Lansing State Journal, Moyed and Russ

[Guest guest]

I'm particularly fond of the comments from CDC. On an off note, reading

comments from people to Mr. Moyed, if I may, I've never received feedback

from my initial message sent to him sending him facts. My dad on the other

hand has been engaging back and forth the battle of masculinity. Bottom

line: Some people can't argue logic, they can only argue. This P.O.S has

shown his blatant ignorance to the public at the cost of what he perceives

as effective journalism... AKA: The Cat in the Hat; the sequel.

He's not worth anyone's time.

Russ, finally got to watch the videotape of . SHJ

Randi

Published 10/28/2001

FDA trying to assist BioPort

By Tim

Lansing State Journal

The federal government is rushing to get BioPort

Corp.'s anthrax vaccine approved as exposures to the

bacteria widen.

BioPort update

The company has sent documentation to the Food and Drug Administration to

gain certification of its renovated north Lansing laboratory. If the lab

passes an upcoming inspection, vaccine made there soon could

be provided to the military.

Secretary of Defense Rumsfeld says the military and the Department of

Health and Human Services will take " one more crack " at helping BioPort get

licensed. The military is frustrated with BioPort because it has spent $126

million on the company but received no new

vaccine.

The Centers for Disease Control and Prevention has begun the process of

gaining access to the military's supply of vaccine in case of an emergency.

The vaccine might be used to treat people who are allergic to

antibiotics.

But it's still not known when the vaccine, made in the United States only by

the Lansing company, will be available.

Although the vaccine is now approved only for U.S. military use, it could

soon be used to help treat civilians who have been exposed to anthrax.

At least 13 cases of anthrax infection have been confirmed since the Sept.

11 terrorist attacks - in Florida, New York, New Jersey and the Washington,

D.C., area. Three people have died.

About 100,000 people potentially exposed to the bacteria, which can cause

fatal lung and brain damage, are taking antibiotics as a precaution.

" The bottom line is we can't discuss time frames,'' said Lenore Gelb, a

spokeswoman for the U.S. Food and Drug Administration. " But we are doing

everything possible to do it as quickly as possible, while

ensuring the safety and effectiveness of the vaccine.''

BioPort needs FDA approval to sell vaccine made at its renovated north

Lansing labs. The company filed paperwork seeking that approval earlier this

month.

BioPort failed FDA inspections in 1999 and 2000. The military has suspended

its anthrax vaccination program because it has nearly run out of the

vaccine.

Company officials are confident they've fixed problems found in earlier FDA

inspections and that they could soon be able to provide the military with

the vaccine.

U.S. Health and Human Services Secretary Tommy has said BioPort

could be distributing anthrax to the military by Nov. 22. But a typical FDA

inspection process takes four to six months.

Meanwhile, the Centers for Disease Control and Prevention is taking steps to

allow the vaccine to be released more broadly in an emergency.

The vaccine might be given to an exposed person who is allergic to

antibiotics. It also might be given to infected people in conjunction with

antibiotics.

" The vaccine can have a role in treatment,'' BioPort spokeswoman

Rossman McKinney said.

It won't be as effective as antibiotics, but would be better than no

treatment at all, the CDC says.

The key issue: response time. Antibiotics are the best available treatment

for people who have already been exposed to anthrax.

The vaccine is more of a preventive measure, designed to be given before

anthrax infection.

Surgeon General Satcher has said it's time to consider allowing the

anthrax vaccine to go to some high-risk civilian workers, such as post

office employees. But Sen. Bill Frist, R-Tenn., says that

would be impractical.

BioPort's anthrax vaccine is given in six doses over an 18-month period. It

requires annual booster shots.

Research already has begun on alternatives that would require fewer doses

over a shorter period.

If successful, those efforts could render BioPort's vaccine obsolete.

But it likely would take a few years for an alternative vaccine to be

developed and approved.

Contact Tim at 377-1061 or tmartin@....

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