and the health risk the product is directed against.1 No single set of criteria defines acceptable limits on the frequency and severity of harmful effects. For this report the committee was charged with assessing the safety of AVA in terms of the frequency, types, and severities of adverse reactions, including differences in those reactions by sex, and long-term health implications of AVA vaccination.

This chapter reviews the concerns about the safety of AVA that have been raised and discusses issues related to the identification of vaccine-related adverse events. The types of information examined by the committee regarding the safety of AVA are summarized as well. The details of the available data and the committee’s findings and recommendations regarding the safety of AVA and further safety monitoring are presented in the subsequent two chapters, with Chapter 5 reviewing the findings that have emerged from case reports of adverse reactions to AVA and Chapter 6 reviewing the results of formal epidemiologic studies.

SAFETY CONCERNS ABOUT THE ANTHRAX VACCINE

AVA was originally licensed in 1970. A Food and Drug Administration (FDA) review completed in 1975 classified AVA as safe and effective and found that use of AVA is indicated “only for certain occupational groups with a risk of uncontrollable or unavoidable exposure to the organism. It is recommended for individuals in industrial settings who come in contact with imported animal hides, furs, wool hair (especially goat hair, bristles, and bone meal, as well as in laboratory workers involved in ongoing studies on the organism” (FDA, 1985, p. 51058). More widespread use of the vaccine during the Gulf War and as part of AVIP, however, has resulted in new concerns about its possible association with serious acute and chronic health problems. Some have proposed that vaccination with AVA could have contributed to the chronic multisystem health complaints of some Gulf War veterans (GAO, 1999b,c; Nicolson et al., 2000). With the expansion of mandatory vaccination under AVIP, there have also been concerns that the health impact of vaccination with AVA was being missed because adverse events were underreported to military health care providers and to the Vaccine Adverse Event Reporting System (VAERS), operated by the Centers for Disease Control and Prevention and FDA (GAO, 1999d; Rovet,

1  

The definition of safety used by FDA is “the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently administered, taking into consideration the character of the product in relation to the condition of the recipient at the time” (21 C.F.R. § 600.3 [1999]).



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