FDA approves anthrax vaccine license supplements

FDA Consumer, May-June, 2002

The FDA has taken the final actions necessary to allow BioPort Corporation to begin routine distribution of licensed anthrax vaccine from the company's renovated facility.

The approval in January involved a supplement to BioPort's biologics license, approving Hollister-Stier Laboratories LLC in Spokane, Wash., as a contract filling facility for the Anthrax Vaccine Adsorbed (AVA). This allows Hollister-Stier to receive the vaccine from BioPort's manufacturing facility, fill vials with the vaccine, and ship them back to BioPort for distribution. This approval followed an FDA inspection of Hollister-Stier's facility and a satisfactory response to deviations noted during that inspection.

This latest approval follows the FDA's approval of BioPort's facility in Lansing, Mich., where AVA is manufactured, in December 2001.

"FDA has worked as quickly as possible to review these license supplements, including resolving outstanding issues with the firm, for the supplements to be approved. Our goal has always been to assure that the anthrax vaccine meets high standards for safety and efficacy," says Bernard A. Schwetz, D.V.M., Ph.D., the FDA's senior advisor for science. Due to the complex nature of biological products, the Public Health Service Act and FDA regulations require FDA approval of major changes made to a facility in which a licensed product is manufactured.

The company that had held the license for the anthrax vaccine since its approval in 1970, Michigan Biologics Products Institute, halted production of the anthrax vaccine in January 1998 to begin a renovation of the facility. In September 1998, the facility was sold to BioPort. The FDA is now satisfied that BioPort's renovated facility can produce a vaccine that meets FDA standards for safety and effectiveness.

The Department of Defense owns all lots of Anthrax Vaccine Adsorbed produced by BioPort in the renovated facility. Currently, the Centers for Disease Control and Prevention does not recommend vaccination for the general public to prevent anthrax infection.