CBER delays Ph II trial of VaxGen anthrax vacc

California, USA-based VaxGen says that the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) is maintaining its clinical hold on the second Phase II trial for its investigational anthrax vaccine, due to the CBER's continued concerns about the vaccine candidate's stability.

The Department of Health and Human Services, under its contract with VaxGen to purchase 75 million doses of rPA102, its recombinant anthrax vaccine had imposed a December 18 deadline for the company to initiate its next clinical trial for the vaccine candidate. The Office of Public Health Emergency Preparedness, the office within HHS that administers the contract, has yet to inform VaxGen what direction it intends to take with respect to the deal.