Even more bad news for VaxGen anthrax vaccine development

Back in March, we wrote about the Washington Post's reporting on setback for VaxGen in their development of a next generation anthrax vaccine as part of a $1 billion contract through Project Bioshield. (The New York Times chimed in back in October, as we noted then as well.)

Today, this story, also from the Washington Post:

"The Food and Drug Administration has postponed advanced testing of a proposed anthrax vaccine that was supposed to be stockpiled this year because of concerns it could lose its potency too fast to be useful, the company developing the drug announced today.

The announcement by VaxGen Inc. was yet another setback to the U.S. government's $1 billion effort to develop a new anthrax vaccine. It followed predictions on Capitol Hill two-and-a-half years ago that a small company like VaxGen wouldn't be able to meet the government's aggressive schedule for stockpiling 25 million doses of the new vaccine by this month."

As this VaxGen press release explains...

"The FDA's Center for Biologics Evaluation and Research (CBER) said the hold notice was issued because data submitted to date by the company are insufficient to determine that the product is stable enough to resume clinical testing. In the notification, the agency expressed concerns that the vaccine's potency could decline during the immunization phase of the trial, potentially resulting in an uninterpretable outcome."