What COVID Vaccine Policymakers Can Learn From Botched Military Anthrax Vaccine Program

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In 2002, the U.S. Government Accountability Office (GAO) issued a report to Congress on the Anthrax Vaccine Immunization Program (AVIP), a mandatory program created by the military in the late 1990s.

The 55-page report detailed a litany of adverse reactions to the anthrax vaccine, and the subsequent mass exodus of military pilots and other highly valuable military personnel who refused the mandated vaccine.

Why revisit a report, written nearly two decades ago, on how the military handled the anthrax vaccine?

First, the report validates many of the concerns parents have voiced for decades about childhood vaccine schedules. It should serve as a warning to parents, especially in light of the rush to develop a COVID-19 vaccine. After all, the Centers for Disease Control and Prevention is directing the Childhood Immunization Program under the same dysfunctional decision-making paradigm as the one used by the military.

Second, the report’s insights into the military’s poor handling of the anthrax program are valuable today — when the threat of a SARS-CoV-2 vaccine mandate looms large — for their potential to reshape our current approach to vaccines and mandates.

We’ve seen recently how a corrupt pharmaceutical industry, just by putting a few letters in the mail and incentivizing the media to broadcast panic, can manipulate officials at the highest level of the federal government into endorsing the need for fast-tracking a vaccine.

It’s time to re-evaluate how the U.S. Food & Drug Administration (FDA), the Department of Defense (DOD) and the Department of Health and Human Services (HHS) make recommendations related to the approval, mandating and monitoring of vaccines.

If government officials do undertake this reevaluation process, they would do well to consider the GAO’s critique of the military’s handling of the anthrax vaccine — including the GAO’s assessment of how one man’s actions needlessly put an entire military population at risk of experiencing a dangerous reaction to an unproven vaccine.

Here’s a look back at the concerns raised by the GAO in 2002 about anthrax, the military and vaccine safety programs.

1. Did the risk of anthrax justify mandating the vaccine for all military members?

The anthrax vaccine had been in development and limited use in the military since 1970. As of 1997, there was talk of making the vaccine compulsory for all 2.4 million military service members, including active duty and reserve personnel and civilian contractors.

The events of September 11, 2001, and subsequent anthrax letter attacks through the U.S. postal system, bolstered calls for mandating the anthrax vaccine throughout the military.  As of 2001, more than 500,000 service members had received at least one dose of the vaccine, which was designed to be administered in six doses.

From 2000 to 2018, the military anthrax mandate was challenged several times in court for lacking FDA approval and licensure, and for lacking proven potency against fatal inhalation of anthrax. During this time, DOD restricted the anthrax vaccine to a smaller group of “at risk troops” and halted and resumed the program several times, without transparency.

In addition to the legal challenges, the GAO report identified that the military had a serious retention crisis due to the anthrax vaccine. The most experienced pilots left or planned to leave the military to avoid the anthrax vaccine — they were even willing to walk away from retirement benefits.

“According to our survey, between September 1998 and September 2000, when AVIP was mandatory, about 16 percent of the guard and reserve pilots and aircrew members had transferred to another unit (primarily to non-flying positions), moved to inactive status, or left the military altogether. In addition, 18 percent of those still participating in units indicated their intention to transfer, move, or leave in the near future. About one-fifth of those who had already left did so knowingly before qualifying for military retirement.”

The pending loss of pilots was undeniable. According to the report, 69% of those pilots who changed their status ranked the anthrax vaccine as the main factor, and 72% of those pilots who planned to leave the military ranked the anthrax vaccine as the main factor. More than half of the losses and potential future losses of aircrew members in the guard and reserve were pilots. These personnel losses included more experienced positions of flight evaluator, flight instructor and aircraft commander, in whom the military had invested years of training.

If the narrowing of the anthrax vaccine program was designed to retain pilots and officers, the data should be investigated. What were the “at risk” criteria? Did the anthrax program target enlisted personnel because officers were refusing the anthrax vaccine twice as frequently as enlisted personnel? Did the anthrax program target personnel with less experience and training, and subsequently less value to the military?

Prior to 2001, DOD had concluded that biological agents such as anthrax were not a threat for mass casualties due to the limited number of countries with the expertise and sophistication required to weaponize and disseminate anthrax. In October 2001, a few letters mailed with anthrax spores became the primary justification for the anthrax vaccine mandate in the military, with media coverage of disrupted businesses and government operations inducing panic. If the mailings originated from someone in the industry with a conflict of interest, then the anthrax vaccine program was based on a manufactured crisis.

As of 2020, the risk of death from the inhalation of anthrax, which was used to justify the program, has never been substantiated.

2. Anthrax manufacturer fraudulently reported mild adverse reactions with low rates 

The GAO report documented that overall injuries, both localized and systemic, from the anthrax vaccine were double the reported rate from the manufacturer. The data also revealed that more serious and long-lasting adverse events were 100 times more frequent than the manufacturer reported.

“According to our survey results, the reported rate and severity of adverse events experienced by personnel who had received the anthrax shots were considerably higher than those published in the vaccine manufacturer’s product insert in use at the time of the survey or reported by DOD. For example, an estimated 84 percent of the personnel who had had anthrax vaccine shots between September 1998 and September 2000 reported having side effects or reactions. This rate is more than double the level cited in the vaccine product insert. Further, about 24 percent of all events were classified as systemic—a level more than a hundred times higher than that estimated in the product insert. The reaction rates from our survey were also consistent with the results of two earlier DOD studies of the anthrax vaccine. In addition, we found that most events were not being reported to either official or informal DOD channels, partly because most individuals were unaware of the reporting process for documenting any such occurrences.”

The report cited two other DOD studies, in Hawaii and Korea, which replicated these findings. The manufacturer’s product insert recommended the vaccination be discontinued when systemic reactions occurred. But most respondents to the military survey had received four doses of anthrax vaccine, and had reacted to  each dose. It is unlikely that any victims knew how to identify or report a systematic reaction linked to the vaccine.

3. Vaccine adverse reaction surveillance does not exist in the U.S.

How can a highly reactive vaccine continue to be administered for more than 20 years?

The GAO report validated what thousands of parents of vaccine-injured children describe via the Vaccine Adverse Event Reporting System (VAERS) — that VAERS is a passive, failure-by-design system incapable of detecting hot lots of vaccines.

The anthrax program administered millions of doses to military members without an active surveillance system acting as a watchdog to monitor health outcomes. The GAO report provided alarming data on the difference in reporting under passive and active monitoring methods:

“DOD continued to use data from VAERS to monitor adverse events or reactions to anthrax vaccination, even though it is a ‘passive’ surveillance system that relies on vaccine recipients or their health care providers to report adverse events after vaccination. Studies show that significantly fewer adverse events are reported under such a system when compared to an active surveillance approach in which vaccine recipients are actively monitored to identify and track any adverse reactions to a vaccine or medication.13 For example, we estimated that almost three-fourths of vaccinated guard and reserve personnel experienced burning in the vaccinated arm and a knot or lump in the vaccinated arm, compared with DOD’s report that 0.007 percent had such reactions. In November 2001, DOD reported that after more than 2 million doses of anthrax vaccine had been administered to more than 522,000 people, only 1,685 VAERS reports were submitted for possible adverse events associated with the vaccine. In contrast, the approximately 380 shot recipients in our survey disclosed more than 6,000 reactions (almost 1,300 of which were systemic) from slightly more than 1,300 shots.”

The GAO report recommended that the Secretary of Defense establish an active surveillance program to identify adverse events, to monitor those affected with adverse reactions and to provide treatment protocols for health care workers. It asserted that VAERS was incapable of any of these functions, and thereby substantiated that a functioning watchdog over the CDC’s Childhood Immunization Schedule is non-existent.

4. DOD information on anthrax safety and efficacy wasn’t credible

The GAO report quantifies the high level of distrust that military personnel had with the anthrax vaccine information provided by DOD. Sixty two percent of respondents were highly dissatisfied with the anthrax vaccine’s effectiveness in battlefield exposures. Sixty two percent were highly dissatisfied with the vaccine’s short-term safety, and 69% were highly dissatisfied with long term safety. According to the report, 69% were highly dissatisfied with information on reactions to the anthrax vaccine.

Despite an extensive DOD campaign to communicate the anthrax as a serious threat, and the anthrax vaccine as safe and effective, most technically proficient military personnel remained unconvinced of either. Overall, 77% of the respondents indicated that they would not have taken the anthrax vaccine if they hadn’t been required to. Only 11% of the respondents reported that they would have taken the shot on a voluntary basis, and 12% percent were uncertain.

The main concerns expressed about the anthrax vaccine were increased risk for autoimmune disease (80%), effects on offspring (63%) and effects on male fertility (51%). The civilian community under state vaccine mandates expresses this same distrust of vaccines in the affluent and educated populations who are most likely to exempt themselves from vaccines.

5. Fear of retaliation from employers and doctors for reporting vaccine adverse reactions

From the report:

“In addition, our survey estimated that about 57%of those who experienced an adverse reaction did not discuss it with anyone in military health care or their individual supervisors. Some 49% cited concern about the loss of flight status, possible adverse effects on their military or civilian careers, and the fear of ridicule as reasons for not discussing vaccination shot reactions with others.”

6. Denial of vaccine-induced disease regarding Gulf War Syndrome

The GAO report noted that anthrax adverse reactions were very similar to Gulf War Syndrome symptoms. These symptoms include skin disorders, chronic fatigue, headache, memory problems, muscle and joint pain, insomnia, gastrointestinal problems, respiratory problems, neurological problems and tumors.

“In addition, some Gulf War veterans are suffering from unexplained illnesses that they believe might have been caused by anthrax vaccinations received during the war.”

The report cites several studies in the U.S. and the UK that showed a relationship between the anthrax vaccine and Gulf War Syndrome, and implicated the squalene, an ingredient in the vaccine.  Gulf War Syndrome occurred in 34% of Persian Gulf War veterans, and 12% of non-Persian Gulf War veterans who reported receiving vaccines during the war but who did not deploy, indicating that the vaccines used during the war may be a contributing factor.

The number of inoculations were associated with increased symptoms of skin and musculoskeletal complaints in UK Gulf War veterans. Declines in long-term subjective health were associated Gulf War veterans who had received the anthrax vaccine. Vaccination against biological warfare was associated with the CDC multi-symptom syndrome in the Gulf War cohort in the UK. The production of anti- squalene antibodies in Gulf War Syndrome patients is linked to the presence of squalene in certain lots of the anthrax vaccine.

The Department of Veterans Affairs (VA) lists potential toxins that could cause Gulf War Syndrome, but dismisses the fact that the squalene-containing anthrax vaccine could be the cause. The VA also omits the plausibility of aluminum, another vaccine ingredient, which has been linked to Gulf War Syndrome. Neurotoxins in vaccines are never considered by healthcare providers for neurotoxic effects in children and adults.

7. Corruption and collusion in the vaccine industry, FDA, DOD and HHS

DOD did not concur with the GAO report. The Pentagon claimed there was no data to justify a new active surveillance program of the anthrax vaccine. DOD also stated that there was no difference between pilot separations from the military before and during the mandatory AVIP program. DOD has maintained that the anthrax vaccine was very safe and needed.

To date, there is no surveillance system to know how anthrax vaccine reactions manifested over time, or how many people are living with a chronic disease as a result.

In 2008, the federal court affirmed that the FDA, HHS and DOD allowed an illegal AVIP program by mandating an experimental anthrax for military personnel that was not licensed for use against inhalation anthrax, nor approved for use by a presidential waiver.

Later in 2008, the FBI accused U.S. Army scientist Bruce Ivins of being responsible for the 2001 anthrax letter attacks. In 2010, the Amerithrax investigation portrayed Ivins’ motive as dedicating 20 years of his life to a dwindling anthrax vaccine program with failing potency tests that would not meet criteria for FDA approval and to being under scrutiny for allegations that the anthrax vaccine contributed to Gulf War Syndrome.

The FBI evidence was based on emails. The FBI alleged that the FDA had suspended the production of the anthrax vaccine just prior to the letter attacks, but the attacks were the basis for the FDA fast-tracking the vaccine that did not meet standards. The FBI affidavits also document that Ivins was honored by DOD for getting the anthrax vaccine into production. HHS allowed the AVIP program to continue until 2018, likely until stockpiles were depleted.

To date, DOD has not considered correcting the records of court-martialed and punished soldiers who refused an illegally-mandated experimental vaccine based on a manufactured crisis.

Can we really believe that one dead man is to blame for the entire anthrax vaccine program while there is evidence that the FDA acted illegally in approving  an experimental vaccine that did not meet standards, DOD responded negligently when adverse reactions were overwhelming in the first year of the program, and HHS allowed the program to continue for eight more years after the FBI reported a crime of treasonous bioterrorism originating from the vaccine industry for financial benefit?

In the likelihood of a near-future SARS-CoV-2 vaccine mandate, the anthrax vaccine program failures should be studied for all of the above reasons, but mainly for the allegation that one man’s actions put an entire military population at risk for a reactive vaccine without demonstrated benefit or necessity — and for the lessons that should be applied to any future COVID-19 vaccine program.