American Forces Press Service

[Guest guest]

By Staff Sgt. Kathleen T. Rhem, USA

American Forces Press Service

WASHINGTON, Oct. 6, 2000 -- DoD officials still feel

strongly that the Anthrax Vaccine Immunization Program is

necessary to protect U.S. forces, but they are examining

different ways to acquire needed stocks of the vaccine.

“The department has moved toward alternative strategies for

vaccine acquisition,” said Cragin, deputy assistant

secretary of defense for reserve affairs, while testifying

before the House Government Reform Committee Oct. 3. “We

realize that while the current vaccine is the most

effective protection available against this lethal weapon,

we must continually explore means to improve that

protection.”

He said the department is working to reduce its reliance on

BioPort Corp. as the only source of the vaccine approved by

the Food and Drug Administration. “We are seeking to

identify a second source for manufacturing the anthrax

vaccine that can share the product license with BioPort,”

he said, noting that DoD has received five “expressions of

interest” thus far. The department will analyze the cost,

schedule and technical feasibility of each of these.

“We admit (that the current) situation, where there is a

single source of the anthrax vaccine, is not the most

optimal position for the department,” said -

Winegar, acting assistant secretary of defense for health

affairs.

DoD is also restricting further payments to BioPort to only

those items “deemed allowable to comply with both good

government fiscal practices and congressional direction,”

Cragin said.

BioPort has been widely criticized for its failure to earn

FDA approval to manufacture anthrax vaccine after retooling

its plant and vaccine manufacturing process in 1998. Cragin

stressed this poses no danger to service members, because

vaccine being administered today comes from previously

approved batches manufactured by the plant’s previous

owner, the Michigan Department of Public Health.

It is the shortage of this previously approved vaccine that

has caused DoD to scale back its vaccination schedule

recently, he said.

DoD experts are also working to develop a completely

different vaccine that would protect against several

biological warfare agents. Cragin said the fiscal 2001

budget provides for research funds, but didn’t say when

such research might be expected to yield results.

FDA official Mark Elengold explained the recent controversy

over the discovery of squalene, a naturally occurring

substance that boosts immune response, in certain batches

of the anthrax vaccine. Both DoD and the FDA had previously

contended there was no squalene in the vaccine, but more

recent tests detected minute amounts.

Elengold explained that earlier tests could detect

substances in parts per million, but the most recent tests

are more sensitive, capable of detecting substances in

parts per billion. The FDA found 10 to 20 parts per billion

of squalene in lots of the anthrax vaccine that were

administered to U.S. service members.

“These limits are so small that … until we developed this

test, the answer would have been none,” Elengold said. He

said the squalene levels likely occurred naturally because

they were about one-millionth the amount that is safely put

into certain other vaccines.

The House committee also heard extensive testimony from

current and former members of the military who had either

had health problems they believe stem from the vaccine or

had left the service after refusing to take the vaccine.

Marine Maj. Gen. Randall West, senior adviser to the deputy

secretary for chemical and biological protection, rebutted

this testimony.

“When you take a population of half a million people and

give them vaccine, some of them are going to go on and get

sick,” he said. “Eventually, all of us are going to die,

but that doesn’t mean … that illness or that death was

caused by the anthrax vaccine.”

He specifically referred to , an Army soldier

who had testified earlier in the day. was diagnosed

with s Syndrome, a disfiguring disease that

causes burns and often vision loss, usually associated with

an allergic reaction to a medication.

West said experts at Army Medical Center, Fort Sam

Houston, Texas, and Emory University in Atlanta had

reviewed ’ case and determined it was not related to

the anthrax vaccine.

Questioned about the case of Air Force Senior Airman

Collosimo, West admitted there are rare reactions to the

vaccine and called the May 2000 incident unfortunate.

“Occasionally, that happens,” he said. “It happens in very

small numbers, and we wish it didn’t happen at all.”

Collosimo suffered severe reactions to the anthrax vaccine,

including blackouts, dizziness and memory loss, and was

sent from Hill Air Force Base, Utah, for treatment at

Walter Army Medical Center here.

West explained why it isn’t feasible for DoD to make the

anthrax vaccination program optional for service members.

“(In the event of an anthrax attack,) it would be very,

very difficult to take care of the half of your force that

wasn’t vaccinated,” he said. “And, it would keep the

(other) half busy taking care of them when they could be

fighting and winning on the battlefield.”

He also said it would be immoral not to use vaccine

currently available, even while experts work to develop a

better one.

“We don’t want to make anybody sick … , but I also don’t

want to sit in front of you some day, after we send a force

into harm’s way, have them run into an aerosolized anthrax

exposure and explain to you why we had hundreds of

thousands of deaths when we had protection available to

keep them from dying.”

#

[Guest guest]

How can they keep getting away with this??? Naturally occuring????

That's like saying - oh, there is just a little rat poop in there - parts

per billion - still doesn't explain how it got in there and why?

Sheri

>

>FDA official Mark Elengold explained the recent controversy

>over the discovery of squalene, a naturally occurring

>substance that boosts immune response, in certain batches

>of the anthrax vaccine. Both DoD and the FDA had previously

>contended there was no squalene in the vaccine, but more

>recent tests detected minute amounts.

>

>Elengold explained that earlier tests could detect

>substances in parts per million, but the most recent tests

>are more sensitive, capable of detecting substances in

>parts per billion. The FDA found 10 to 20 parts per billion

>of squalene in lots of the anthrax vaccine that were

>administered to U.S. service members.

>

>“These limits are so small that … until we developed this

>test, the answer would have been none,” Elengold said. He

>said the squalene levels likely occurred naturally because

>they were about one-millionth the amount that is safely put

>into certain other vaccines.

>

--------------------------------------------------------

Sheri Nakken, R.N., MA

Vaccination Information & Choice Network, Nevada City CA

http://www.nccn.net/~wwithin/vaccine.htm

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