GAO report on anthrax vaccine production does not instill confidence

The Government Accountability Office released a progress report on the production of a safe effective vaccine against anthrax. We have posted copies of the May 9th report and the highlights on the FAS website.

The report, like their past reports on this issue, cites continued disorganization on the part of the government. Namely, they note that there has been little progress in the area of testing of the current vaccine for safety, effectiveness and reliability. The GAO had previously noted that there has been no long-term safety data, no studies on the optimum number of doses, and inadequate human clinical data. The GAO called upon the Director of Homeland Security to form a strategic plan for the development and safety testing of the vaccine including interagency cooperation.

In 2004, the Department of Health and Human Services awarded a contract for $877.5M for 75 million doses of anthrax vaccine to VaxGen, Inc, a company that had not previously developed and marketed any drugs or vaccines. The contract was noteworthy because it was the first award for bioterrorism countermeasure production under the Project Bioshield.

The GAO noted that the biotech community is watching the anthrax vaccine development and production carefully and warned that if it fails, companies will be less than eager to get involved with government contracts to produce future countermeasures.