The same day that President Bush signed the Pandemic and All-Hazards Preparedness Act into law, the government canceled their contract for the production of 75 million doses of anthrax vaccine. The contract, with VaxGen, was the most significant from the much criticized Bioshield program. But the cancellation was anticipated by many after VaxGen, who has never brought a vaccine or drug to market missed several deadlines and, most recently, had their application for testing their vaccine in humans rejected by the FDA.
The company only has one other product in its pipeline, a new smallpox vaccine, but they do not have a contract to produce it. So, after shelling out approximately $175 million of its own cash, they have been left at the table with the bill. This scenario is precisely why no large pharmaceutical companies bid on the anthrax vaccine contract when it was offered. It was simply too much of a gamble. Granted, VaxGen’s 5 year time line for production of a next generation vaccine was overly ambitious by most standards, and they have no one to blame but themselves for signing a contract that there was little chance of completing on time.
The US will continue to stockpile the previously available anthrax vaccine from Emergent BioSolutions even though its safety has been a topic of concern for some time and that it has to be delivered in several doses over 6 months.
The cancellation of the contract and the passing of the Pandemic and All-Hazards Preparedness Act represent a welcome step back and reevaluation of how the US has been approaching countermeasure development. Amongst several provisions, the act calls for a reorganization of the Bioshield program and establishes the Biomedical Advanced Research and Development Authority, or BARDA, under the Department of Health and Human Services, which will be tasked with organizing vaccine and therapeutic development for potential bioterror agents. Having a more organized and accountable system for spending the $5.6 billion dollars in Bioshield funding will most certainly be a step forward.