Anthrax Vaccine Maker Criticized

by Thomas D. Williams

The Hartford Courant

October 31, 2000

BioPort Corp., the manufacturer of the controversial anthrax vaccine, has once again been sharply criticized by federal inspectors over its manufacturing process.

Last week, the U.S. Food and Drug Administration cited BioPort for 18 violations of manufacturing procedures after about 2¸ weeks of inspections of its Lansing, Mich., plant.

An FDA report on the inspections was not available to the public Monday, but BioPort acknowledged criticism from the FDA inspectors.

The FDA cited BioPort for lack of consistency in its manufacturing processes, and for problems with assurances of sterility in vaccines, drug products other than anthrax and its overall procedure for packaging and filling vaccines, said Kelly Rossman-McKinney, a BioPort spokeswoman.

Although the anthrax vaccine was one of the products involved in the packaging and filling operation, said Rossman-McKinney, it had been already closed down in July. The FDA cited that operation anyway in an attempt to remedy BioPort's procedures.

But Rossman-McKinney said the problems cited by the FDA are not crucial to continued operations, do not involve its efforts to produce its own new batches of the vaccine, and will be corrected.

This marks at least the fourth time federal inspectors have raised serious questions about operations at BioPort or the previous manufacturer of the vaccine.

The vaccine, aimed at eventually protecting 2.4 million service members from airborne anthrax spores used as a warfare and terrorist weapon, has been under heavy attack for more than a year from a number of members of Congress, who have demanded the inoculation program be shut down. Those members of Congress, including U.S. Rep. Christopher Shays, R-4th District, claim the vaccine has not been proven either safe or effective.

The Pentagon has made the vaccine mandatory and threatened reluctant military personnel with courts martial or hefty fines if they refuse to take it. But when supplies of the vaccine ran low this year, the Pentagon limited the shots to those going overseas to areas of high conflict risk.

Last December, the Pentagon announced that the second phase of its vaccination program had been postponed for six months to a year because of BioPort's failure to pass inspections to produce its own vaccine supply. The company has been exclusively using old supplies of the vaccine since it purchased the operation from the state of Michigan's health department two years ago.

The vaccine's former manufacturer had been threatened with a shutdown of its operations during FDA inspections in 1996 and 1997.

More than 1,500 service people have complained about side effects, of varying severity, that they blame on the vaccine. Hundreds of service people have refused to be inoculated and have been disciplined or discharged.