临床免疫安全评估 (CISA) 项目:COVID-19疫苗咨询和病例审查
Paula M Campbell1, Gabriella J Ess2, Allison Lale3
1Division of Pediatric Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, United States.
Vaccine
|September 28, 2025
概括
临床免疫安全评估 (CISA) 项目为医疗保健提供者提供了及时的COVID-19疫苗安全咨询. 该服务成功地解决了有关免疫接种和疫苗安全指导的不良事件的供应商询问.
科学领域:
- 免疫学 免疫学 免疫学
- 公共卫生 公共卫生
- 疫苗学 疫苗学 疫苗学
背景情况:
- 临床免疫安全评估 (CISA) 项目是CDC与医学研究中心的合作,旨在解决疫苗安全问题.
- CISA为美国医疗保健提供者 (HCP) 提供专家咨询,并进行疫苗安全研究.
- 本报告详细介绍了CISA在COVID-19大流行期间管理供应商查询的方法.
研究的目的:
- 总结CISA项目在COVID-19大流行期间处理医疗保健提供者疫苗安全调查的战略.
- 描述CISA向医疗保健提供者提供关于COVID-19疫苗安全性的咨询.
主要方法:
- 疾病预防控制中心在COVID-19大流行期间建立了24 / 7随时调用CISA咨询服务.
- 临床上复杂的调查被选择为全面的,结构化的CISA临床病例咨询.
- 咨询后进行了提供者满意度调查和患者结果后续调查.
主要成果:
- 从2020年12月到2022年12月,进行了79次咨询,主要涉及COVID-19疫苗接种后免疫接种后不良事件 (AEFI).
- 神经 (42%) 和过敏/过敏 (19%) 症状是AEFI咨询的最常见原因.
- 所有返回的供应商满意度调查 (30%) 显示该服务是有帮助的,而37%的后续调查报告后续接种疫苗耐受良好.
结论:
- CISA咨询服务为医疗保健提供者提供了有价值和及时的COVID-19疫苗安全评估.
- 尽管调查参与率很低,但该服务通过提供专家疫苗安全指导,在疫情应对中发挥了关键作用.
- 在CISA的全面案例咨询中,CISA在关键的公共卫生时期解决了复杂的疫苗安全问题.
相关概念视频
Vaccinations
51.3K
Overview
51.3K
Pharmacovigilance
1.6K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.6K
Principles of Disease Surveillance
466
Disease surveillance is the systematic collection, analysis, and interpretation of health data essential to the planning, implementation, and evaluation of public health practice. This process integrates data dissemination to entities responsible for preventing and controlling disease, injury, and disability. Surveillance systems provide crucial information for action, helping public health authorities make informed decisions to manage and prevent outbreaks, ensure public safety, optimize...
466
Development of Immunocompetence
790
The initiation of cell-mediated immunity can be observed as early as the third month of fetal growth, with active antibody-mediated immunity following approximately one month later.
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...
790
Bioequivalence studies: Biowaivers
227
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
227


