COVID-19 pediatric vaccine authorization, FDA authority, and individual misperception of risk

IF 2.5 2区 哲学 Q1 ETHICS Journal of Law and the Biosciences Pub Date : 2024-04-19 DOI:10.1093/jlb/lsae006
Joanna K Sax, Neal Doran
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Abstract

Abstract Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to recommend Emergency Use Authorization (‘EUA’) of the COVID-19 vaccine for children ages 5–11. The results of the study demonstrate that most comments opposed EUA and these comments were associated with statements that indicated misperceptions of risk. Findings provide interesting insights regarding the role of public comments generally but also suggest that the public participation process in notice and comment can be modified to serve as an intervention to align individual perceptions of risk more closely with evidence-based assessment of risk. In addition, the findings provide opportunities to consider strategies for public health messaging.
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COVID-19 儿科疫苗授权、FDA 权威和个人对风险的误解
摘要 疫苗是缓解 COVID-19 大流行的公共卫生战略的一个组成部分。在美国,对 COVID-19 疫苗的犹豫不决一直是个问题,这并不奇怪,因为近几十年来,人们对疫苗的整体犹豫不决的态度越来越严重。大多数疫苗都是在儿童时期接种的。因此,了解这一年龄段人群对接种疫苗的犹豫不决可能会为减少疫苗犹豫不决的干预措施提供启示。本研究分析了为响应食品药品管理局疫苗咨询小组会议通知而张贴的 130,000 多条公众意见的子集。会议讨论了是否建议对 5-11 岁儿童使用 COVID-19 疫苗进行紧急使用授权('EUA')。研究结果表明,大多数意见都反对紧急使用授权,而且这些意见都与表明风险认知错误的声明有关。研究结果就公众意见的一般作用提供了有趣的见解,同时也表明,可以对通知和意见中的公众参与过程进行修改,以作为一种干预措施,使个人对风险的认识与基于证据的风险评估更加一致。此外,研究结果还提供了考虑公共卫生信息传播策略的机会。
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来源期刊
Journal of Law and the Biosciences
Journal of Law and the Biosciences Medicine-Medicine (miscellaneous)
CiteScore
7.40
自引率
5.90%
发文量
35
审稿时长
13 weeks
期刊介绍: The Journal of Law and the Biosciences (JLB) is the first fully Open Access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard University Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. The Journal contains original and response articles, essays, and commentaries on a wide range of topics, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.
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