v-safe 疫苗接种后健康状况监测:美国疾病预防控制中心应对 COVID-19 大流行期间的主动疫苗安全监测。
The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response.
机构信息
CDC COVID-19 Response Team, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop V18-4, Atlanta, GA 30329-4027, United States.
CDC COVID-19 Response Team, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop V18-4, Atlanta, GA 30329-4027, United States.
出版信息
Vaccine. 2023 Feb 10;41(7):1310-1318. doi: 10.1016/j.vaccine.2022.12.031. Epub 2023 Jan 23.
The Centers for Disease Control and Prevention (CDC) developed and implemented the v-safe after vaccination health checker (v-safe) to monitor COVID-19 vaccine safety and as an active surveillance supplement to existing CDC vaccine safety monitoring programs. V-safe allows persons who received COVID-19 vaccines to report on post-vaccination experiences and how symptoms affected their health at daily, weekly, and monthly timepoints after vaccination. Text message reminders are sent linking to Internet-based health check-in surveys. Surveys include questions to identify v-safe participants who may be eligible to enroll in a separate pregnancy registry activity that evaluates maternal and infant outcomes in those pregnant at the time of vaccination or receiving vaccine in the periconception period. We describe the development of and enhancements to v-safe, data management, promotion and communication to vaccination sites and partners, publications, strengths and limitations, and implications for future systems. We also describe enrollment in v-safe over time and demographics of persons participating in v-safe during the first year of operation (December 14, 2020 - December 13, 2021). During this time, 9,342,582 persons submitted 131,543,087 v-safe surveys. The majority of participants were female (62.3 %) and non-Hispanic White (61.2 %); median age was 49.0 years. Most participants reported receiving an mRNA COVID-19 vaccine as their first recorded dose (95.0 %). V-safe contributed to CDC's vaccine safety assessments for FDA-authorized COVID-19 vaccines by enabling near real-time reporting of reactogenicity once the COVID-19 vaccination program began in the community, encouraging reports to the Vaccine Adverse Event Reporting System and facilitating enrollment in a large post-vaccination pregnancy registry. Given that v-safe is an integral component of the most comprehensive safety monitoring program in U.S. history, we believe that this approach has promise as a potential application for future pandemic response activities as well as rollout of novel vaccines in a non-pandemic context.
美国疾病控制与预防中心(CDC)开发并实施了疫苗接种后健康检查应用(v-safe),以监测 COVID-19 疫苗的安全性,并作为现有 CDC 疫苗安全监测计划的主动监测补充。v-safe 允许接种 COVID-19 疫苗的人报告接种后体验以及症状如何影响他们的健康,频率为每日、每周和每月。会发送文本消息提醒,链接到基于互联网的健康登记调查。调查包括问题,以确定 v-safe 参与者中哪些人可能有资格参加单独的妊娠登记活动,该活动评估接种疫苗时已怀孕或在受孕期间接种疫苗的母亲和婴儿的结局。我们描述了 v-safe 的开发和增强、数据管理、向接种点和合作伙伴的推广和沟通、出版物、优势和局限性,以及对未来系统的影响。我们还描述了 v-safe 在运营第一年(2020 年 12 月 14 日至 2021 年 12 月 13 日)的注册情况和参与者的人口统计学特征。在此期间,934.2582 人提交了 13154.3087 份 v-safe 调查。大多数参与者为女性(62.3%)和非西班牙裔白人(61.2%);中位年龄为 49.0 岁。大多数参与者报告接种了第一剂 mRNA COVID-19 疫苗(95.0%)。v-safe 通过在社区开始 COVID-19 疫苗接种计划后实现对不良反应的近乎实时报告,鼓励向疫苗不良事件报告系统报告,并促进在大型接种后妊娠登记中注册,为 CDC 对 FDA 授权的 COVID-19 疫苗的安全性评估做出了贡献。鉴于 v-safe 是美国历史上最全面的安全监测计划的一个组成部分,我们相信这种方法在未来的大流行应对活动以及在非大流行背景下推出新型疫苗方面具有应用潜力。