The History of Anthrax Vaccine
Anthrax vaccine was first licensed against cutaneous anthrax in 1970. Grant of the license was based on a single study performed in the 1950s[1], and other unpublished data, collected on its effectiveness against cutaneous anthrax in workers of animal hides.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]
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, in 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.
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.
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An Illegal Mandate
In 2004 a legal action brought my six military plaintiffs forced a suspension of the vaccine mandate on the grounds that anthrax vaccine had only been certified for use against cutaneous anthrax, and not against inhaled spores which would be the means of exposure when used as a biological weapon. The court ruled it to be illegal to mandate an experimental product.[18,19] The FDA responded in 2005 by granting an Emergency Use Authorisation (EUA) so that the vaccine could be administered on a voluntary basis, and then in 2007 licensing the vaccine against inhalation anthrax. Whether the servicemen who were prosecuted for refusal to take the vaccine prior to 2005 can appeal their convictions on the grounds that the mandate was illegal has not been tested in court.
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: there were insufficient ready stocks for the size of the force deployed and it was impossible to increase production rapidly enough to make up the difference; 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.
In 1998 when vaccination against anthrax was reintroduced the rationale was to preempt those problems in the event of another war.
Following the Money
However there may also 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]
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A subsequent contract awarded in 2011 paid $1.25 billion for the next five years, [30]
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In 2016 a $1.6 billion contracted was awarded to Emergent Biosolutions for a more advanced vaccine. [31]
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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 Biotrhax to the stockpile the following year. [119]
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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]