Problems manufacturing the anthrax vaccine...
October 25, 2001
BioPort Altered Anthrax Vaccine Filters
Without Notifying the FDA, GAO Says
interactive.wsj.com
By ROBERT TOMSHO
Staff Reporter of THE WALL STREET JOURNAL
BioPort Corp., the only U.S. maker of anthrax vaccine, didn't notify the Food and Drug Administration about manufacturing changes that may have affected the vaccine's composition, according to the General Accounting Office, the investigative arm of Congress.
Moves by the company, which has produced the vaccine since 1990, included three changes in the filters used by the Lansing, Mich., concern, according to a GAO report released Tuesday. The GAO said it found no records of required regulatory notifications, although the FDA investigated after the GAO notified the agency in February. The FDA approved the filter changes in July, after reviewing BioPort data indicating vaccine quality hadn't been altered. Direct comparisons with pre-1990 product weren't possible, however, because vaccine from that era no longer existed, the GAO said.
The GAO said an unpublished 1990 Department of Defense study suggested that the filter change had resulted in "up to a hundredfold increase" in the level of protective antigens in the vaccine. Subunits of both the anthrax toxin and the vaccine, protective antigens aren't themselves harmful and there are no studies to indicate what effect such an increase might have, the GAO said. Noting reports of an increase in adverse reactions to the vaccine since the Gulf War, however, the GAO suggested further study.
"The GAO has spent a lot of time and money looking for a smoking gun and the fact is that there is no smoking gun here," said BioPort spokeswoman Kim Brennan Root, who said the FDA has approved its filter changes and found that they didn't affect product quality.
An FDA spokeswoman didn't immediately respond to a request for comment.
A 1998 FDA inspection found numerous deficiencies at BioPort's plant, which was closed for renovations. Newly made vaccine hasn't been released since 1999. In the aftermath of Sept. 11 terrorist attacks, the company has sought FDA approval to distribute vaccine made at the renovated facility.
Write to Robert Tomsho at rob.tomsho@wsj.com |
