ORIGINAL CONTRIBUTION Relationship Between Prepregnancy Anthrax Vaccination and Pregnancy and Birth Outcomes Among US Army Women

peatedly affirmed the safety and effi-cacy of the anthrax vaccine.1-5 Until 1990, the primary recipients of this vac-cine were individuals occupationally ex-posed to anthrax (textile mill work-ers, selected veterinarians, certain laboratory workers). With the advent of the Persian Gulf War, the US De-partment of Defense determined there was a credible threat of anthrax expo-sure to its troops from biological weap-ons and a large-scale vaccination pro-gram with anthrax vaccine was started. Due to the persistent threat of bio-logical weapons use, the US Depart-ment of Defense directed in 1998 that all military services begin an anthrax vaccination program.6-9 The US mili-tary has given more than 2 million an-thrax vaccinations to more than 500000 individuals since beginning the vacci-nation program. Military personnel at Fort Stewart, Ga, and Hunter Army Air-field, Ga, began a program of anthrax vaccinations in the fall of 1998. Medi-cal exemptions to vaccination were granted as clinically appropriate, the most common being deferral of vacci-nation during pregnancy. The pro-gram continued until March 2000, when it was curtailed because of a short-age of vaccine. After March 2000, new vaccine starts were limited to persons assigned to “high-threat ” areas. Anthrax vaccine adsorbed, distrib-uted by BioPort Corp (Lansing, Mich), consists of aluminum hydroxide– adsorbed supernatant material, princi-pally protective antigen, from an aviru-lent, nonencapsulated strain of Bacillus anthracis.1,10 There is no live material in this vaccine. The vaccine series con-sists of 6 doses over 18 months, fol-lowed by an annual booster. Injection-site reactions (principally due to the aluminum hydroxide) have been well described.1,4,10-13 Limited studies of long-term effects found no evidence of ad-verse consequences.13,14 Although no biologically plausible mechanism for a reproductive effect has ever been pro-posed, this vaccine is administered to large numbers of women in their early reproductive years. Questions relat-ing to reproductive effects are the most common concerns among callers to th