Approximately 137,850 doses of botulinum toxoid were sent to the Gulf, and it is estimated that 8,000 individuals were vaccinated (Committee on Veterans’ Affairs, 1998). However, medical records from the Gulf War contain little or no information about who received vaccines, how frequently vaccines were administered, or the timing of vaccinations relative to the other putative exposures (OSAGWI, 1999). Further, existing record entries show no consistency in recording the type of vaccine (notations include “A-Vax,” “Vacc A,” “Vacc B,” and “B Vaccination”). A report by the Office of the Special Assistant for Gulf War Illnesses (OSAGWI) found that documents from the Gulf War indicate confusion about where, or whether, the vaccinations were to be recorded (OSAGWI, 1999).

Investigations since the war by the United Nations Special Commission (UNSCOM) and the International Atomic Energy Agency have found that Iraq had biological weapons prior to the Gulf War, but no evidence was found of their release. Investigators found that Iraq had produced 200 biological bombs in 1990; 100 were filled with botulinum toxin, 50 with anthrax, and 7 with aflatoxin (Zilinskas, 1997). Additionally, 13 Al Hussein (SCUD) warheads were found to have contained botulinum toxin, 10 warheads contained anthrax, and 2 contained aflatoxin (USAMRIID, 1996).

This chapter discusses several vaccine-related issues that have been of particular concern to Gulf War veterans. The chapter discusses animal and human studies that have been conducted on the safety of the anthrax vaccine and the botulinum toxoid vaccine. Additionally, the issue of multiple vaccinations is addressed. Finally, the chapter provides an overview of the scientific literature regarding squalene, an issue the committee was asked to address.

The committee issued a letter report on the safety of the anthrax vaccine in April 2000 (IOM, 2000). This letter report was issued in response to a congressional conference report (House Report 106-371). The Institute of Medicine (IOM) is currently conducting a separate two-year study on the safety and efficacy of the anthrax vaccine. That study will review some of the unpublished non-peer-reviewed information that was not available to this committee.

ISSUES IN IDENTIFYING ADVERSE EFFECTS

Vaccines are acknowledged to be one of the most effective tools in the prevention of infectious diseases. Dramatic reductions have been seen in the incidence of many diseases including pertussis, polio, rubella, measles, diphtheria, and mumps in the United States, and globally, smallpox has been eradicated (Keusch and Bart, 1998). In general, individuals experience either no adverse effects from a vaccination or mild local effects (e.g., tenderness, soreness) at the injection site. The administration of some vaccines has been determined to be associated with the potential for transient local or systemic adverse health outcomes (e.g., increased risk of fever, local pain, and/or swelling near the injection site) (Keusch and Bart, 1998). More serious reactions are rare (IOM, 1994). This section highlights some of the major issues that must be considered in deter-



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