Anthrax Vaccine Won't Meet Deadline

VaxGen Reports Failure During Human Testing; Year Behind Schedule

(CBS/AP)  A company awarded a government contract to produce a new anthrax vaccine says it won't be able to meet a November deadline to deliver 25 million doses by November and will default on its deal with the government unless it is granted an extension, The Washington Post reported Friday.

Officials at VaxGen Inc. of Brisbane, Calif., reported failure during human testing of the vaccine and said the process is at least a year behind schedule. Company officials told The Post say they believe they have figured out the problem and will soon fix it, but that they are still behind schedule.

According to the newspaper, the problem is that the vaccine was unstable: Batches lose potency within months. The purpose of the vaccine is to sit on a shelf, ready for use when a threat occurs.

The government had wanted to build a stockpile of 75 million doses of a new anthrax vaccine during the five-year contract announced in November 2004. The company was to deliver first 25 million vaccine doses within two years and the balance within three years.

The 75 million doses could treat roughly 25 million people — roughly equivalent to the entire populations of the Washington and New York metropolitan areas. VaxGen's product is expected to require no more than three shots. The latest technology uses a purified recombinant protein to coax the body's immune system to produce antibodies to battle anthrax toxins.

With the new product delayed, the government recently bought 5 million doses of an older, controversial anthrax vaccine, enough to treat fewer than 2 million people, and hopes to order more when funds are identified.

Administrators at the Health and Human Services Department declined to talk about details of the VaxGen contract. But they told the Post that they are still building a defense against anthrax spores and have stockpiled enough antibiotics to treat 40 million people after a large-scale attack.

"I think overall we are certainly making progress in our anthrax preparedness program," said Gerald Parker, the chief deputy in a Heath and Human Services office that manages emergency preparations, the Post reported.

However, the paper said that VaxGen's finances are "wobbly," and there is a question whether the company can survive an extra year without receiving any payment from the government.

Drug companies working on biowarfare defenses as part of the Bush administration's BioShield program receive research subsidies to get a project started, and payments at the end, after the products are delivered. But the expensive middle stages must be financed by the companies, and that period has been dubbed the "Valley of Death" by the industry.

"The so-called Valley of Death is long and hot," Lance Ignon, VaxGen's vice president for corporate affairs, told the Post. "How we emerge will be very important — it will send a strong signal to the rest of the industry."