ANTHRAX: FDA Cites BioPort for Production Problems

Last week, the FDA cited anthrax vaccine producer BioPort Corp. for 18 violations of "manufacturing procedures" at its Lansing, Mich. facility. According to the Hartford Courant, a spokesperson for BioPort said the government accused the company of a "lack of consistency in its manufacturing processes" and of having problems with vaccine sterility assurance and packaging procedures. This is at least the fourth time federal inspectors have raised "serious questions" about operations at BioPort or its predecessor (Williams, Hartford Courant, 10/31). After the plant failed past FDA production requirements, the company "was prepared to discuss anything that would meet military needs for the vaccine," including a possible government takeover of BioPort's refurbished plant (American Health Line, 7/13). This time, however, the company says the problems are "not crucial" to operations and will be corrected. The military hopes to use the vaccine to inoculate 2.4 million soldiers from airborne anthrax spores, but production problems and "attack[s]" from members of Congress have postponed the program. Of the soldiers who have received the vaccine so far, more than 1,500 complained of side effects, and hundreds have been disciplined or discharged after refusing the vaccine (Hartford Courant, 10/31).