BioPort Corp, the only US company that makes a vaccine for anthrax, a bacterial agent considered a potential terrorist weapon, has been unable to sell the product for three years because it can't meet federal manufacturing standards.
The closely held company has a contract with the Defense Department to supply the vaccine to US troops. Since the Sept. 11 terrorist attacks, BioPort says it has been fielding inquiries from concerned individuals about releasing vaccine for civilian use and has set up a hotline to handle calls, explaining military needs come first.
BioPort hasn't delivered vaccine to the military since 1998 as it renovates a plant to fix flaws found by the US Food and Drug Administration, including inadequate monitoring of vaccines' sterility and potency. The government's reliance on a single supplier was criticized in a recent report to Congress that recommended letting other companies compete for the business.
"We haven't been able to get the best and the brightest into this business," said Fred Cilluffo, a terrorism expert at the Center for Strategic and International Studies. "There are a hell of a lot bigger markets for Viagra."
Terrorists could obtain anthrax bacteria from countries such as Iraq, which has stockpiled biological weapons, according to the Centers for Disease Control and Prevention. Anthrax is a livestock bacteria that kills by shutting down the lungs. Anthrax infections that occur when bacterial spores are inhaled are almost uniformly fatal if not treated immediately.
Because the disease cannot be passed from person to person, infecting large populations would require dispersing spores over a wide area. That requires technological expertise to package the spores in aerosol or powdered form.
Lansing, Michigan-based BioPort is an offshoot of the Michigan Biologic Products Institute, a state-owned agency that supplied anthrax vaccine to troops during the Gulf War.
The company's production problems have forced the Defense Department to delay vaccinating all 2.4 million active and reserve troops and limit immunizations to those in high-risk areas. That will allow the military to keep "a small reserve" of vaccine for emergencies, according to the department.
The department is "assessing the performance of BioPort Corp on all of its contracts," said department spokesman Jim Turner.
Poor manufacturing practices cited by the FDA include rust on plant equipment, evidence of air leaks in sterile facilities, failure to ensure temperature control in certain areas, and use of an expired chemical in some processes, according to FDA inspection reports.
After the attacks, Congress authorized US$40 billion for anti-terrorism measures. Last week, US Defense Secretary Donald Rumsfeld proposed that part of the money be used to speed development of a "second-generation anthrax vaccine, to improve the current product and to tackle new strains of the bacteria.
US Department of Health and Human Services officials didn't return calls seeking comment.
The report to Congress earlier this month recommended US$3.2 billion be set aside to pay for Defense Department research and development of vaccines. It advocated creation of a government-owned vaccine manufacturing plant that could be used by drugmakers to produce a range of vaccines for military personnel and potentially for civilian use in the event of a terrorist attack using biological weapons.
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