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U.S. Department of Health and Human Services

Drugs

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FDA APPROVES LICENSE SUPPLEMENTS FOR ANTHRAX VACCINE

FOR IMMEDIATE RELEASE
P02-04
January 31, 2002
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

Lots From Renovated Facility Can Be Released And Distributed

FDA today took the final actions necessary to allow the BioPort Corporation to begin routine distribution of licensed anthrax vaccine from its renovated facility.

Today's action was the approval of 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 approval follows an FDA inspection of that facility from January 7 through 10, 2002, and a satisfactory response to deviations noted during that inspection.

On December 27, 2001, FDA approved BioPort's facility in Lansing, Mich., where AVA is manufactured. The pre-approval inspection for this facility was completed December 19, 2001.

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

In addition, each lot of anthrax vaccine undergoes thorough testing for purity, potency, identity and sterility. No lot of anthrax vaccine can be distributed from the renovated facility until FDA's Center for Biologics Evaluation and Research releases it based on the results of these tests. This process, called lot release, helps assure product safety by providing yet another quality control check on product specifications. Today, FDA is releasing the three consistency lots submitted in support of the supplements for the facility renovation and contract filling by Hollister-Stier.

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 comprehensive renovation of the facility. In September 1998, the facility was sold to BioPort. FDA is now satisfied that BioPort's renovated facility can produce a vaccine that meets FDA standards for safety and efficacy.

The Department of Defense (DoD) owns all lots of Anthrax Vaccine Adsorbed produced by BioPort in the renovated facility. Currently, the Centers for Disease Control (CDC) does not recommend vaccination against anthrax for the general public to prevent disease.