollment questionnaires, collaborate with laboratory services to type and genetically sequence specimens, collate and curate EHR data, collaborate across the Network with Component A sites, share data with Network Coordination Center (Component B), share specimens with site leading Component E, participate in Network research activities including dissemination, and develop new methods for estimation and inference in VE. Our specific aims to meet the goals of the US Flu VE Network are: Aim 1. Establish a platform to estimate VE of seasonal influenza and COVID-19 vaccines against respiratory viral illnesses in preventing laboratory- confirmed illness among children and adults with mild or moderate illness seeking care in ambulatory settings (Objective 1); Aim 2. Establish a protocol to obtain influenza and SARS-CoV-2 viral sequences from specimens collected among infected participants in the proposed outpatient network (Objective 2); Aim 3. Describe capacity and diagnostic test methods available in KPWA and methods to obtain COVID-19 vaccination data outside influenza season (Objective 3). Aim 4. Improve precision of the test-negative design by incorporate two-phase sampling methodology (methods aim).