Anthrax Vaccine: Twenty Year History
of Legal and Regulatory Problems
 
FDA's incomplete rulemaking in 1985 rendered the anthrax vaccine program illegal:  In a Food and Drug Administration (FDA) Proposed Rule, 50 FR 51002. Dec. 13, 1985, the FDA published, but never finalized, a licensing rule for the anthrax vaccine in the Federal Register based on an expert review panel's findings, which included the fact that the "Anthrax vaccine efficacy against inhalation anthrax is not well documented," and that "No meaningful assessment of its value against inhalation anthrax is possible due to its low incidence," and that "The vaccine manufactured by the Michigan Department of Public Health has not been employed in a controlled field trial."  The lack of a final anthrax vaccine rule led to the declaration in 2004 that the program was illegal, though the court never ruled on what it termed the "numerous substantive challenges to FDA's Final Rule and Order" (footnote 10).
 
DoD knew a modern vaccine was needed:  In 1985 the United States Army submitted a "request for proposal" to solicit a new anthrax vaccine from the pharmaceutical industry. The Army candidly discussed the limitations of the current vaccine with its high adverse reaction rate and its questionable efficacy against different strains of anthrax, writing, "There is an operational requirement to develop a safe and effective product which will protect US troops against exposure from virulent strains of Bacillus anthracis. There is no vaccine in current use which will safely and effectively protect military personnel against exposure to this hazardous bacterial agent ... A licensed vaccine against anthrax, which appears to afford some protection from the disease, is currently available for human use...The vaccine is, however, highly reactogenic, requires multiple boosters to maintain immunity and may not be protective against all strains of the anthrax bacillus."
 
Once upon a time the DoD told the truth about the anthrax vaccine:  In 1989 an Office of the Secretary of Defense (OSD) letter to Senator John Glenn reiterated the safety and efficacy problems with the anthrax vaccine, saying "Current vaccines, particularly the anthrax vaccine, do not readily lend themselves to use in mass troop immunization for a variety of reasons: the requirement in many cases for multiple immunizations to accomplish protective immunity, a higher than desirable rate of reactogenicity, and, in some cases, lack of strong enough efficacy against infection by the aerosol route of exposure."
 
Once upon a time the DoD published the truth:  In an article titled "Military Immunizations Past, Present, and Future Prospects" in the journal Infectious Disease Clinics of North America in March 1990, Army Doctors / Colonels Takafuji and Russell of Fort Detrick described the anthrax vaccine as a: "Limited use vaccine...unlicensed experimental vaccine."
 
Congress knew there were problems:  In a 1994 Senate Veteran Affair's Committee Staff Report, SR 103-97, Major General Ronald Blanck acknowledged a possible link between the anthrax vaccine and Gulf War Illness to Committee investigators.  Their report noted, "Although anthrax vaccine had been considered approved prior to the Persian Gulf War, it was rarely used. Therefore, its safety, particularly when given to thousands of soldiers in conjunction with other vaccines, is not well established. Anthrax vaccine should continue to be considered as a potential cause for undiagnosed illnesses in Persian Gulf military personnel because many of the support troops received anthrax vaccine, and because the DoD believes that the incidence of undiagnosed illnesses in support troops may be higher than that in combat troops."
 
Congress knew the vaccine was investigational:  The Senate Committee concluded in the same Senate Veterans Affairs Committee Staff Report 103-97 that "Records of anthrax vaccinations are not suitable to evaluate safety...However, the vaccine's effectiveness against inhaled anthrax is unknown. Unfortunately, when anthrax is used as a biological weapon, it is likely to be aerosolized and thus inhaled. Therefore, the efficacy of the vaccine against biological warfare is unknown The vaccine should therefore be considered investigational when used as a protection against biological warfare."
 
Key scientists previously said the anthrax vaccine was unsatisfactory:  In the 1994 civilian medical textbook "Vaccines," Colonel (Dr.) Arthur Friedlander, the Army's chief anthrax vaccine researcher at Ft. Detrick, authored a chapter on the anthrax vaccine. The article was co-authored by Dr. Phillip Brachman and edited by Dr. Stanley Plotkin, both involved with the original study of the vaccine thirty years earlier. The chapter acknowledged the shortcomings of the vaccine used for the AVIP, including its high adverse reaction rates, and noted, "The current vaccine against anthrax is unsatisfactory for several reasons. The vaccine is composed of an undefined crude culture of supernatant adsorbed to aluminum hydroxide. There has been no quantification of the protective antigen content of the vaccine or of any of the other constituents, so the degree of purity is unknown. ... The undefined nature of the vaccine and the presence of constituents that may be undesirable may account for the level of reactogenicity observed. ... There is also evidence in experimental animals that the vaccine may be less effective against some strains of anthrax. Clearly a vaccine that is completely defined, that is less reactogenic, and that requires one or two doses to produce long-lasting immunity would be highly desirable."
 
US Army tried to fix problems:  In September 1995 the US Army developed a plan at Fort Detrick to obtain FDA approval for the licensing of the anthrax vaccine against aerosolized or inhalation anthrax. The plan's text included the fact that "This vaccine is not licensed for aerosol exposure expected in a biological warfare environment."
 
Improper licensure:  In a report prepared by the Joint Program Office for Biological Defense (JPOBD) in December 1997, the DoD acknowledged, "Anthrax and Smallpox are the only licensed vaccines that are useful for the biological defense program, but they are not licensed for a biological defense (i.e. inhalation) indication."
 
Flawed testing:  Mr. Joseph Little, a contracting officer for the anthrax vaccine at the Pentagon, confirmed via email in May of 1999 that results of the anthrax vaccine testing were "all over the board," while recommending they "suspend any further potency testing' or else the results "must be reported to the FDA."
 
DoD cover-up:  Brigadier General Eddie Cain, in email exchanges with Colonel John Wade, referring to a 29 APR 99 Congressional hearing, said, "two key areas in which we came up flat were the GAO's assertion that #1, the anthrax vaccine licensed was NOT the one tested and #2, how can DoD say that reported Desert Storm illnesses were not cause (sic) by the anthrax vaccine when we have no record of who received the shots. If we cannot answer these questions we (DoD & the Administration) are in big time trouble."
 
GAO confirms problems:  The April 1999 GAO Report T-NSIAD-99-148 confirmed that the "long-term safety of the vaccine has not yet been studied," that the "vaccine and the manufacturing process (were) changed," that "the ingredients used to make anthrax vaccine were changed from the original vaccine," and that "Prior to the time of licensing, no human efficacy testing of the MDPH vaccine was performed."
 
IOM confirmed safety problems:  On March 30, 2000, the Institute of Medicine (IOM) published "A Letter Report: Assessment of the Safety of the Anthrax Vaccine" concluding, "There is a paucity of published peer-reviewed literature on the safety of the anthrax vaccine...The Committee concludes that in the peer-reviewed literature there is inadequate/insufficient evidence to determine whether an association does or does not exist between anthrax vaccination and long-term adverse health outcomes."
 
Sole Congressional report confirmed problemsHouse Government Reform Committee Report 106-556 dated April 3rd, 2000, and titled "Unproven Force Protection," recommended suspension of the AVIP due to its "experimental" status. The Committee determined, "While an improved vaccine is being developed, use of the current anthrax vaccine for force protection against biological warfare should be considered experimental and undertaken only pursuant to FDA regulations governing investigational testing for a new indication."
 
Presidential Candidate George W. Bush empathized with the troops:  In US Medicine in September of 2000 candidate President Bush empathized with the troops that "The Defense Department's Anthrax Immunization Program has raised numerous health concerns and caused fear among the individuals whose lives it touches. I don't feel the current administration's anthrax immunization program has taken into account the effect of this program on the soldiers in our military and their families. Under my administration, soldiers and their families will be taken into consideration."  Senator McCain concurred, stating in the San Diego Union Tribune in February 2000 that, "I think that there should be a pause. I think that they have not done the job in educating the members of the military, and ... right now members of the armed services, the Guard and reserves are not accepting it."  Stephen Hadley, who later became Bush's Assistant National Security Adviser, confirmed the same on the PBS NewsHour in Sept. 2000, stating, "The vaccination program is a very serious issue. Maintaining the trust and confidence of our men and women in uniform is critical to the future of our armed forces. Some months ago, Governor Bush called for the Commander-in-Chief and our military leaders to be very mindful of the concerns of our men and women in uniform and their families about the vaccine, and called for the government to do more to address their concerns. Hopefully the [Clinton] administration will respond."
 
Senate Majority Leader, a doctor, criticized the anthrax vaccine:  Sen. Bill First criticized the vaccine on CNN in December 2001 stating, "The vaccine is a dated vaccine, it's an old vaccine. There are very real and potentially serious side effects from the vaccine and anyone who elects to receive the vaccine needs to be made aware of that. I do not recommend widespread inoculation for people with the vaccine in the Hart Building ...There are too many side effects and if there is limited chance of exposure the side effects would far outweigh any potential advantage."
 
Court rulings confirm illegality of mandatory anthrax inoculations:  In December 2003 and October 2004 a Federal Court Ruling confirmed that "The involuntary anthrax vaccination program, as applied to all persons, is rendered illegal absent informed consent or a Presidential waiver."  In February 2006 the DC Federal Appeals Court declined to vacate or overturn the ruling that the anthrax vaccine was illegal, despite FDA's attempt to fix the paperwork and re-license the vaccine in December 2005.
 
GAO confirms vaccine problems remain:  Via testimony in report GAO-06-756T the Congressional watchdog agency continued to question the "long-term and short-term safety of the vaccine, including gender differences; and the vaccine's efficacy."  GAO again confirmed that the "long-term safety of the licensed vaccine has not been studied," and that the efficacy of the vaccine for DoD's intended use against inhaled anthrax "may not be extrapolated to humans."
 
DoD and its Courts attempt to rewrite the history of the anthrax vaccine:  DoD begins misinformation campaign to negate the importance of Federal Court decisions, which previously confirmed the anthrax vaccine program was illegal.  Pentagon spokesperson claims, "No judicial judgment has declared such orders to have been unlawful," which is untrue.  Additionally, military judges at the Court of Appeals for the Armed Forces rule that the DoD previously presumed the order to be legal.  They refuse to reverse court-martial convictions of vaccine refusers, while omitting the finding of fact and law that the anthrax vaccine program was declared illegal prior to the FDA's December 2005 flawed licensure.
 
Bottom line:  The fundamental facts remain unaltered, despite DoD's attempts to change the history of the anthrax vaccine.  The vaccine, in DoD's own words, is or was unsatisfactory, inadequate, highly reactive, of limited effectiveness, and therefore was experimental / investigational.  It is clear that the anthrax vaccine was improperly licensed, and the data to support efficacy do not exist.  DoD cannot erase the paper trail of intellectually honest criticisms of the vaccine that were made prior to the decision to mandate its use.  The new license, for the same old vaccine, remains improper because the legally required clinical trials never occurred.  DoD's intended use of the vaccine for inhaled anthrax remains unproven, according to GAO testimony.  Therefore the license was granted improperly, and mandating the vaccine is arguably illegal.  FDA's continued failures to properly regulate use of the vaccine only complicate the situation.  DoD actions with respect to the anthrax vaccine violate the armed forces' honor codes, core values, oath of office and the basic trust American's seek to have in their government.