Bruce C. Tierney1, Stacey W. Martin
1, Laura H. Franzke
1, Nina Marano
2, Dori B. Reissman
3, Randy D. Louchart
1, Joyce A. Goff
1, Nancy E. Rosenstein
2, John L. Sever
4, and Michael M. McNeil
1. (1) Anthrax Team, Bacterial Vaccine Preventable Disease Branch, ESD, NIP, CDC, 1600 Clifton Rd, NE Mailstop E-61, Atlanta, GA, USA, (2) Meningitis and Special Pathogens Branch, DBMD, NCID, CDC, (3) Bioterrorism Preparedness and Response Program, NCID, CDC, (4) Children’s National Medical Center, George Washington University
KEYWORDS:
Anthrax vaccine, adverse event, ciprofloxacin, allergic interstitial nephritis
BACKGROUND:
In October 2001, in response to the bioterrorism-related outbreak of anthrax, CDC recommended post exposure prophylaxis (PEP) for more than 10,000 individuals. In November 2001, anthrax vaccine (AVA) became available. In addition, data suggested passive aerosolization from contaminated envelopes might result in persistence of spores for longer than 60 days. Furthermore, problems with adherence to antibiotic therapy were also documented.
OBJECTIVE:
CDC initiated the Anthrax Vaccine and Antibiotic Availability Program to provide 40 days of additional antibiotics, alone or with three doses of AVA to individuals at risk for inhalational anthrax who had already received 60 days of antibiotics. CDC collected data on serious adverse events (SAE) in this population.
METHOD:
Program participants were monitored by both passive and active surveillance. Reported adverse events were evaluated for potential SAEs as defined by the FDA. SAEs were classified based on the causal relationship to treatment.
RESULT:
Overall, 1,730 persons enrolled; 1,537 (89%) received antibiotics only and 193 (11%) received antibiotics and AVA. Twelve participants were identified with a SAE. These SAEs were further classified based on the causality assessments as: definite (0), probable (1), possible (2), unlikely (5), not related (4), and unclassifiable (0). There were no reported deaths and only one participant, who received antibiotic therapy only and developed ciprofloxacin-induced allergic interstitial nephritis, was classified as probably related to participation.
CONCLUSION:
SAEs were rare among individuals who received AVA and antibiotics as PEP in response to a bioterrorism event. This information will prove helpful in another event in reassuring the public and public health community as to the safety of this intervention.
LEARNING OBJECTIVES:
To recognize the low rate of SAEs associated with PEP using AVA and antibiotics and to understand surveillance mechanisms for SAEs in a PEP public health response program to bioterrorism.
See more of An Overview of the Anthrax Vaccine and Antibiotic Availability Program and Future Directions for Anthrax Vaccine Adverse Event Surveillance
See more of The 37th National Immunization Conference
