Whereas, Bioport Corporation of Lansing, Michigan has failed numerous inspections , received warning letters and notices of intent to revoke its license from the U. S. Food and Drug Administration (FDA) , and is still not licensed to produce anthrax vaccine in its newly renovated facility which cost U. S. taxpayers millions of dollars ; and

Whereas, Bioport possesses millions of doses of quarantined anthrax vaccine that the FDA refuses to release because the vaccine has not met legally-required current good manufacturing practice (CGMP) specifications, was not a sterile product, and was contaminated with unknown particulate matter ; and

Whereas, the FDA Compliance Policy Guides Manual, Sec. 400.200, titled Consistent Application of CGMP Determinations (CPG 7132.12), states:

CGMP deficiencies supporting a regulatory action also support decisions regarding non-approval of drug marketing applications, government purchasing contracts, candidates for MAC, etc. Therefore, the issuance of a warning letter or initiation of other regulatory action based upon CGMP deficiencies must be accompanied by disapproval of any pending drug marketing application, or government contract for a product produced under the same deficiencies. ; and

Whereas, the FDA has never approved Bioports September 1996 application to market the vaccine for protection against an aerosol attack , nor is the vaccine accepted as effective for such use , , ; and

Whereas, members of the United States Armed Services were forced to take anthrax vaccine for an unlicensed airborne protection use, both during the Gulf War and since 1998; this in spite of the fact that the Army itself testified before Congress in 1989 that the vaccine was unsuitable for mass inoculations because of high adverse reaction rates and lack of efficacy ; and

Whereas, such military use was allowed only because 1) the FDA waived informed consent (Gulf War) or 2) because a top FDA official violated FDA regulations on experimentation by using a personal, legally-insufficient, non-binding memo to give the Pentagon a go-ahead in March 1997 ; and

Whereas, such FDA violations that allowed the forced military use have generated a pending lawsuit by service members to declare the vaccine experimental ; and

Whereas, a February 17, 2000 Congressional Report recommended terminating anthrax vaccine use on our troops after six public hearings on vaccine injuries and program mismanagement , and

Whereas, the FDA recommends using the antibiotic ciproflaxin after possible exposure to airborne anthrax ; and

Whereas, an FDA official stated in a July 11, 2001 speech to the Institute of Medicine Committee to Review the Safety and Efficacy of the Anthrax Vaccine in Washington, D. C. that Bioports quarantined lots could be used on the public in the event of an aerosol anthrax attack ; therefore

WE, THE UNDERSIGNED supporters of the public health and our fellow citizens in the military, do petition Bioport Corporation to destroy all their quarantined Anthrax Vaccine lots and provide a video and written record to the general public of such action.,, & (click on Oct 2000 Inspection Report - (pdf file)) &
Pentagon Assessing BioPort, Review of Contract with Lansing Firm Started This Month, Lansing State Journal, Friday, August 24, 2001, article by Tim Martin (p. ?)
From a Transcript Of a Speech by the FDAs Mark Ellengold to The Institute Of Medicine Committee To Review The Safety And Efficacy Of The Anthrax Vaccine July 11, 2001 in Washington, D. C. at the Foundry Building:
When I took this job, the first regulatory action that landed on my desk was the notice of intent to revoke the license of Bioport for many of their products including AVA. Signing that letter which has been placed up on several TV shows has brought me numerous compliments over the years from the Congress, and I (inaudible) to explain it. (audience laughter). Nonetheless, that notice of intent to revoke was followed by the February 98 inspection, and in that inspection, we noted several lots had questions (inaudible) 12, 14, or 16, and they fell into basically three categories. There were unresolved spec issues, there were sterility issues, and there was one lot that had unexplained particulate matter. Telephone conversations (inaudible) with Bioport and then with DoD, they agreed immediately to quarantine those lots and not release them until investigations were done that resolved the outstanding issues.
Investigational New Drug application (IND 6847), Michigan Biologic Product Institute, September 20, 1996. The following quote is in section 3.1 of the IND application: The ultimate purpose of this IND is to obtain a specific indication for inhalation anthrax and a reduced vaccination schedule.
Dr. David Ashford, who co-authored the CDC Advisory Committee on Immunization Practices December 2000 report on anthrax vaccine, stated last year: we do not have specific information on the efficacy of the existing vaccine for the prevention of inhalational anthrax and we probably never will. - "Anthrax Vaccine Is Safe, U.S. Health Experts Say", Reuters Health, July 10, 2000, article by Eliza Bussey.
Centers for Disease Control, "Use of Anthrax Vaccine in the United States, Recommendations of the Advisory Committee on Immunization Practices", December 15, 2000. Under the section Bioterrorism Preparedness on this website is the following quote: Although groups initially considered for preexposure vaccination for bioterrorism preparedness included emergency first responders, federal responders, medical practitioners, and private citizens, vaccination of these groups is not recommended.
Federal Register / Vol 50. No. 240 / Friday, December 13, 1985, FDA Proposed Rules, pp 50158-9: Anthrax vaccineefficacy against inhalation anthrax is not well documentedNo meaningful assessment of its value against inhalation anthrax is possible due to its extremely low incidence
Army Faulted on Germ War Research, Development of Defenses Said to Be Target of Unlikely Biological Threats, Washington Post, January 29, 1991, article by R. Jeffrey Smith (p. A 17). Viewable at Click on 1989: Army Says Vaccine Not Suited to Mass Inoculation under the Hot Topics section Click on Declaratory Judgment Lawsuit under the Law section. Click on 9/7/00 in the Letter Posted column for the drug entry Cipro (Ciprofloxacin Hydrochloride) Tablets, IV Solution, IV in 5\% Dextrose, IV in 0.9\% Saline, & Oral Suspension, Rx submitted by Bayer Corporation
From a Transcript Of a Speech by the FDAs Mark Ellengold to The Institute Of Medicine Committee To Review The Safety And Efficacy Of The Anthrax Vaccine July 11, 2001 in Washington, D. C. at the Foundry Building:
As far as I can remember, only one of those lots has ever been moved over to release. The rest are still under quarantine or have been destroyed. The reason we have not insisted on destruction is that we recognize the imminent and constant threat of an anthrax attack, and while these products are technically in violation because of unexplained testing or GMP issues, were not at all sanguine about the fact that theyre totally unsafe or ineffective as far as being a public health liability. So weve worked with Bioport and DoD and the CDC to encourage the submission of an IND and worked with them to establish which lots, in case of an emergency, would be the best to use in an emergency situation with informed consent and under an IND situation. And were still working on that.

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    Adam is my Grandson and caugh in this so-called vaccine
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  • 11 September 2015346. Noelia G
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