The History of Anthrax Vaccine
The first vaccine against anthrax was created in the 1950s and first produced on a large scale by Merck Pharmaceutical Corporation. Subsequently the Michigan Department of Public Health took over production, and as it did so changed the manufacturing process using a different strain of anthrax and different ingredients. [131] License against cutaneous anthrax (exposure through the skin) was granted in 1970. Grant of the license was based on a single study performed in the 1950s[1], and other unpublished data, collected on the original Merck vaccine’s effectiveness against cutaneous anthrax in workers of animal hides The only mention of reactions to the vaccine in the initial study was limited to local reactions at the injection site.
Before military use started in 1990, approximately 68000 doses were administered to civilians.[2]
Subsequently the manufacturing process has been changed a number of times, including in 1990 when the fermenters were changed from glass to stainless steel and the filters were changed from ceramic to nylon; the filters were changed again in 1997 to polyvinylidene. If any testing was performed following the changes the results have never been made public.[3] Whether the strain of anthrax has been changed has not been made public.[156]
During the Gulf War from 1990 into 1991, anthrax vaccine was one of several vaccines against biological warfare agents administered to some of the forces deployed to Saudi Arabia and Kuwait. Many of the servicemen deployed experienced serious chronic health problems after the war, with some of the afflicted saying that the symptoms had shortly followed the shots. The investigations of the causes of the illnesses never studied vaccination in a meaningful way.[3]
Evidence did point to other Gulf War exposures causing health problems[3], but since exposures were not universal to all of those afflicted and the symptoms associated with the colloquial term Gulf War Syndrome were non-specific, it was clear that the same exposure was not responsible for every case. A detailed analysis by Congress published in 2008 of the causes of Gulf War Undiagnosed Illnesses, as they came to be known, stated:
‘...limited evidence from both animal research and Gulf War epidemiologic studies indicates that an association between Gulf War illness and receipt of a large number of vaccines cannot be ruled out.’[3]
In 1992 the DoD indemnified the manufacturer of anthrax vaccine:
‘...against all liability arising from: the unusually hazardous risks associated with potentially severe adverse reactions and the potential lack of efficacy of the AVA. These concerns stem from: a) the limited use of the vaccine to date, i.e., tests prior to approval of the vaccine by the Food and Drug Administration are on too small a scale to permit accurate assessment of types and severity of adverse reactions (only widespread use can provide this assessment); and b) insufficient experience in mass immunization programs to truly evaluate the efficacy of the vaccine.’[2]
AVA stands for Anthrax Vaccine Adsorbed.
Despite the lingering concerns, on May 28th 1998 anthrax vaccine was mandated as a standard measure for all forces deploying to Central Command and the Korean peninsula [4] (the initial plan had called for the entire military force to be vaccinated, but was scaled back). The mandate extended to many units which faced a minimal threat from biological weapons such as those on warships, or on non-combat tours well away from potentially active combat zones, or in South Korea which had been peaceful for forty five years. The mandate was enforced by subjecting those who refused to a court martial. In one case a court martial was brought against a mother in the Army who refused the vaccine because she was breast-feeding her child.[146] No studies have ever been conducted on the vaccine’s effects on pregnant or lactating women. [154].
The mandate was not implemented because of any increase in the threat. As noted by the GAO in 1999:
‘The nature and magnitude of the military threat of biological warfare (BW) has not changed since 1990, both in terms of the number of countries suspected of developing BW capability, the types of BW agents they possess, and their ability to weaponize and deliver those BW agents.’ [131]
Such was the controversy that in 1999 legislation was introduced into 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’. [135]
The heavy-handed approach led an investigation by Congress in the year 2000 to reflect:
‘Many members of the armed forces do not share that faith. They do not believe merely suggestive evidence of vaccine efficacy outweighs their concerns over the lack of evidence of long term vaccine safety. Nor do they trust DOD has learned the lessons of past military medical mistakes: atomic testing, Agent Orange, Persian Gulf war drugs, and vaccines. Heavy handed, one-sided informational materials only fuel suspicions the program understates adverse reaction risks in order to magnify the relative, admittedly marginal, benefits of the vaccine.’[2]
And even more concisely:
’As a health care effort, the AVIP compromises the practice of medicine to achieve military objectives.’[2]
AVIP stands for Anthrax Vaccine Immunization Program.
Meanwhile the wisdom of the mandate was summed up:
‘Because the anthrax vaccine is still being studied as a potential causative or contributing factor in Gulf war veterans’ illnesses, the subcommittee measured the program against this standard: Any expanded use of the same vaccine should be undertaken only with the greatest care and only to the extent necessary. As currently designed and implemented, the anthrax vaccine program fails on both counts. The AVIP lacks a consistent standard of care and is designed to reach far beyond those at risk.’[2]
Reports of chronic health problems following the vaccine started to flow in once again following its reintroduction in 1998 just as they had in 1991.
The Backdrop
Both chemical and biological weapons can cause far higher levels of casualties than conventional munitions When forces were deployed in 1990 to Saudi Arabia following the Iraqi invasion of Kuwait there was a genuine fear that Saddam Hussein would use chemical weapons against the coalition forces as he had been doing on a systematic basis against Iranian forces throughout the 1980s, he had also used them against his own people in the Kurdish region. It needs to be be assumed that an enemy that is willing to use chemical weapons may also be willing to use biological weapons, and it later emerged in 1996 from inspections of Iraqi weapons that anthrax spores had indeed been loaded onto bombs and ballistic missiles. [3]
The first line of protection against both chemical and biological weapons is protective clothing with a respirator, but it cannot be worn continuously, and while equipment existed in 1990 to detect chemical contamination of the environment there was no way of detecting the presence of biological contaminants, so vaccination against the common agents such as anthrax was the only protection available when unmasked.
Numerous problems were encountered however when the plan for vaccination against biological weapons was pulled off the back burner where it had been sitting during the Cold War: in 1988 a contract had been signed 300,000 doses to be created and stored over the course of five years, but by the time the shooting started in 1991 there were only enough available for 150,000 of the half million troops in the force. [150] It was impossible to increase production rapidly enough to make up the difference; also forces such as the 82nd Airborne had to deploy before there was time to build up immunity, and there were logistical difficulties in transporting vaccines which needed to be kept refrigerated half way around the world to units in the desert. Some of the shots that were administered were not properly documented in medical records.[126 Appendix Q]
As a step towards rectifying the problems, in 1993 a DoD directive was issued for the Assistant Secretary of Defense for Health Affairs to: ‘identify vaccines available to protect against biological threat agents designated by the Chairman of the Joint Chiefs of Staff and recommend appropriate immunization protocols’, and to: ‘Issue instructions to the Military Departments and the other appropriate DoD Components on the immunization of DoD personnel, under the guidelines of this Directive, and monitor and evaluate the implementation of those instructions.’ The Secretary of the Army was designated as the: DoD Executive Agent for the Immunization Program for Biological Warfare Defense; with responsibilities which included gathering: ‘All relevant data on the effectiveness of each vaccine against the corresponding biological warfare threat agent’ and: ‘The expected type, frequency, and severity of vaccine-associated adverse reactions.’[127]
The development of vaccines against biological agents was assigned to the the Joint Vaccine Acquisition Program (JVAP) [128]
Also in 1993 the Senate held a hearing: ‘Persian Gulf War Illnesses. Are We Treating Veterans Right?’ During the hearing Senator Daschle commented:
‘I find a remarkable similarity between much of what is now being discussed with regard to this issue and the history we've experienced on Agent Orange now for more than 20 years. There was a denial on the part of DOD and this Government about its responsibility related to veterans' health for more than 25 years. The burden of proof was put on the veterans themselves. They were the ones who had to draw the connection. They were the ones who had to find the science. They were the ones who had to continue to press the Government into action. There was a lot more talk than there was action for so many, many years. As a result of the leadership taken by your predecessor and many others in the Congress over many years, ultimately, after all of that wait—unfortunately, too late for many—some veterans harmed by Agent Orange ultimately received the treatment, the care, the understanding, the priority that they deserved. We find ourselves back at the same tables once again debating issues so similar, and it seems to me that if we've learned anything, we owe, as you said, Mr. Chairman, the benefit of the doubt to these veterans, so that they do not have to experience the horrendous wait, the extraordinary pain that so many of their predecessors who were veterans in Vietnam had to experience.’
In 1994 the Senate asked the question: ‘Is military research hazardous to veteran’s health?’, and noted that for:
‘at least 50 years, DOD has intentionally exposed military personnel to potentially dangerous substances, often in secret’, and that the: ‘DOD has repeatedly failed to comply with required ethical standards when using human subjects in military research during war or threat of war’; the: ‘DOD and DVA have repeatedly failed to provide information and medical followup to those who participate in military research or are ordered to take investigational drugs’, the: ‘Federal Government has failed to support scientific studies that provide timely information for compensation decisions regarding military personnel who were harmed by various exposures’; and that: ‘DOD has demonstrated a pattern of misrepresenting the danger of various military exposures that continues today’.
'It made the recommendation:
‘The Feres Doctrine should not be applied for military personnel who are harmed by inappropriate human experimentation when informed consent has not been given’. [130]
How effective the vaccine would be was questioned since it could not be tested against inhalation anthrax on human subjects so animal studies were all that were possible. Intelligence also indicated that former Soviet Union had created at least thirty biological agents, possibly including vaccine and drug resistant strains of bacillus anthracis. [128]
The attitude to safety was summed up by Dr, Stanley Plotkin, arguably the most eminent vaccine specialist in the world, who in 2002 commented
‘With the military anthrax vaccine, for example, initially there were no data to support the claim that the vaccine was indeed safe. New vaccines must have built-in surveillance in order to discredit unsubstantiated claims about adverse reactions based on anecdotal data.’[128]
In 2002 the package insert for AVA stated:
'Other infrequently reported serious adverse events that have occurred in persons who have received BioThrax have included: cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.' [141]
In 2003 a ‘Sense of the Senate’ motion stated: [146]
‘Secretary of Defense should reconsider the mandatory nature of the anthrax and smallpox vaccine immunization program, pending the development of new and better vaccines that are under development as of the date of enactment of this resolution.’
And:
‘The Secretary of Defense and the intelligence community should reevaluate the threat of anthrax and smallpox attacks on troops in Iraq and Afghanistan to reflect operational realities as of the date of enactment of this resolution when considering the continuation of a mandatory military vaccination program;’'
noting:
'There appears to be little evidence available that Al Qaeda or Saddam have the capability to deliver anthrax or smallpox against our troops in Iraq or Afghanistan. Even if there was such a threat, it is likely extremely small at this point. Again, if nothing else, this change in the threat to our troops requires an immediate reevaluation of DOD vaccination policy.’
It also noted:
'we do not even know if the anthrax vaccine works at all on inhalation anthrax or weaponized anthrax, so the vaccine may be completely ineffective.’
Further:
'The Secretary of Veterans Affairs should assess those adverse events being reported with respect to the anthrax and smallpox vaccines, research causal relationships, and estimate a future cost to the Department to treat these conditions the current smallpox and anthrax vaccines have real and serious consequences that must be weighed against the potential benefits the long-term consequences of the vaccine programs for the health and well-being of our military personnel and our veterans is in question and should be addressed.’
And even:
‘The Secretary of Defense and Board for Correction of Military Records should reconsider adverse actions already taken or intended to be taken against servicemembers for refusing to accept the anthrax or smallpox vaccine.’
All such recommendations were ignored and the mandate continued.
At the same time, it was possible to detect respirable aerosols in real time although the best detection systems took 15 - 45 minutes to identify a specific biological warfare agent, so the vaccine was not the only protection available.[128]
Manufacturing Problems
From 1970 the vaccine was manufactured at the Lansing Biologics laboratory which had been founded by the Michigan Department of Public Health in 1926. In 1995 the Michigan Biologic Products Institute (MBPI) was created as a public corporation to sell the vaccine to the private sector. [147]
The FDA first inspected the facility in 1993, having previously been denied access because the inspectors had not been vaccinated against anthrax [138]. That inspectors would have to take a product before inspecting its manufacture could be regarded as having things backwards. The FDA recommended changes to the laboratory, and in that year the state government approved the improvements and associated renovations, but did not schedule the work to begin until 1998. [147]
In 1996 the DoD placed a $33.5 million order for AVA to be created, tested, and stored until 1999, with terms that included the renovations.
Also in 1996 the FDA made another inspection and issued a damning report, requiring a ‘written commitment to full compliance within ten days’ and a ‘comprehensive plan for correcting all deficiencies within thirty days’. It noted that: ‘similar deficiencies have been identified during past inspections; and determined: ‘that a continuing problems represent a failure to comply with regulations’. Violations extended into: ‘organization and personnel, buildings and facilities, equipment, control of components, drug product containers and closures, production and process controls, laboratory controls, and records and reports.’
One example was the ‘failure to calibrate instruments, apparatus, gauges, and recording devices at suitable intervals’. In March 1997 the FDA issued a Notice of Intent to Revoke the production license. [126 Appendix H]
In 1997 the DoD determined that the production capacity was insufficient for its intention of force wide vaccination, and the plant was closed for a $3.7 million renovation. [147]
Problems continued, and in May 1998 there was a request from within the plant to: ‘suspend any further potency testing under the supplementary testing program because results continue to be all over the board and then have to be reported to the FDA.’ [126 App P]
In July 1998, the State of Michigan sold MBPI, which had been losing money, to BioPort for $25 million. BioPort offered all MBPI employees salary increases and stock options to continue, and enough did so that the FDA approved the transfer of MBPIs AVA-production license to BioPort, although with the proviso that the revocation of license was also transferred. [147, 152]
The DoD immediately awarded a contract to BioPort for $29.4 million at $4.36 per dose. [147, 150]
That same year the FDA placed further requirements on manufacture based on incidents of deadly contamination elsewhere. [147]
In September 1998 the Army noted that the vaccine had:
‘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’,
and indemnified the manufacturer against:
‘the risk of adverse reactions, or the failure to confer immunity against anthrax, from the administration of the vaccine to any person of the vaccine manufactured or delivered under this contract. For the purpose of this clause, the phrase “adverse reactions” includes anaphylaxis and any other foreseeable reactions, as well as any unforeseen reactions.’ [126 Appendix J]
The renovations to the plant were completed in December 1998 and manufacture restarted in April 1999, with the vaccine stored pending FDA approval. BioPort submitted a Biologies License Application Supplement in August because there had been:
‘changes to the product, production process, equipment, facilities, or responsible personnel that have a "substantial potential" to have an adverse effect on the identity, strength, quality, purity, or potency of a vaccine.’
In November 1999 the FDA inspected the plant, and in December: ‘cited 18 comments and questions that needed to be resolved before BioPort would be allowed to resume AVA distribution or testing of stockpiled AVA.’
The DoD then provided extraordinary contract relief to BioPort of an interest-free advance of $18.7 million; and also reduced the number of doses to be produced from 7.9 million to 4.6 million, with an increase in the price per dose to $10.64. [147]
In December 2000 it emerged that the FDA had never been notified of the changes to the manufacturing process that went as far back as 1990, including the changes to the filters. Nylon filters do not absorb as many proteins as ceramic filter so the composition of the vaccine many have changed significantly, and unpublished data from 1990 showed up to a hundredfold increase in antigen levels after the filter change. [138] The GAO first brought the issue to the attention of the FDA, and observed:
‘In April 2001, BioPort submitted documentation, primarily in-process tests and lot release data, to FDA to demonstrate that the filter changes had not had a significant impact on vaccine quality. FDA reviewed and accepted the data and approved the filter changes in July 2001. Although the lot release data included lots produced immediately before and after the filter changes, the data submitted did not include the type of data that, according to FDA officials, would normally have been required if a license amendment application had been filed contemporaneously with the changes it is not now possible to definitively resolve the question of whether the anthrax vaccine produced after the filter changes is the same as that produced before the changes (a demonstration that is normally required in a license amendment application.’ [138]
On June 8, 2001, the Secretary of the Army ordered a slowdown in vaccination because the availability was dwindling and the FDA had still not approved further manufacture. [128] Lots manufactured before the revocation of the license had continued to be administered from 1998 onwards. Some of the lots had expired but were approved after the manufacturer tested their potency and found them to be within limits. [144]
When a citizen’s petition was filed to the Department of Health and Human Services in 2001 [152], almost all of the regulatory problems it raised were dismissed. One notable claim in the response to the petition was:
‘DOD’s continuous involvement with, and intimate knowledge of, the formulation and manufacturing processes of all of these versions of the anthrax vaccine provide a foundation for a determination that BioPort’s anthrax vaccine is comparable to the original DOD vaccine.’ [144]
And then:
‘The Brachman study does, in fact, demonstrate that BioPort’s anthrax vaccine is effective because the BioPort vaccine is comparable to the DOD vaccine used in the Brachman study.’[144]
It was not specified why the involvement of the same customer would make different vaccines from different manufacturers comparable. The continuous involvement of the DoD in the manufacture did however increase the conflict of interest in the Pentagon still further.
With regard to the changes to manufacturing the response said:
'The U.S. General Accounting Office investigated the claim and asked FDA about the effect of the change in filters. In February 2001, FDA sent a letter to BioPort requesting specific information about the changes in filters, and BioPort responded in April 2001. We reviewed BioPort’s response and found that it adequately addressed FDA’s questions and concerns. In addition, we reviewed the lot release protocols, which include product release test results, for all lots of anthrax vaccine released between 1978 and 2001. Based on this information, we concluded that the filter change did not adversely affect the product’s safety, purity, or potency.' [144]
No reasoning behind the decision was given.
The response also stated:
‘Finally, there are ample clinical data and information from the CDC observational safety study, conducted under IND in the 196Os, which demonstrate that the MDPH vaccine is safe. All these data taken together demonstrate that BioPort’s anthrax vaccine is safe and effective and is comparable to the vaccine used in the Bra&man study.’[144]
Which meant that no new data on safety had been gathered since the 1960s.
Overall, it deemed BioPort to have taken the necessary steps:
'We communicated with MBPI and later with BioPort to resolve these issues. FDA inspections in October 1998, and later in October 2000, disclosed that BioPort had made continued progress toward meeting the objectives of the strategic plan and bringing the facility into compliance. We did not initiate license revocation proceedings against BioPort because the firm had implemented corrections and demonstrated its commitment to comply with all applicable FDA requirements, BioPort did this by, among other things, renovating its manufacturing facility, discontinuing the manufacture and distribution of all non-anthrax related products, closing BioPort’s corrective measures resulted in FDA approving a BLA supplement for the firm’s anthrax vaccine manufacturing facility in December 2001.' [144]
The Anthrax Letters
During the 2000 presidential campaign then Governor George Bush said:
‘The Defense Department’s Anthrax Immunization Program has raised numerous health concerns and caused fear among the individuals whose lives it touches. I don’t feel the current administration’s anthrax immunization program has taken into account the effect of this program on the soldiers in our military and their families. Under my administration, soldiers, and the families will be taken into consideration.’ [146]
By the summer of 2001 vaccination had largely been suspended due to the manufacturing problems.
On August 10th 2001 two under-secretaries, a former Secretary of the Air Force named Peter Aldridge, and Dr. David Chu, recommended to Secretary Rumsfeld:
'The current Anthrax Vaccine Immunization Program will continue at a minimum level (critical personnel and project only). USD(AT&L) will implement an acquisition strategy to purchase additional bio-detectors and stockpiles of antibiotics to augment force protection, in the absence of an anthrax vaccine.’. [126 App S]
The Joint Chiefs countered on Aug 30th 2001:
'The Services and combatant commanders are unanimous in their continued support for the military requirement to vaccine our forces against anthrax, and view the vaccine as the centerpiece of our defense against the most likely biological threat agent.’[126 Appendix R]
Before a decision was made, on September 18th 2001 two letters laced with live anthrax spores were sent to two addresses in New York City; one to the New York Post and the other to the journalist Tom Brokaw at NBC News. A journalist who inhaled the anthrax was diagnosed on 4th October and died the next day. [149]
On October 12th 2001 Secretary Rumsfeld was asked at a press briefing:
‘Before September 11, the Pentagon was wrestling with the decision about whether to invest more money into BioPort, the nation's sole maker of anthrax vaccine, which so far has had difficulty producing FDA-certified vaccine. Are you now prepared to put -- invest whatever it takes in that facility to produce a vaccine, or are you inclined to go in some other direction?’
To which he replied:
‘The answer is, I think, that I would have to talk to Dr. David Chu and Pete Aldridge. They have been addressing that issue. And there were any number of issues around that situation which were quite complicated, for a variety of reasons. And it has been something that I -- preceded us, me, here as a problem for this department. And to my knowledge, those problems that have not been worked out. But I would have to talk to them.’ [151]
Shortly after the first fatality was announced on October 5th, two more letters were sent to the Washington DC offices of Senator Daschle and Senator Leahy, and arrived on October 15th.
A total of eleven people contracted anthrax by inhalation, five of whom died, and a further eleven contracted and survived cutaneous anthrax. [149]
On October 18th 2001, three days after the letters had arrived at the Senate, Secretary Donald Rumsfeld was asked at another press briefing:
‘Mr. Secretary, I wonder if you can give us an update on the Pentagon's anthrax vaccine program? The sole manufacture in Michigan hasn't produced vaccine for quite some time, and it could be months before they can start producing again. You have a minimal amount of vaccine, and you're only doing a certain number of troops, small numbers of troops. And finally, last week there was a petition sent to FDA by military officers, and others, calling for them to pull the license and destroy the stockpiles of the vaccine. Can this program be saved, do you think, or are you going to look at alternatives to the vaccine?’
To which he replied:
‘We're going to try and save it. There have been other efforts that have failed over a period of years. And it may or may not be savable, but I met this morning with Pete Aldridge and David Chu, and we discussed this at some length. And they or their representatives are going to be meeting with people from HHS and Secretary Thompson's office and try to fashion some sort of an arrangement whereby we give one more crack at getting the job done with that outfit. It's the only outfit that -- in this country that has anything underway, and it's not very well underway, as you point out. We're trying to fashion a way that the -- it's a combination of things, but they have not been approved by the FDA, as I understand it. They do not have what looks to be -- well, I shouldn't be characterizing a private entity that way, but things have not been going swimmingly for them. And what we're trying to do is figure out a way where we might get some help so that they might improve their performance.’ [139]
In November 2001 military doctors were advising workers at the Senate to receive the vaccine as they reached the end of the standard 60 day course of antibiotics, based on evidence that spores can live beyond 60 days in the lungs. Most declined but Senator Daschle was one of those vaccinated, and stated: ‘I support that decision ... Many of my staff are directly affected and I think it is a wise course of action simply because of the unknowns, because of the uncertainty.’
At the same time, Senator Bill Frist, a doctor, warned:
‘The vaccine is a dated vaccine, it's an old vaccine. There are very real and potentially serious side effects from the vaccine and anyone who elects to receive the vaccine needs to be made aware of that.’ All who received the vaccine had to sign a waiver indemnifying the manufacturer from any liability for adverse effects.' [142, 143, 146]
Colonel Thomas Rempfer USAF, who had been playing a leading role in political and legal actions to end the use of the vaccine, has said that there had been a growing sense in Washington that the vaccine was flawed, with Senator Daschle one of the leading players, until the letters were sent. Immediately afterwards, all communications from Senator Daschle ceased. [126]
In 2010 the FBI released the results of its investigation into the letters. On October 12th 2001 the letter sent to Tom Brokaw had been intercepted unopened, and the strain of anthrax it contained was traced to the Army’s own research laboratory. After the apparent suicide of the chief culprit, Dr. Bruce Ivins, no prosecutions were brought. His motive was described as:
‘According to his e-mails and statements to friends, in the months leading up to the anthrax attacks in the fall of 2001, Dr. Ivins was under intense personal and professional pressure. The anthrax vaccine program to which he had devoted his entire career of more than 20 years was failing. The anthrax vaccines were receiving criticism in several scientific circles, because of both potency problems and allegations that the anthrax vaccine contributed to Gulf War Syndrome. Short of some major breakthrough or intervention, he feared that the vaccine research program was going to be discontinued. Following the anthrax attacks, however, his program was suddenly rejuvenated.’ [149]
An Illegal Mandate
When AVA was first licensed it was only against cutaneous anthrax, not for use against anthrax spores which had been inhaled as would be the case when exposed to a biological weapon. The fact was acknowledged by the Army in 1995, [126 App U] and in 1996 the MBPI submitted an an Investigational New Drug application to use AVA against inhalation anthrax, BioPort filled out a similar application in 1999. [126 AppV]
In 1998 a law was passed:
‘Limitation and Waiver.—(1) In the case of the administration of an investigational new drug or a drug unapproved for its applied use to a member of the armed forces in connection with the member's participation in a particular military operation, the requirement that the member provide prior consent to receive the drug in accordance with the prior consent requirement imposed under section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) may be waived only by the President. The President may grant such a waiver only if the President determines, in writing, that obtaining consent is not in the interests of national security.’
It could only be administered with:
(1) Clear notice that the drug being administered is an investigational new drug or a drug unapproved for its applied use.
(2) The reasons why the investigational new drug or drug unapproved for its applied use is being administered.
(3) Information regarding the possible side effects of the investigational new drug or drug unapproved for its applied use, including any known side effects possible as a result of the interaction of such drug with other drugs or treatments being administered to the members receiving such drug.
Thus the mandate for the vaccine in 1998 violated the law irrespective of the issues surrounding the license for its manufacture.
The illegality of the mandate was acknowledged by Congress in 2000. [2]
In 2002 a law suit was filed in federal court against the DoD over its illegal mandate, and in 2003 a judge granted a preliminary injunction:
‘AVA is an investigational drug and a drug being used for an unapproved purpose. As a result of this status, the DoD is in violation ...’
The same judge gave a final ruling in 2004 which rendered the mandate illegal. [137]
Whether those who were convicted by a court martial for refusing the vaccine can have their convictions overturned on the grounds that the mandate was illegal has not been tested in court.
In 2006 the FDA licensed AVA against inhalation anthrax, and the mandate resumed.
In a law suit filed in Canada in 2000, a military judge ruled that civil rights were violated by mandating a vaccine which could be unsafe. [134]
Following the Money
There may have been an ulterior motive at work to explain the mandate being extended beyond those who faced a realistic threat of attack with biological weapons. The contract awarded for the vaccine in the year 2000 paid $1.3 billion despite the vaccine costing just $225 million to manufacture[28] and despite the government having paid for the vaccine's development and having indemnified the manufacturer against almost all adverse reactions; meanwhile the manufacturer, Bioport (later Emergent Biosolutions), had some senior figures closely tied to the Clinton administration. [29, 132]
Large stakes in BioPort were held by the MBPI,, Intervac L.L.C., a pharmaceutical investment firm, and Neogen Corporattion. Adm. Crowe and Fuad El-Hibri, along with his wife and father, shared the ownership of Intervac.[147]
A subsequent contract awarded in 2011 paid $1.25 billion for the next five years, [30]
In 2016 a $1.6 billion contracted was awarded to Emergent Biosolutions for a more advanced vaccine. [31]
In 2016 the CDC paid $911 million for Biothrax for the Strategic National Stockpile, while the Biomedical Research and Development Agency (BARDA) paid a further $100 million to add more Biothrax to the stockpile the following year. [119]
In July 2023 a new variant of the vaccine was approved named Cyfendus, which used a different adjuvant with the intention that it would be effective post-exposure to anthrax, and a contract worth $75 million was awarded for it by BARDA. [120]
The most recent DoD contract has been more modest with the 2024 contract paying $236 million for a five year supply. [121]