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Urgent Action Request: FDA Petition
 

Are you aware of the FDA Petition concerning the Anthrax Vaccine?  With the recent attacks and 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-martial for refusing the vaccine. 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  Preliminary results of a recent unpublished study of infants born to women in the U.S. military service worldwide in 1998 and 1999 suggest that the vaccine may be linked with an increase in the number of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 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 in forwarding this to anyone on your list.  Directions are listed below.  The writers of this petition are experts on the AVIP (Anthrax Vaccination Immunization Program) Thank you for your time in this crucial matter.

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

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 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, click here.  The petition is above the web site counter.

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.

To make your petition known to FDA, click here.  When corresponding with the FDA please use the address fdadockets@oc.fda.gov and insert RE: Docket No. 01P-0471 in the subject area.


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 BioThrax™)

Anthrax Vaccine Home Page, Dr. Meryl Nass

Anthrax Vaccine Immunization Program Process Analysis
by Maj Thomas L. Rempfer, USAFR and
Maj Russell E. Dingle, USAFR

Anthrax Vaccine Network  Please read the stories of Anthrax Heros.

Anthrax Vaccine Links and Information


 


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Most recent revision Saturday, August 24, 2002