Anthrax Vaccine: December 2006 Archives

Anthrax Vaccine Contract Voided, Thwarting Administration

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VaxGenBy Renae Merle, Washington Post

Federal health officials yesterday scuttled the largest piece of the Bush administration's two-year program to counter bioterrorism, canceling an $877.5 million contract with VaxGen to develop an anthrax vaccine after the company missed a deadline to begin human testing.

The decision, delivered in a one-page letter, ends a troubled effort by the small California firm that has come to symbolize the failures of the government's ambitious $5.6 billion Project BioShield. The termination occurred on the same day President Bush signed legislation attempting to salvage the program by reorganizing its management and pumping more money into firms doing the work.

Critics question safety of vaccine additives

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anthrax vaccineA persistent criticism from opponents of the Pentagon’s anthrax vaccination program is the charge that defense officials purposely put squalene in some vaccine lots to boost troops’ immune responses and increase the length of time vaccine stocks would remain effective.

The Pentagon and the vaccine’s manufacturer have repeatedly denied those charges, but opponents continue to question whether the fatlike substance may have played a role in illnesses developed by some troops who got anthrax shots during the 1991 Persian Gulf War and in the early stages of the Pentagon’s mandatory anthrax vaccine program in the late 1990s.

VaxGenBRISBANE, Calif., Dec. 18 /PRNewswire-FirstCall/ -- VaxGen, Inc. (Pink Sheets: VXGN.PK) announced today that the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has informed the company that it is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine. The hold is due to CBER's continued concerns about the vaccine candidate's stability.

The Department of Health and Human Services (HHS), under its contract with VaxGen to purchase 75 million doses of its recombinant anthrax vaccine, rPA102, had imposed a deadline of today, December 18, for the company to initiate its next clinical trial for the vaccine candidate. The Office of Public Health Emergency Preparedness (OPHEP), the office within HHS that administers the contract, has yet to inform VaxGen what direction it intends to take with respect to the contract.