lates of protection in animal models can be used to test the efficacy of AVA, as well as new vaccines against anthrax. The production, testing, and licensure of a new vaccine requiring fewer doses and producing fewer local reactions are needed.

Anthrax Vaccine Adsorbed1 (AVA) was licensed in 1970. More than 2 million doses have been administered, and most of those doses have been given since 1998 to U.S. military personnel to protect them against possible exposure to anthrax spores used as biological weapons. The terrorist attacks of September 11, 2001, and the subsequent distribution through the U.S. mail of potent doses of anthrax spores drew new attention to the risks of anthrax exposure and to questions about the anthrax vaccine.

Until the 1990s, AVA had primarily been used by a small population with a risk of occupational exposure to anthrax (e.g., textile mill workers and veterinarians). In 1990, concerns that Iraq had biological weapons containing anthrax spores motivated the U.S. military to administer AVA to an estimated 150,000 service members deployed for the Gulf War. The existence of an Iraqi biological weapons program was confirmed in the mid-1990s (Henderson, 1999; Zilinskas, 1997), and in 1997 the Department of Defense (DoD) announced a plan to vaccinate all U.S. service members with the licensed anthrax vaccine. DoD’s Anthrax Vaccine Immunization Program (AVIP) began in March 1998 with personnel scheduled for deployment to higher-risk areas (e.g., Korea and Southwest Asia). In 2000 a limited vaccine supply, the result of delays in federal approval for release of newly manufactured vaccine lots, began slowing plans to vaccinate all military personnel. As more service members were vaccinated under the mandatory AVIP, some raised concerns about the safety or the efficacy of AVA, and more than 400 personnel refused vaccination (Weiss, 2001). Some had also suggested a link between vaccination with AVA and illnesses in Gulf War veterans.

STUDY PROCESS AND INFORMATION SOURCES

Responding to the concerns about the anthrax vaccine and AVIP, the U.S. Congress directed DoD to enter into a contract with the National Research Council for a study of the vaccine’s efficacy and safety.2 In October 2000 the Institute of Medicine (IOM) convened the Committee to

1  

As of January 31, 2002, AVA will be manufactured under the name Biothrax.

2  

The study was called for in the conference report accompanying the 2000 DoD appropriations act P. L. No. 106-79 (1999).



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