Anthrax vaccines

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No Hope for Stockpile of New Anthrax Vaccine by

November

Developer Seeks Extension After Setback on Crucial

Test

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Friday, March 17, 2006;

The government's $1 billion effort to develop a new

anthrax vaccine has run into difficulty, with the

company in charge of the project reporting failure in

a major human test and falling at least a year behind

schedule.

Officers at VaxGen Inc. of Brisbane, Calif., said in

interviews that they believe they have isolated the

problem with their vaccine and are well on their way

to fixing it. But they acknowledged that they have no

hope of meeting a deadline to deliver 25 million doses

of the vaccine into a national stockpile by November

and will default on their contract with the government

unless it grants an extension they have requested.

 

The difficulties appear to confirm predictions on

Capitol Hill two years ago that a small company like

VaxGen wouldn't be able to meet an aggressive schedule

for stockpiling millions of doses of a new anthrax

vaccine. Until the full stockpile of 75 million doses

is ready, the United States would depend on

antibiotics to treat a large-scale anthrax attack, a

strategy that terrorists could overcome by creating

antibiotic-resistant anthrax.

Administrators at the Health and Human Services

Department declined to discuss specifics of the VaxGen

contract. But they said that, despite some setbacks,

they are building a national defense against anthrax

spores, among the most fearsome of bioterror weapons.

In particular, they noted, they have already

stockpiled enough antibiotics to treat 40 million

people after a large-scale attack.

" I think overall we are certainly making progress in

our anthrax preparedness program, " said Gerald Parker,

the chief deputy in an HHS office that manages

emergency preparations.

With the VaxGen product delayed, the government

recently bought 5 million doses of an older,

controversial anthrax vaccine, enough to treat fewer

than 2 million people, and hopes to order more when

funds are identified.

The anthrax program is emblematic of larger problems

in Project BioShield, President Bush's ambitious

biowarfare defense program. It's becoming clear that

many of the robust national safeguards against

biological and radiological terrorism that Bush

promised when he got Congress to create BioShield

simply won't be ready any time soon. HHS Secretary

Michael Leavitt told Congress yesterday that " more can

and must be done to aggressively and efficiently

implement Project BioShield, " and he pledged to

reorganize the responsible office.

An injection of federal money into the program, $5.6

billion over a decade plus additional research funds,

has piqued the interest of biotechnology companies.

But many analysts say the research and development

needed to create new products is moving at a glacial

pace.

Moreover, most of the nation's biggest drug companies

have eschewed the program, seeing little profit but

big risk to their reputations if they mess up a

high-profile government contract.

The government has thus had to depend on small,

financially shaky biotechnology companies. Yet in

contrast to the way the Pentagon buys goods, HHS lacks

the legal authority to use public funds extensively to

shore up companies. It can pay them up to 10 percent

of the value of a contract in advance, but that isn't

much -- the seemingly mundane tasks of building

production lines and perfecting large-scale

manufacturing techniques are riddled with pitfalls and

can eat up tens or even hundreds of millions in

capital.

The companies can get research subsidies early in a

project, and they stand to receive hefty government

payments at the end, after they deliver a product. But

they must finance the expensive middle stages largely

on their own. Biotech companies have dubbed that

financing gap the " Valley of Death, " and it remains to

be seen if any of them can get to the other side of it

on a major BioShield contract.