Anthrax vaccine lab on verge of winning Pentagon approval

LANSING, Mich. -- In 1998, the buyers of the only U.S. laboratory making the anthrax vaccine thought they had a can't-miss deal.

The aging state-owned lab in Michigan needed millions in renovations on top of the $24 million purchase price. But the Pentagon already had announced it would require all 2.4 million American military personnel to take a series of six shots of the vaccine, and turning the lab into a profitable enterprise seemed childishly easy.

Four years later, Lansing-based BioPort Corp. has yet to ship a single dose of the vaccine to the Pentagon.

Unable to pass inspections by the Food and Drug Administration, BioPort has intermittently produced the vaccine but has not been able to release it.

Now, the company appears to be on the verge of finally winning FDA approval to begin shipments, possibly as early as this month.

"It's clearly a very positive story for the company," said BioPort spokeswoman Kim Brennen Root.

A few more hoops

A laboratory in Washington state that puts the vaccine into vials still needs FDA approval, and the vaccine still must be tested for purity, potency and sterility before batches will be released by the FDA.

The vaccine was held up by contamination, inadequate record-keeping and unapproved procedures at the laboratory.

"I'm glad it took four years. That stuff needed to be done right," said Rep. Mike Rogers, R-Mich., whose district includes BioPort.

BioPort is under contract to the Pentagon to supply 4.6 million doses for $53.5 million.

Pressure to get the lab approved has grown since U.S. troops began heading overseas in the war on terrorism and since last fall's anthrax outbreak killed five people on the East Coast. Because of the standstill at Bioport, the Pentagon stockpile of the vaccine is dwindling.

Amid the anthrax scare and the war on terrorism, some have questioned whether the FDA is being pushed to overlook problems at BioPort.

"The FDA is under tremendous pressure to cave on this," Lingg Brewer, a former state lawmaker, said last fall.

Health and Human Services Secretary Tommy Thompson said in October that the FDA would give the laboratory close scrutiny and that science, not politics, would decide when it got the OK.

"I can assure you nobody is pressuring FDA to approve this," he said.

Claims of illness

Even if the FDA gives BioPort the green light, more problems lie ahead.

Some military personnel say the vaccine they were given in the late 1990s made them ill, leading to congressional inquiries and lawsuits. Opponents to the vaccine have asked the FDA to declare all stockpiles adulterated and to revoke BioPort's license.

BioPort officials have said the vaccine is safe, and the Pentagon said severe side effects happen only about once per 200,000 doses.