New concerns raised about anthrax vaccine maker

by Kate Fodor

Reuters Health

November 14, 2000

NEW YORK, Nov 14 (Reuters Health) - A recent Food and Drug Administration (FDA) inspection of Bioport Corporation, the sole manufacturer of the US military's supply of anthrax vaccine, reveals a troubling picture of the company's manufacturing processes and facilities.

The 17-page document posted on the FDA website this week lists dozens of infractions related to product sterility, monitoring of manufacturing facilities and documentation. The investigators found, among numerous other violations, that the company follows an inadequate procedure for cleaning its product filling area, fails to thoroughly investigate potentially contaminated products and does not hold its employees to strict standards regarding gowning and hand washing.

The anthrax vaccine, which is designed to help protect against the threat of biological warfare, has been the focus of widespread publicity recently, both because of concerns about its safety and because it is in critically short supply.

The inspection report charges that Bioport has not adequately documented or investigated adverse events possibly linked to the vaccine. The company has received information on side effects possibly caused by the vaccine that are not listed on the product's labeling-including memory loss, dizziness and black outs-but has not followed up on the reports, the inspectors wrote.

While the FDA requires reporting of adverse events for all vaccines, it may be particularly crucial for the anthrax vaccine, given the fierce debate over the product's safety, an issue that was taken up at a recent Congressional hearing.

The FDA has said that the adverse event rate for the anthrax vaccine is lower than for many vaccines. But reports of dangerous reactions to the product, including the death of a Michigan man after he received his 11th dose, have frightened some troops into refusing to be inoculated.

Some members of Congress have said publicly that they believe the vaccine to be dangerous, in part because of concerns about Bioport's manufacturing facility that existed even before the latest inspection report. Bioport's facility is not yet licensed by the FDA, although the agency predicted before the unfavorable inspection that the licensing would take place by the summer of 2001.

In 1998, before the facility was sold to Bioport by the Michigan Biologics Products Institute, the FDA cited several violations of manufacturing regulations committed there. And last month, Bioport recalled one lot of anthrax vaccine due to an incorrect expiration date on the label and pulled lots of two other products because of concerns about sterility.

In a telephone interview with Reuters Health, an FDA spokeswoman stressed that the recent inspection report, which is known as a 483 form, reflects only the unconfirmed observations of the inspectors and is not considered conclusive. Such reports are generally followed by a more in-depth and fully documented inspection before they are evaluated by the agency, she noted.

The spokeswoman declined to comment further on the report, which was signed by three inspectors and documents an inspection conducted at Bioport's Lansing, Michigan-based facility between October 10 and October 26.

If a final report bears out the inspectors' initial observations, the government could find itself in a bind, as censuring Bioport could potentially worsen the shortage of the anthrax vaccine.

In July, experts from the Department of Defense testified before a Senate committee that, as a result of the shortage, the military has been forced to ration the vaccine and fears that it will run out entirely. Because no other companies supply the vaccine, the government has made a number of efforts so far to help keep Bioport viable, including making a $20 million interest-free loan to the company.

Calls to Bioport had not been returned at deadline.