There was no long-term monitoring for adverse outcomes. The committee did not compare the incidence of transient effects with other vaccines.

Studies of the anthrax vaccine have not used active surveillance to systematically evaluate long-term health outcomes. This situation is unfortunately typical for all but a few vaccines. The committee strongly encourages active monitoring to evaluate the long-term safety of the anthrax vaccine.

To date, published studies have reported no significant adverse effects of the vaccine, but the literature is limited to a few short-term studies. Reviewing the large body of results that have not yet been published would enable more definitive conclusions about the vaccine’s safety. The committee strongly urges investigators conducting studies on the safety of the anthrax vaccine to submit their results to peer-reviewed scientific journals for publication.

The committee’s findings are best regarded as an early step in the complex process of understanding the safety of the anthrax vaccine, which began with the vaccine’s licensure in 1970 and the 1985 FDA advisory panel finding that categorized the vaccine as safe and effective. Active long-term monitoring of large populations will provide further information for documenting the relative safety of the anthrax vaccine.

The committee concludes that there is sufficient evidence of an association between anthrax vaccination and transient acute local and systemic effects (e.g., redness, swelling, fever) typically associated with vaccination.

The committee concludes that there is inadequate/insufficient evidence to determine whether an association does or does not exist between anthrax vaccination and long-term adverse health effects.

The latter finding means that the evidence reviewed by the committee is of insufficient quality, consistency, or statistical power to permit a conclusion regarding the presence or absence of an association between the vaccine and a health outcome in humans.

BOTULINUM TOXOID

Botulinum toxins, known primarily for causing cases of foodborne botulism,9 are produced by the anaerobic bacterium Clostridium botulinum. The organism itself is not thought to play a role in the poisoning syndrome (Middle-

9  

Botulism is a paralytic disease with three primary clinical manifestations: foodborne, wound, and infant (Sellin, 1984; Fauci et al., 1998). Incidence of the disease is low, fewer than 100 cases of botulism are reported in the United States each year (Lopez, 1998). Ingestion of botulinum spores is the primary exposure pathway. A trivalent equine antitoxin is available from CDC for the treatment of foodborne botulism. A heptavalent antitoxin is currently in IND status (Franz et al., 1997).



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