U.S. to Stockpile New Anthrax Vaccine

Plans are to have enough to inoculate 25 million people

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HealthDay Reporter

THURSDAY, Nov. 4, 2004 (HealthDayNews) -- The U.S. government announced Thursday that it has awarded an $877.5 million contract to a private company to manufacture and deliver 75 million doses of a new vaccine for inhalation anthrax.

The supply, enough to fully vaccinate 25 million people, will go to the Strategic National Stockpile to protect against a bioterrorist attack. The company, VaxGen Inc. of Brisbane, Calif., must deliver the first 25 million doses within two years and the entire 75 million within the following three years.

"This is a critical step forward in our preparedness," U.S. Health and Human Services (HHS) Secretary Tommy Thompson said at a news conference. "This is a key step towards protecting American public in the event of another anthrax attack."

Though it hasn't been tested for its effectiveness, "we have a lot of faith in this vaccine, and we believe it is the right way to move forward to protect the country against anthrax," added Dr. Philip Russell, medical advisor to the HHS.

The conference, which was attended by several other representatives of the government and private industry, was interrupted by queries about whether Thompson would continue at his post during the second Bush administration. He sidestepped them. "All I can tell you is that this is a discussion about anthrax, and [we] will have to talk about my future some other time," Thompson said.

The contract is the first awarded under Project BioShield, inaugurated earlier this year to expedite the development, purchase and availability of medical countermeasures for biological, chemical, radiological and nuclear threats.

"This is visionary legislation," Thompson said. "It is going to make America a lot safer because we are going to be able to encourage companies to get into the business of producing vaccines and drugs and therapies such as this one."

HHS funded development of the vaccine, beginning in September 2002. The military has been conducting research into this particular type of vaccine for about a decade.

The vaccine still needs to go through testing and is not yet licensed by the U.S. Food and Drug Administration.

The vaccine is made using purified recombinant protective antigen, a protein that elicits antibodies against anthrax toxins.

"It's a matter of honing down on the purity of the protein," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "It's not making a modified protein. It's just having the DNA technology to be spitting out a whole bunch of purified protein that is essentially identical to what the microbe itself would make if you let it grow in culture. It's a highly efficient and purified way of getting it."

The vaccine will probably be given intramuscularly and will require three doses to become effective, Russell said. "The final clinical studies have not been done to determine the final schedule," he said.

Thompson said the vaccine would be available for emergency use only.

Vaxgen President and CEO Lance Gordon said he anticipated the first delivery to be made at the beginning of 2006. As for when it might be available outside of the government stockpile, "our time line currently anticipates filing for licensure in 2007," he added.

More information

The government has more on Project BioShield.

SOURCES: Nov. 4, 2004, press conference with Tommy G. Thompson, U.S. Secretary of Health and Human Services; Anthony Fauci, M.D., director, National Institute of Allergy and Infectious Diseases; Lance Gordon, president and CEO, VaxGen Inc.; Philip Russell, M.D., medical advisor, U.S. Department of Health and Human Services

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