GAO Report Cites Waste In Anthrax Vaccine Cache

By Renae Merle
Washington Post Staff Writer
Tuesday, October 23, 2007

Federal health officials are potentially wasting a stockpile of anthrax vaccine worth more than $100 million, according to a government report to be released today.

Six years after anthrax attacks killed five people in Washington and elsewhere, officials are struggling to prepare for another strike, the Government Accountability Office report said.

About $12 million of anthrax vaccine in the Strategic National Stockpile has expired. The vaccine had been kept for use in an emergency, even though federal standards prohibit expired vaccines from being administered.

Starting in 2008, about $100 million of the stockpiled vaccine would go bad each year, the report said. The GAO also said that because the Defense Department buys its vaccine separately, having two programs was wasteful.

The Department of Health and Human Services' effort to replace that vaccine with one easier to use and with fewer side effects has been hobbled by unrealistic expectations, the report said.

The report, to be discussed at a Senate hearing today, is the latest hit against the Bush administration's $5.6 billion BioShield program, established in 2004 to counter bioterrorism threats.

Last year, HHS scuttled the largest piece of the program, an $877.5 million contract with VaxGen of California to develop a new vaccine. The vaccine was to replace the stockpiled version made by Emergent BioSolutions of Gaithersburg, which must be administered over 18 months in six shots.

"We have an awful lot to do in the area of medical readiness and, to me, the results of the government's efforts to protect Americans through countermeasures and new technologies are mixed," Sen. Joseph I. Lieberman (I-Conn.), chairman of the Homeland Security and Governmental Affairs Committee, said in a statement.

The government rushed into the contract with VaxGen, setting unrealistic standards and timelines that would have been difficult for even a large firm to meet, the GAO said.

HHS is expected to issue a new contract for a vaccine this year, but has not completed a report on why the VaxGen effort failed, raising complaints from Congress.

"This GAO report makes clear that the federal attempt to procure an improved anthrax vaccine has yielded not a new vaccine, but instead a textbook example of prodigious waste," Sen. Susan Collins (R-Maine), ranking member of the homeland security committee, said in a statement. "HHS must learn the lessons from past failures so that we can improve our preparedness for a possible terrorist attack using biological weapons."

The report also examined the latest version of the vaccine, BioThrax, which has been around since the 1970s. By 2006, the HHS had acquired 10 million doses of BioThrax; it recently put in an order for an additional 10 million. But the agency does not have an effective strategy for stopping the waste of the vaccine, the report found.

Keeping the old vaccine past its expiration date violates Food and Drug Administration rules, but was considered necessary in an emergency, the report said.

In a response to the report, the HHS said it never planned to use the expired doses and considers developing a new vaccine a top priority. "The expired vaccine in question is being quarantined until a decision on disposition is made," the HHS said in its response.

The agency is in discussions with the Pentagon, which has its own stock of anthrax vaccine, about better management, the HHS response said. The agency said that transferring its vaccines to the Defense Department when necessary could save the government up to $25 million a year.

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