University of Pennsylvania, Philadelphia, PA 19104, USA.
Milbank Q. 2012 Jun;90(2):250-77. doi: 10.1111/j.1468-0009.2012.00663.x.
Two vaccines to prevent Lyme disease (LD) were developed and tested in the 1990s. Despite evidence of their safety and efficacy in clinical trials and initial postmarketing surveillance, one vaccine was withdrawn before the regulatory review and the other after only three years on the market. An investigation of their history can illuminate (1) the challenges faced by many new risk-reducing products and practices and (2) the important role played by their social and psychological, as distinct from their biomedical or scientific, efficacy in how they are used, and their ultimate market success or failure.
This article reviewed medical and popular literature on LD vaccines, analyzed the regulatory hearings, and conducted interviews with key participants.
Even if proved safe and effective, LD vaccines faced regulatory and market challenges because the disease was geographically limited, treatable, and preventable by other means. Pharmaceutical companies nevertheless hoped to appeal to consumers' desire for protection and control and to their widespread fear of the disease. The LD advocacy community initially supported the vaccines but soon became critical opponents. The vaccines' success was seen as threatening their central position that LD was chronic, protean, and difficult to treat. The activists' opposition flipped the vaccines' social and psychological efficacy. Instead of the vaccines restoring control and reducing fear, demand was undermined by beliefs that the vaccines caused an LD-like syndrome.
The social and psychological efficacy of many risk-reducing practices and products, such as new "personalized vaccines," is to provide insurance and reduce fear. Yet the actions of self-interested actors can easily undermine this appeal. In addition to evaluating the scientific efficacy and safety of these practices and products, policymakers and others need to understand, anticipate, and perhaps shape the potential social and psychological work they might do.
两种预防莱姆病（LD）的疫苗在 20 世纪 90 年代开发并进行了测试。尽管在临床试验和初始上市后监测中都证明了它们的安全性和有效性，但其中一种疫苗在监管审查前被撤回，另一种疫苗在上市仅三年后就被撤回。对它们的历史进行调查可以阐明：（1）许多新的降低风险的产品和实践所面临的挑战；（2）它们的社会心理，与生物医学或科学，在它们的使用方式以及最终的市场成功或失败方面的疗效。
本文回顾了关于 LD 疫苗的医学和通俗文献，分析了监管听证会，并对关键参与者进行了访谈。
即使被证明是安全有效的，LD 疫苗也面临着监管和市场的挑战，因为这种疾病在地理上是有限的，可通过其他手段治疗和预防。制药公司仍然希望迎合消费者对保护和控制的渴望，以及他们对这种疾病的广泛恐惧。LD 倡导界最初支持这些疫苗，但很快就成为了批评者。疫苗的成功被视为对他们的核心立场的威胁，即 LD 是慢性的、多变的，难以治疗。活动家的反对使疫苗的社会心理疗效发生了逆转。疫苗不是恢复控制和减少恐惧，而是由于人们认为疫苗会引起类似 LD 的综合征，需求被破坏了。
许多降低风险的做法和产品的社会心理疗效，如新的“个性化疫苗”，是提供保险和减少恐惧。然而，自利行为者的行为很容易破坏这种吸引力。除了评估这些实践和产品的科学疗效和安全性外，政策制定者和其他人还需要了解、预测并可能塑造它们可能产生的潜在社会和心理影响。
