[Ip-health] Washington Post: Production of Anthrax Vaccine Delayed Again

[Amy Nunn]

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Production of Anthrax Vaccine Delayed Again


By Justin Gillis
<http://projects.washingtonpost.com/staff/email/justin+gillis/>

Washington Post Staff Writer
Wednesday, May 10, 2006; Page D01

A troubled government program to produce a new anthrax vaccine has fallen at
least another year behind schedule, and sources said last night that
tensions between the government and its main contractor have become so
severe the future of the program could be in doubt.

VaxGen Inc., the contractor producing the anthrax vaccine, has scheduled a
news briefing for this afternoon. A company officer would not discuss the
latest developments last night.






In testimony before a House panel yesterday, Gerald Parker, a ranking
administrator at the Department of Health and Human Services, revealed that
the government has approved contract changes under which the company will
not begin delivering anthrax vaccine until late 2008, with final delivery in
2009.

Until the changes, the company was required to deliver the vaccine starting
at the end of this year, a schedule it has acknowledged it has no hope of
achieving. The company previously predicted it would begin delivering some
doses in late 2007, but now even that delayed schedule appears to be out the
window.

VaxGen, of Brisbane, Calif., has blamed the delay on problems with the
potency of the vaccine but has said it is well on its way to fixing them.
The problems have been a political embarrassment for the Bush
administration, which awarded VaxGen some $1 billion in contracts to produce
what was supposed to be a modern vaccine that could protect as many as 25
million people from exposure to deadly anthrax spores in the event of a
terrorist attack.

In his testimony on Capitol Hill yesterday, Parker did not discuss the
tensions between VaxGen management and the government. Two sources with
knowledge of the situation -- who spoke on condition of anonymity because
they had not been authorized to speak ahead of the company's news briefing
today -- described a situation in which the company and the government seem
almost certain to wind up in a legal battle over contract changes.

VaxGen is expected to seek millions of dollars in compensation for new
requirements imposed by the government, a politically difficult request on a
contract that has already drawn considerable fire on Capitol Hill. It was
unclear last night what the new requirements are, but after VaxGen ran into
problems with vaccine stability, some scientists had predicted the company
would be ordered to conduct expensive, time-consuming new tests before the
government would accept the product.

The new developments are merely the latest problems in a program that was
supposed to showcase the Bush administration's commitment to developing a
broad national defense against bioterror attacks. Congress approved more
than $5 billion over 10 years for the program, Project BioShield, but lately
members from both parties have criticized the government's handling of it
and demanded more progress. The anthrax program is by far the biggest
contract awarded under BioShield to date.

Parker, principal deputy in the HHS office overseeing Project BioShield,
noted in his testimony that delays in ambitious projects of this sort "are
not unexpected or unprecedented."



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