GAO critiques anthrax vaccine procurement, management

Oct 31, 2007 (CIDRAP News) – The US government's attempt to add a next-generation anthrax vaccine to its stockpile failed because of a premature contract award, unrealistic expectations, and confusion about how the vaccine would be used, according to the Government Accountability Office (GAO), the investigative agency of Congress.

The GAO also concluded that the government lacks a strategy for preventing waste and duplication in managing its stockpile of the existing anthrax vaccine, which could result in annual $100 million losses as stored vaccine lots expire.

The findings were detailed in a 41-page report the GAO released on Oct 23. Four members of Congress had requested the investigation after the Department of Health and Human Services (HHS) cancelled an $877 million contract with VaxGen, a small biotechnology company based in Brisbane, Calif., last December. The company had failed to meet certain project milestones.

The contract, awarded in 2004, was the first under Project BioShield, a program meant to spur the development and production of medical countermeasures for chemical, biological, and radiological weapons.

"The failure of this procurement effort raised larger questions regarding the country's ability to develop a new anthrax vaccine and robust and sustainable biodefense medical countermeasure industry," the GAO report states, adding that the problems cast doubt on the government's ability to clearly spell out the requirements of future contracts with its pharmaceutical and biotechnology industry partners.

The VaxGen vaccine was based on a recombinant form of protective antigen (rPA), a key anthrax protein. It was expected to provide immunity in 3 doses, rather than the 6 doses required for the licensed vaccine, and to cause fewer side effects. Avecia, a biotechnology company based in Manchester, England, is also developing an rPA anthrax vaccine with grant support from the National Institutes of Health.

VaxGen announced in May that it hoped to license its rPA vaccine to another company in hopes that the product could someday be added to the national stockpile.

Dissecting a failed procurement
HHS awarded its first contract to VaxGen for the rPA vaccine at a very early development stage, before critical issues such as stability could be addressed, the GAO says. The award also interrupted an existing development contract VaxGen had with the National Institute for Allergy and Infectious Diseases (NIAID).

HHS officials told the GAO that they felt an urgency to tell the public an improved anthrax vaccine was on the horizon and that they were 80% to 90% confident in VaxGen's ability to successfully develop and produce the vaccine.

Industry experts told the GAO that, given the early stage of development, the expectation that VaxGen could deliver 75 million doses of the vaccine was unrealistic, and would have been so even for a large pharmaceutical firm.

GAO investigators assert that VaxGen took several "unrealistic" risks in accepting the HHS contract: the delivery deadline was too aggressive, the company lacked in-house technical expertise to address vaccine stability and formulation issues, and it had few resources to pay for additional testing to meet regulatory requirements.

Another problem was that HHS did not tell VaxGen how it planned to use the vaccine, because at the start of the contract the Food and Drug Administration (FDA) was still defining the data and testing requirements for the rPA anthrax vaccine as part of its new guidance on emergency use authorization for unlicensed products in the Strategic National Stockpile.

The GAO says HHS has announced that it will issue another rPA anthrax vaccine proposal but has not formally reviewed what went wrong with the VaxGen contract. "They may repeat their mistakes in the absence of a corrective plan," the report says.

"If this is not done, the government risks future interest and participation of the biotechnology industry," the report says.

Licensed vaccine going to waste
In examining how the government manages the current anthrax vaccine in the national stockpile—anthrax vaccine adsorbed (AVA), developed in the 1950s—investigators raised two main concerns. One is that HHS doesn't have a strategy to minimize wasted vaccine. The report says $12 million worth of vaccine has already expired, and without an effective management plan, $100 million more per year could be lost as vaccine lots in the stockpile expire.

HHS recently announced that it awarded the manufacturer of the AVA vaccine, Emergent BioSolutions, based in Gaithersburg, Md., a contract worth up to $448 million for 18.75 million doses of the AVA vaccine, which would allow the agency to maintain a 10 million-dose stockpile through 2011.

The GAO report says HHS could minimize the waste by developing a single inventory that can be shared with the Department of Defense (DoD), which has a mandatory anthrax vaccination program. However, HHS responded in the report that it explored the vaccine rotation option in 2004, but identified funding, legal, and logistical obstacles.

The GAO's second concern about management of the existing anthrax vaccine stockpile is that HHS planned to use vaccine that had expired in 2006 and 2007, which would violate FDA rules.

The GAO said using expired vaccine could undermine the public's confidence and that HHS should destroy the expired lots.

Both HHS and DoD generally concurred with the investigators' findings, the report says, but each added detailed technical responses to the report.

See also:

Oct 23 GAO report on anthrax vaccine procurement
http://www.gao.gov/cgi-bin/getrpt?GAO-08-88

Dec 20, 2006, CIDRAP News story "HHS cancels VaxGen anthrax vaccine contract"

Sep 26 CIDRAP News story "HHS orders 18 million doses of anthrax vaccine"

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