and efficacy. Information relevant to assessing the efficacy of the vaccine is presented in Chapter 3. The establishment of efficacy is crucial before one can consider the use of any such intervention, and no safety risk is tolerable in the absence of efficacy. Chapter 4 introduces the types of information available concerning the assessment of vaccine safety, whereas Chapters 5 and 6 review the safety data available on this vaccine from case reports and from epidemiologic studies, respectively. Issues related to manufacturing are reviewed in Chapter 7, and in Chapter 8 the committee discusses needs for future efforts, including gaps in research.
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