GAO Pins Blame for Failed Anthrax Vaccine Contract

By Elaine M. Grossman
Global Security Newswire

WASHINGTON –— The watchdog arm of Congress this week took the Health and Human Services Department to task for a failed $877 million effort to develop and produce a new anthrax vaccine that might be widely distributed in case of a bioterrorist attack (see GSN, April 6).

Until now, blame for the contract’s cancellation has fallen largely on the vaccine manufacturer, VaxGen.  The government ended the contract in December 2006 when the company failed to meet a critical milestone in its effort to manufacture 75 million doses of the vaccine (see GSN, Dec. 20, 2006).

VaxGen’s product — called a recombinant protective antigen anthrax vaccine — was to use genetic engineering technology to create a biochemical capable of triggering a human or animal immune response to anthrax, an infectious disease.  By contrast, the anthrax vaccine commonly administered to U.S. military personnel and others utilizes laboratory cultures of a nonvirulent strain of anthrax to produce a protective antigen.

In the new report, the Government Accountability Office said the government and the company shared responsibility for the Project Bioshield failure:

— Health and Human Service’s preparedness and response office awarded the contract to VaxGen in November 2004, when the small California biotechnology firm was just in the initial stages of developing the vaccine.  At the time, several “critical manufacturing issues” had yet to be sorted out.  Moreover, “the contract required VaxGen to deliver 25 million doses of the vaccine in two years, which would have been unrealistic even for a larger manufacturer.”

— VaxGen “took unrealistic risks in accepting the contract terms,” including an “aggressive delivery time line,” a “lack of in-house technical expertise,” and the company’s “limited options for securing any additional funding needed.”

— The government secured the contract before the Food and Drug Administration made known what kinds of data and testing would be required before the new vaccine would be eligible for use in an emergency.

In a formal response submitted to the Government Accountability Office, Health and Human Services said it agreed with some findings and disagreed with others.

Among the most notable comments is the agency’s insistence that VaxGen’s vaccine development was sufficiently mature by the time the contract was awarded.

“HHS strongly disagrees with the assertion that VaxGen’s candidate [anthrax] vaccine was not sufficiently advanced to warrant a Project Bioshield contract award,” the agency said.  Existing development risks were “deemed to be appropriate given the urgency of the requirement” for a new vaccine in the wake of the 2001 anthrax attacks, according to the Oct. 4 response letter.

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