The United States' sole manufacturer of anthrax vaccine has launched a lobbying blitz, urging lawmakers to back a national immunization strategy for civilians. BioPort Corporation of Lansing, Michigan went to Capitol Hill last week armed with a report predicting that the next wave of anthrax attacks would be even more deadly than last fall's assault, because of the ease of engineering antibiotic-resistant strains.

The company disputes the federal rationale that a shortage of anthrax vaccine makes mass immunization impractical, claiming that BioPort can supply enough vaccine for the entire nation. "At the time that policy was announced, DHHS [Department of Health and Human Services] said that were it not for a supply constraint by the manufacturer, this policy would change," BioPort president Bob Kramer told The Scientist. "It is completely unacceptable for public health and our country's preparedness to be dictated by a capacity constraint," he said.

The federal government is stockpiling enough smallpox vaccine to immunize everyone in the country, but is vaccinating only military personnel in high threat areas against anthrax. The government is also accumulating a smaller civilian stockpile of anthrax vaccine adsorbed, or AVA, which BioPort manufactures under the trade name BioThrax.

In March, a committee of the National Academies of Science Institute of Medicine (IOM) determined the anthrax vaccine to be safe and effective. But the IOM panel cited shortcomings in BioPort's manufacturing process, which relies on older technologies, as well as the 18-month immunization process, to support its conclusion that the US really needs a new and improved vaccine.

A plan to vaccinate millions of members of the military stalled in June 2000 while BioPort struggled to correct manufacturing problems that caused the Food and Drug Administration (FDA) to stop anthrax vaccine shipments. Money from the Pentagon kept the company alive while it revamped processes to address violations related to safety, sterility and consistency, Kramer acknowledged.

Citing contract confidentiality, Kramer would not say how much federal money had been invested in BioPort since 1998, when it took over a troubled manufacturing facility. Published reports estimate the Pentagon has spent more than $120 million on the anthrax vaccine manufacturer, which is owned in part by Admiral William Crowe Jr., former head of the Department of Defense Joint Chiefs of Staff.

BioPort won FDA approval in December 2001, Kramer said, and lined up a manufacturing partner in order to ramp up for full capacity production. But the senior government officials with whom BioPort met with last year have so far failed to act on a concerted anthrax immunization strategy, he said.

The company's renewed lobbying effort, Kramer explained, is based in part on a report commissioned by BioPort, which urges development of a plan for civilian anthrax vaccination, as has been done for smallpox. Former US Army Surgeon General Ronald Blanck headed the BioPort panel, which also included Gilbert Ross, executive director of the American Council on Science and Health, a corporate-sponsored non-profit organization whose recent publications include a book disputing evidence that children are more vulnerable than adults to environmental toxins.

But chances of a bioengineered strain of antibiotic-resistant anthrax are high, the report concluded, and such a strain would likely defeat the government's current best anthrax defense strategy, which relies on a combination of post-exposure vaccination and antibiotics.

"What the panel members are recommending in this report is that the appropriate government agency, DHHS or [the Department of] Homeland Security, needs to do a fundamental risk assessment similar to what's been done with smallpox in order to determine the subset that is at risk and should be considered for immunization," Kramer said.