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CDC Rushed Paperwork For Anthrax Vaccinations

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Ingri Cassel

Saturday, December 22, 2001 11:24 PM

CDC Rushed Paperwork For Anthrax Vaccinations

 

 

Sheri Nakken writes:

 

good grief - hope they monitor these people. It isn't like hundreds of us

haven't been screaming about this killer vaccine for 4 years now.

 

 

Contaminated vaccine from a contaminated lab - yeah, good idea

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

 

http://www.washingtonpost.com/wp-dy...-2001Dec21.html

 

CDC Rushed Paperwork For Anthrax Vaccinations

48 Congressional Aides Received Inoculations

 

By Shankar Vedantam and Mary Pat Flaherty

Washington Post Staff Writers

Saturday, December 22, 2001; Page A10

 

 

Just hours before 48 congressional staffers received the anthrax vaccine

Thursday, officials at the Centers for Disease Control and Prevention had

yet to finish the paperwork that would lay out the risks and benefits of

the shots.

 

The late-night session Wednesday to finalize consent forms for the

inoculations exemplifies the pressure federal officials faced as they tried

to implement their unprecedented vaccination plan this week.

 

With Hill staffers about to leave for the holidays, CDC officials raced to

get needed approvals that would enable them to offer the vaccine to anyone

who requested it. A CDC board responsible for reviewing patient protections

in research wrapped up its work on the vaccine proposal between 9 and 10

p.m. Wednesday, by CDC accounts. By the start of Thursday's workday at 10

a.m., four dozen Hill staffers who had been exposed to anthrax were

receiving the first of three shots they will get over the next month in the

vaccination program.

 

The groundwork for the anthrax inoculation program had been laid in

October, when the CDC submitted an application to the Food and Drug

Administration. It proposed providing vaccine and extra doses of

antibiotics to people known to have been exposed to anthrax spores.

 

The CDC needed FDA clearance because its proposed use of the vaccine and

extended use of antibiotics were new and had not received a formal

government review. In addition, the vaccine's maker, BioPort Corp., has yet

to receive FDA approval for its manufacturing facility.

 

Between Oct. 5 and this week, the CDC amended its plan four times,

including significant changes to the consent forms. In its Oct. 5 filing,

the CDC endorsed the vaccine in its consent form, saying it " can prevent

anthrax disease " and, used with antibiotics, " could save your life. "

 

The final versions of the forms released Thursday are much more

constrained. They state that the Department of Health and Humans Services

is not " making a recommendation whether you should or should not take this

vaccine " and that " you should not consider the vaccine as treatment for

anthrax. "

 

The original request seeking FDA approval was made when federal health

officials were worried about an influx of new cases, CDC Director Jeffrey

P. Koplan said, adding that having the application pending positioned the

agency to move more quickly as events evolved.

 

Offering the vaccine to those already exposed " wasn't an option that sprang

to mind then, " Koplan said.

 

FDA regulations require the agency to review applications for

investigational uses of new drugs within 30 days, which helps explain the

seeming haste in the plan, Mary Pendergast, a former deputy at the FDA,

said. And it is not uncommon for the FDA and the sponsor of a proposed drug

test to have back-and-forth discussions about how to bring a proposal into

compliance with FDA rules.

 

But she also noted that federal agencies " appear to have given themselves a

deadline of making the vaccine available before Congress went out for the

session so that put them up against the clock. "

 

As part of its FDA application, the CDC was required to estimate how many

people would be eligible for the vaccine and how it would be administered.

The application also had to present a proposed informed consent sheet that

subjects in the vaccine program would receive.

 

The first version of the plan estimated between 100 and 5,000 people could

be eligible, while acknowledging an unforeseen scenario could drive the

number higher. The final version estimates between 100 and 10,000 people

could be eligible, barring an unforeseen event.

 

CDC officials say that the speed with which the proposal was developed and

approved reflected the fluidity of the crisis.

 

" Some of these individuals may have been more highly exposed than what we

once thought -- that's where the urgency comes from, " CDC spokesman Tom

Skinner said. Scientists, he said, are also theorizing that small numbers

of spores might persist in some individuals who have been heavily exposed

and could burst into a lethal infection once a 60-day course of antibiotics

-- as exposed workers already have been offered -- was completed.

 

Skinner said that CDC's most recent amendment to the application followed

the release of results from a Canadian experiment, in which a test subject

sat in a room about the size of a single-car garage and slit open an

envelope filled with nontoxic bacteria and lay the open envelope down on a

table. Sensors and tests evaluated how many of the spores from the bacteria

were released into the air and how many got in the volunteer's body.

 

Greg Martin, an infectious diseases expert at the National Naval Medical

Center who has been helping treat Senate staffers who had been exposed to

anthrax, said that the Canadian results caused researchers to recommend the

vaccinations.

 

 

 

© 2001 The Washington Post Company

 

 

 

 

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

Sheri Nakken, R.N., MA

Vaccination Information & Choice Network, Nevada City CA & Wales UK

$$ Donations to help in the work - accepted by Paypal account

vaccineinfo

(go to http://www.paypal.com) or by mail

PO Box 1563 Nevada City CA 95959 530-740-0561 Voicemail in US

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

 

 

 

 

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