Evidence-based decision making for vaccines: The need for an ethical foundation

Evidence-based decision making (EBDM) is a tool to assess the value of medical interventions by weighing costs and health outcomes that has increasingly been applied to vaccines. However, many of the ethical considerations that support EBDM when used to evaluate therapeutic care do not readily translate to prevention. This mismatch can result in policy decisions that produce unanticipated negative consequences, including public resistance. In its emphasis on quantifiable outcomes, EBDM invokes the ethical principle of rule-utilitarianism, which values the optimal long-run balance of benefit over harm. Vaccines raise a number of competing ethical concerns in ways that individual medical treatments do not. They rely on widespread compliance for effectiveness, which can limit individual autonomy, emphasize population over individual effects, which can obscure the imperative of beneficence to help the vulnerable, require a just allocation process within populations, and sometimes challenge strong social norms. For EBDM to effectively guide vaccine policy makers, such as the Advisory Committee on Immunization Practices (ACIP) in the United States, an ethical foundation is needed that systematically considers all relevant values and transparently places vaccination recommendations in the context of social norms and individual concerns. (C) 2011 Elsevier Ltd. All rights reserved.