title: Anthrax vaccine: short-term safety experience in humans.
abstract: Bacillus anthracis is the major terrorist and biological warfare agent of concern to civilian and military medical planners. The licensed anthrax vaccine, adsorbed (AVA) is believed to be an effective prophylactic medical countermeasure against this threat. Our objective in this report was to expand the safety database for this vaccine by assessing data on self-reported, short-term safety of AVA during more than 25 years of use, measured by local and systemic adverse events temporally associated with the administration of AVA. A minority of AVA recipients reported systemic and injection site reactions. Females reported a higher incidence of injection site and systemic adverse events than males. Data show a difference in incidence of local reactions between lots. A prospective, randomized, placebo-controlled study to actively examine reactogenicity is needed to more completely define the extent and nature of reactions associated with receipt of AVA in humans as well as to confirm the gender lot differences in local reaction rates.
authors.affiliation: Division of Medicine, US Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, USA. phillip.pittman@det.amedd.army.mil
authors.forename: P R
authors.initials: PR
authors.lastname: Pittman
authors.forename: P H
authors.initials: PH
authors.lastname: Gibbs
authors.forename: T L
authors.initials: TL
authors.lastname: Cannon
authors.forename: A M
authors.initials: AM
authors.lastname: Friedlander
mesh_terms: D000293:Adolescent; D000328:Adult; D022122:Anthrax Vaccines / Q000009:adverse effects* / Q000302:isolation & purification; D005260:Female; D006801:Humans; D008297:Male; D012307:Risk Factors; D012449:Safety; D012727:Sex Characteristics; D013997:Time Factors
chemical_list: D022122:Anthrax Vaccines