The FDA has put a clinical hold on VaxGen's next Phase II trial for its troubled anthrax vaccine, "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, VaxGen added, the agency expressed concerns that the vaccine's potency could decline during the immunization phase of the trial, potentially resulting in an uninterpretable outcome.
VaxGen has run into repeated trouble with the FDA over its anthrax vaccine. The agency has accused VaxGen of making exaggerated claims about the vaccine and threatened court action this year in an effort to make the company shape up. And the Washington Post reported last spring that trouble in developing the vaccine was delaying delivery past an agreed November deadline.
- here's the release on VaxGen