June 21, 1968 |
Letter by the Public Health Service Ad Hoc Committee granted licensing recommendation for the anthrax vaccine. |
Michigan Department of Public Health’s license for the anthrax vaccine is recommended pending the submission of supporting human clinical efficacy data. This data was requested by CDC, however the study ultimately did not guarantee efficacy, as noted by Margaret Pittman at NIH. It also did a poor job of guaranteeing safety, performing active surveillance only at 48 hours post-vaccination and only for injection site reactions. Statistical analysis of the data was confounded by arithmetic errors. One nurse's observations of a large number of systemic reactions at the largest mill involved in the study were dismissed. |
February 6, 1969 |
Letter by the Public Health Service Ad Hoc Committee Evaluation of initial anthrax vaccine’s Clinical data. |
Initial submission of controlled human clinical data establishing efficacy is rejected as inadequate: "…persons in the Talladega mill can hardly be accepted as scientific evidence for efficacy of the vaccine." |
February 10, 1969 |
Letter by the Public Health Service |
Ad Hoc Committee recommends the license be granted pending CDC request of "data with a view to determine human efficacy of the product." |
November 2, 1970 |
Letter by the Public Health Service |
Anthrax Vaccine License granted despite not conducting a controlled field trial. Data from an earlier trial (known as the Brachman Study, using a different vaccine prepared by Merck, Sharp, & Dohme) was provided to satisfy the licensing requirements established by the Public Health Service. GAO reported on April 29, 1999 that this vaccine differed from the original vaccine in three ways. First, the Manufacturing process changed when MDPH took over. Second, the strain of anthrax that Merck used to grow the original vaccine was changed, and another strain was used to grow the MDPH vaccine. Finally, to increase the yield of the protective antigen (which is believed to be an important part of the vaccine's protective effects), the ingredients used to make vaccine were changed from the original vaccine |
November 20, 1973 |
FDA publishes standards for making, using and storing MDPH/Bioport anthrax vaccine -- Federal Register Vol. 38, No. 223, pages 32067-32068. Established in Title 21 of the Code of Federal Regulations Sections 620.20 - 620.25 for Anthrax Vaccine, Adsorbed (AVA). |
Section 620.24 specified "These standards are based on a single human dose of 0.5 ml and a total primary immunizing doses [sic] of three single doses." … Section 620.25 said "Modification of any particular manufacturing method or process or the conditions under which it is conducted as set forth in the additional standards relating to anthrax vaccine, shall be permitted whenever the manufacturer presents evidence that demonstrates the modification will provide assurances of the safety, purity and potency of the vaccine that are equal to or greater than the assurances provided by such standards, and the Commissioner of Food and Drugs so finds and makes such findings a matter of official record." There is no record of the manufacturer presenting evidence, or FDA approval, of any changes to the license from three to six doses. |
December 13, 1985 |
FDA Specific Product Review of the Vaccine as printed in the Federal Register, CFR 620 |
"Anthrax vaccine … efficacy against inhalation anthrax is not well documented." "The vaccine manufactured by the Michigan Department of Public Health has not been employed in a controlled field trial. Brachman employed a similar vaccine prepared by Merck Sharp & Dohme for Fort Detrick in a placebo-controlled field trial in mills processing imported goat hair. … No meaningful assessment of its value against inhalation anthrax is possible due to its low incidence." … "There is a conflict, however, with additional standards for anthrax vaccine. Section 620.24(a) (21 CFR 620.24(a)) defines a total primary immunizing dose a 3 single doses of 0.5 ml. The labeling defines primary immunization as 6 doses (0, 2, and 4 weeks plus 6, 12, and 18 months). …Labeling revisions in accordance with this Report are recommended." |
1988 |
Army contracts for experimental MDPH [Bioport] anthrax vaccine |
Ft Detrick bought 300,000 doses for $7.60 each. Page 3, Section C.2, Specifications, says, "The objective is to procure sufficient anthrax vaccine to immunize 100,000 personnel. The government shall consider three immunizations per individual sufficient to complete the initial series; therefore, a minimum of 300,000 shall be acquired." This language is contrary to the license and therefore, experimental. |
March 1990 |
Army Doctor describes the anthrax vaccine as an "experimental" |
Dr Takafuji of the Army Surgeon General’s office describes the anthrax vaccine as an "experimental deployment vaccine." (Infectious Disease Clinics of North America, 3/90, p. 156) |
September 4, 1990 |
Anthrax vaccine meeting at FDA concerning unresolved potency testing problems |
FDA and MDPH aware of problems with potency test as early as 1990 but have yet to develop an accurate test for potency. As late as October of 2000 the potency testing problems continue to be unresolved. |
January 28, 1991 |
Senate Government Affairs Hearing on anthrax vaccine use by DoD |
Congressional hearing reveals that military officials told Senator John Glenn's Government Affairs Committee in August 1989 that the only available anthrax vaccine was not suited to mass troop vaccinations because of a "higher than normal rate of reactogenicity," or adverse medical effects, and its relative lack of effectiveness once troops were exposed to the germ. |
August 1992 |
Army doctors write that biowarfare vaccines are always experimental |
Military Medicine, 8/92, p. 404 (article by 2 Army physicians): "products designed to protect against chemical and biological agents . . . never advance beyond the investigational stage." |
October 6, 1992 |
US Army Researcher reports on efficacy test results |
Dr Arthur Friedlander, USAMRIID, provided a memo summarizing the results of animal tests prepared by Dr Bruce Ivins on the efficacy of the MDPH vaccine. Dr Ivins reported that the MDPH-PA vaccine afforded little or no protection against certain other strains. Dr Ivins concluded the vaccine provided some protection at very low level exposures, but virtually no protection at higher exposure. |
May 7, 1993 |
FDA conducts first inspection of Michigan Department of Public Health Anthrax Vaccine Production |
From FDA Warning letter issued later that year: " we note that significant deviations have been documented during previous FDA inspections of May 4 through May 7,1993 … The seriousness of these deficiencies was emphasized to you in a letter dated December 22,1993." |
February 9, 1994 |
Acting ASD (Health Affairs), Admiral Martin, criticizes DoD vaccine stockpiling decision |
Acting Assistant Secretary of Defense for Health Affairs (ASD/HA), Admiral Ed Martin asserts the biological warfare vaccines would be controversial, would send the enemy the wrong message, and included possible informed consent requirements. He recommended rescinding the Chairman of the Joint Chiefs of Staff Memo dated May 1991 (SECRET) that established the need for BW vaccines. |
May 25, 1994 |
Senate Report reveals the sale of Bacillus Anthracis to Iraq by US firms |
The Riegle Report stated that before the Gulf War "records… show that during this time, pathogenic … toxigenic… and other biological research materials were exported to Iraq pursuant to application and licensing by the U.S. Department of Commerce." |
1994 |
Senate Report 103-97 deems anthrax vaccine considered investigational when used as a protection against biological warfare |
"FINDINGS AND CONCLUSIONS: Records of anthrax vaccinations are not suitable to evaluate safety (Note 61-63). …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." |
1994 |
Medical Textbook Vaccines by Chief Army Medical Researcher questions efficacy of anthrax vaccine |
1994 -- Textbook "Vaccines," in a chapter on the anthrax vaccine absorbed, questions effectiveness against inhalation anthrax infection, by US Army Col. Arthur M. Friedlander, ed. Plotkin and Mortimer, (Philadelphia: W. B. Saunders Company, 1994), pg. 737. |
February 2, 1995 |
US Army Operational Requirements Document dictating a need for an Improved Anthrax Vaccine |
Paragraph 3 described the "Shortcomings of Existing Systems" (meaning MDPH/BIOPORT’s anthrax vaccine): "The currently licensed human anthrax vaccine is available for persons at risk of acquiring anthrax, specifically those working with animals and unprocessed animal products, such as hides, wool, meat and bones. This vaccine is inoculated sub-cutaneously and occasionally causes locally painful reactions. Six immunizations are required initially, with yearly booster inoculations thereafter. This immunization schedule creates serious logistical obstacles, especially for reserve forces. In addition, recent reports suggest that this vaccine may not provide universal protection against all anthrax strains." |
August 31, 1995 |
FDA letter Warning Letter to the anthrax vaccine manufacturer |
FDA issued an official Warning Letter to the anthrax vaccine manufacturer based on an inspection conducted on April 28 to May 5, 1995. The letter detailed numerous deviations from manufacturing standards, including poor quality control, contamination, lack of personnel training, and inadequate documentation. |
October 20, 1995 |
DoD Joint Project Office meeting to discuss obtaining approval for the anthrax vaccine for use against inhaled anthrax and for a reduced dosage schedule |
Important internal documents detailing discussions between DoD and the anthrax vaccine manufacturer in late 1995 acknowledged that data to support efficacy in humans for inhalation anthrax did not exist. A US Army/Joint Program Office for Biological Defense memorandum dated 13 Nov 1995 said: During a 20 Oct 1995 meeting Dr. Arthur Friedlander, Chief of Bacteriology of the US Army Medical Research Institute for Infectious Diseases, stated that: ‘it is impossible to conduct human studies involving inhalation of anthrax spores; therefore, animal models must be developed, and the data related to humans.’ He noted that, ‘there was insufficient data to demonstrate protection and against inhalation disease.’ … There was extensive discussion in the 20 Oct 1995 meeting about the consequences of placing the anthrax vaccine into IND status, which would be required to obtain FDA approval for an indication reflecting efficacy for inhalation anthrax. … Brigadier General Walter Busbee, then-Joint Program Manager for Biological Defense, stated that "the DoD position is 'soldier's are citizen's first and whatever studies are formulated, they have to be done with this concept in mind. Soldiers have the same Constitutional rights as other citizens.’ Finally, the meeting minutes include a remark by BGen Busbee that there is ‘a need to make the case that anthrax is currently the principal biological warfare (BW) threat.’... A primary matter of discussion was how to reduce the recommended dosage to a two-shot schedule. Col. Friedlander reportedly said, "There is no evidence that six doses are necessary to protect humans against anthrax infection." The minute’s report that even in 1995 lab workers were considered protected with only three immunizations (shots). SAIC’s Dr Walter Brandt said the original vaccine made by Merck was the one tested on humans. After two fully immunized workers at Ft Detrick and one at a wool mill became infected with anthrax, an investigator "arbitrarily recommended" three more immunizations." |
September 16, 1996 |
Deputy SecDef Memorandum |
Annual Validation and Prioritization of Biological Warfare Threats to DoD Personnel "makes the case" that anthrax is the top BW threat |
September 20, 1996 |
IND (Investigational New Drug) Application submitted by MBPI, and anthrax vaccine manufacturer, to obtain inhalation anthrax approval |
This IND application is still pending with the FDA. It is interesting to note that the original human efficacy trial data for the current vaccine requested by the CDC in 1969 has never been provided. Additionally, the Federal Register and all the published medical literature maintain that the anthrax vaccine’s efficacy against inhalation anthrax is unknown. |
October 2, 1996 |
Washington Post documents reversal by top DOD official despite earlier opposition to mass anthrax inoculations |
"Reversing earlier opposition, the nation's military chiefs have endorsed a plan to vaccinate all U.S. forces against anthrax in what would be the Pentagon's first regular inoculation program against a germ warfare agent, Defense Department officials said. … Military leaders initially were dubious about the need for the anthrax vaccine, instead favoring work on a multipurpose vaccine that could counter a number of biological warfare agents. … In addition, some commanders thought that the United States could deter an enemy from launching an anthrax attack simply by threatening massive retaliation -- an approach that worked in the Persian Gulf War in preventing Iraq from using biological and other unconventional weapons. Some military leaders also needed to be reassured the vaccine has no debilitating side effects. … ‘The meetings were unusual in that we were starting at the top instead of trying to staff an issue from the bottom up,’ said one of the organizers." ("Military Chiefs Back Anthrax Inoculations," By Bradley Graham, Washington Post,; Page A01) |
October 2, 1996 |
Senator Rockefeller Protests to FDA about the Pentagon Announcement to vaccinate service members against anthrax |
In a letter to FDA Commissioner David Kessler, Senator Rockefeller notes that given "the multitude of questions" surrounding the use of PB tabs in the Gulf War, "detailed information about testing, side effects, and record keeping should be provided to the troops, the Congress, and the public before soldiers are ordered to take another vaccine." The senator requested a myriad of data and information on the vaccine and the decision-making process used to determine necessity. Program implementation is delayed. |
February 18, 1997 |
Internal FDA Memo by Karen Goldenthal indicates DOD usage of AVA could be experimental |
Dr Goldenthal indicates that if the military plans on using a different dosage regimen than the 6 shot protocol approved by the FDA, then informed consent would be appropriate. |
February 26, 1997 |
Internal FDA memo acknowledging the legal issues surrounding the anthrax mass vaccination |
Internal FDA memo from Mary Pendergast to Jeanne Novak referencing anthrax mass vaccinations: "I do not want to attend the meeting with DOD, but I would like a briefing afterwards by FDA staff. This is a scientific/legal issue … It is important for General Counsel to be there." |
March 4, 1997 |
DOD letter to new FDA Commissioner in an attempt to obtain inhalation exposure approval interpretation |
Assistant Secretary of Defense for Health Affairs, Dr. Joseph, wrote to FDA stating: "While the package insert for this vaccine is non-specific as to route of exposure, DoD has long interpreted the scope of the license to include inhalation exposure, including that which would occur in a biological warfare context. Please advise whether FDA has any objection to our interpretation of the scope of the licensure for the anthrax vaccine." It is noteworthy that this letter from DoD to FDA was sent four days after the resignation of former FDA Commissioner Dr. Kessler, and was addressed to the Lead Deputy Commissioner, Dr. Michael Friedman. Dr. Joseph's assertion that DoD had "long held" that the license included an indication for inhalation anthrax is undercut by internal DoD documents and the inclusion of a new indication as one of the reasons for the IND application that DoD prepared for the manufacturer. |
March 13, 1997 |
FDA responds to DoD’s request for inhalation anthrax approval interpretation |
FDA's Lead Deputy Commissioner, Dr. Friedman, responded to DoD in a letter that stated: "While there is a paucity of data regarding the effectiveness of Anthrax Vaccine for prevention of inhalation anthrax, the current package insert does not preclude this use...Therefore, I believe your interpretation is not inconsistent with the current label." In this memo FDA acknowledges the lack of efficacy of anthrax vaccine IAW the government and medical documents over the previous three decades. A personal opinion by a FDA official does not satisfy the requirements of the CFR’s Advisory Opinion process and is not legally binding. |
March 14, 1997 |
FDA memo correcting DOD press releases |
Dr Karen Goldenthal, FDA Public Health Service, in a memo to Lori Harrison, disputed a DoD press release indicating that "each batch of vaccine is tested for potency and safety by the FDA." In actuality, Dr Goldenthal said the truth was that "While FDA does review protocols [test plans] for lot release, not every lot is tested. In fact, Dr Fitzgerald indicated that NO lots have been tested from 1993 to the present." This is contrary to the requirements of the CFR’s. |
March 20, 1997 |
FDA NOIR (Notice of Intent to Revoke License) submitted to the anthrax vaccine manufacturer |
FDA sent a letter to the anthrax vaccine manufacturer that was a Notice of Intent to Revoke (NOIR) the manufacturer's license. It detailed "numerous significant deviations" from FDA manufacturing standards. To emphasize the recurring problems FDA had found at the manufacturer's plant, the FDA letter stated: "While these deviations were documented in the most recent inspection, we note that significant deviations have been documented during previous FDA inspections of May 4 through May 7, 1993; May 31 through June 3, 1994; and April 24 through May 5, 1995. The seriousness of these deficiencies was emphasized to you in a letter dated December 22,1993, and a Warning Letter dated August 31, 1995." (FDA letter to MBPI, 20 Feb 1997). |
July 31, 1997 |
SecDef fires USAF General for failing to adequately protect US forces in Saudi Arabia |
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." |
November 8, 1997 |
President Clinton announces a "Force Health Protection" program |
President Clinton announced a "Force Health Protection" program as the US was deploying thousands of troops to the Persian Gulf in response to Iraq's expulsion of UN arms inspectors. On 15 Dec 1997 DoD announced the anthrax vaccination policy as a prototype component of the President's "Force Health Protection" program. At a press conference announcing the program, a DoD spokesman stated, "Vaccination is safe, it's effective, it is a legitimate vaccination. It fits with our strategic concepts..." This was the beginning of claims by DoD about the safety and efficacy of the anthrax vaccine that have not been substantiated by science, and were inconsistent with internal DoD documents and governmental and medical literature pre-dating the. |
November 15, 1997 |
Joint Program Office for Biological Defense published a briefing |
Joint Program Office for Biological Defense published a briefing chart showing some drawbacks to the use of vaccines. In this chart, "1% to 4.72% [of fully inoculated people] do not develop adequate immunity." The chart shows what would happen to a fighting force of 100,000 marines after an attack with anthrax. Since 5% will not have immunity even though they were fully inoculated, the "warfighting strength will be at 95%. Expect 1,250 to 5,000 casualties." |
December 15, 1997 |
DOD Press Release -- DEFENSE DEPARTMENT TO START IMMUNIZING TROOPS AGAINST ANTHRAX |
SecDef Cohen instructs the military to start the anthrax program after several conditions are met: 1. Supplemental testing, consistent with Food and Drug Administration standards, to assure sterility, safety, potency and purity of the vaccine. 2. Implementation of a system for fully tracking personnel who receive the anthrax vaccinations. 3. Approval of appropriate operational plans to administer the immunizations and communications plans to inform military personnel of the overall program. 4. Review of health and medical issues of the program by an independent expert. RADM Cowan, Joint Staff J-4, attends a DOD press background briefing the day AVIP is announced. 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." |
February 19, 1998 |
Fourth pre-condition for independent expert review of anthrax program is announced as complete |
DoD received a report on the anthrax vaccine policy from Dr. Gerard Burrow of Yale University. Dr. Burrow, a gynecologist, had been asked by now-Deputy Secretary of Defense Rudy DeLeon to act as an "independent expert" to review the proposed AVIP, and Burrow's "approval" was made a prerequisite by the Secretary of Defense for DoD to proceed with immunizations. Dr. Burrow concluded, "The anthrax vaccine appears to be safe and offers the best available protection against wild-type anthrax as a biological warfare agent." Yet when Dr. Burrow was asked by Congress to testify at a 29 Apr 1999 hearing about his review, he declined. In a 26 Apr 1999 letter to the Representative Christopher Shays, Burrow stated: "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." |
February 20, 1998 |
FDA deems: "The manufacturing process for Anthrax Vaccine is not validated" in an FDA inspection report |
FDA inspection report, dated 20 Feb 1998, found: "The manufacturing process for Anthrax Vaccine is not validated." The FDA's report documented numerous instances of redating of vaccine lots that had either expired or failed potency testing. All of the vaccine given to US troops under the AVIP to-date has come from a stockpile that was manufactured or re-dated during the 1993-1998 period of repeated failed FDA inspections. In January 1998, just a few weeks before the FDA was to return to the anthrax vaccine manufacturer, MBPI (now Bioport, Inc), unilaterally stopped production of the anthrax vaccine because of "renovations". |
March 3, 1998 |
DOD Press Release -- ACCELERATED ANTHRAX VACCINATION PROGRAM TO ENHANCE FORCE PROTECTION ANNOUNCED |
"Secretary of Defense William S. Cohen announced today his decision to vaccinate U.S. military personnel deployed to the Arabian Gulf region against the biological warfare agent anthrax" …"When the military-wide anthrax immunization plan was first announced last December, Cohen specified that four conditions be met before vaccinations would begin. Work on each of these items for use by the U.S. Central Command is complete." |
May 5, 1998 |
DoD policy on use of antibiotics |
In policy memorandum that was posted on the Defense anthrax internet web page, the Acting Assistant Secretary of Defense, Gary Christopherson reiterated DoD’s policy from the Gulf War. When there is suspected exposure to anthrax all persons must take antibiotic treatment, regardless of whether they had previously been inoculated with anthrax vaccine. He wrote, "Antibiotics taken after exposure to a large number of anthrax bacteria, such as would occur after a weaponized release, will probably result in greater protection than is afforded by the vaccine alone." |
May 22, 1998 |
DOD Press Release -- TOTAL FORCE ANTHRAX VACCINATION DECISION ANNOUNCED |
Cohen explained that, "I have approved implementation of the Anthrax Vaccination Program for the total force. This is an efficient, effective and safe way to protect our forces against an emerging threat." |
September 3, 1998 |
DOD grants indemnification from lawsuits to the anthrax vaccine manufacturer |
MEMORANDUM OF DECISION -- SUBJECT: Authority Under Public Law 85-804 to Include an Indemnification Clause in Contract DAMD17-91-C1086 with Michigan Biologic Products Institute (MBPI) … "The obligation assumed by MBPI under this contract 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. Although AVA has been extensively tested under the auspices of the Food and Drug Administration, the size of the proposed vaccination program may reveal unforewarned idiosyncratic adverse reactions. Moreover, 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 to confer immunity. These concerns, coupled with the uncertain and evolving state of product liability law with regard to vaccines, lead me to the conclusion that the performance of this contract will subject MBPI to certain unusually hazardous risks. /signed/ Louis Caldera, S E C R E T A R Y O F T H E A R M Y |
October 26, 1998 |
Lawsuit Filed against Bioport for defrauding the State of Michigan |
Michigan State Representative Lingg Brewer and others file a complaint in the Michigan Court of Claims that Bioport is defrauding the State of Michigan. Allegations are of Conflict of interest on part of state plant employees responsible for getting highest price for the state who were trying to purchase the plant for themselves with Bioport officials at the lowest possible price, Conspiracy to rig bids, and negligent misrepresentation. |
January 11, 1999 |
BIOPORT objects to DOD selling AVA to foreign militaries |
Retried Admiral Crowe writes SecDef Cohen to obtain assurances that increases Pentagon AVA sales will not occur and thus interfere with BIOPORT’s plans to sell AVA overseas itself and thus interrupt a lower DOD price and availability. BIOPORT needs overseas sales to finance its lower price to DOD. |
January 15, 1999 |
Hartford Courant reports the first of hundreds of mass resignations of Air Force Reserve and Air National Guard Pilots over the Anthrax vaccine mandate |
When the first unit in the Air Reserve Components faced mandatory inoculation, eight Connecticut Air National Guard pilots (25% of the combat arm of the unit) refuse anthrax vaccine and are forced to resign and transfer from their unit. After researching the AVIP issues the officers chose to resign and transfer in lieu of disobeying a direct verbal order from their Commander. ("Pilots Quit Bradley Unit In Anthrax Dispute," Hartford Courant, 15 Jan 1999) |
March 24, 1999 |
Government Reform Committee’s Subcommittee on National Security, Veterans Affairs, and International Relations hearing entitled, "The Anthrax Immunization Program" |
First hearing responding to service member’s complaints of program insensitivity to adverse health effects, inadequate medical record keeping and heavy-handed program operation, the Subcommittee initiated an oversight investigation into the design and implementation of the Department of Defense (DOD) force-wide, mandatory Anthrax Vaccine Immunization Program (AVIP). Because the anthrax vaccine is still being studied as a potential causative or contributing factor in Gulf War veterans illnesses (PL 105-277, Title XVI, sec. 1603(d).), the Subcommittee measured the program against this standard. |
April 1, 1999 |
Association of American Physicians and Surgeons & Doctors for Disaster Preparedness submit a statements in the Congressional record opposing the AVIP |
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." |
April 5, 1999 |
US Army admits that widespread use of the anthrax vaccine by veterinarians claim by the DOD referred to military laboratory researchers only |
In an article published in the Army Times newspaper the US Army admitted that their claims of widespread use of the anthrax vaccine referred to use by military researchers. Subsequently the "education" materials distributed to US Armed Forces members are modified to say the vaccination is widely used by "at risk" veterinarians instead of the previous claims of widespread use by veterinarians nationwide. |
April 22, 1999 |
Congressman Jones writes SecDef |
Urges a moratorium on the anthrax program until further studies resolve questions |
April 29, 1999 |
Government Reform Committee’s Subcommittee on National Security, Veterans Affairs, and International Relations hearing entitled, "DoD’s Mandatory Anthrax Vaccine Immunization Program for Military Personnel" |
Mr. Kwai Chan, Director of Special Studies and Evaluations, National Security and International Affairs Division, General Accounting Office (GAO) made the following statements:
|
May 13, 1999 |
Rep Metcalf writes SecDef |
Requests clarification and study of the squalene controversy |
May 25, 1999 – |
DOD meeting was held at Fort Detrick, MD for 100 military physicians |
A DOD informational meeting was held at Fort Detrick, MD for 100 military physicians. Data presented cast doubts on previous DOD claims of safety of the anthrax vaccine. Briefing slides included the following statistics: 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. |
May 27, 1999 |
BIOPORT Requests Contract Modifications and Extraordinary Financial Relief |
Manufacturer asks for a $10.7million advance payment, release of some doses for foreign sales at higher prices, and price increases, among other provisions. Pentagon ultimately awards the manufacturer of the controversial anthrax vaccine a more than doubling of the price of the shots and an $18.7 million interest-free advance payment. |
June 11, 1999 – |
5 Marines face court-martials and are ultimately sent to prison, and 25 % of WI Air Guard fighter-pilots forced to resign for refusing the anthrax inoculation based on safety concerns |
Five Marines, who refused an anthrax vaccine at Twenty-Nine Palms MCAS, California were court-martialed and jailed, without being able to present defense arguments concerning the legality of the anthrax vaccine mandate. A judge ruled the men were given a lawful order when they were told to take the shot. Additionally, Wisconsin Air National Guard pilots who refused anthrax vaccines are forced to resign. |
June 30, 1999 |
Government Reform Committee’s Subcommittee on National Security, Veterans Affairs, and International Relations hearing entitled, "Department of Defense's Sole-Source Anthrax Vaccine Procurement" |
The anthrax vaccine manufacturer ‘s IND (Investigational New Drug) application to the FDA is revealed. DoD had prepared the IND application for the manufacturer. The IND application (FDA form 1571) listed three reasons for the application: 1) an Indication for Inhalation Anthrax, 2) Change in Vaccination Schedule, 3) Change in Route of Administration. The FDA has neither approved nor disapproved this IND application, and according to testimony by Bioport's CEO, Mr. Fuad El-Hibri, before the House Government Reform Committee on 30 Jun 1999, the IND application is still pending. While DoD is currently conducting trials (using informed consent) to support a change in dosage and route of administration, it has not obtained FDA approval for a protocol that would support a claim of efficacy for inhalation anthrax. |
July 12, 1999 |
DOD announces plans to conduct and publish long-term safety studies on the anthrax vaccine. |
Responding to concerns about the safety of anthrax immunizations, the Department of The Defense Department announces plans to study the anthrax 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 according to 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," A six-person team will design the study -- three from the Department of Defense and three from the private sector. |
July 20, 1999 |
Letter from six Congressmen to the Secretary of Defense |
"Dear Mr. Secretary: We are writing to you to express our concerns with the Anthrax vaccination program currently being implemented by the Department of Defense. … Mr. Secretary, you had set four specific conditions that had to be met before the vaccination program could start … According to the hearing testimony before the Subcommittee, none of these conditions was satisfactorily addressed before the vaccine program was implemented. While we do not want to duplicate the efforts of our colleagues who are pursuing their own investigations, we would request that you direct your attention to the following issues. … The first of these relates to the overall effectiveness of the vaccine. The FDA approval cited by the Defense Department was for a vaccine that was designed to protect workers in the woolen industry from cutaneous contact with anthrax spores. Conversely, the primary anthrax threat facing military personnel is not cutaneous, but weaponized versions of the bacteria, which are inhaled by their victims. There has been little or no testing of the vaccine's effectiveness in humans against this form of anthrax for obvious reasons. Additionally, we have yet to see any evidence from the Defense Department that this vaccine would be effective against altered or multiple anthrax strains. Given that the Soviet Union placed a high priority on the development of the deliverable multiple anthrax strains, this is a legitimate concern. Analyses of tissue samples from Russians killed in an accidental anthrax release from a production facility in the 1970s have indicated infection from a combination of individual strains. In fact, the Russian biowarfare expert, Ken Alibek, has even been quoted as saying vaccines aren't the answer. Given the extremely poor performance of the vaccine against even individual multiple strains in the Ft. Detrick guinea pig studies, does the Defense Department have any evidence that the vaccine currently being issued is effective against a combination of multiple anthrax strains? We are also concerned about the value of supplemental testing and whether such testing can really determine the sterility, potency, purity, and safety of the vaccine. Written GAO testimony from the April 29 hearing left this issue unresolved. They wrote, ". . . quality cannot be guaranteed for final tests on random samples but only from a combination of in-process tests, end-product tests, and strict controls of the entire manufacturing process." The FDA inspection results from February 1998 already indicate a significant lack of quality controls during manufacturing. It would seem that any damage done could not really be reversed at this point. Can you provide specific details of just how the supplemental testing process is able to overcome problems already present in the final vaccine product without remanufacturing the lots? |
July 21, 1999 |
GAO Report entitled: Medical Readiness: Issues Concerning the Anthrax Vaccine |
GAO noted that: "(1) no studies have been done to determine the optimum number of doses of the anthrax vaccine; (2) a study done during the early 1950s showed that animals could be protected against coetaneous anthrax using a three-dose schedule; (3) however, the number of doses was increased to six when three people who had received three doses of the vaccine were infected after exposure to anthrax; (4) in a study of the vaccine's human efficacy published in 1962, a six-dose schedule was used, and the researchers concluded that the vaccine provided protection against cutaneous exposure to anthrax; (5) in 1998, the manufacturer of the vaccine submitted a Food and Drug Administration (FDA) application to determine whether the number of shots in the initial schedule could be reduced from six to five; (6) although annual boosters are given, the need for this frequency and the amount of the booster dose has also not been evaluated; (7) Department of Defense (DOD) submits data on adverse events associated with the anthrax vaccine to the Vaccine Adverse Events Reporting System; (8) this system has several advantages; (9) it alerts FDA and Centers for Disease Control and Prevention (CDC) to previously unreported or unexpected increases in reported adverse events; (10) it is also a relatively affordable way to supplement the data collected on vaccines before they are licensed; (11) however, it is a passive surveillance system, which means that FDA and CDC must rely on vaccine recipients or their health care providers to report any adverse events after receiving the vaccine; studies show that adverse events are reported significantly less than they would be in an active surveillance system; (12) DOD has conducted three efforts to actively collect data on adverse reactions after service members received the anthrax vaccine; (13) data from these efforts show that women reported twice the rate of adverse reactions than men for both local and systemic reactions; (14) a higher proportion of women than men reported making an out patient medical visit after a vaccination, and more than twice the percentage of women reported that they missed one or more duty shifts after their vaccinations than did men; (15) the anthrax vaccine has several disadvantages; (16) the amount of protective antigen in the vaccine cannot be precisely measured, and it varies from lot to lot; and (17) also, the requirement for a six-dose schedule and annual booster shots, rather than a smaller number of doses, complicates the logistics of inoculating all of DoD’s troops and increases the cost of the vaccine program." |
July 23, 1999 |
DoD policy statement for DTRA employees |
Defense Threat Reduction Agency implements policy of "informed declination" for civilian employees for the anthrax vaccine. |
August 1999 |
BIOPORT AWARDED PRICE INCREASE |
Now at $10.64 per dose, costing taxpayers more than three times the original price |
August 3, 1999 |
Press Conference held by 6 legislators on the AVIP |
The Congressmen announce the submission of HRs #2548 and #2543 HR 2548 – provides a moratorium on the anthrax policy whereas HR 2543 makes the policy voluntary. |
August 23, 1999 |
Congressman Jones writes Secretary of State Albright on voluntary AVA use |
Calling the discrepancy "baffling and wrong" between State and Defense Departments voluntary vs. mandatory use of the AVA, the Congressman requests Secretary Albright for information on the DOS reasoning for their voluntary program. |
September 16, 1999 |
Congressman Gilman writes DOD Legislative Affairs requesting answers on several AVIP issues |
Specifically, a 60-day delay in administering the vaccine at Stewart, NY ANG base where many pilots intended to resign. The Congressman also noted the fact that General Weaver claimed only 1 pilot had resigned due to AVIP, while his staff had personally met with many aviators that had resigned or intended to over the AVIP. Finally, he requested an explanation on the "stark discrepancy" between mandatory shot for DOD personnel and voluntary ones for Defense Threat Reduction Agency employees who must inspect biowarfare facilities in Russia. |
September 29, 1999 |
Government Reform Committee’s Subcommittee on National Security, Veterans Affairs, and International Relations hearing entitled, "The Impact of the Anthrax Vaccine Program on Reserve and National Guard Units" |
Final Subcommittee hearing on the AVIP reveals several revelations by DOD and FDA. First, the Assistant Secretary of Defense for Reserve Affaires, Charles Cragin, announced that no one in the Guard or Reserve would be punished for refusing the anthrax vaccine. MG Weaver, the Director of the Air National Guard announced only one Servicemembers had departed due to the anthrax policy, while dozens to that date had been documented in the press and several were in the hearing room. MG Weaver agrees to survey all pilots departing the Air National Guard if the anthrax vaccine is a factor. DOD officials also assert they can give only three vaccinations to be protected which prompts the FDA to deliver a letter the same day clarifying that the six doses approved regimen is the only FDA approved protocol. |
September 30, 1999 |
House Armed Services Committee’s Subcommittee on Military Personnel hearing entitled, "Department of Defense Anthrax Vaccine Immunization Program" |
First House Armed Services Committee Hearing on AVIP. During this hearing the Chairman, Rep. Buyer, a lieutenant colonel in the Army Reserves, commented: 'What I find unique here at the moment is there is perhaps not a specialty in the force - pilots - that I end up spending so much of my personal time on their issues,' Buyer said. 'They are the most pampered in the world." The weekend following this hearing 28 aircrew, pilots and enlisted, plus 32 additional support personnel, refused to be inoculated with the vaccine in question at the TN ANG in Memphis and submitted their resignations or transfer requests. |
September 30, 1999 |
President Clinton signs Executive Order 13139 |
Coincident with the HASC hearing the Commander in Chief announced an Executive Order reaffirming that a waiver of Servicemember’s informed consent can only be directed by the President, thus maintaining accountability for such an act in war or state of national emergency at the highest level of government. |
October 13, 1999 |
Representative Nethercutt writes SecDef |
Expresses concern of the impact of AVIP on recruiting and retention, requests all records on punishment for refusers, transfers in Guard and Reserve, and vaccination schedules for Phases I and II implementation of the AVIP program. |
November 3, 1999 |
Congressional Letter asking FDA to deem the anthrax vaccine investigational |
Congressman Gilman, Jones, Burton and Shays deliver a message to the FDA asking them to deem the Anthrax vaccine as investigational in accordance with the Federal Register. The Representatives also asked for the FDA to address important issues such as redating and relabeling, and the questionable oversight of the FDA in the past three decades. |
November 9, 1999 |
Notice of Proposed Rulemaking (NPRM) announced by the FDA |
In a tacit acknowledgment that data to support efficacy of the anthrax vaccine and other new biowarfare product do not exist, the FDA published a Notice of Proposed Rulemaking (NPRM) in late 1999 intended to circumvent the current legal requirement that investigational new drugs may never proceed to a fully licensed status unless two separate human clinical trials demonstrating efficacy are conducted. On 9 Nov 1999 Dr. William Raub, HHS deputy assistant secretary for science policy, testified to Congress: ".... FDA is proposing to amend its new drug and biological product regulations to identify the information needed to provide substantial evidence of the efficacy of new drug and biological products… without adequate and well-controlled efficacy studies in humans (21 CFR 314.126)." |
November 10, 1999 |
American Public Health Association Policy Statement urges the US Department of Defense to delay any further immunization against anthrax using the current vaccine or at least to make immunization voluntary |
Policy Statement #9930 Adopted by the Governing Council of the American Public Health Association states: The APHA: "1. Urges the US Department of Defense to delay any further immunization against anthrax using the current vaccine or at least to make immunization voluntary; and 2. Urges that a commission of military and non-military public health experts be formed to review the evidence for effectiveness and safety of the current vaccine and the time at which an improved vaccine may be available, and to make recommendations about the continuation of the current immunization program. … This policy statement is based upon the controversy in the medical literature about the efficacy of the vaccine; the lack of valid monitoring of its potential adverse effects; and the stance taken by the United Kingdom and other allies that they receipt of the vaccine remain voluntary among their troops." |
November 23, 1999 |
FDA reiterates in an inspection deviation report that "The manufacturing process for the production of Anthrax Vaccine Adsorbed is not validated." |
A FDA inspection from 15-23 Nov 1999 of the anthrax vaccine manufacturer, Bioport, Inc., reiterated once again the failure to meet FDA standards. The FDA again concluded: "The manufacturing process for the production of Anthrax Vaccine Adsorbed is not validated." At a 13 Apr 2000 Senate Armed Services Committee hearing DoD officials admitted that they do not expect the FDA to certify the new anthrax vaccine production facility until late 2000 -- nearly three years after the old facility was. |
December 16, 1999 |
Letter to SecDef from 3 Congresswomen |
Letter notes new FDA labeling cautions for women, lack of data on safety and efficacy, indiscriminate vaccinations outside the threat area, and recommends making the vaccine voluntary for women of child-bearing age |
January, 2000 |
Over 50% of Air National Guard Fighter Pilots Quit over Anthrax inoculation mandate |
At both the Indiana Air National Guard at Ft. Wayne, and the Michigan Air National Guard at Battle Creek 50% of pilots resign over anthrax vaccine mandate despite the DOD official delay of mandatory Phase Two anthrax inoculations after the manufacture fails latest inspections. Regardless, local Commanders continue to enforce a mandatory inoculation or resignation policy. |
March 22, 2000 |
Office of Inspector General, Department of Defense, issued an audit report on Contracting for Anthrax Vaccine (Report D-2000-105) |
Report discovers over $2 million in taxpayer funds advanced to Bioport not spent on improvements to vaccine production, but spent on office remodeling, furniture for CEO, parking lot repaving, unwarranted travel expenses, unsubstantiated consulting costs, and an unrelated medical program. Additionally, senior managers plan on awarding themselves $1.2 million in bonuses. A retired employee is also collecting $10,000/month in severance and consulting fees. |
March 30, 2000 |
Institutes of Medicine reiterate GAO conclusions that the long-term safety of the anthrax vaccine is unknown. |
In response to a Congressional mandate, on 30 Mar 2000 the Institutes of Medicine submitted a preliminary report to DoD on the safety of the anthrax vaccine, but declined to issue an opinion on the efficacy of the anthrax vaccine. The IOM stated: "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." The IOM is planning a more detailed report on both the safety and efficacy of the anthrax vaccine, but it will take 24 months to complete. (See http://www.nap.edu/html/anthrax_vaccine/) |
April 3, 2000 |
Full Committee on Government Reform adopts the 17 Feb 2000 Subcommittee report recommending suspension of the experimental anthrax program |
UNPROVEN FORCE PROTECTION Findings in Brief 1. The AVIP is a well-intentioned but over-broad response to the anthrax threat. It represents a doctrinal departure over emphasizing the role of medical intervention in force protection. 2. The AVIP is vulnerable to supply shortages and price increases. The sole-source procurement of a vaccine that requires a dedicated production facility leaves DOD captive to old technology and a single, untested company. Research and development on a second-generation, recombinant vaccine would allow others to compete. 3. The AVIP is logistically too complex to succeed. Adherence to the rigid schedule of six inoculations over 18 months for 2.4 million members of a mobile force is unlikely, particularly in reserve components. Using an artificial standard that counts only shots more than 30 days overdue, DOD tolerates serious deviations from the Food and Drug Administration (FDA) approved schedule. 4. Safety of the vaccine is not being monitored adequately. The program is predisposed to ignore or understate potential safety problems due to reliance on a passive adverse event surveillance system and DOD institutional resistance to associating health effects with the vaccine. 5. Efficacy of the vaccine against biological warfare is uncertain. The vaccine was approved for protection against cutaneous (under the skin) infection in an occupational setting, not for use as mass protection against weaponized, aerosolized anthrax. Recommendations in Brief 1. The force-wide, mandatory AVIP should be suspended until DOD obtains approval for use of an improved vaccine. To accomplish this: 2. DOD should accelerate research and testing on a second-generation, recombinant anthrax vaccine; and, 3. DOD should pursue testing of the safety and efficacy of a shorter anthrax inoculation regimen; and, 4. DOD should enroll all anthrax vaccine recipients in a comprehensive clinical evaluation and treatment program for long term study. 5. 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. |
April 13, 2000 |
Senate Armed Services Committee first hearing on the anthrax vaccine program -- LTG Ronald Blanck, Army Surgeon General misrepresenting facts of the on the IND application to get inhalation anthrax approved |
Sen. Roberts: "General Blanck, the annual Congressionally mandated chemical and biological defense program report to Congress submitted on March 15, 2000, states: "The Department submitted data to the FDA last year to license the vaccine to provide protection against aerosol (inhalation) exposure to anthrax." My question is why is the Department seeking a license for the vaccine when the license for the anthrax vaccine has existed since 1970?" Gen. Blanck: "It is really for the facility, not for the vaccine per se." Sen. Roberts: "Oh, I see, okay. All right. That clears that up." To the contrary, the IND application was specifically for the anthrax vaccine absorbed, not the "facility per se." The modification sought by the manufacturer, at the request of and with DoD assistance, and would have applied regardless where the anthrax vaccine was manufactured. The 20 Sep 1996 IND application cover letter from the manufacturer, Michigan Biologic Products Institute, contains no mention of the facility. It simply states: "The purpose for filing this IND is to conduct clinical investigations designed to investigate changes in the approved labeling for the licensed product. The potential labeling changes would affect the specific clinical indication, route, and vaccination schedule for AVA [anthrax vaccine absorbed]." The IND application was submitted following an Army, Joint Staff, and OSD staff process where there was acknowledgement that it was necessary to obtain FDA approval of a new licensed indication for inhalation anthrax before DoD could start mass anthrax vaccinations. That consensus was reversed within a month of Mr. Cohen being confirmed as SecDef, with DoD pressure on FDA to give permission to begin vaccinations without obtaining a new licensed indication. |
May 16, 2000 |
34 Representatives write the SecDef |
Congressional members call for an end to the AVIP. |
June 2000 |
BIOPORT awarded new contract |
$2-$2.5 Million per month to cover costs related to getting the company to pass FDA approval of renovated anthrax production facilities |
June 16, 2000 |
Army ROTC Cadets receive anthrax vaccine overdose |
25 Army ROTC cadets at Ft. Lewis, WA were administered an Anthrax vaccine dosage that exceeded the authorized amount |
June 23, 2000 |
Letter from Chairman Dan Burton, Government Reform Committee, to Honorable William Cohen |
Letter explained how vaccinating officer candidates and cadets improperly adds to the growing list of concerns about the flawed AVIP. The Chairman requested 5 copies of program briefing information to ROTC cadets and midshipmen, an accounting of how many ROTC cadets have received the Anthrax vaccine, and an accounting of the adverse reactions of the Anthrax vaccine reported by ROTC cadets – by June 30, 2000. |
July 13, 2000 |
House Armed Services Committee’s Subcommittee on Military Personnel hearing entitled, "Department of Defenses’ Management of the Anthrax Vaccine |
During the first SASC hearing concerning the anthrax vaccine, Kathryn Zoon, Ph.D., Director, FDA’s Center for Biologics Evaluation And Research states: "FDA has no objection to DoD deviating from the approved shot protocol on the product license." To the contrary FDA’s Dr. Zoon wrote on September 29, 1999 that the FDA approved no deviation. Further she stated that FDA doesn’t regulate the DoD under oath on 12 Oct 1999 to the House Subcomm. On National Security in an answer to Rep Shays’ question on who’s regulating the DoD's use of the anthrax vaccine and who’s protecting the troops? What Dr. Zoon failed to tell the SASC was that informed consent is required if a regimen deviation is planned with the anthrax vaccine. |
July 27, 2000 |
Letter from Chairman Dan Burton, Government Reform Committee, to Mr. Joseph Lieberman, Office of the Inspector General, Department of Defense |
The letter requested an answer to why the DOD IG ignored and dismissed a complaint by 73 officers from 25 states regarding the alleged false statements of Mr. Charles L. Cragin, Principal Deputy Assistant Secretary of Defense (Reserve Affairs), and Major General Paul A. Weaver, Director of the Air National Guard, during congressional hearing on September 29, 1999 concerning attrition attributable to the AVIP (DOD Hotline case number 74998). As a result of this letter the case was reopened. |
July 28, 2000 |
FDA approves Ciprofloxacin for inhalation anthrax |
FDA approves Ciprofloxacin, produced by Bayer Corp, as the first licensed post-exposure protective measure against inhalation anthrax. |
August 9, 2000 |
News Release from Mr. Charles Cragin, Principal Deputy Assistant Secretary (Reserve Affairs) |
DOD announced a comprehensive satisfaction survey of military Reserve force personnel and their spouses. No where on the survey is the anthrax vaccine policy listed as a possible cause for any lack of morale or dissatisfaction that will lead to resignation, despite the specific direction from Chairman Shays on September 29, 1999 to survey this information in the Guard and Reserve. |
August 10, 2000 |
Response letter from Mr. Donald Mancuso, Acting Inspector General, Office of the Inspector General, Department of Defense |
The letter stated that at the time of the complaint the evidence did not suggest that the two senior DOD officials made false statements with intent to deceive. After re-examination, the IG is going to finally investigate, and will send results upon completion. |
August 15, 2000 |
Letter from Chairman Dan Burton, Government Reform Committee, to Honorable William Cohen, Secretary of Defense |
The letter requested that the scope of the Reserve force morale survey be expanded to include an assessment of the AVIP and the GWS impact upon Reserve Component personnel. The surveys were mailed on August 16, 2000 without these changes, despite a specific request to delay the delivery so these questions may be included. |
August 25, 2000 |
Bioport Scientists seek royalties for their part in changing the anthrax vaccine manufacturing process |
Bioport asks state of MI to help it retrieve legal transcripts that show the recipe for making the U.S. military's anthrax vaccine from their former scientists. who want royalties for their work on the anthrax vaccine. Bioport officials say the missing documents could help solve production problems that have kept the company from getting U.S. Food and Drug Administration approval of its renovated labs. The documents surfaced during a state hearing to determine whether the former state workers should get a portion of the vaccines' profits. Dr. George Burgoyne, Richard Hoort and Judith Boice filed a grievance with the state's Civil Service Hearings Division in 1998. "It was not until '88-'89 when the military showed interest in the vaccine that changes had to be made so that larger quantities quicker could be made. This was just before the Gulf War," Burgoyne, who headed the production, testified in a March 3 Civil Service hearing. Burgoyne also testified that the changes - including the use of additional filters and a new type of container to grow the vaccine - improved the vaccine's safety by ensuring sterility. The changes also made it cheaper to produce. |
August 30, 2000 |
Bioport Voluntarily Recalls Lot of Anthrax Vaccine, FDA |
The U.S. Food and Drug Administration said on its Web site that the Lansing, Michigan-based company, Bioport, voluntarily recalled the vaccine because the labeled expiration date, Sept. 9, 2001, was more than seven months after the correct expiration date of Feb. 3, 2001. The FDA also said Bioport is voluntarily recalling two other products because it can't assure those products are sterile. |
October, 2000 |
Navy faces 3 Court of Military Appeals cases on rulings against vaccine refusers based on unlawful order defense |
Defense arguments are based on the fact that the Pentagon is using a personal, inconclusive opinion of one FDA employee to say the FDA, as an institution, approves the vaccine for inhaled anthrax protection. More specifically, application procedures for formal FDA opinions are outlined in 21 C.F.R. § 10.85(k) and § 10.90. This process requires opinions be openly recorded for public comments. Dr. Friedman’s FDA memo completely circumvents these requirements, does not represent FDA approval, and thus has no effect on the vaccine. Additionally, a recent Supreme Court case (Christensen v. Harris County) notes that even formal opinion letters have no particular legal impact. Hence, DoD’s unapproved IND application for inhalation anthrax use, and the Congressional investigation conclusion that the vaccine is being used experimentally, both require informed consent or an optional anthrax vaccine policy be implemented. This is a requirement unless the President waives such informed consent IAW the law (Title 10, Section 1107 of the US Code) and /or Executive Order 13139. Such waiver has not been given for using the anthrax vaccine for protection against inhaled exposure, thus a mandatory vaccine policy is unlawful. |
September 27, 2000 |
Congressman Jack Metcalf released a report culminating a three year investigation into the conduct of the DOD with regard to the possibility that squalene, a substance in vaccine adjuvant formulations not approved by the FDA, was used in inoculations given to Gulf War era service personnel. According to the GAO, scientists have expressed safety concerns regarding the use of novel adjuvant formulations in vaccines, including squalene. |
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