更新:免疫实践咨询委员会(ACIP)关于在 2010-11 年度期间在美国使用 CSL 季节性流感疫苗(Afluria)的建议。

Update: Recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding use of CSL seasonal influenza vaccine (Afluria) in the United States during 2010-11.

出版信息

MMWR Morb Mortal Wkly Rep. 2010 Aug 13;59(31):989-92.

DOI:
Abstract

During the 2010 influenza season in Australia, administration of a 2010 Southern Hemisphere seasonal influenza trivalent inactivated vaccine (TIV) (Fluvax Junior and Fluvax) manufactured by CSL Biotherapies was associated with increased frequency of fever and febrile seizures in children aged 6 months through 4 years. Postmarketing surveillance indicated increased reports of fever in children aged 5-8 years after vaccination with Fluvax compared to previous seasons. An antigenically equivalent 2010-11 Northern Hemisphere seasonal influenza TIV (Afluria) manufactured by CSL Biotherapies is approved by the Food and Drug Administration (FDA) for persons aged >or=6 months in the United States. Prescribing information for the 2010-11 Afluria formulation includes a warning that "Administration of CSL's Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years". In the United States, annual influenza vaccination is recommended for all persons aged >or=6 months. On August 5, 2010, the Advisory Committee on Immunization Practices (ACIP) recommended that the 2010-11 Afluria vaccine not be administered to children aged 6 months through 8 years. Other age-appropriate, licensed seasonal influenza vaccine formulations should be used for prevention of influenza in these children. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5-8 years who has a medical condition that increases their risk for influenza complications, Afluria can be used; however, providers should discuss with the parents or caregivers the benefits and risks of Afluria use before administering this vaccine to children aged 5-8 years.

摘要

在 2010 年澳大利亚流感季节期间,接种 CSL Biotherapies 公司生产的 2010 年南半球季节性流感三价灭活疫苗(TIV)(Fluvax Junior 和 Fluvax)与 6 个月至 4 岁儿童发热和热性惊厥的频率增加有关。上市后监测表明,与前几个季节相比,接种 Fluvax 的 5-8 岁儿童发热报告增加。CSL Biotherapies 公司生产的抗原等效的 2010-11 年北半球季节性流感 TIV(Afluria)已获得美国食品和药物管理局(FDA)批准,可用于年龄>或=6 个月的人群。2010-11 年 Afluria 配方的处方信息包括一项警告,即“CSL 的南半球流感疫苗接种后,与前几年相比,年龄主要在 5 岁以下的儿童发热和热性惊厥的上市后报告增加”。在美国,建议所有年龄>或=6 个月的人每年接种流感疫苗。2010 年 8 月 5 日,免疫实践咨询委员会(ACIP)建议不要为 6 个月至 8 岁的儿童接种 2010-11 年 Afluria 疫苗。应使用其他适合年龄的、已许可的季节性流感疫苗制剂来预防这些儿童的流感。如果对于 5-8 岁的儿童,没有其他适合年龄的、已许可的灭活季节性流感疫苗可用于预防流感,且该儿童有增加流感并发症风险的医疗状况,可使用 Afluria;但是,在为 5-8 岁的儿童接种这种疫苗之前,医务人员应与父母或看护人讨论使用 Afluria 的益处和风险。

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