inst aerosolized anthrax is unknown, but exposure to skin can be reduced through early recognition, antibiotics, and vaccination (Eitzen et al. 1-3). The vaccine that is being questioned is produced exclusively by the Michigan Biologic Products Institute. In 1970, the Food and Drug Administration (FDA) approved the vaccine for controlled use in high-risk occupations. Veterinarians and agricultural laborers were given the vaccine to prevent contracting anthrax through the mishandling of animals and animal products (Anthrax n.pag.). The vaccination process consists of six doses administered over an 18-month period, then followed by annual booster shots. To accommodate the Department of Defense (DOD) Anthrax program, thousands of batches had to be produced quickly.During mass production, the Michigan Biologics Products Institute has come under disapproval for illegal manufacturing practices. Since 1993, the FDA has cited the Michigan plant several times on quality control. A year before the military was to start the program; an investigation conducted by the FDA found the following problems. Mixing of different batches, replacing old batches with new expiration dates, weakened harvest filters used in producing the vaccine serum, and no documentation of tests performed for contaminants in the vaccine batches. One particular batch manufactured on April 13, 1993 was relabeled Feb. 6, 1998 and sent to the USS Independence in the Persian Gulf where thousands of sailors were given the vaccine. Astonishingly, the FDA did not shut down the anthrax production line at the Michigan plant. However, in a letter written by the FDAs senior advisor for regulatory operations stated, Significant improvements must be made prior to continuing production of the vaccine (Hafem n.pag.). Facts related to the FDAs lenient attitude towards the Michigan plant are unknown, but suspicions lead to Department of Defense pressure. Secretary of Defense, Will...
