McGrath Leah J, Brookhart M Alan
a Department of Epidemiology; Gillings School of Global Public Health ; University of North Carolina ; Chapel Hill , NC USA.
Hum Vaccin Immunother. 2015;11(3):537-44. doi: 10.1080/21645515.2015.1011026.
High-dose inactivated, influenza vaccine was licensed by the FDA in December 2009 for adults aged 65 y and older. The ACIP did not issue or state a preference for a specific vaccine in the elderly population. The extent of its on-label and off-label use is unknown. Using the MarketScan Commercial Claims and Encounters and the Medicare Supplemental database, we identified individuals who received the high-dose influenza vaccine or the standard, seasonal trivalent influenza vaccine between January 1, 2010 and December 31, 2012. For people aged ≥65 y, we used multivariable regression to assess the association between patient and provider level variables and high-dose influenza vaccine versus standard influenza vaccine. We characterized all off-label high-dose vaccine administered to people younger than 65 y of age, and investigated whether sicker patients were targeted for off-label use by examining the association between various comorbid conditions and receipt of the high-dose vaccine among adults aged 18-64. Among patients aged ≥65 y who received an influenza vaccine, 18.4% received the high-dose vaccine. Uptake was minimal in 2010, but 25% and 32% of influenza shots were the high-dose formulation in 2011 and 2012, respectively. Almost 27,000 seniors received a second high-dose vaccine with a median of 368 d (IQR: 350-387 days) between doses. Older age, family practice physicians, and having PPO insurance were positively associated with receiving high-dose vaccine. There were 36,624 off-label high-dose vaccines administered. Half of the patients receiving off-label doses were aged 50-64. Adults aged 18-64 y receiving high-dose vaccine were more likely to have chronic comorbidities than people receiving standard influenza vaccine; however, there was not one specific illness that seemed to be targeted by physicians. In the first 3 y since licensure, use of the high-dose vaccine among seniors has been limited. The safety of this vaccine should be monitored closely among 2 groups of people - seniors receiving repeat doses and people <65.
2009年12月，高剂量灭活流感疫苗获美国食品药品监督管理局（FDA）批准，用于65岁及以上成年人。美国免疫实践咨询委员会（ACIP）未针对老年人群体发布或表明对特定疫苗的偏好。其标签内和标签外使用的范围尚不清楚。利用市场扫描商业索赔和病历数据库以及医疗保险补充数据库，我们确定了在2010年1月1日至2012年12月31日期间接种高剂量流感疫苗或标准季节性三价流感疫苗的个体。对于65岁及以上的人群，我们使用多变量回归来评估患者和医疗服务提供者层面的变量与高剂量流感疫苗和标准流感疫苗之间的关联。我们对所有给65岁以下人群接种的标签外高剂量疫苗进行了特征描述，并通过检查18 - 64岁成年人中各种合并症与高剂量疫苗接种之间的关联，调查病情较重的患者是否成为标签外使用的目标人群。在接种流感疫苗的65岁及以上患者中，18.4%接种了高剂量疫苗。2010年的接种率很低，但2011年和2012年分别有25%和32%的流感疫苗接种为高剂量剂型。近27000名老年人接种了第二剂高剂量疫苗，两剂之间的中位间隔时间为368天（四分位间距：350 - 387天）。年龄较大、家庭执业医生以及拥有优先提供者组织（PPO）保险与接种高剂量疫苗呈正相关。共接种了36624剂标签外高剂量疫苗。接受标签外剂量疫苗的患者中有一半年龄在50 - 64岁之间。与接种标准流感疫苗的人群相比，18 - 64岁接种高剂量疫苗的成年人更可能患有慢性合并症；然而，似乎没有一种特定疾病是医生针对的目标。在获批后的头3年里，老年人中高剂量疫苗的使用一直有限。对于两组人群——接受重复剂量的老年人和65岁以下人群，应密切监测这种疫苗的安全性。
