FDA核准用於年長者的高劑量季節性流感疫苗

作者：Yael Waknine  
出處：WebMD醫學新聞

December 28, 2009 — 美國食品藥物管理局(FDA)宣布快速核准一種高劑量季節性流感疫苗(商品名Fluzone High-Dose，Sanofi Pasteur公司)，用於65歲以上的年長者，以預防A型或B型流感病毒引起的疾病。
　　
　　年長者受到季節性流感感染後，相當容易發生併發症而須住院，甚至造成死亡。這個新的疫苗含有180 μg 的流感病毒紅血球凝集素(HA)，而非標準的45-μg劑量，新疫苗顯示可以促進此一族群的免疫反應。
　　
　　FDA生物製劑評估與研究中心執行主任Karen Midthun醫師在該局的新聞稿中表示，當人年長時，他們的免疫系統一般會比較虛弱，這是首次使用較高劑量來誘導更強之免疫反應的流感疫苗，使年長者對於季節性流感有更好的保護力。
　　
　　FDA也提醒，相較於該公司的標準劑量流感疫苗(Fluzone)，含較多HA的新疫苗與不嚴重的副作用增加有關。最常報告的不良反應有注射部位疼痛、紅疹與腫脹，以及頭痛、肌肉痛、發燒與心神不安。因為這個疫苗含有雞蛋蛋白質，對雞蛋或蛋製品過敏者不應使用。


FDA Approves High-Dose Seasonal Flu Vaccine for Seniors

By Yael Waknine
Medscape Medical News

December 28, 2009 — The US Food and Drug Administration (FDA) has granted accelerated approval for a high-dose seasonal influenza vaccine (Fluzone High-Dose, Sanofi Pasteur, Inc) to prevent disease caused by influenza virus subtypes A and B in people aged 65 years and older.

Seniors who contract seasonal influenza are most susceptible to complications that can lead to hospitalization and death. The new vaccine, which contains 180 μg of influenza virus hemagglutinin (HA), rather than the standard 45-μg dose, has been shown to produce an enhanced immune response in this population.

"As people grow older, their immune systems typically become weaker," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research, in an agency news release. "This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza."

The FDA also warned that the high HA content has been linked to an increased rate of "non-serious" adverse events compared with the company's standard influenza vaccine (Fluzone). Injection site pain, erythema, and swelling, as well as headache, muscle aches, fever, and malaise, were the most commonly reported adverse events. Because it contains egg protein, the vaccine should not be used in people who are allergic to eggs or egg products.