Fort Bragg Booster Study. Pittman and colleagues (1997) conducted an open-label study of DoD personnel 2 years after they had received anthrax and/or botulinum vaccines during Operation Desert Shield/Desert Storm in 1990–1991. As described above in the discussion of the anthrax vaccine, the objectives of the study were to assess the persistence of antibodies to the vaccines, to determine the serological response 30 days after receiving a booster dose (subjects received boosters for either the anthrax or the botulinum vaccine or both, depending on what they had received in 1990–1991), and to evaluate the reactogenicity of the vaccines. Of the 459 volunteers who received booster injections of the anthrax and botulinum vaccines, 13 percent reported erythema, and 15 percent noted induration at the site of the botulinum toxoid injection. The report states that the local reactions measured 3–60 mm (no severe local reactions [>210 mm] occurred). Low-grade fever occurred in 2.8 percent of the recipients.

CDC reports. As noted above, the botulinum toxoid is an Investigational New Drug and has not yet received FDA approval. As the holder of the IND, CDC submits annual progress reports to the FDA. These annual reports provide information on the number of injections given and summarize the adverse effects noted on the CDC Response to Investigational New Drug forms.12 Additionally, the report provides summary statistics on injections since 1970. The committee examined five of the most recent progress reports (CDC, 1994b, 1995, 1996, 1997, 1998).

The CDC progress report for March 2, 1997, to March 1, 1998 (the most recent one reviewed by the committee) reported on 955 injections (728 primary and 227 booster injections) given to 422 individuals (CDC, 1998). Of the 955 total, 879 recipients (92 percent) noted no reaction or a mild reaction; 56 (5.9 percent) experienced a moderate reaction, 4 (0.4 percent) had a severe local reaction and/or systemic reaction,13 and no response was recorded for 16 injections (1.7 percent). The four severe reactions were a 21-cm area of erythema and swelling, induration of approximately 35 cm, a severe local reaction, and severe swelling below the elbow.

Summary tables in the CDC report record the number of reactions for the 16,676 injections of the botulinum toxoid administered between 1970 and 1997 (CDC, 1998). Of this total, local reactions were characterized as 15,207 (91.2 percent) none or mild; 1,208 (7.2 percent) moderate; 63 (0.4 percent) severe; and no response recorded for 198 reactions (1.2 percent). Another summary table indi-

12  

The directions on the form state that it should be completed for each individual who receives the initial series and should be returned following the third injection. Additionally, a form should be completed and returned to CDC following each booster injection.

13  

Mild is defined as erythema, edema or induration 30 mm or less in any one diameter. Moderate is defined as edema or induration measuring greater than 30 mm but less than 210 mm in any one diameter. Severe is defined as any reaction measuring more than 210 mm in any one diameter or any reaction accompanied by marked limitation of motion of the arm or marked axillary node tenderness.



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