General and Crosscutting Issues

In its discussion of recommendations related specifically to the MMR-autism question, the committee identified more general concerns that it could not adequately or appropriately address in this report. These concerns are briefly noted here in anticipation of more complete consideration at a later time.

First, a recurring dilemma in the minds of many concerned about vaccine safety focuses on how to align the appropriate public health attention with a possibly small vaccine safety risk. The committee had little difficulty recommending that continued attention be devoted to the hypothesized MMR and ASD link with the specific recommendation being for targeted research. However, the committee recognizes that in addressing future safety issues, a recommendation regarding the level of future public health response might be quite difficult.

The committee sees a need for a dialogue between various vaccine-safety advocates—including researchers, parents, manufacturers, immunization program implementers, and policymakers—in order to come to a common understanding of key issues that factor into this alignment. These discussions might include but are not limited to: the difficulty of proving the null hypothesis (i.e., no association between two events), identification of a level of vaccine risk that is acceptable given the benefit of the vaccine, the meaning to various stakeholders of terms such as associations and causality and the evidence required to support scientific conclusions such as these, and how to research vaccine exposure as a trigger for conditions of multifactorial etiologies. The committee regrets that it could not begin to address explicitly these issues in its first report. Some of the reactions to this report will center on our inability to do so at this time. The committee will address these issues in the future and welcomes assistance from all who are concerned about vaccine safety.

Second, the committee is concerned about the current status of research on vaccine risk and benefit communication. The committee is aware from its background reading and from discussions that some members of the public perceive serious deficiencies in the available information on the risks and benefits of vaccines. For example, some have noted that the CDC and FDA websites are difficult to navigate and that important material is “hidden” within the sites. It has also been said that the role of public input into federal advisory committees on vaccines and immunization policy is unclear and in some cases minimal. In addition, clinical-provider information about the VAERS system or about vaccine safety is reportedly lacking. Another concern is the relative lack of discussion about the ethical issues regarding provision of information on the small but predictable risks of vaccinations, even for those that are mandatory and for which exemptions on religious or philosophic grounds are uncommon.

The committee acknowledges the seriousness of these concerns but was unable to address them appropriately in this fast report. There have been many discussions in recent years about vaccine communication, but the impact of these discussions is unclear. To date, only a few papers have examined issues in vaccine risk communication (see Bostrom, 1997). More research needs to be