PUBLIC WILLINGNESS TO TAKE A VACCINE OR DRUG UNDER EMERGENCY USE AUTHORIZATION DURING THE 2009 H1N1 PANDEMIC
PUBLIC WILLINGNESS TO TAKE A VACCINE OR DRUG UNDER EMERGENCY USE AUTHORIZATION DURING THE 2009 H1N1 PANDEMIC
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DOI：
10.1089/bsp.2009.0041
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发表时间：
2009-09-01
期刊：
影响因子：
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通讯作者：
Musa, Donald
中科院分区：
文献类型：
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作者：
Quinn, Sandra Crouse;Kumar, Supriya;Musa, Donald
2009 年 4 月 26 日，美国宣布进入公共卫生紧急状态，以应对 H1N1 流感（即猪流感）日益严重但不确定的威胁。六月，世界卫生组织宣布大流行。 2009年8月6日，美国因猪流感住院的人数为6,506人，其中436人死亡；所有 50 个州均报告了病例。宣布公共卫生紧急状态后，美国食品和药物管理局批准了多项紧急使用授权 (EUA)，允许向公众分发未经批准的药物或超说明书使用已批准的药物。到目前为止，有 2 种抗病毒药物作为 EUA 药物可供公众使用。 H1N1 疫苗可能会在秋季以 EUA 形式首次发布，这是 EUA 机制的首次大规模使用。这项研究探讨了公众在 FDA 关于 EUA 的非约束性指南规定的条件下使用药物或疫苗的意愿。我们利用 Knowledge Networks 小组对来自美国人口代表性样本的 1,543 名成年人进行了一项互联网调查，其中还对非裔美国人和讲西班牙语的西班牙裔进行了 2 次超样本调查。我们的完成率为 62%。我们研究了接受 EUA 药物或 H1N1 疫苗的意愿、与服用任一药物或 H1N1 疫苗相关的担忧程度、受访者接受 EUA 药物或疫苗的条件，以及 EUA 情况说明书中的语言对人们为自己或子女接受药物的意愿的影响。我们还研究了这些变量与种族/族裔、教育水平、对政府的信任、以前的疫苗接受度以及对 H1N1 流感的个人后果的感知之间的关联。这些结果为我们当前大流行中关于 EUA 药物和疫苗的沟通挑战提供了重要的见解。
On April 26, 2009, the United States declared a public health emergency in response to a growing but uncertain threat from H1N1 influenza, or swine flu. In June, the World Health Organization declared a pandemic. In the U. S., hospitalizations due to swine flu numbered 6,506 on August 6, 2009, with 436 deaths; all 50 states have reported cases. The declaration of a public health emergency, followed by the approval of multiple Emergency Use Authorizations (EUAs) by the Food and Drug Administration, allowed the distribution of unapproved drugs or the off-label use of approved drugs to the public. Thus far, there are 2 antiviral medications available to the public as EUA drugs. It is possible that an H1N1 vaccine will be initially released as an EUA in the fall in the first large-scale use of the EUA mechanism. This study explores the public's willingness to use a drug or vaccine under the conditions stipulated in the FDA's nonbinding guidance regarding EUAs. Using Knowledge Networks' panel, we conducted an internet survey with 1,543 adults from a representative sample of the U. S. population with 2 oversamples of African Americans and Spanish-speaking Hispanics. Our completion rate was 62%. We examined willingness to accept an EUA drug or an H1N1 vaccine, the extent of worry associated with taking either, the conditions under which respondents would accept an EUA drug or vaccine, and the impact of language from the EUA fact sheets on people's willingness to accept a drug for themselves or their children. We also examined the association among these variables and race/ethnicity, education level, trust in government, previous vaccine acceptance, and perceived personal consequences from H1N1 influenza. These results provide critical insights into the challenges of communicating about EUA drugs and vaccine in our current pandemic.