(Original info paper chronology follows at the end of this document up to the latest Nov 99 failed FDA inspection of the manufacturer when the FDA reiterated: "the anthrax manufacturing process is not validated.")

"...What does the military officer do when he is ordered by a

Statesman to take a measure which is militarily absurd…?"

"The existence of professional standards justifies military disobedience."

Samuel Huntington, The Soldier and the State, p.77

Quoted in testimony to Congress, 12 Oct 1999:

From The Washington Post Outlook Section, 30 January 2000:

&

1. Purpose: To inform senior policy makers on the DOD’s mandatory Anthrax Vaccination Immunization Program (AVIP), and its implications on the readiness and morale of the military.
2. Background: In Dec 1997 SECDEF Cohen announced the AVIP program ostensibly due to perceived increase in threat from rogue states (Iraq, North Korea, etc.) and terrorists. (1) He mandated four conditions be met prior to start of the program. Hundreds of Servicemembers have since refused the vaccine – and have been subjected to various levels of military discipline. DOD asserts the vaccine is "safe, effective and FDA-approved." Vaccination refusals in the reserve components became public in Jan 1999 when eight officers (fighter pilots) in the Connecticut Air National Guard were forced to resign from their unit after they declined to be vaccinated. (2) The House Committee on Government Reform (Rep Shays R-CT) conducted hearings in Mar (3), Apr 1999 (4), June and July on the safety, efficacy, and necessity of the vaccine. Separately, in late Mar 1998 the GAO issued a study calling for a DOD-funded study on the presence of antibodies to squalene (an experimental, non-approved vaccine booster) in the blood of Gulf War Illness veterans. (5) A week later Vanity Fair (6) and Insight Magazine (7) reported on the possibility that in 1991 DOD had funded the development of anthrax vaccine using the experimental booster (adjuvant) squalene instead of the approved booster alum. DOD categorically denies producing a squalene based anthrax vaccine, although it admits funding human vaccine studies using squalene since 1988. (8) Rep Metcalf (9) (R-WA), Rep Mica (R-FL), and Rep Jones (10) (R-NC) have called for hearings by the House Armed Services Committee to investigate whether DOD produced and used experimental anthrax vaccine on soldiers. SECDEF Cohen recently stated, "I would be derelict in my duties" if he did not mandate the anthrax vaccine. (11)
3. Discussion:

4. Conclusion: Safety and efficacy of anthrax vaccine are in question. Congressmen are asking why a decades-old vaccine is now necessary against a threat that has existed even longer. SECDEF-mandated review of vaccine by a non-expert was cursory. DOD has used inaccurate information to convince military personnel of vaccine’s safety and the UCMJ to intimidate those opposed to program. Possible link between Gulf War Illness and anthrax vaccine exists.
5. Recommendation: DOD should terminate the mandatory anthrax vaccinations pending an impartial review of the safety, efficacy, and doctrinal necessity of the AVIP.

• 1990-1991 – Approximately 150,000 (25) of over one half million military personnel involved in the Gulf War are vaccinated for anthrax, including some who do not deploy to Southwest Asia. Vaccinations stop after Gulf War ends and do not resume again until March 1998.
• Feb 1993 – World Trade Center is bombed with conventional explosive.
• Mar 1995 – Japanese cult uses Sarin gas and botulinum toxin in Tokyo subway attack. Same group attempted to use anthrax in an ineffective attack in June 1993. (26)
• Apr 1995 – Oklahoma City federal building is bombed with conventional explosive
• Jun 1995 – President Clinton issues Presidential Decision Directive PDD-39, outlining U.S. counter-terrorism strategy to consist of three main elements: 1 -- Reduce vulnerabilities and prevent and deter terrorist acts before they occur. 2 -- Respond to terrorist acts that do occur, including managing crises and apprehending and punishing terrorist perpetrators. 3 -- Manage the consequences of terrorist attacks. (27)
• 1996 – Nunn-Lugar-Domineci legislation passes Congress mandating DOD responsibility to train first-responders for domestic terrorism response.
• 1997-1999 – At his Jan 1997 Senate confirmation testimony SECDEF Cohen began his term by emphasizing one of his major concerns: "The proliferation of weapons of mass destruction threaten our interests, our forces and even our homeland." (28) He has given numerous speeches referencing the threat from biological weapons, including anthrax. (29)
• Mar 1997 – FDA threatens to revoke the license of the sole anthrax production facility due to numerous quality control deficiencies. (30) This followed a previous warning letter issued by FDA in Aug 1995 (31) and deficiencies noted by DOD during a March 1992 inspection. (32) The State of Michigan later sold the plant to a new private firm called Bioport, Inc.
• 1 May 1997 – DOD issues report to Congress: "Domestic Preparedness Program in the Defense Against Weapons of Mass Destruction." (33) Report responds to 1996 Nunn-Lugar-Domenici legislation requiring DOD to train WMD first-responders for domestic terrorism. (34) Report noted that officials from four major cities had told FEMA: "Beyond technical experts, personnel resources would be required by local governments to assist with the potentially massive public impacts of such incidents - whether it be mass casualties or large-scale evacuation." (35)
• 31 Jul 1997 – SECDEF Cohen effectively ends the career of USAF BGen Schwalier for inadequate force protection measures related to the Khobar Towers bombing in Saudi Arabia. Cohen stated: "The bombing of Khobar Towers Housing Complex in Saudi Arabia last year highlighted the threat of terrorism that our military faces around the world and the requirement for effective force protection. My own assessment is that we need to have one standard, and everybody has to understand what force protection means and be trained appropriately and be held accountable under those circumstances." (36)
• Nov 1997 – Forces deploy to the Persian Gulf in order to react to the refusal of Iraqi regime to comply with UN monitoring and inspection teams. Force protection questions evolve with respect to Iraqi biological warfare threat to US forces in region and US vulnerability to weapons of mass destruction. (37)
• Dec 1997 – SECDEF Cohen announces the Anthrax Vaccine Immunization Program (AVIP). Press release asserts that the anthrax vaccine is "widely used" by veterinarians, a statement later repeated at virtually every Pentagon press conference on anthrax and in a brochure given to troops. (38) Over a year later DOD is forced to change the brochures because information regarding usage by veterinarians was incorrect. (39) DOD mandates a four-point review of the vaccine before program begins (each pre-requisite is now in question):

• Supplemental testing, consistent with Food and Drug Administration standards, to assure sterility, safety, potency and purity of the vaccine. (Suspended by the DOD, see endnote #45)
• Implementation of a system for fully tracking personnel who receive the anthrax vaccinations. (Criticized by 29 April 1999 Congressional hearings as "passive", see endnote #77)
• Approval of appropriate operational plans to administer the immunizations and communications plans to inform military personnel of the overall program. (Communications to military personnel contained factually incorrect information that DOD has been forced to correct, see endnote # 39)
• Review of health and medical issues of the program by an independent expert. (Dr. Burrow admits he has no expertise in anthrax, see endnote #42)

• Dec 1997 – RADM Cowan, Joint Staff J-4, attends a DOD press background briefing the day AVIP is announced. He states: "This is a force protection issue…It fits with our strategic concepts." He also says that there are 1.2 million troop-equivalent doses (six shots each) of vaccine stockpiled and claims that DOD had found no impurities in the stockpile. (40) Later testing proves this incorrect. When asked whether the AVIP is another step in a biological arms race RADM Cowan states: "I don't know. It could be, but I'm not prepared to answer that."
• Feb 1998-Apr 1999 – Dr. Gerard Burrow, Yale OB/GYN, writes a letter dated 19 Feb 1998 approving the AVIP program. (41) He releases his report to DOD on 2 Mar 1998. In the letter he thanks personnel at the Pentagon and within the DOD for their assistance in conducting his review. In a 26 Apr 1999 letter Dr. Burrow responded to requests by Congressman Shay’s Committee to testify about his expertise in anthrax. It included the following statement in a letter in lieu of testimony: "The Defense Department was looking for some [sic] to review the program in general and make suggestions, and I accepted out of patriotism. I was very clear that I had no expertise in Anthrax and they were very clear they were looking for a general oversight of the vaccination program. (42)
• Feb 1998 – One year after threatening to revoke the license of Michigan Biologic Products Institute, FDA issues inspection report on the sole anthrax production plant which begins: "The manufacturing process for Anthrax Vaccine is not validated." (43)
• Mar 1998 – Sole anthrax vaccine production plant is closed for "renovation" following unsatisfactory FDA report the prior month. DOD is paying for cost of renovation. (44) All vaccinations given under AVIP to-date are from stocks existing prior to plant closure. Bioport (formerly Michigan Biologic Products Institute) was allowed to conduct supplemental tests of its own product before it was shipped for use in the AVIP. Mitretek Corp conducted monitoring of the test results and procedures. DOD later suspended supplemental testing due to "inconsistencies" in the testing procedure and sent a "Tiger Team" to Bioport to resolve the problem. DOD expects to resume supplemental testing in late 1999. (45)
• 2 Mar 1998 – In response to threat assessment by the CINCUSCENTCOM, anthrax vaccinations begin before the SECDEF-mandated four-part review is complete. On the same day Dr. Burrow's report is submitted, DOD declares the review complete only for CENTCOM. Contrary to Dr. Burrow’s recommendations, DOD communications on anthrax were inadequate and misleading. Many Servicemembers were not advised of how to submit a Vaccine Adverse Event Reporting System (VAERS) report and it appears DOD did not have a system designed to track adverse reactions.
• Apr 1998 – First large-scale refusals to take the vaccine occur – ten sailors on USS Independence. Grassroots effort to counter AVIP begins, initially led by the mother of a Navy sailor who became ill after being inoculated. (46)
• 18 May 1998 – SECDEF Cohen approves AVIP for all DOD military personnel. Same day President Clinton issued Presidential Decision Directive PDD-62, ordering federal agencies to take significantly expanded and better-coordinated steps to protect against the consequences of biological and other unconventional attacks, especially potential bioterrorism directed at civilian populations. Special new funding of $144 million was added for HHS efforts in FY 1999, bringing total HHS spending on bioterrorism preparedness to $158 million this year. FY 2000 budget will propose another significant increase to a total $230 million. (47)
• 14 Aug 1998 – Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs, and RADM Michael Cowan, Joint Staff J-4 Medical Readiness, hold a press briefing to attempt to respond to increasing refusals by Servicemembers to be vaccinated. (48) Cowan states: "But our position is this is very safe. I've also taken it. I have absolutely -- none of us have any concerns. And we think it's of the order of magnitude of saying to someone, ‘You have to wear your helmet.’
• Sep 1998 – Congress changes federal law restricting use of federal military Reserves (not National Guard) from activation for "serious natural or manmade disaster, accident, or catastrophe." (49) Reserves may now be used "to provide assistance in responding to an emergency involving a use or threatened use of a weapon of mass destruction." (50)
• Jan 1999 – When the first unit in the Air Reserve Components faced mandatory inoculation, eight CT Air National Guard pilots (25% of the combat arm of the unit) refuse anthrax vaccine and are told to resign and transfer from their unit. (51) These officers worked within chain of command for five months seeking answers to questions on safety, efficacy, and necessity of vaccine, but were told "there are no answers to your questions." (52) After researching the AVIP issues the officers chose to resign and transfer in lieu of disobeying a direct verbal order from their Commander. (53)
• 22 Jan 1999 – President Clinton gives address to National Academy of Sciences on "Keeping America Safe in the 21^st Century." He states: "We have to be ready to detect and address a biological attack promptly, before the disease spreads." (54) White House emphasizes significant increase in funding to develop vaccines. (55)
• 25 Jan 1999 – In response to increasing refusals to accept the vaccine, eight reserve component general and flag officers attend semi-annual convention of the Reserve Officers Association and are vaccinated en masse on stage. (56) Government Executive magazine acknowledges "dozens of troops have refused the Pentagon's recent order to be vaccinated against Anthrax because they don't trust service leaders' assertions that the vaccinations are safe." (57) ROA concluded their convention with the passage of a resolution supporting vaccine protection, BUT NOT WITH THE CURRENT STOCKPILE – a compromise recognizing potential problems with the vaccine. (58)
• Jan-Feb 1999 – Joint Staff prepares answers to CT Air National Guard officer’s questions in preparation for a possible "20/20" report that ultimately does not delve into the questions. (59)
• Feb-Mar 1999 – USAF Airman Bettendorf demands court-martial in response to threatened punishment for refusal to accept vaccination. (60) Defense counsel requests for samples of the vaccine during pre-trial discovery were refused by the government. (61) USAF ultimately grants a general discharge, under other than honorable conditions, avoiding a trial. (62)
• Jan-Apr 1999 – The first unit in the USAF Reserve to face mandatory inoculation, the 79^th Air Refueling Squadron, had 20 KC-10 tanker aircrew resign (just less than 50% of the aircrew in the unit). USAF attempted to obscure the number of pilots, who resigned or transferred in these units due to anthrax, then later admitted actual numbers. Potential retention problems in other reserve component flying units exist if vaccinations continue, which may exacerbate a growing shortage of pilots throughout the military. It costs $6 million to train a new pilot, and pilot production is already running at capacity.
• 9 Feb 1999 – Department of Health and Human Services announces initiative on domestic bioterroism response. (63)
• 16-17 Feb 1999 – National Symposium on Medical and Public Health Response to Bioterrorism hosted by Johns Hopkins University in Arlington, VA. (64) Dr Phillip Russell of Johns Hopkins and formerly director of USAMRIID advised "against further development of this [anthrax] vaccine, and emphasized the need for a "second generation vaccine" which could be given in 2 doses, preferably with purified antigen as the immunogen." (65)
• 9 Mar 1999 – SECDEF Cohen tells troops in Kuwait that he would be "derelict" in his duties if he failed to protect U.S. service members from anthrax and other biological weapons, and he also told them the vaccine is completely safe. (66)
• 9-10 Mar 1999 – Conference on WMD & Domestic Preparedness: Integrating First Response & Medical Management in Washington, DC. Keynote address by Johns Hopkins Univ. Dr. Thomas Inglesby on response to bioterrorism. (67)
• 24 Mar 1999 – Representative Shays (R-CT) begins first of four hearings by the House Government Reform Subcommittee on National Security on the safety, efficacy, and necessity of AVIP. (68)
• 29 Mar 1999 – GAO releases a report on squalene adjuvants in vaccines and a possible link to Gulf War Illness. (69) Subsequent articles in Vanity Fair (70) and Insight Magazine (71) elaborate on GAO report by detailing findings of independent medical researchers. Congressman Metcalf (R-WA) calls for hearings by House Armed Services Committee.
• 31 Mar 1999 – DOD modifies (accelerates) AVIP. All U.S. military personnel and DOD emergency essential civilians and contractors who travel to Southwest Asia and the Korean peninsula for duty of any duration will receive the anthrax vaccination series. (72) Previous requirement was to be vaccinated if deployed for more than 30 days to one of these areas. (73)
• 1 Apr 1999 – In response to AVIP hearings by the House Government Reform Committee the Association of American Physicians and Surgeons submitted a report including the following statement: "Informed consent must be observed even by military. No consent can be informed if the information is based on science that violates fundamental precepts of honesty and integrity and lacks a proper research design that can disprove the hypothesis of safety if indeed there are significant adverse effects." Doctors for Disaster Preparedness, a national organization of physicians and scientists, also submitted a statement recommending more comprehensive protection: "Because of the limited efficacy of the anthrax vaccine, prevention of exposure with shelters and protective gear remains indispensable." (74)
• 21 Apr 1999 – USAF airman is convicted in a summary court-martial for refusal to take anthrax vaccination and convicted to one month in confinement. (75) The USAF prosecuting attorney (JAG) stated after the trial: "People need to think twice before accepting at face value everything they see on the Internet… There's a lot of half-truths, misinformation and outright lies out there, and it really should not be looked at as an infallible source of reliable information." (76)
• 29 Apr 1999 – 2^nd House Committee on Government Reform hearing is held covering FDA oversight of anthrax vaccine. The last two hearings will investigate manufacturer practices and procurement, and doctrinal implications of the program will occur in June and the fall of 1999 respectively. Hearings reveal DOD has suspended supplemental testing of anthrax vaccine by manufacturer and sent a "Tiger Team" to Bioport to remedy problems. Additionally, Dr Sharma, GAO investigator, testified that the FDA approved the vaccine in 1970 without evaluating the 3 main differences between the '50s/'60s vaccine - the new manufacturing process, the new strain of anthrax used to make the vaccine, and the new adjuvant. (77)
• Apr-May 1999 – ADM Jay Johnson, Chief of Naval Operations, continued to decline to be vaccinated. His office states that he is not scheduled for vaccination until 2003 – well after his retirement from the Navy. (78)
• May 1999 – Additional Representatives join Rep Metcalf’s (R-WA) and Rep Shay’s (R-CT) in the call for a moratorium on the mandatory inoculations until further review is conducted – Rep Souder (R-IN), Rep Jones (R-NC), and Rep Mica (R-FL). Additional elected representatives are expected to follow.
• 5 May 1999 – Following at least two adverse reactions at Dover Air Force Base in Delaware Col. Felix Grieder, the wing commander, temporarily suspended vaccinations on the 3,600 Servicemembers. His spokesman explained the performance of a Pentagon briefer sent to explain the shots had been "inadequate to dispel rumors and misinformation" about the vaccine's safety. (79) Later reports from the military spokesman confirmed at least four adverse reactions, while further investigation with unit members revealed Col Grieder's troops had at least 8 adverse reactions, with more suspected among pilots who are reluctant to report.
• 11 May 1999 – Col. Felix M. Grieder's stand was short-lived. The shots were resumed at Dover AFB on Tuesday after Grieder was briefed by high level Air Force officials. A USAF Surgeon General visited the base and supplied the DOD’s answers to questions on vaccine safety posed by airmen in two closed sessions. After he suspended the program, Grieder was called to Washington Monday to confer with high level Air Force officials. (80)
• 25-27 May 1999 – A DOD informational meeting was held at Fort Detrick, MD for 100 military physicians. Data presented casts doubts on previous DOD claims of safety. Briefing slides included the following statistics: (81)

• In a study of 337 vaccinated Servicemembers from Korea, the rate of any reaction (from very minor to severe) was 40% in men, but 70% in women. Reactions led to "decreased activity" in 3% of males, and 8% of females.
• The ongoing study of 600 Servicemembers at Tripler Army Medical Center, Hawaii, resulted in 20% (120 people) developing a systemic reaction after at least one of the first three injections. Only 4 VAERS have been filed for this group.
• At Dover Air Force Base, 20-25 persons have been identified with a similar, Gulf War-like illness resulting in a more than 50% reduction in function, compared to their pre-vaccine state, according to Col. (Dr.) Renata Engler, Chief of the Allergy/Immunology Department, Walter Reed, and Consultant to OTSG, Allergy-Immunology.

• 11 June 1999 – Five Marines who refused an anthrax vaccine at Twenty-Nine Palms MCAS, California face court-martials. A judge ruled the men were given a lawful order when they were told to take the shot. Investigative news research though alludes to the realization that a more complex story is emerging: (82)

• CBS News has uncovered information that calls into question the credibility of the anthrax vaccine. In April, the General Accounting Office echoed concerns of the refusnik marines, reporting "the long-term safety of the vaccine has not yet been studied".
• The Food and Drug Administration questions whether the vaccine even works against wartime use of anthrax spread through the air: "its efficacy against inhalation anthrax is not well documented."
• In 1997, when the FDA finally gave the Pentagon permission to use the vaccine for mass immunizations, it was anything but a ringing endorsement. "There is a paucity of data regarding the effectiveness of anthrax vaccine," wrote Lead Deputy FDA Commissioner Michael Friedman.

• 19 June 1999 – At least six pilots in the Wisconsin Air National Guard are expected to refuse anthrax vaccines ordered by the U.S. Department of Defense and could face expulsion from the service or be forced to resign. Mike Angarole, a lieutenant colonel and fighter pilot, said he hasn't officially refused to take the shots but has notified his commanders that he does not plan to take them by the July 24 deadline for Wisconsin Guard members. Another Wisconsin Guard pilot, Randy Psyk of Stoughton, said he has officially informed his unit commander that he will not take the anthrax shot. (83)
• June 1999 – US Air Force Reserve Colonel Redmond Handy speaks out against the AVIP. Col. Handy is the 1996 National Award Recipient -- Reserve Officer Association Outstanding Individual Air Force Reserve Officer of the Year -- Chosen from among 5,000 eligible field grade individual (non-unit) reservists. Active Duty and Reserve from 1975 to 1999, Col. Handy attained the rank of O-6 before retiring as a Ltc in deference to the AVIP. Col. Handy served numerous special Pentagon tours for the last 7 years supporting the AF Reserve and logistics. Col. Handy testified at the first hearing to review the AVIP setting the precedent for senior military officers to professionally encourage a review of the anthrax policy. (84)
• 24 June 1999 – NEWS RELEASE: Congressman Christopher Shays of Connecticut, and the House Subcommittee on National Security, Veteran Affairs and International Relations will convene June 30 for a Hearing on the DOD's Sole Source Procurement of the Anthrax Vaccine. "Since the Gulf War, DOD has pursued a sole source strategy to acquire anthrax vaccine," Chairman Shays said. "Other production sources and other vaccines were not pursued. Now the Pentagon is locked in a dependent relationship with a new, unproved company. It appears DOD may have misjudged the financial and technical capabilities of the company to perform under the contract." At the Subcommittee's request, the General Accounting Office (GAO) studied the structure and nature of the relationship between DOD and BioPort, and will present new findings at the hearing. Shays said, "A mandatory, force-wide immunization program ought to be based on more than an optimistic business plan. Resting on so weak a foundation, the anthrax vaccine program may not be safe or sustainable." (85)
• JUNE 1999 – US Marines imprisoned due to their professional dissent to a DOD policy. Servicemembers concerns, hearings in Congress, the impact on readiness, and media reports appear to support the need for further review.

• 29 June 1999 – Even as the Pentagon is conducting a comprehensive educational campaign to convince American troops that mandatory anthrax vaccinations are safe, military documents indicate high-level acknowledgment of potential dangers. Documents obtained by The San Diego Union-Tribune show that Secretary of the Army Louis Caldera agreed in September 1998 to accept the burden of potential liability claims made against the vaccine manufacturer by service members. The vaccine, according to a memo signed by Caldera, "involves unusually hazardous risks associated with the potential for adverse reactions in some recipients and the possibility that the desired immunological effect will not be obtained by all recipients." Moreover, the Secretary concluded, "there is no way to be certain that the pathogen used in tests measuring vaccine efficacy will be sufficiently similar to the pathogen that U.S. forces might encounter" during warfare. (86)
• 1 July 1999 – The Washington Post reports that the only U.S. company that produces anthrax vaccine has run into serious financial trouble, imperiling a Pentagon program launched recently to immunize all U.S. troops against the deadly germ warfare agent said Rep. Christopher Shays (R-Conn.), who yesterday chaired a House subcommittee hearing on the matter. He pressed BioPort executives on how they could have so miscalculated, and he chided Pentagon authorities for making a critical program dependent on a newly established manufacturer that evidently was undercapitalized and overly optimistic about its prospects. "BioPort's financial troubles engender fears that cost-cutting will affect vaccine quality. It should raise grave concerns about the security of the sole production facility and the predictability of vaccine supply," Shays said. Top officials from BioPort Corp. said yesterday that renovation delays and other transition problems after their purchase of the vaccine production facility from the state of Michigan have pushed the company close to bankruptcy. Unless the Pentagon agrees to more than triple the price it pays for the vaccine--from $3.50 to about $10 per dose--company officials suggested they have little hope of meeting the terms of a $29 million contract with the Defense Department. (87)
• 4 July 1999, Independence Day – Effort of citizens, parents, and military members uncovered a second indemnity document repeating language disputing earlier claims of safety and efficacy by the DOD. The new document also dealt with the production of anthrax and relieved an additional contractor from liability. The Secretary of the Army, M.P.W. Stone, on 3 September 1991, granted the MEMORANDUM OF DECISION under the authority Public Law 85-804 to include an indemnification clause in contract DAMD17-91-C1086 between Program Resources, Inc. (a wholly owned subsidiary of DynCorp.) and the US Army's Medical, Research and Development Command (USAMRDC). According to the indemnity document the contract stipulated that after bulk lots have been produced, the vaccine would be shipped to the Michigan Department of Public Health (MDPH) in Lansing, Michigan. There, under separate contract, MDPH would perform the purity testing, bottling and labeling of the vaccine. This contract would be performed in conjunction with Interagency Support Agreement No. Y03-CO-10567 between the National Cancer Institute and USAMRDC. The obligation assumed by PRI under this contract involves unusually hazardous risks associated with potentially severe adverse reactions and the potential lack of efficacy of the anthrax vaccine. According to the document these concerns stemmed from:

1. The limited use of the vaccine to date, i.e., tests prior to approval of a vaccine by the Food and Drug Administration were on too small a scale to permit accurate assessments of types and severity of adverse reactions (only widespread use can provide this assessment);
2. Insufficient experience in mass immunization programs to have truly evaluated the efficacy of the vaccine. Moreover, there was no way to predict whether the pathogen against which the vaccine could be used would be sufficiently similar to the pathogen used in tests to ensure vaccine efficacy. The Sec. of the Army found that performance of this contract would subject PRI to certain unusually hazardous risks defined in ATTACHMENT A:

• 12 July 1999 -- Responding to concerns about the safety of anthrax immunizations, the Department of Defense now plans a study on the vaccines' long-term health effects. Although the vaccine has been licensed since 1970, no long-term studies have been done on the long-term effects. Fear of the unknown is causing concern among service members, particularly among the 300,000 who have received the shot. Many are alarmed by a notice included in the vaccine which says no studies have been performed to determine whether the vaccine could affect reproduction or cause cancer. Those two questions are among the issues to be addressed by the long-term study, said Army Maj. Guy Strawder, director of the Anthrax Vaccine Immunization Program Agency. The lack of long-term studies "is the number one concern right now of service members," he said. But, he said, the anthrax vaccine is being held to "a higher standard" than other vaccines, which also lack long-term studies. A six-person team will design the study -- three from the Department of Defense and three from the private sector. (89)
• 14 July 1999 -- POC -- (202) 225-2548, Congressman Christopher Shays convenes July 21 Hearing on adverse reactions of DOD's Anthrax Vaccine Program. Hearing on July 21 to examine the Anthrax Vaccine Immunization Program (AVIP), focusing on the willingness and ability of the Department of Defense to acknowledge, diagnose and treat adverse reactions. The hearing was announced today by Congressman Dan Burton (R-IN), Chairman of the Committee on Government Reform. "The rigorous practice of medicine, not aggressive public relations, should be driving the adverse event reporting process," Shays said. "But it appears the program glosses over potential side-effects, fails to offer legitimate medical exemptions from the inoculation, and resists attempts to associate adverse reactions with the vaccine. So we have to ask: Who's protecting the force from the harm caused by this medical force protection program?" (90)
• 16 July 1999 -- CONTACT: Kimberly Nielsen, 202-225-3415; JONES CALLS FOR ANTHRAX VACCINE PROGRAM TO BE MADE VOLUNTARY -- Bill Scraps Mandatory Program Until FDA Approves New Vaccination or Reduced Shot Course -- Congressman Walter B. Jones (R-NC), Member of the House Committee on Armed Services, today introduced legislation to make the current Department of Defense anthrax vaccination immunization program voluntary for all members of the Uniformed Services. Jones' bill, the American Military Health Protection Act, will make the current mandatory program voluntary to United States military personnel until the Food and Drug Administration (FDA) approves a new anthrax vaccination for humans or approves a reduced course of shots, down from the existing six-shot program. "The lack of a single, conclusive independent study on the long-term health effects of the anthrax vaccine in humans has created legitimate growing concerns among our men and women in uniform," Jones said. "Despite continued assurances by the Department of Defense that adverse reactions to the vaccination are minimal, the Department's standards used to measure the reactions haven't been able to support their claims." (91)
• 21 July 99 -- Additional Legislation announced by Congressman Gilman, NY -- Department of Defense Anthrax Vaccination Moratorium Act, HR 2548 IH 106th CONGRESS -- To suspend further implementation of the Department of Defense anthrax vaccination program until the vaccine is determined to be safe and effective and to provide for a study by the National Institutes of Health of that vaccine. The Secretary of Defense set out four specific conditions that had to be met before the vaccination program could start: First, supplemental testing to assure sterility, safety, potency, and purity of the vaccine stockpile; second, implementation of a system for fully tracking anthrax immunizations; third, approval of operational plans to administer the vaccine and communications plans to inform military personnel; and fourth, review of medical aspects of the program by an independent expert.

• According to the hearing testimony before the subcommittee, none of these conditions was satisfactorily addressed before the vaccine program was implemented.

• An ongoing Air Reserve Component effort by Servicemembers to tabulate current and future attrition due to transfers, retirements and resignations, as well as reported reactions, due to the Anthrax Vaccine Immunization (AVIP) Policy is represented by the data below:

[The tabulated data below is constantly being updated to reflect maximum accuracy. It is a compilation of concerned Servicemembers and citizen's inputs from around the country to aid in the ongoing investigations and inquiries by Congressional sources. The objective is to analyze future retention implications so that long-term readiness will not suffer. This data represents a small fraction of the total Guard and Reserve force. (113).]

Updated by: Major Thomas L. Rempfer

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