August 5, 2002

Anthrax vaccine maker says future in doubt

United Press International

LANSING, Mich., Aug. 5 (UPI) -- BioPort Corp., the only company currently producing anthrax vaccine, says the federal government has put its future in jeopardy by failing to finalize the amount it will order and preventing the company from selling the vaccine to non-U.S. government entities willing to pay up to $100 a dose.

BioPort President Robert Kramer said the government has estimated it will need 3.4 million doses, for which the Defense Department is paying $20 a dose.

Though the price is three times what it was three years ago, the company said it is insufficient to enable the firm to make the investments it needs to survive.

The hang-up has been negotiations over who will pay for the vaccine. Several military and civilian agencies want to stockpile it.

"It's crazy for us as a business to risk our financial viability due to government indecision," Kramer told Monday's New York Times. "Our long-term viability is at risk given the current situation."

The government refuses to take responsibility, noting the troubles BioPort had in passing Food and Drug Administration inspections and the recent destruction of 180,000 doses -- about two weeks production -- deemed substandard.

However, the Pentagon also has changed its plans to vaccinate all 2.4 million members of the military. It decided to limit vaccinations to those in "higher risk" areas like the Middle East and the Korean peninsula.

Anthrax is an infectious disease that normally afflicts animals, especially cattle and sheep. The spores can be produced in a dry form, which when inhaled by humans can cause respiratory failure and death within a week.

Since anthrax is odorless, colorless and tasteless, those who have been exposed may be unaware of the exposure and therefore unable to seek treatment in a timely manner. For treatment to be effective, it has to be started within 24 hours of exposure.

Five people died of anthrax last year and 17 were sickened when a still-unidentified person or persons sent spores through the mail. Additionally, Iraqi leader Saddam Hussein is believed to have stockpiled a weapons-grade anthrax that could be used in the event of war or by terrorists.

BioPort received approval in January to begin shipping vaccine, the first produced since 1998, when the former Michigan Biologics Products Institute was sold by the state of Michigan and renovations on the production facility began. BioPort is the only company with a contract to produce the vaccine and the military already has spent at least $126 million to acquire the doses.

The FDA prohibited any new vaccine from being produced until BioPort fixed dozens of problems, some involving the quality of the vaccine. A few relatively minor problems -- mostly involving record keeping -- were the final issues to be resolved.

The FDA completed its final inspection of BioPort's facility Dec. 19, citing seven deficiencies, some of which were fixed immediately. The final holdup involved the Spokane, Wash., company -- Hollister-Stier Laboratories -- that packages the vaccine. The FDA found six deficiencies at that operation.

About 500,000 troops already have received one dose of the vaccine. Anthrax vaccination involves a series of six injections given over an 18-month period.

In September 1998, BioPort bought the assets of the former Michigan Biologic Products Institute. The company is headquartered in Lansing and develops and manufactures vaccines and plasma derivatives.