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Can Anthrax vaccine cause injury and death?

Updated December 29, 2023


As with any pharmaceutical product, there is always the possibility that anthrax vaccine can cause death. There is limited published data on controlled human trials to test the vaccine’s effectiveness, and any injuries and deaths, due and lack of generalized use of the vaccine. 

A search of the federal Vaccine Adverse Event Reporting System (VAERS) using MedAlerts in May 2024 notes that 9,370 reports had been submitted relating to anthrax vaccine. VAERS is a passive reporting system and reports submitted are used to detect safety signals.

Event Outcome

Count

Percent

Death

31

0.33%

Life Threatening

246

2.63%

Permanent Disability

424

4.53%

Birth Defect

4

0.04%

Hospitalized

641

6.84%

Hospitalized, Prolonged

42

0.45%

Emergency Doctor/Room

165

1.75%

Emergency Room

3,703

39.52%

Office Visit

422

4.5%

Recovered

4,258

45.44%

None of the Above

2,410

25.72%

TOTAL

† 12,346

† 131.76%

† Because VAERS cases can have multiple vaccinations, symptoms, and event outcomes, a single case can account for multiple entries in this table. This is why the Total Count is greater than 9,370 (the number of cases found), and the Total Percent is greater than 100.

 Many of the serious anthrax vaccine adverse events in the VAERS database are associated with soldiers and military personnel receiving Biothrax vaccine simultaneously with other vaccines, such as smallpox vaccine, even though the manufacturer states in the product information insert that Biothrax has never been studied in controlled clinical trials in combination with other vaccines given simultaneously. 

According to the CDC, common side effects following anthrax vaccination include: 

  • Redness, itching, pain, swelling, or bruising at the injection site
  • Muscle aches and decreased range of motion in the arm where the vaccine was given
  • Headaches or fatigue

The Biothrax product information insert lists the following as serious adverse events: 

  • anaphylaxis
  • angioedema
  • rash
  • urticaria
  • erythema multiforme
  • anaphylactoid reaction
  • Stevens-Johnson Syndrome
  • paresthesia syncope
  • dizziness
  • tremor
  • ulnar nerve neuropathy
  • lymphadenopathy
  • nausea
  • malaise
  • pain
  • cellulitis
  • flu-like symptoms
  • insomnia
  • pruritis
  • flushing
  • arthralgia
  • arthropathy
  • myalgia
  • rhabdomyolysis
  • alopecia

Additionally, there have been reports of chronic multisystem disorders involving fatigue, mood cognition, and the musculoskeletal system.

In the late 1990s and early 2000s, congressional hearings were held in the U.S. House of Representatives Government Reform Committee on anthrax vaccine safety, efficacy, and lack of informed consent protections with the military’s mandatory anthrax vaccination policies. Testimony from vaccine-injured military veterans included several hundred cases where career soldiers chose to face court-martial rather than agree to be vaccinated or revaccinated with anthrax vaccine after serious reactions had occurred.  

In 2002, Congress's General Accounting Office (GAO) published a survey that revealed that 85 percent of the Air National Guard and Air Force Reserves personnel experienced adverse reactions following anthrax vaccination, and was significantly higher than the reported 30 percent claimed by the vaccine’s manufacturer.

This report also stated that Additionally, an estimated one in five (18 percent) of those still participating in or assigned to a unit in 2000 - that is those who had not already changed their status -indicated their willingness to leave in the near future. Both groups, those who had already left and those indicating their intention to leave, ranked AVIP [Anthrax Vaccine Immunization Program as a key factor in their decision to leave or change their participation.   

In 2002 the Institute of Medicine (IOM) issued a report on the safety and efficacy of anthrax vaccine, stating that The available data are limited but show no convincing evidence at this time that personnel who have received AVA have elevated risks of later-onset health events.  

The serious anthrax vaccine reactions resulting in permanent autoimmune and brain dysfunction reported included the below conditions. 

  • chronic disabling fatigue;
  • persistent headaches;
  • severe memory loss
  • brain inflammation
  • seizures
  • 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
  • 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
  • liver abscess
  • death. 

Gulf War Illness (GWI) is a debilitating syndrome affecting many military members who served during the Gulf War. Research has linked GWI to multiple vaccinations, including the anthrax vaccine. It is estimated that between 28 and 32 percent of veterans serving during the Gulf War era continue to have symptoms, which include cognitive deficits, musculoskeletal weakness, chronic pain, mood disorders, headache, fatigue, and numerous multi-system complaints. Several papers have been published regarding GWI and its association to vaccines that were required for military troops serving during this era.     

One published study which evaluated the health outcomes of Gulf War veterans in Kansas found that non-deployed individuals who received vaccines had a four-fold increased risk of neurological and gastrointestinal problems as well as chronic somatic pain in comparison to those who were not vaccinated. Deployed soldiers who served in the Gulf War region had an 11 times higher risk of health problems than those who were not deployed and who did not receive vaccines. 

There continues to be inadequate research to support or deny a link between multiple vaccines administered simultaneously or in a short period of time to members of the military, and chronic long-term health issues. Researchers evaluating the available data on GWS conclude that: 

“With regard to health policy, the practice of administering multiple vaccinations simultaneously, or within a highly compressed time frame, should be subject to an urgent safety review. Research is needed to evaluate the health effects of mass vaccination programs, especially when (as here) the recipients are in a position of limited autonomy, and to understand the factors affecting individual responses to vaccination. The benefits derived from short-term protection against infectious disease also need to be weighed against the potential long-term health risks of multiple vaccinations administered synchronously or near-synchronously, and in association with other potentially toxic exposures.”

Anthrax vaccine is considered a under the 2005 Public Readiness and Emergency Preparedness (PREP) Act. The PREP Act eliminates liability for injuries and deaths caused by anthrax vaccines. 

Individuals who die or suffer serious harm due to the administration anthrax vaccines, may be eligible to receive compensation through the Countermeasures Injury Compensation Program (CICP), whether the harm was a result of willful misconduct on the part of the vaccine manufacturer or person administering the vaccine. 

Between 2010 and May 1, 2024, no claims for injuries sustained from anthrax vaccines have been deemed eligible for compensation from the CICP.  Four anthrax vaccine injury claims were denied due to failure to submit medical records,  six anthrax vaccine injury claims were denied because government officials ruled that the injury was not related to vaccination,  and four were denied due to missing the one year filing deadline.  Two anthrax vaccine injury claims, one for inflammation and one for Guillain-Barre Syndrome, are currently pending review.    

IMPORTANT NOTE: NVIC “Quick Facts” is not a substitute for becoming fully informed about anthrax and the anthrax vaccine. NVIC recommends consumers read comprehensive information NVIC provides on anthrax, the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.

According to the package insert, common adverse reactions following CYFENDUS include redness, swelling, and pain at the injection site, arm motion limitation, muscle aches, fever, fatigue, and headache. 

Serious adverse events reported during pre-licensing clinical trials of CYFENDUS include Ulcerative Colitis, diffuse alopecia, spontaneous urticaria, acute cholecystitis, spontaneous abortion, pre-term premature rupture of membranes resulting in fetal death, Graves’ disease, autoimmune thyroiditis, celiac disease, Polymyalgia rheumatica, Psoriatic arthropathy, Systemic lupus erythematosus, Subacute cutaneous lupus erythematosus, Guttate psoriasis, Alopecia areata, and death. 

No post-marketing data is available on adverse events associated with CYFENDUS; however, the manufacturer reports that the post-marketing experience of Biothrax anthrax vaccine is relevant since both vaccines have similar manufacturing practices. CYFENDUS, however, contains the CPG 7909 adjuvant, which is not found in Biothrax.  


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