Major setback for VaxGen anthrax vaccine

From today's Washington Post:

"The government's $1 billion effort to develop a new anthrax vaccine has run into difficulty, with the company in charge of the project reporting failure in a major human test and falling at least a year behind schedule.

Officers at VaxGen Inc. of Brisbane, Calif., said in interviews that they believe they have isolated the problem with their vaccine and are well on their way to fixing it. But they acknowledged that they have no hope of meeting a deadline to deliver 25 million doses of the vaccine into a national stockpile by November and will default on their contract with the government unless it grants an extension they have requested."

As the story notes, this setback is only the latest for activities related to Project Bioshield. Most large vaccine manufacturers have stayed away from the program, citing concerns about profit limitations and potential damage to their reputations if problems are encountered fulfilling contract terms. Thus, the work has largely fallen to smaller outfits such as VaxGen that lack the track record of Merck, Sanofi, and GSK, for example. In fact, seeing an opportunity to fill this void, VaxGen touts its 'biodefense business model' on its website. (Oddly, there's no mention in the business model of high-profile failures such as this.)

According to the Post, government contracts to VaxGen for anthrax vaccine work approach $1 billion. Today's news means that 2008 or 2009 is the earliest that a vaccine could be delivered.

In the meantime, the only anthrax vaccine available is an older product made by Bioport, a subsidiary of Emergent Biosolutions. As its FAQ notes, all of Bioport's vaccine production is owned by the U.S. military. There was some controversy a few years back when members of the military expressed reluctance at receiving the vaccine due to safety concerns. In response, the Department of Defense has this impressively-designed site that outlines their positions on the importance of military vaccinations and the safety of the Bioport vaccine.

Update, 10:31 PM: Perhaps not surprisingly, VaxGen took issue with much of today's Washington Post story. Here's a press release from their CEO with responses.