WASHINGTON: California biotechnology firm VaxGen Inc. said the U.S. Food and Drug Administration has postponed the advanced testing of an anthrax vaccine it is developing. The company was about to start second mid-stage clinical trial of the vaccine -- meaning testing on humans.
The FDA issued the notice as it found the data submitted by the company to be insufficient to prove the stability of the product enough to resume clinical testing. The vaccine could lose potency too quickly to be useful, felt the FDA.
VaxGen could not say the time it would take to address the concerns of the FDA. The vaccine is intended to prevent diseases caused by inhaling anthrax spores and millions of doses of the vaccine were to have been stocked as part of Bush administration's Project BioShield, a $5.6 billion project to counter bioterrorism threats. The company had said in March initial human test of the vaccine had failed. It had also said there could be a delay of about a year in the target date of its launch.
The possibility of the delay has led to the department of health and human services issuing a warning to the company that it might terminate the order for stocks of the vaccine worth about $1 billion.
The military has been using a vaccine produced by Emergent BioSolutions Inc. but the government wanted to have another version and the work was entrusted to VaxGen.
Company officials said it may have to create new data on the current vaccine formula or make improvements in order to address the concerns of the FDA. They said some deterioration in the potency is to be expected when it is stockpiled.
Brisbane-based VaxGen's stock crashed after the announcement, falling $2.24 a share, or more than 56 per cent, to $1.75 on the Nasdaq Stock Market.
