HHS buys anthrax vaccine for civilian stockpile

May 6, 2005 (CIDRAP News) – The Department of Health and Human Services (HHS) will soon receive the first of 5 million doses of anthrax vaccine for civilian biodefense under a $122.7 million contract that was awarded today.

Following up on plans announced last November, HHS is buying the supply of Anthrax Vaccine Adsorbed (AVA) from Bioport Corp. of Lansing, Mich., HHS announced in a news release. The Department of Defense (DoD) uses the same vaccine in a program that has generated controversy and lawsuits because of concern about side effects.

"BioPort is already manufacturing the vaccine, and we expect to start taking delivery within the next couple of weeks," Marc Wolfson, a spokesman for the HHS Office of Public Health Emergency Preparedness in Washington, told CIDRAP News. He said the company has 18 months to deliver all 5 million doses.

The vaccine will be stored in the Strategic National Stockpile for use in the event of an anthrax attack, HHS said. "The BioPort vaccine will add another important medical countermeasure for anthrax to the Strategic National Stockpile," said Stewart Simonson, HHS assistant secretary for public health emergency preparedness, in the news release.

The BioPort contract is the third one awarded under the Project Bioshield Act of 2004, which authorized spending of up to $5.6 billion on medical defenses against biological, chemical, radiological, and nuclear threats.

HHS first revealed plans to buy 5 million doses of anthrax vaccine from BioPort last November. At about the same time, the department announced the award of an $877 million contract for 75 million doses of a new, as-yet-unlicensed anthrax vaccine from VaxGen Inc. of Brisbane, Calif.

To provide full protection, AVA requires six doses over 18 months, followed by annual boosters, which is the regimen used in the military. Authorities hope that the VaxGen vaccine will provide protection with three doses and have less frequent side effects. Wolfson said HHS expects to receive the first doses from VaxGen in November 2006.

The VaxGen vaccine uses a recombinant form of just one anthrax component, protective antigen, whereas AVA is derived from whole anthrax microbes and therefore contains protective antigen and a mix of other components, HHS officials have said.

Under the BioPort contract, the cost of AVA is about $24.50 per dose, more than double the per-dose cost of about $11.70 under the HHS contract with VaxGen.

"I'm not sure what accounts for the difference in cost," said Wolfson. He said the VaxGen vaccine involves "a whole separate process with a separate set of negotiations."

Wolfson said he didn't know what DoD is paying BioPort for its supply of the vaccine, and information was not immediately available from DoD officials this afternoon.

Officials announced earlier this week that DoD's anthrax vaccination program would resume on a voluntary basis after being suspended by a federal court order since last October. A judge in Washington, DC, ruled in October that the Food and Drug Administration (FDA) had not followed proper procedures in approving the vaccine for inhalational anthrax.

DoD obtained an emergency authorization from the FDA to resume the vaccination program because of the perceived risk of anthrax attacks on US troops. But the authorization required that the shots be optional, instead of mandatory as in the past.

See also:

May 6 HHS news release
http://archive.hhs.gov/news/press/2005pres/20050506.html

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