Information Paper on the Anthrax Vaccine Immunization Program (AVIP)
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1) Purpose: To inform the new administration about the Clinton Administration's Anthrax Vaccine Immunization Program (AVIP), and the damage AVIP has inflicted on America's armed forces.
  • The involuntary use of over 2 million doses of suspect vaccine on over 500,000 Servicemembers from a manufacturer that failed FDA inspections so many times that production "voluntarily" ceased.
  • The court-martial, jailing, and dishonorable discharge of hundreds of active-duty Servicemembers for expressing their safety and health concerns, plus coerced resignations of countless more volunteers.
  • The loss of over 250 pilots, worth over $1 billion, in the Guard and Reserve in just the first 5% of the units vaccinated. GAO confirms in their investigations the probable loss of 25% of aircrew members.
  • The adverse health impact to over 1500 Servicemembers filing FDA vaccine adverse event reports (VAERs), as of the Oct. 2000 hearings. Numbers increase dramatically as troops learn to file VAERs.
  • Jailing of Servicemembers who lost faith in their chain of command and the legality of their orders.
2) Background:

Unlike the use of the anthrax vaccine during the Persian Gulf conflict, where the military vaccinated due to an imminent wartime threat, the current AVIP is a force-wide program in peacetime following DoD acknowledgement of vaccine inadequacies. Additionally, the program was implemented despite significant deficiencies that surfaced through FDA inspections beginning in 1993, and a critical 1994 Senate Veteran Affairs Committee report. SecDef Cohen announced the AVIP following Iraq's expulsion of United Nation's weapon inspectors in late 1997, which prompted tough force protection questions about how the United States would protect US forces in the theater. AVIP's implementation required the accomplishment of four preconditions established by the Secretary of Defense. None were adequately addressed. Most notably, the independent expert asked to review the program was a professor who later told Congress that he had "no expertise in anthrax," and the required supplemental testing was terminated when the results were "all over the board." In Feb 2000, following six congressional hearings, the House Government Reform Committee issued House Report 106-556, titled "Unproven Force Protection," recommending the immediate cessation of the AVIP. The report echoed the 1994 Senate Report 103-97, and deemed DoD's mandatory use of the anthrax vaccine to be "experimental" and thus, illegal under federal law (10 USC 1107) without a Presidential waiver. Today the highly controversial anthrax program suffers from literal vaccine exhaustion based on the sole manufacturer's inability to obtain FDA certification. Subsequently, serious flaws were discovered in chemical / biological protective suits and masks. Clearly, renewed efforts on critical areas such as antibiotics for pre-and-post-exposure protection, biological protective suits and detection systems, and a modern improved anthrax vaccine based on the latest vaccine technology are required now that the AVIP faŤade of force protection has been exposed.

3) Chronology:
  • 1991 -- Sen. Glenn (D-OH) reveals in Senate Government Affairs Committee hearings that DoD officials in 1989 rejected the idea of mass inoculations with this anthrax vaccine due to high adverse reaction rates and lack of effectiveness.
  • 1993 -- FDA begins inspections of the anthrax vaccine manufacturing line, after 23 years of no regulatory oversight. FDA maintained that the "anthrax vaccine manufacturing process is not validated" after inspections annually from 1994 to 1999, and issued a "notice of intent to revoke" license in 1995 & 1997.
  • 1994 -- Sen. Jay Rockefeller (D-WV), in Senate Report 103-97, deems the anthrax vaccine "investigational when used as a protection against biological warfare," and therefore illegal to give without informed consent, or a Presidential waiver, according to US law and FDA regulations.
  • 1994 -- Medical textbook "Vaccines" chapter on the anthrax vaccine, written by Army's chief anthrax researcher, states effectiveness of vaccine against inhalation anthrax infection is unproven.
  • Dec 1997 -- SecDef Cohen announces AVIP just weeks after Iraq expels United Nation inspectors. DoD and FDA officials circumvent the law with convenient "CYA" memos to make AVIP appear legal.
  • Feb 1998 -- Anthrax vaccine plant again fails an FDA inspection concurrent within one day of the SecDef Cohen's "independent expert" approving the DoD anthrax vaccine program.
  • 1998 -- Anthrax vaccine plant sold by State of Michigan to a foreigner who gave 11% of company to retired Admiral William Crowe -- the only senior military officer to endorse Clinton in 1992.
  • 1998 -- Court-martials, jailing, and less than honorable discharges of Servicemembers who refuse vaccine begin, and continue to-date. Military judges refuse to admit evidence about vaccine safety and efficacy, which is fundamental to the legality of the vaccine mandate under federal law.
  • Jan 1999 -- Clinton hints in his State of the Union Address, and tells the NY Times that "he hoped that a major legacy of his Presidency would be to stave off unconventional [biological warfare] attacks."
  • 1999 -- Exodus of Air National Guard and USAF Reserve pilots due to mandatory vaccinations begins despite DoD denials and false reporting to Congress and the media on retention and attrition.
  • Apr 1999 -- Hearings ensue and "independent expert" recants qualifications to avoid testifying.
  • Aug 1999 -- First DoD bailout of anthrax vaccine manufacturer approved by SecDef Cohen, including $18.7 million interest free loan and tripling of contracted vaccine price.
  • 1999-2000 -- Multiple General Accounting Office (GAO) reports critical of anthrax program.
  • Dec 1999 -- Second DoD bailout of vaccine manufacturer following another failed FDA inspection.
  • Feb 2000 -- HR 106-556 recommends suspension of the AVIP, finding the program experimental.
  • Mar 2000 -- Institute of Medicine Report questions DoD assertions of anthrax vaccine safety.
  • Jun 2000 -- DoD IG criminal investigation of vaccine manufacturer revealed while military JAGs maintain the anthrax program is in violation of US law - 10 USC 1107.
  • Jul 2000 -- FDA refusal to certify new production vaccine line causing program "curtailment."
  • Aug 2000 -- Manufacturer missing documents concerning unapproved manufacturing changes.
  • March '01 --CT Attorney General Blumenthal wrote the SECDEF and the FDA saying "cease and desist" in your illegal implementation of the anthrax program."
*   Note -- these chronological facts are not included on the DoD's anthrax propaganda website.

4) Conclusion:

The new Commander in Chief, President Bush, is currently "reviewing" whether or not to resurrect the previous administration's anthrax vaccine program. President Bush should take a formal policy stance against the Anthrax Vaccine Immunization Program, and adopt the pre-Gulf War position of DoD during the Bush Administration (1989) that the current vaccine is unsuitable to mass inoculations. Additionally, the doctrinal shift emphasizing the use of vaccines against biological weapons warrants review, as 18 additional bio-warfare vaccines are under development in the Joint Vaccine Acquisition Program (JVAP).

Most importantly, the soldiers of America's armed forces should not be punished for highlighting the previous official position of the Defense Department concerning the questionable safety, effectiveness and experimental nature of the anthrax vaccine. Instead, the Defense Department, FDA and Bioport officials responsible for the use of an adulterated and experimental vaccine on America's military should be held accountable for their willful circumvention of the laws and violations of US Servicemember's rights health rights under the law.

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