FDA PETITION / NEW Name for anthrax vac = BioThraxT

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Monday, February 04, 2002 7:25 PM

FDA PETITION / NEW Name for anthrax vac = BioThraxT

 

 

> > Are you aware of the FDA Petition concerning the Anthrax Vaccine?

> >

> > With the recent attacks of the anthrax mailings, we should all be

> concerned

> > that this is yet another vaccine to add to the list of many more to

come.

> > This vaccine is mandatory for all military, with many members leaving

the

> > service, ill or facing court-marial. Federal workers have been given

this

> > vaccine and now the postal workers. Preliminary results of a recent

> > unpublished study of infants

> >

> > born to women in the U.S. military service worldwide in 1998 and 1999

> suggest

> >

> > that the vaccine may be linked with an increase in the number of birth

> >

> > defects Now the manufacturer has been given approval by the FDA after

> years

> > of habitual failures!

> >

> > In a hearing before congress, Dr. JOHNSON-WINEGAR states, " We certainly

> view

> > most of these vaccines in three tiers, tier 1 being the military, the

> > core military, whether that is active duty or active duty and Reserve, I

> > defer to people who have expertise in that area. The second area would

be

> our

> > allies and host nation civilians and certainly critical DOD civilians

> would

> > be the second tier. And the third tier would be something larger that

> could

> > extend potentially to the entire population of the United States. Also

in

> > that second tier I would include people that we classify as the first

> > responders, the police, the fire, the medical people who would be the

ones

> to

> > come and respond to an incident. "

> >

> > The absence of valid statistical data has been a stumbling block for

those

> > interested in understanding how safe - or unsafe - the anthrax vaccine

> really

> > is.

> > Now, the patients themselves are initiating scientific studies to gather

> the

> > information. Women appeared to experience a higher systemic rate than

men.

> > We would like your support and forward this to anyone on your list.

> > Directions are listed below. Thank you for your time in this crucial

> matter.

> >

> > The writers of this petition are experts on the AVIP.

> > If you have any questions, you may contact:

> > Major Tom Rempfer (USAFR) at 860-668-1512, or 1513

> > Major Russ Dingle (USAFR) at 860-568-8767

> >

> > * * * *

> > FDA Citizen Petition/Anthrax Vaccine

> >

> > I would like to ask that you please take a short minute or two to submit

a

> > comment to the FDA in support of the FDA citizen petition .

> >

> > This petition is a valid and legal instrument that has been filed with

> FDA.

> > It seeks action by the FDA commissioner concerning the anthrax vaccine.

By

> > law, FDA is required to respond to this petition. Their response to our

> > requests then becomes their legally binding position on the anthrax

> vaccine.

> >

> > All that you need to do is write something on the order of " I support

this

> > petition, docket number 01P-0471 " Of course, more detailed comments are

> > welcome. (Emphasis in future docket entries should be placed on the

> > verification by GAO in their 23 OCT 01 testimony to Congress of the

> > unapproved manufacturing changes to the anthrax vaccine filters, and the

> > subsequent unreported chemical changes caused as a result.)

> >

> > Below is a summary of the petition. To read the Citizen Petition in full

> > please go to http://www.enter.net/~jfsorg/ . Link: <A

> > HREF= " http://www.enter.net/~jfsorg/ " >Anthrax Vaccine Risks</A> (the

> petition

> > is above the web site counter)

> >

> > Here you will also be able to read official documents of the General

> > Accounting Office (GAO) Reports (the latest 10/01: Changes to the

> > Manufacturing Process), FDA Reports and Congressional Testimony.

> >

> > *When corresponding to the FDA please use the address below and insert

in

> the

> > subject area the following:

> >

> > Address: fdadockets

> > RE: Docket No. 01P-0471

> >

> > * * * * * * *

> > Dockets Management Branch

> > Department of Health and Human Services

> > Food and Drug Administration; Room 1-23

> > 12420 Parklawn Drive

> > Rockville, Maryland 20857

> > CITIZEN PETITION:

> > The undersigned submit this petition under Section 360bbb-2 of the

Federal

> > Food, Drug and Cosmetic Act, section 553(e) of the Administrative

> Procedures

> > Act, and Title 21 Subsection 10.30 of the Code of Federal Regulations to

> > request the Commissioner of Food and Drugs to take the administrative

> actions

> > listed below regarding anthrax vaccine adsorbed.

> >

> > A. Action requested

> >

> > (1) Issue a Final Rule on the drug category placement of anthrax vaccine

> as

> > Category II (unsafe, ineffective, or misbranded) amending the as yet to

be

> > finalized Proposed Rule as published in the Federal Register 13 December

> 1985.

> > (2) Declare as adulterated all stockpiles of anthrax vaccine adsorbed in

> the

> > possession of BioPort Corporation and all doses in private, public, U.S.

> or

> > foreign government possession.

> > (3) Enforce FDA Compliance Policy Guide, Section 400.200 Consistent

> > Application of CGMP Determinations (CPG 7132.12) with respect to anthrax

> > vaccine adsorbed (license #1260).

> > (4) Revoke the anthrax vaccine adsorbed license (license #1260) held by

> > BioPort Corporation.

> >

> > Other links of important interest:

> >

> > The new package insert of the Anthrax Vaccine (Now called BioThraxT)

> > SEE: <A HREF= " http://www.fda.gov/cber/label/biopava0131022LB.pdf " >

> > http://www.fda.gov/cber/label/biopava0131022LB.pdf</A>

> >

> > <A HREF= " http://www.anthraxvaccine.org/ " >ANTHRAX VACCINE HOME PAGE</A>

> > http://www.anthraxvaccine.org/

> >

> > <A HREF= " http://www.anthraxvaccine.net/ " >Anthrax Vaccine Network</A>

> > http://www.anthraxvaccine.net/ - Anthrax Heros. Please read their

stories,

> > and please pass these stories along to everyone you know. We are

grateful

> for

> > your interest and concern.

> >

> > <A HREF= " http://www.dallasnw.quik.com/cyberella/index.htm " >ANTHRAX

VACCINE

> > LINKS and INFORMATION</A> -

> http://www.dallasnw.quik.com/cyberella/index.htm

> >

> > <A

> HREF= " http://www.airpower.maxwell.af.mil/airchronicles/cc/rempfer.html " >

> > Anthrax Vaccine Immunization Program Process An.</A>

> > http://www.airpower.maxwell.af.mil/airchronicles/cc/rempfer.html

>