FDA Blocks Human Tests of Anthrax Vaccine

The U.S. Food and Drug Administration has prohibited human testing of a new anthrax vaccine, possibly signaling the end to the troubled flagship initiative of the Project Bioshield program to develop countermeasures against weapons of mass destruction (see GSN, Sept. 29).

In 2004, the United States ordered 75 million doses from California biotechnology firm VaxGen. Inc. of an experimental vaccine that would be more easily administered than the current treatment.

The company said Friday it did not know how long it would take to deal with FDA concerns about the vaccine’s deterioration rate once it is placed in the Strategic National Stockpile, the Washington Post reported.

“We were encouraged by the improvements we’ve made to the vaccine and the stability data we have compiled, and we felt it supported re-entry into the clinic,” said VaxGen Executive Vice President James Panek.  “Unfortunately the FDA disagreed, citing remaining concerns about the vaccine’s stability.”

The FDA decision “is endangering performance of the contract,” Health and Human Services Department contracting officer Brian Goodger stated in a letter Friday to VaxGen.  The issue must be addressed within 10 days or “the government may terminate for default,” he wrote.

The contract calls for human safety testing of the vaccine to begin by Nov. 13, the Post reported.

VaxGen originally was scheduled to begin delivering the vaccine in November 2005.  That is now not expected to occur until 2008.  The company will not receive most of the money until that point.  There are questions on whether the company will survive long enough to fill the contract (Renae Merle, Washington Post, Nov. 4).

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