as an indication of inadequate pre-licensing testing. Others, however, may view the withdrawal as an indication of the successful use of VAERS as a warning system and appropriate responsiveness of immunization policymakers.

A fundamental concern for immunization policymakers, discussed in previous reports from this committee (IOM, 2001a,b), is that apprehensions about the safety of vaccines will lead to lower rates of vaccination and increases in serious morbidity and mortality from vaccine-preventable disease, as experienced recently in the United Kingdom (Communicable Disease Report, 2001). Gellin and colleagues (2000) called for periodic assessments of parental attitudes toward vaccines and immunization policy so that clinicians, researchers, and policymakers will have a better understanding of concerns about immunization and can develop more effective responses. But a better understanding of how such concerns affect decisions about immunization will also be needed.

Considering Alternative Approaches to Immunization Policy

The increasing number of vaccines in the childhood immunization schedule—and the anticipated addition of still more vaccines—is raising questions not only about the safety of multiple immunizations but also about the adequacy of the current approach to immunization policy-making, which emphasizes national recommendations and state mandates for universal immunization. For example, the public may perceive new vaccines as less compelling if an assessment of these vaccines are based on their cost-benefit, not their public health benefit. Immunization policies must, implicitly or explicitly, make tradeoffs among a variety of factors, including disease risks, the efficacy and safety of vaccines, the financial costs of disease and vaccines, and the differing perspectives of individuals and society.

A recent paper by Feudtner and Marcuse (2001) argued for greater attention to ethical considerations in developing immunization policies and explores some of the complexities that should be addressed in evaluating policy alternatives. The authors propose a policy framework that explicitly incorporates ethical considerations along with the epidemiological and economic considerations that dominate current decisionmaking. Such a framework should guide both the articulation of policy objectives and the evaluation of policy options to achieve those objectives. In particular, they emphasize the importance of considering matters of personal liberty and equity in the distribution of the benefits and burdens of immunization. For instance, there may be benefits to individuals who have philosophical reasons to refuse immunization. However, there also may be an increased burden on those individuals should they be affected by a vaccine-preventable illness, and the burden would extend to the caretakers of those individuals and to society at large.

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