Journal Article

Serious Adverse Events among Participants in the Centers for Disease Control and Prevention's Anthrax Vaccine and Antimicrobial Availability Program for Persons at Risk for Bioterrorism-Related Inhalational Anthrax

Bruce C. Tierney, Stacey W. Martin, Laura H. Franzke, Nina Marano, Dori B. Reissman, Randy D. Louchart, Joyce A. Goff, Nancy E. Rosenstein, John L. Sever and Michael M. McNeil

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 37, issue 7, pages 905-911
Published in print October 2003 | ISSN: 1058-4838
Published online October 2003 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/377738
Serious Adverse Events among Participants in the Centers for Disease Control and Prevention's Anthrax Vaccine and Antimicrobial Availability Program for Persons at Risk for Bioterrorism-Related Inhalational Anthrax

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On 20 December 2001, the Centers for Disease Control and Prevention (CDC) initiated the Anthrax Vaccine and Antibiotic Availability Program (hereafter, the “Program”) under an investigational new drug application with the US Food and Drug Administration. This Program provided options for additional preventive treatment for persons at risk for inhalation anthrax as a result of recent bioterrorism attacks who had concluded or were concluding a 60-day course of antimicrobial prophylaxis. Participants were offered an additional 40 days of antibiotic therapy (with ciprofloxacin, doxycycline, or amoxicillin) or antibiotic therapy plus 3 doses of anthrax vaccine. By 11 February 2002, a total of 5420 persons had received standardized education about the Program and 1727 persons (32%) had enrolled. Twelve participants have been identified as having serious adverse events (SAEs). One SAE, which occurred in a participant with ciprofloxacin-induced allergic interstitial nephritis, was considered to be probably associated with treatment received in the Program. No SAEs were associated with anthrax vaccine. CDC will continue to monitor Program participants during the next 2 years.

Journal Article.  3988 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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