HHS plans to buy disputed anthrax vaccine for civilian use

The Health and Human Services Department plans to buy 5 million doses of anthrax vaccine for civilian inoculations, even though a federal judge ruled last week that the product has not been properly validated as safe and effective.

HHS announced Thursday that it intends to negotiate a sole-source contract with BioPort Corporation of Michigan to buy up to 5 million doses of the company's BioThrax vaccine within two years for the nation's Strategic National Stockpile. The contract is part of Project Bioshield, a $6 billion program to create and expand the nation's stockpile of vaccines and treatments to combat potential bioterrorism agents.

A federal judge ruled Oct. 27 that the military must stop administering the BioThrax vaccine, also known as Anthrax Vaccine Adsorbed, to service members. Judge Emmet Sullivan of the U.S. District Court for the District of Columbia ruled that the vaccine was not properly classified as "safe and effective," essentially overturning a determination by the Federal Drug Administration.

The FDA issued a final rule and order in December 2003 that licensed the anthrax vaccine as safe and effective. The judge, however, vacated the final rule and order and told the FDA to get more public input and reevaluate the vaccine.

"Unless and until FDA properly classifies AVA as a safe and effective drug for its intended use, an injunction shall remain in effect prohibiting [the military's] use of AVA on the basis that the vaccine is either a drug unapproved for its intended use or an investigational new drug," Sullivan wrote. "Accordingly, the involuntary anthrax vaccination program, as applied to all persons, is rendered illegal absent informed consent or a presidential waiver."

More than 1.2 million troops have been inoculated under this program since 1998.

An HHS spokesman said Friday the department intends to proceed with procuring the BioThrax vaccine for civilian use because it's the only vaccine available in the event of an anthrax attack.

"As far as HHS is concerned, the BioPort anthrax vaccine has an FDA license and we need it for the stockpile," he said. "As far as we're concerned, it does have an FDA license for use and we need it to protect the country."

A spokesperson from BioPort could not be reached Friday.

On Thursday, HHS also awarded a contract worth almost $880 million to VaxGen Inc. of California to produce 75 million doses of a new type of anthrax vaccine, HHS Secretary Tommy Thompson announced.

The vaccine is set to be produced using purified recombinant protective antigen, a protein that elicits antibodies to neutralize the toxins produced by the anthrax bacterium, according to an HHS press release. About 25 million people would be inoculated through the plan, which stipulates a three-dose regimen for the new vaccine.

The contract is the first to be awarded under Project Bioshield.

"In an exceptionally short period of time, we have dramatically accelerated our research capacity to develop a new medical countermeasure against one of the most deadly agents of bioterrorism," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "Without Project Bioshield, we would likely still be years away from a new anthrax vaccine and today's announcement might never have been possible."

FDA must still approve the VaxGen vaccine, the Associated Press reported.

Under the contract, VaxGen will deliver the first 25 million doses within in two years, beginning in 2006, company president Lance Gordon said. The remaining 50 million doses would be delivered within three years, according to AP.

House Homeland Security Committee Chairman Christopher Cox, R-Calif., Friday praised the announcement of the vaccine contract.

"This is another milestone in the war on terrorism. By securing the production of anthrax vaccines, we are reducing the biothreat," Cox said. "By using our country's best intelligence to understand terrorist threats, we can allocate our resources and focus our efforts on the bioterror agents that pose the greatest threat to American lives."