临床免疫安全性评估（CISA）项目：COVID-19疫苗咨询和病例审查。

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-09-27 DOI:10.1016/j.vaccine.2025.127781

Paula M. Campbell , Gabriella J. Ess , Allison Lale , Kawsar R. Talaat , Elizabeth D. Barnett , Stephen I. Pelton , Elizabeth P. Schlaudecker , Mary Staat , Melissa S. Stockwell , Phillip S. LaRussa , Emmanuel B. Walter , Michael J. Smith , Neal A. Halsey , Nicola P. Klein , Michael M. McNeil , Karen R. Broder , Tom T. Shimabukuro , Matthew B. Crist , Tarayn A. Fairlie , Shashi Sharma , Kathryn M. Edwards

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引用次数: 0

摘要

背景：临床免疫安全性评估（CISA）项目是由美国疾病预防控制中心免疫安全办公室（ISO）和7个医学研究中心的疫苗安全专家组成的网络。CISA回应来自美国医疗保健提供者（HCPs）的询问并进行疫苗安全性研究。本报告总结了CISA在COVID-19大流行期间解决供应商疫苗安全咨询的方法，并描述了这些咨询。方法：在2019冠状病毒病大流行期间，疾控中心建立了24/7全天候CISA咨询服务。对询问进行了审查，并选择了一些临床最复杂的病例进行全面、结构化的CISA临床病例咨询。在保密协商后，发送了提供者满意度调查，并询问了提供者的患者结局以及患者是否耐受随后的COVID-19疫苗接种。结果：从2020年12月14日至2022年12月31日，CDC工作人员和CISA调查员进行了79例综合临床病例咨询，其中73例涉及COVID-19疫苗接种后免疫不良事件（AEFI）， 6例涉及疫苗接种前问题。在73例AEFI咨询中，31例（42%）包括神经系统症状，14例（19%）包括过敏或超敏反应症状。心脏病学和血液学的调查占了剩余的大部分。24份（30%）提供者满意度调查被退回；所有受访者都认为这项服务很有帮助。在38份（总共79份，48%）患者随访调查中，14份（37%）报告后续接种了COVID-19疫苗，病例患者耐受性良好。讨论：尽管满意度和患者随访调查参与率较低，但CISA会诊服务通过全面的临床病例会诊和疫苗安全指导，及时为医护人员提供新冠肺炎疫苗安全性评估，在大流行应对中发挥了独特作用。

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Clinical immunization safety assessment (CISA) project: COVID-19 vaccine consultations and case reviews

Background

The Clinical Immunization Safety Assessment (CISA) Project is a network of vaccine safety experts from the Centers for Disease Control and Prevention (CDC) Immunization Safety Office (ISO) and seven medical research centers. CISA responds to inquiries from U.S. healthcare providers (HCPs) and conducts vaccine safety research. This report summarizes the CISA approach to addressing provider vaccine safety inquiries during the COVID-19 pandemic and describes these consultations.

Methods

During the COVID-19 pandemic, CDC established a 24/7 on-call CISA consultation service. Inquiries were reviewed, and some of the most clinically complex were selected for comprehensive, structured CISA clinical case consultations. After confidential consultations, provider satisfaction surveys were sent, and providers were queried about patient outcomes and whether patients tolerated subsequent COVID-19 vaccinations.

Results

From December 14, 2020, through December 31, 2022, CDC staff and CISA investigators conducted 79 comprehensive clinical case consultations (73 regarding adverse events following immunization (AEFI) after COVID-19 vaccine, and 6 pre-vaccination questions). Of the 73 AEFI consultations, 31 (42 %) included neurologic and 14 (19 %) allergic or hypersensitivity symptoms. Cardiology and hematology inquiries comprised most of the remainder. Twenty-four (30 %) provider satisfaction surveys were returned; all respondents found the service helpful. Of 38 (79 total; 48 %) returned patient follow-up surveys, 14 (37 %) reported that subsequent COVID-19 vaccines were administered and were well-tolerated in case patients.

Discussion

Despite low participation rate in satisfaction and patient follow-up surveys, the CISA consultation service provided timely COVID-19 vaccine safety evaluations for HCPs through comprehensive clinical case consultations and vaccine safety guidance, a unique role in the pandemic response.

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.