Doubts Are Raised on Push for Anthrax Vaccine

[Guest guest]

" But delivering that protection may be difficult: the vaccine is unproven

in humans, the maker has legal and accounting troubles, and health

officials are not prepared to distribute the vaccine quickly if it is needed. "

" The federal government has had its own recent embarrassments with

vaccines: the shortage of flu vaccine this year and the aborted effort in

2003 to vaccinate health care workers against smallpox. "

AMEN brother " " This anthrax threat is extraordinarily exaggerated, " said

Victor Sidel, a professor at the Albert Einstein College of Medicine in the

Bronx and past president of the New York City Public Health Association.

" All of this is simply playing to the politics of fear. " "

" The only anthrax vaccine now approved for use in this country requires six

injections over 18 months, an extremely long time for a vaccine. It is hard

to produce in large batches: it would take a decade to make 75 million

doses under the current production method, federal officials said Because

of the imprecise way it is made, there are great variations in potency,

which researchers believe has contributed to side effects in some military

personnel. "

http://www.nytimes.com/2004/12/11/national/11anthrax.html?oref=login

Doubts Are Raised on Push for Anthrax Vaccine

By ERIC LIPTON

Published: December 11, 2004

In ordering a new $877 million anthrax vaccine last month, the federal

government said it was a major step toward creating a " bioshield " to

protect Americans from germ warfare. But delivering that protection may be

difficult: the vaccine is unproven in humans, the maker has legal and

accounting troubles, and health officials are not prepared to distribute

the vaccine quickly if it is needed.

Bush administration officials, as well as the top executives at VaxGen, the

manufacturer in California, say they are confident they can fulfill their

promise.

" This program needs to be a success for all of us - the federal government,

for the company and for the American public, " said Lance K. Gordon,

VaxGen's chief executive.

But some scientists say the effectiveness of the vaccine, which is to be

delivered starting early in 2006, is still in doubt.

" When the day comes and we have to give this to 20 million people, in terms

of this new vaccine, what will happen? " said Jack Melling, former head of

Britain's biodefense vaccine program and now a consultant to the United

States Government Accountability Office. " The jury is still out; it is

still an open question. "

The vaccine contract, enough to inoculate 25 million Americans, is part of

a $5.6 billion effort called Project BioShield intended to build a drug

stockpile and other defenses against any diseases terrorists might try to

inflict on the population.

VaxGen, which is to produce 75 million syringes of vaccine with a formula

it is still fine-tuning, has had recent setbacks, including the removal

this summer of its stock from the Nasdaq market because of accounting

problems and lawsuits from investors who say it exaggerated the prospects

for its AIDS vaccine, which has been abandoned.

The federal government has had its own recent embarrassments with vaccines:

the shortage of flu vaccine this year and the aborted effort in 2003 to

vaccinate health care workers against smallpox.

Some experts question the value of the whole Project BioShield, as the

investment in the bioterrorism stockpile will perhaps mean less money for

research or treatment of other health problems, like AIDS, cancer or even

the flu.

" This anthrax threat is extraordinarily exaggerated, " said Victor Sidel, a

professor at the Albert Einstein College of Medicine in the Bronx and past

president of the New York City Public Health Association. " All of this is

simply playing to the politics of fear. "

Bacillus anthracis, the naturally occurring, spore-forming bacterium that

causes anthrax, most commonly affects livestock. Before the mailing in 2001

of anthrax-laced letters that killed five people and sickened 17 others,

the disease had been extremely rare among humans in this country,

particularly in its most dangerous form, when it is inhaled into the lungs.

Federal officials consider anthrax one of the most serious biological

threats. The culprit in the 2001 mailings is still at large. And a study

published last year by the National Academy of Sciences suggested that the

aerial release of 2.2 pounds of anthrax in a major American city could

cause more than 100,000 deaths.

" Our most important priority is to safeguard the American people, " Tommy G.

, the secretary of health and human services, said last month in

announcing the VaxGen contract. " This vaccine is a key step towards

protecting the American public in the event of another anthrax attack. "

Pasteur developed the first anthrax vaccine in the 1880's, but it was only

for use in animals. Human anthrax vaccines date from the 1950's and 1960's,

when the United States and other governments started to experiment with

anthrax as a weapon.

The only anthrax vaccine now approved for use in this country requires six

injections over 18 months, an extremely long time for a vaccine. It is hard

to produce in large batches: it would take a decade to make 75 million

doses under the current production method, federal officials said Because

of the imprecise way it is made, there are great variations in potency,

which researchers believe has contributed to side effects in some military

personnel.

The Department of Health and Human Services also has a stockpile of more

than one billion antibiotic pills, enough to treat 20 million people for

the required 60 days. But because inhaled spores can live longer than two

months and antibiotic resistant strains of anthrax might emerge, an

effective vaccine is considered an important protection, federal health

officials said.

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