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An Assessment of the Safety of the Anthrax Vaccine: A Letter Report
only in secondary sources (e.g., reviews, congressional testimony, and reports from the General Accounting Office). The publication of these studies would substantially increase the available body of information on which conclusions regarding health effects can be made.
TABLE 1. Unpublished and Ongoing Studies of the Anthrax Vaccine
Study
Brief Description
Licensure Safety Study
Data submitted in support of the application for licensure describes approximately 7,000 persons who received approximately 16,000 doses
Special Immunization Program Safety Study
Follow-up study on 1,590 workers at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) who received 10,451 doses since 1973
Ft. Bragg Booster Study
An assessment of the safety of booster shots given to 486 male military personnel who had received initial anthrax vaccinations during the Gulf War
Canadian Forces Safety Survey
Active monitoring of 576 persons in the Canadian military who received the anthrax vaccine in 1998
USAMRIID Reduced Dose and Route Change Study
Pilot study involving 173 persons who received a reduced dose schedule or vaccination via a different route (intramuscular)
Tripler Army Medical Center Survey
Survey of 603 health care personnel who were vaccinated at Tripler Army Medical Center in 1998–1999
U.S. Air Force Vision Study
A comparison of visual acuity in 354 vaccinated aircrew members with 363 unvaccinated aircrew personnel
Korea Survey
Survey of military personnel at the time they received subsequent doses of the vaccine
SOURCES: Claypool, 1999; GAO, 1999b.
Conclusions on Human Studies
There is a paucity of published peer-reviewed literature on the safety of the anthrax vaccine. The committee located only one randomized peer-reviewed study of the type of anthrax vaccine used in the United States (Brachman et al., 1962). However, the formulation of the vaccine used in that study differs from the vaccine currently in use. The series of Ft. Detrick studies shows no clinical sequelae from multiple vaccinations, including the anthrax vaccination, over 25 years of intermittent observation in a highly selected cohort. However, there was no active surveillance for chronic symptoms in these studies, which raises the possibility of underreporting of symptoms.
The published studies have found transient local and systemic effects (primarily erythema, edema, or induration) of the anthrax vaccine. There have been no studies of the anthrax vaccine in which the long-term health outcomes have been systematically evaluated with active surveillance. That is not unusual, however, as few vaccines for any disease have been actively monitored for adverse effects over long periods of time. The commit-
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