Safety signal detected: Anaphylaxis after attenuated dengue vaccine (TAK-003) – Brazil, march 1, 2023-march 11, 2024

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2024-10-04 DOI:10.1016/j.vaccine.2024.126407

Jadher Percio, Carla Dinamerica Kobayashi, Roberta Mendes Abreu Silva, Ana Karolina Barreto Berselli Marinho, Leon Capovilla, Paulo Henrique Santos Andrade, Martha Elizabeth Brasil da Nóbrega, Cibelle Mendes Cabral, Monica Brauner de Moraes, Guilherme Loureiro Werneck, Eder Gatti Fernandes

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引用次数: 0

Abstract

The aim was to describe cases of anaphylaxis following the Attenuated Dengue Vaccine (TAK-003) in Brazil, from March 1, 2023, to March 11, 2024. A descriptive study of anaphylaxis cases following TAK-003 was conducted, as reported in the National System of Surveillance of Adverse Events Following Immunization (AEFI). Percentages and notification rates of AEFI per million doses administered (DA) were calculated. In total, 380,358 doses of TAK-003 were administered, and 626 AEFI were reported. Of these, 85 were cases of immediate hypersensitivity, with 24 (63.1 cases per million) being anaphylaxis, including three anaphylactic shock. For 10 (41.7 %) cases, reactions began within 15 min after vaccination. No deaths related to anaphylaxis were reported. In light of the safety signal identification (increased frequency of anaphylaxis post-dengue vaccination), the Ministry of Health of Brazil published recommendations for intensifying actions for safe vaccination, including healthcare professional training and post-vaccination observation.

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检测到安全信号：注射减毒登革热疫苗（TAK-003）后出现过敏性休克--巴西，2023 年 3 月 1 日至 2024 年 3 月 11 日。

目的是描述 2023 年 3 月 1 日至 2024 年 3 月 11 日期间巴西接种减毒登革热疫苗 (TAK-003) 后出现的过敏性休克病例。根据国家免疫接种不良事件监测系统（AEFI）的报告，对接种 TAK-003 后出现的过敏性休克病例进行了描述性研究。研究计算了每百万注射剂量（DA）中过敏性休克病例的百分比和通报率。共接种了380,358剂TAK-003，报告了626例AEFI。其中85例为即刻过敏，24例（63.1/百万）为过敏性休克，包括3例过敏性休克。10例（41.7%）在接种后15分钟内开始出现反应。没有与过敏性休克相关的死亡报告。鉴于安全信号的确定（接种登革热疫苗后过敏性休克的频率增加），巴西卫生部公布了加强安全接种行动的建议，包括医疗保健专业人员培训和接种后观察。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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

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