Maro Judith C, Fryback Dennis G, Lieu Tracy A, Lee Grace M, Martin David B
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, United States of America.
Department of Population Health Sciences, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, United States of America.
PLoS One. 2014 Dec 23;9(12):e115553. doi: 10.1371/journal.pone.0115553. eCollection 2014.
Managing emerging vaccine safety signals during an influenza pandemic is challenging. Federal regulators must balance vaccine risks against benefits while maintaining public confidence in the public health system.
We developed a multi-criteria decision analysis model to explore regulatory decision-making in the context of emerging vaccine safety signals during a pandemic. We simulated vaccine safety surveillance system capabilities and used an age-structured compartmental model to develop potential pandemic scenarios. We used an expert-derived multi-attribute utility function to evaluate potential regulatory responses by combining four outcome measures into a single measure of interest: 1) expected vaccination benefit from averted influenza; 2) expected vaccination risk from vaccine-associated febrile seizures; 3) expected vaccination risk from vaccine-associated Guillain-Barre Syndrome; and 4) expected change in vaccine-seeking behavior in future influenza seasons.
Over multiple scenarios, risk communication, with or without suspension of vaccination of high-risk persons, were the consistently preferred regulatory responses over no action or general suspension when safety signals were detected during a pandemic influenza. On average, the expert panel valued near-term vaccine-related outcomes relative to long-term projected outcomes by 3:1. However, when decision-makers had minimal ability to influence near-term outcomes, the response was selected primarily by projected impacts on future vaccine-seeking behavior.
The selected regulatory response depends on how quickly a vaccine safety signal is identified relative to the peak of the pandemic and the initiation of vaccination. Our analysis suggested two areas for future investment: efforts to improve the size and timeliness of the surveillance system and behavioral research to understand changes in vaccine-seeking behavior.
在流感大流行期间管理新出现的疫苗安全信号具有挑战性。联邦监管机构必须在权衡疫苗风险与益处的同时，维持公众对公共卫生系统的信心。
我们开发了一个多标准决策分析模型，以探讨大流行期间在新出现的疫苗安全信号背景下的监管决策。我们模拟了疫苗安全监测系统的能力，并使用年龄结构分区模型来制定潜在的大流行情景。我们使用一个由专家得出的多属性效用函数，通过将四种结果指标组合成一个单一的关注指标来评估潜在的监管反应：1）避免流感带来的预期疫苗接种益处；2）疫苗相关热性惊厥带来的预期疫苗接种风险；3）疫苗相关格林-巴利综合征带来的预期疫苗接种风险；4）未来流感季节中寻求疫苗行为的预期变化。
在多种情景下，当在大流行性流感期间检测到安全信号时，与不采取行动或全面暂停相比，无论是否暂停对高危人群的疫苗接种，风险沟通始终是更受青睐的监管反应。平均而言，专家小组对近期疫苗相关结果与长期预测结果的重视程度为3:1。然而，当决策者影响近期结果的能力很小时，反应主要根据对未来寻求疫苗行为的预测影响来选择。
所选的监管反应取决于相对于大流行高峰和疫苗接种开始而言，疫苗安全信号被识别的速度有多快。我们的分析提出了两个未来投资领域：努力提高监测系统的规模和及时性，以及开展行为研究以了解寻求疫苗行为的变化。
