Testing of Anthrax Vaccine Still on Hold

VaxGen Misses Deadline for Clinical Trial; FDA Concerns Remain

VaxGen said yesterday that it did not meet a federal deadline to begin human testing of its anthrax vaccine.

The Food and Drug Administration has put the clinical trial on hold since November. The Department of Health and Human Services had given the company until yesterday to begin testing or risk losing its contract but didn't say what action it would take.

The FDA continues to have concerns about the vaccine's reliability, according to a company statement. The hold will remain until "sufficient vaccine stability" has been demonstrated, the statement said.

"I don't think we're in a position to make predictions on how long this will take," said Lance Ignon, VaxGen's vice president of corporate affairs. "We continue to believe that with the right kind of commitment, we can develop and deliver a modern anthrax vaccine."

HHS spokesman Bill Hall said no decisions have been made about the contract's fate.

After a recent meeting, the FDA indicated it was interested in having technical discussions with VaxGen about its proposed methods for measuring the vaccine's potency and stability, Ignon said. "We felt that the conversation with the FDA was very productive," he said.

The company's $1 billion vaccine effort, already years behind schedule, is by far the largest component of the Bush administration's Project BioShield, a $5.6 billion plan to counter bioterrorism threats. The project has been marked by delays and operational problems. Congress passed legislation this month to revamp and salvage the BioShield effort, reorganizing its management and providing struggling companies with periodic cash infusions for their research and testing.

But Ignon said the legislation will not address the breakdown in communication that has festered between VaxGen and HHS. "We have repeatedly tried to engage them in what we feel would be productive conversation" about the future of the program, he said. He declined to give specific examples of the proposals the company wants to address.

Hall said that while HHS is not privy to many of VaxGen's conversations with the FDA, there is a formal process in place. "Our contracting staff has regular communication with VaxGen as we do with any company with which we hold a contract," he said.

The contract calls for VaxGen to produce enough of the vaccine for 25 million people, roughly the equivalent of the population in the New York and Washington areas combined.