that VAERS is an extremely useful tool, when used the way it was designed (i.e., for hypothesis generating for unusual and unexpected adverse reactions) rather than for quantification of expected adverse reactions. As such, VAERS should not be eliminated from the safety system. Rather, the committee suggests that VAERS be used as a backup system and a system for generating hypotheses.

To help identify the combination of VAERS, PVS, and other surveillance systems that offers the best opportunity for identifying all possible adverse reactions, the committee encourages CDC to continue consulting state epidemiologists, vaccine program managers familiar with tracking other vaccine-associated adverse reactions, and clinicians to address these issues.

Quickly identifying adverse reactions in vulnerable contact populations will be important for ensuring the safest vaccination program possible. The committee encourages CDC to explore the benefit and feasibility of using data from surveillance systems for vulnerable contact populations (e.g., Medicaid data, cancer registries) as an ancillary approach to monitoring adverse reactions.

The committee suggests that CDC consider using mortality surveillance to supplement the adverse reaction surveillance occurring through VAERS and PVS. To reach this end, the committee encourages CDC to reach out to and coordinate with medical examiners and coroners to educate them about the pre-event smallpox vaccination program and to provide guidelines that can be used for determining whether a death was the result of a serious adverse reaction from the smallpox vaccine or from a random unconnected cause. Mortality surveillance also might help identify an otherwise unrecognized actual smallpox case.

CDC mentioned plans to develop a pregnancy registry, to track the outcomes of any pregnancies in recent vaccinees. The committee agrees that the development of a pregnancy registry would be a prudent step and could add to the limited body of knowledge that currently exists on the risk of spontaneous abortions to recent smallpox vaccinees and the incidence of fetal vaccinia.

Gathering Data on Background Rates of Conditions That Could Be Confused with Adverse Reactions

The nature of any large population experience is that there will be substantial numbers of unusual adverse reactions that, in fact, do not relate to vaccine administration but simply represent background rates of disease. Thus, of the approximately 500,000 vaccine recipients in phase I, it is likely that there will be reports of acute diseases such as influenza or local outbreaks of viral gastroenteritis. Surveillance would be useful in identifying



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