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The first rotavirus vaccine and the politics of acceptable risk

机译：第一种轮状病毒疫苗和可接受风险的政策

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Context: Vaccination in the United States is a frequent source of controversy, with critics alleging failures by public health officials to adequately identify, monitor, and respond to risks associated with vaccines. In response to these charges, the case of RotaShield, a vaccine withdrawn in 1999 following confirmation of a serious adverse event associated with its use, is regularly invoked as evidence of the effectiveness of current vaccine safety activities. Methods: This article examines the history of RotaShield, with particular attention paid to decision making regarding its use in the United States and internationally. I reviewed and analyzed federal advisory committee meeting transcripts, international conference reports, government and scientific publications, media coverage, and other primary and secondary source materials. I also conducted six semistructured interviews with former senior officials and advisory committee members at the U.S. Centers for Disease Control and Prevention who participated in decisions regarding the vaccine. Findings: Decision making regarding RotaShield, including the ultimate withdrawal of its recommendation for use, was shaped significantly by government health officials' concern for preserving public confidence in overall U.S. vaccination efforts amid several unrelated vaccine risk controversies ongoing at that time. This attention to public perception and external pressures occurred in tandem with the evaluation of the quantitative evidence regarding the magnitude and severity of the risk associated with the vaccine. The decisions made in the United States resulted in foreseen but unintended consequences for international use of the vaccine, including in nations where the profile of risks and potential benefits was dramatically different. Conclusions: As enthusiasm for evidence-based decision making grows throughout medicine and public health, greater explicit attention should be directed to the processes by which decision makers and their expert advisers evaluate such evidence and translate it into regulation and policy by means of qualitative judgments.
机译：背景：在美国，疫苗接种经常引起争议，批评者指称公共卫生官员未能充分识别，监控和应对与疫苗相关的风险。针对这些指控，定期援引RotaShield疫苗一案，该疫苗是在确认与使用有关的严重不良事件后于1999年撤回的，以此作为当前疫苗安全活动有效性的证据。方法：本文研究了RotaShield的历史，并特别注意了有关在美国和国际上使用它的决策。我审查并分析了联邦咨询委员会的会议记录，国际会议报告，政府和科学出版物，媒体报道以及其他主要和次要资料。我还与美国疾病控制与预防中心的前高级官员和咨询委员会成员进行了六次半结构化访谈，他们参与了有关疫苗的决策。调查结果：在当时发生的数不相关的疫苗风险争论中，政府卫生官员对维护公众对美国总体疫苗接种工作的信心，极大地影响了有关RotaShield的决策，包括最终撤销其使用建议。对公众看法和外部压力的关注与对与疫苗相关的风险的大小和严重性的定量证据的评估同时进行。在美国做出的决定给疫苗的国际使用带来了可预见但未曾预料到的后果，包括在风险和潜在利益的分布截然不同的国家。结论：随着在医学和公共卫生领域对基于证据的决策热情越来越高，应更加明确地关注决策者及其专家顾问评估这些证据并将其通过定性判断转化为法规和政策的过程。

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