Percio Jadher, Kobayashi Carla Dinamerica, Silva Roberta Mendes Abreu, Marinho Ana Karolina Barreto Berselli, Capovilla Leon, Andrade Paulo Henrique Santos, da Nóbrega Martha Elizabeth Brasil, Cabral Cibelle Mendes, de Moraes Monica Brauner, Werneck Guilherme Loureiro, Fernandes Eder Gatti
Ministry of Health of Brazil, Secretariat of Health and Environmental Surveillance, Brasília - Federal District, Brazil.
Vaccine. 2024 Dec 2;42(26):126407. doi: 10.1016/j.vaccine.2024.126407. Epub 2024 Oct 4.
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.
目的是描述2023年3月1日至2024年3月11日期间巴西减毒登革热疫苗（TAK-003）接种后发生过敏反应的病例。按照国家免疫后不良事件监测系统（AEFI）中的报告，对TAK-003接种后发生的过敏反应病例进行了描述性研究。计算了每百万剂疫苗接种量（DA）的AEFI百分比和报告率。共接种了380358剂TAK-003，报告了626例AEFI。其中，85例为速发型超敏反应，24例（每百万剂63.1例）为过敏反应，包括3例过敏性休克。10例（41.7%）病例的反应在接种后15分钟内开始。未报告与过敏反应相关的死亡病例。鉴于安全信号识别（登革热疫苗接种后过敏反应频率增加），巴西卫生部发布了加强安全接种行动的建议，包括医护人员培训和接种后观察。
