of the armed services have been concerned that AVA may cause later-onset systemic or multisystem adverse effects. To date there is limited information pertaining to any possible association between vaccination with AVA and later-onset health conditions, as with most vaccines. The available data, however, provide no evidence of a causal connection between receipt of AVA and later-onset or long-term adverse outcomes.

The history of the facility that manufactures AVA has been fraught with difficulties. Over the course of the study, the committee reviewed extensive and detailed exchanges between the manufacturer, BioPort, and the Food and Drug Administration (FDA) regarding the changes to the manufacturing process that were needed. That BioPort has successfully met FDA requirements is welcome news.

Nevertheless, the committee is convinced that relying only on the current anthrax vaccine and the current specifications for its use is far from satisfactory. Not only are many avenues for important research toward the development of a different and better vaccine available, but particular improvements in how the current vaccine is used are also urgently needed. Many of these improvements are feasible, which makes their implementation even more compelling. This chapter suggests some directions for further research and action.

FUTURE USE OF AVA

Finding: Current events in both the military and the civilian arenas highlight and confirm the importance of ensuring both the availability and the quality of the nation’s anthrax vaccine.

Less than a month before this report went to press, BioPort received approval for the first release of lots of AVA produced since 1998. Because the supply of AVA has been limited, the Department of Defense’s (DoD’s) Anthrax Vaccine Immunization Program (AVIP) was proceeding at a reduced rate. Renewed availability of AVA will make possible the resumption of the AVIP schedule. Current events, including the deployment of U.S. troops to Afghanistan and surrounding areas and sabotage of the U.S. mail with items contaminated with B. anthracis spores, strongly suggest not only the resumption but also possibly the expansion of vaccination against anthrax. As stated in the new product label (see Appendix D), the licensed product is indicated for “individuals between 18 and 65 years of age who come in contact with animal products such as hides, hair, or bones that come from anthrax endemic areas, and that may be contaminated with B. anthracis spores. AVA, now carrying the brand name BioThrax,1 is also

1  

Biothrax is the name under which AVA will be manufactured as of January 31, 2002.



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