LANSING, Mich. – With heightened concern about anthrax since a Florida man died from it, the only U.S. manufacturer of a vaccine to fend off the disease is facing growing criticism.
Bioport Corp., under contract to provide the vaccine for the military, has been unable to ship any of its product during its three years of operation. It has been stymied by its failure to meet federal drug agency standards for its renovated plant here.
And questions have arisen over Bioport's ability to produce the anthrax vaccine, and over whether the Pentagon's exclusive contract with the company has kept newer, better vaccines from being developed.
"It's very expensive to do this right," said Tara O'Toole, deputy director of the Center for Civilian Biodefense Studies at Johns Hopkins University. "Nobody wanted to pay what it was worth."
BioPort Corp. officials insist they have made the changes necessary to produce the vaccine and on Monday plan to submit new information to the U.S. Food and Drug Administration.
The FDA has up to six months to review the information, and Bioport is hopeful it could ship the vaccine for use by early next year.
"There is a formidable stockpile available," BioPort spokeswoman Kim Brennen Root said Tuesday. "This vaccine is the centerpiece of protection for the U.S. military."
Root declined to say how much of the vaccine is available, citing national security. The military refuses to say how much vaccine it has left, but it had only 60,000 doses last December. Root said BioPort has been manufacturing the vaccine even as it awaits FDA approval.
The vaccine has come to the forefront as the United States and its allies began military strikes to root out the terrorist organizations. At least 10 countries are believed to have the capacity to produce biological weapons using anthrax.
Citizens worried about a bioterrorist attack in this country have called BioPort and a company it's working with in Spokane, Wash., asking if they can get immunized. Most health officials see little need for a nationwide anthrax immunization program, even if any of the vaccine were available.
Root said that any decision by Bioport to set aside some vaccine for civilians will have to be made by the departments of Defense and Health and Human Services. Other companies, including Corixa Corp. of Seattle, are attempting to develop a vaccine, but those are years away.
Corixa is working with a $3.5 million grant from the Department of Defense to develop anthrax-fighting drugs administered by inhaler or nasal spray.
Anthrax produces a toxin that can cause severe damage to the respiratory system and brain, killing untreated patients within days. Treatment with antibiotics is often successful if the infection is caught in time.
Production of the vaccine requires live anthrax bacteria -- which must be carefully stored. So manufacturing has been limited for decades to one building, a squat brick facility in a quasi-industrial section on Lansing's north side.
But the amount is too small and isn't in a form that would be of use to terrorists, company officials have said. Michigan National Guard troops have been stationed at the plant since last week, however.
Since buying the aging facility from the state in 1998, BioPort has spent $1.8 million to upgrade it and $15 million to expand, with much of the money coming from the federal government. It also got the Pentagon to triple the per-dose payment, increasing its government contract to more than $50 million.
But it hasn't been able to pass FDA requirements to ship the anthrax vaccine. The lab failed FDA inspections in 1999 and 2000, mostly for packaging problems.
The company still has some vaccine that was made when the state produced it before BioPort bought the plant. But some of that vaccine has expired or failed potency or purity tests while in storage, according to a government report.
Lingg Brewer, a former state representative who opposed the sale of the state laboratory to BioPort, said the money the Pentagon now is spending on its BioPort contract would be better spent on letting others come up with a different vaccine, or even on stockpiling more antibiotics to treat anthrax infections.
He wants to make sure the FDA, if it grants BioPort approval to ship vaccine, does so for the right reasons.
"The FDA is under tremendous pressure to cave on this," Brewer said. "It's really important to let the FDA do its job."
Root said BioPort has no desire to have the FDA cut corners.
O'Toole, of Johns Hopkins, criticizes Pentagon officials for underestimating the amount of money and time it would take to turn BioPort into a major manufacturer of the anthrax vaccine.
Calls to the Pentagon for comment were not returned.
This isn't the first time the relationship between BioPort and the Pentagon has been criticized.
Last year, the Committee on Government Reform issued a report that accused the Pentagon and BioPort of having a relationship that blocked the creation of newer and better forms of the anthrax vaccine, left the vaccine program vulnerable to supply shortages and price increases and left the Pentagon "captive ... to a single, untested company."
The report also raised doubts over whether the anthrax vaccine, which was created in what was then a state-owned laboratory in 1970, would work against airborne anthrax in biological warfare. The vaccine is given in a series of six shots over 18 months. The Pentagon has said it offers protection as soon as the third shot is given, one month after the first shot, but others have disputed that.
The report even questioned the vaccine's safety, noting that some military personnel and reservists said the military-required vaccines they took in the late 1990s made them ill.
BioPort officials have repeatedly said they have a viable program to produce the vaccine and that it is safe. Since the Sept. 11 attacks, the company's 220 employees are more eager than ever to do their part to protect U.S. troops, Root said.
About 500,000 of the 2.4 million troops and reservists the military wants to vaccinate have received the vaccine.