Bloomberg.com
September 26, 2001
BioPort, Sole Anthrax Vaccine Maker, Beset By Flaws
By Kim Dixon
Washington -- BioPort Corp., the only U.S. 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 U.S. troops. Since the Sept. 11 terrorist attacks,
BioPort says it has been fielding inquiries 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 U.S. 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 into the air over a wide area.
That requires technological expertise to package the spores in aerosol or
powdered form.
Offshoot of State Agency
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 Persian 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,'' department spokesman Jim Turner said in an e-mail.
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 $40 billion for anti- terrorism
measures. Last week, 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.
U.S. Department of Health and Human Services officials didn't return calls
seeking comment.
Government-Owned Plant
The report to Congress earlier this month recommended $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.
It would cost about $1.56 billion to build and run such a plant for 20
years, according to the report, which lawmakers received the week before the
attacks on the World Trade Center and the Pentagon.
``Biological agents, even if adversaries intend them solely for use against
military targets, could have the potential for causing severe primary or
collateral civilian damage,'' Surgeon General David Satcher wrote in a
letter to Defense Secretary Donald Rumsfeld, which is attached to that
report, supporting the construction of such facility.
After the initial infection and a course of antibiotics, treatment with a
vaccine can prevent anthrax spores that remain in the body from causing new
infections. Bayer AG's Cipro is the only antibiotic approved for treatment
of the spore form of anthrax.
Civilian Vaccine Stockpile
Some experts have called for stockpiling anthrax vaccine to protect civilian
populations exposed to the bacteria or spores in a terrorist attack. The
vaccine would be given only to people thought to be exposed, and wouldn't be
used to immunize large populations.
Creating a civilian stockpile of the anthrax vaccine for use after exposure
``is absolutely a good idea,'' said Ronald Atlas, University of Louisville
professor and co-chair of the American Society for Microbiology's Task Force
on Biological Weapons. ``It can conceivably come back so you want a
stockpile for post- infectious situations.''
BioPort, a firm with 220 employees, plans to file an application next month
seeking permission to resume production of the vaccine, according to BioPort
spokesman Kim Root.
``We've been producing just what we needed to produce to gain approval from
FDA for the facility,'' Root said. ``We're in an annual maintenance phase.''