An Assessment of the Safety of the Anthrax Vaccine A Letter Report (2000) / Chapter Skim
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An Assessment of the Safety of the Anthrax Vaccine: Letter Report
An Assessment of the Safety of the Anthrax Vaccine: Letter Report
Pages 1-8
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The opportunity to provide limited information relating to the safety of anthrax vaccine is possible due to the ongoing work of the TOM Committee on Health Effects Associated with Exposures During the Gulf War, which was tasked with conducting literature reviews on six Gulf War exposures (including the anthrax vaccine)
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in studies conducted in nonhuman primates, no remarkable local or systemic reactions were seen (DarIow et al., 1956; Ivins et al., 1998~. Few meaningful conclusions regarding adverse effects in humans can be drawn from the animal studies of the vaccine; the primary goal of the majority of those studies has been to determine the vaccine's efficacy.
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The committee notes a recent literature review (Demicheli et al., 1998) on anthrax vaccine studies conducted according to the Cochrane Collaboration guidelines for systematic reviews of health care interventions.
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The participants were examined 24 and 48 hours following each vaccination to assess both focal and systemic reactions to the vaccine. There was no report of subsequent active or passive surveillance for possible adverse effects beyond 48 hours aher each vaccination (there was further monitoring for the vaccine's efficacy, however)
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The reports of serious events include severe injection site reactions, a wiclespread allergic reaction, a case of aseptic meningitis, an onset of lupus, an onset of inflammatory demyelinating disease, a diagnosis of bipolar disease, and two cases of Guillain-Barre syndrome (Ellenberg, 1999~. FDA and CDC are responsible for monitoring the VAERS data to detect unusual trends and occurrences of adverse health effects.
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Arrny Medical Research Institute of Infectious Diseases (USAMRIID) who received 10,451 doses since 1973 An assessment of the safety of booster shots given to 486 male military personnel who had received initial anthrax vaccinations during the Gulf War Active monitoring of 576 persons in the Canadian military who received the anthrax vaccine in 1998 Pilot study involving 173 persons who received a reduced dose schedule or vaccination via a different route (intramuscular)
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no significant adverse effects of the vaccine, but the literature is limited to a few short-term studies. The committee's findings are best regarded as an early step in the complex process of understanding the vaccine's safety, which began with the vaccine's licensure in 1970 and the 1985 FDA advisory pane} finding that categorized the anthrax vaccine as safe and effective.
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. Adverse Effects of Pertussis and Rubella Vaccines.
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