thrax were of the cutaneous type; there were not enough cases of inhalation anthrax to determine if vaccination was effective against this, the most lethal form of anthrax.
The typical reaction was described as a ring of erythema (1–2 cm in diameter) at the injection site, with local tenderness that lasted 24–48 hours. Some individuals (the authors did not report the number) reported more extensive edema, erythema (>5 cm in diameter), pruritus, induration, and/or small painless nodules at the injection site (lasting up to several weeks). Twenty-one persons had moderate local edema that lasted up to 48 hours. Three individuals had edema extending from the deltoid to the mid-forearm (in one case, to the wrist) that dissipated within 5 days. Systemic reactions occurred in two individuals (0.9 percent of the actively immunized subjects) who experienced “malaise” lasting 24 hours following vaccination. The study notes that three individuals who received the placebo (0.1 percent alum) had mild reactions.
Several other studies, discussed below, had information on the safety of the anthrax vaccine, but these studies have not been published in the peer-reviewed literature and were not considered in the committee’s conclusions regarding the strength of the evidence for associations with adverse health outcomes. Publication of these studies would substantially increase the body of information needed to form conclusions regarding health effects of the anthrax vaccine. Most of the studies are currently described only in secondary sources (e.g., reviews, congressional testimony, General Accounting Office [GAO] reports). Additionally, a recently published article in the CDC Morbidity and Mortality Weekly Report (CDC, 2000) provided summary results of several of the studies. A few of the studies have only recently been completed or are ongoing.
Investigational new drug data. In the early 1970s, CDC submitted data on the safety of the anthrax vaccine in support of an application to license the vaccine. The committee did not have access to primary data but examined the information provided in secondary sources (Friedlander et al., 1999; GAO, 1999b,c,d). At the end of its study, after the committee had completed its work, the committee received the IND information that had been requested earlier through a FOIA (Freedom of Information Act) request. Another Institute of Medicine committee that is currently studying the safety and efficacy of the anthrax vaccine will be able to examine this information.
The IND data included information on the reactions of approximately 7,000 individuals who had received approximately 16,000 doses of the vaccine (four lots manufactured by MDPH). With active monitoring (there was no description of the monitoring methods), mild local reactions (≤3 cm) occurred in 3–20 percent of all doses, moderate local reactions (>3 to <12 cm) in 1–3 percent of all doses, and severe reactions (≥12 cm) in less than 1 percent of doses. Four indi-