HHS Buys New Anthrax Vaccine for Stockpile; Purchase Is the First Project BioShield Contract

WASHINGTON, D.C.  -- HHS Secretary Tommy G. Thompson

announced today that HHS has awarded a contract for $877.5 million to VaxGen,

Inc. to manufacture and deliver 75 million doses of a new anthrax vaccine.

The full supply of the vaccine will be added to the Strategic National

Stockpile and would be used to protect the public against a terrorist attack

in which anthrax spores were released.

"The intentional release of anthrax spores is one of the most significant

biological threats we face," Thompson said.  "Acquiring a stockpile

of this new anthrax vaccine is a key step toward protecting the American

public against another anthrax attack."

VaxGen, based in Brisbane, Calif., will produce the new anthrax vaccine

using purified recombinant protective antigen (rPA), a protein that elicits

antibodies that neutralize anthrax toxins, thus providing protective immunity.

Evidence from laboratory and animal research has shown that the rPA vaccine is

effective in providing protection against aerosol exposure to deadly anthrax

spores.  In addition, clinical testing has shown the rPA vaccine to be safe in

humans.

 The vaccine is being evaluated as a three-dose vaccination series.  Based

on 75 million doses, this regimen would provide sufficient anthrax vaccine to

protect 25 million people.  The contract awarded today requires VaxGen to

obtain licensure from the Food and Drug Administration (FDA) for using the new

vaccine in both pre- and post-anthrax exposure settings.  The vaccine will be

made using modern manufacturing technologies, and the FDA will review the

vaccine production process along with testing of individual test lots of

vaccine to assure its safety and effectiveness.  The contract with VaxGen is a

fixed-price contract, which protects taxpayers from any cost overruns.

HHS, through its National Institute of Allergy and Infectious Diseases

(NIAID) at the National Institutes of Health, funded the development of rPA

vaccine beginning in September 2002 as part of its broader effort to

accelerate research into developing new medical countermeasures against

potential bioterror attacks.  This effort was based on more than a decade of

basic rPA vaccine research carried out by the Department of Defense.

This award represents the first contract under the Project BioShield, a

new program intended to accelerate the development, purchase and availability

of medical countermeasures for biological, chemical, radiological and nuclear

threats.  President Bush introduced Project BioShield in his 2003 State of the

Union address.  Congress passed the Project BioShield Act of 2004 and the

President signed it into law on July 21, 2004.

"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 S. Fauci,

M.D., director of NIAID.  "Without Project BioShield, we would likely still be

years away from a new anthrax vaccine and today's announcement might never

have been possible."

HHS' Office of Public Health Emergency Preparedness, which oversees the

research and procurement efforts under the Project BioShield program, will

manage this new rPA anthrax vaccine contract.

Source:  U.S. Department of Health and Human Services