为年龄≥65 岁人群(流感全病毒高剂量疫苗)许可使用高剂量灭活流感疫苗(Fluzone High-Dose)并提供使用指南 - 美国,2010 年。
Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010.
出版信息
MMWR Morb Mortal Wkly Rep. 2010 Apr 30;59(16):485-6.
Persons aged >or=65 years are at greater risk for hospitalization and death from seasonal influenza compared with other age groups, and they respond to vaccination with lower antibody titers to influenza hemagglutinin (an established correlate of protection against influenza) compared with younger adults. On December 23, 2009, the Food and Drug Administration (FDA) licensed an injectable inactivated trivalent influenza vaccine (Fluzone High-Dose, Sanofi-Pasteur) that contains an increased amount of influenza virus hemagglutinin antigen compared with other inactivated influenza vaccines such as Fluzone. Fluzone High-Dose is licensed as a single dose for use among persons aged >or=65 years and will be available beginning with the 2010-11 influenza season. The Advisory Committee on Immunization Practices (ACIP) reviewed data from prelicensure clinical trials on the safety and immunogenicity of Fluzone High-Dose and expressed no preference for the new vaccine over other inactivated trivalent influenza vaccines. This report summarizes the FDA-approved indications for Fluzone High-Dose and provides guidance from ACIP for its use.
年龄大于或等于 65 岁的人因季节性流感住院和死亡的风险高于其他年龄组,并且与年轻成年人相比,他们对流感血凝素的抗体滴度较低(这是预防流感的既定相关因素)。2009 年 12 月 23 日,美国食品和药物管理局(FDA)批准了一种注射用灭活三价流感疫苗(Fluzone High-Dose,Sanofi-Pasteur),与其他灭活流感疫苗(如 Fluzone)相比,该疫苗含有更多的流感病毒血凝素抗原。Fluzone High-Dose 被批准为 65 岁及以上人群的单剂量使用,将于 2010-11 流感季节开始供应。免疫实践咨询委员会(ACIP)审查了 Fluzone High-Dose 疫苗的上市前临床试验的安全性和免疫原性数据,对新疫苗与其他三价灭活流感疫苗相比没有偏好。本报告总结了 FDA 批准的 Fluzone High-Dose 疫苗的适应症,并提供了 ACIP 对其使用的指导。