Anthrax Overview

Anthrax

Special NVIC Report
Barbara Loe Fisher, Editor
December 2001 

 

BIOLOGICAL WARFARE AND ANTHRAX VACCINE 

   The terrorist attacks on New York City and Washington, D.C. on September 11, 2001 and, soon after, the release of anthrax-contaminated mail in the U.S. postal system, have prompted calls by some for use of anthrax vaccine in the civilian population. Although there is a possibility that terrorists will attempt to launch an attack on civilians in the continental U.S. using anthrax organisms, there are logistical problems associated with a successful biological weapons assault, including difficulty of delivering the organisms to large numbers of people.  Most notably, a successful bioterrorism attack involving large numbers of American civilians will require a failure of both internal and external homeland security measures, which were put in place following September 11. 

   Every vaccine, like every drug, carries an inherent risk of injury or death and some individuals will be genetically or biologically more vulnerable to vaccine reactions than other individuals. All vaccination campaigns result in casualties and, therefore, benefits and risks must be carefully assessed before implementation, especially in the absence of a proven attack.  Every precaution must be taken to minimize vaccine casualties while protecting the informed consent rights of all citizens. 

BIOLOGICAL WARFARE

   Biological warfare is not a new phenomenon. History is full of examples of warring factions trying to weaken each other’s troops or civilian populations by making them sick. From the ancient Greeks and Romans, who polluted the water supplies of their enemies with dead animals, to warriors in medieval times who catapulted corpses of people infected with bubonic plague into the castles of their enemies, to European conquerors who came to the New World and used smallpox contaminated blankets to kill native Indians with no natural immunity to smallpox, there is a long history of man using disease as a weapon. 

  Modern biological weapons using lethal microorganisms were developed in the 1930s by Japanese scientists, including an aerosolized anthrax that was designed to be used in a specially designed fragmentation bomb. Both the U.S. and Britain developed biological weapons during World War II using anthrax, botulinum toxin, encephalitis virus, staph enterotoxin and other deadly organisms.  Even though the U.S. has had biological weapons capability, the U.S. has never used biological weapons on any nation. 

ANTHRAX DISEASE 

    Anthrax is a serious bacterial infection caused by Bacillus anthracis and most commonly occurs in animals such as cattle, sheep, horses and goats after they graze in areas contaminated with spores of B. anthracis. The body wastes and carcasses of infected animals, or flies that eat infected carcasses, and contaminated hides and meat are all sources of anthrax. Individuals who work with animals or animal by-products or are exposed to contaminated soil are at highest risk of contracting anthrax. 

    The bacteria, which must be in the presence of oxygen to survive, produce spores that can survive for years in dry soil but are destroyed by boiling or by treatment with hydrogen peroxide or dilute formaldehyde. Most common strains of B. anthracis are susceptible to penicillin and certain other antibiotics. However, a genetically engineered strain of anthrax that has been chemically treated and designed specifically as a biological weapon may be lethal enough to evade the protection that current antibiotics provide. 

    B. anthracis can invade the human bloodstream, multiply and spread to lymph nodes and many organs and kill quickly. The bacteria, which produce virulent toxin, can enter the bloodstream through a cut in the skin; by inhaling the anthrax spores through the nose; or by swallowing the spores into the gastrointestinal system.  The cutaneous (skin) route is much less deadly than inhaling or swallowing the organism.  

   Anthrax is not a contagious disease. Someone who is directly exposed to anthrax spores and becomes sick cannot pass the disease along to someone else by coughing or sneezing as most infectious diseases can be spread.  Each individual who gets sick with anthrax must have come into direct contact with the bacteria through a cut in the skin, through inhaling the spores into the lungs or through swallowing the spores, such as by eating contaminated meat. 

   Symptoms of Cutaneous (Skin) Anthrax:  If the anthrax exposure route is through the skin, symptoms include a formation of a small, red skin lesion(s) that becomes swollen, larger and blackened over a week’s time. There may or may not be fever and swollen lymph nodes. Spontaneous healing occurs in 80 to 90 percent of cases. In 10 to 20 percent of cases that go on to develop bacteremia (massive bacterial infection of the blood), high fever and rapid death follows. 

   Symptoms of Inhalation (Lungs) Anthrax:  Within one to three days of breathing in the anthrax spores, there is headache, fever, muscle aches, extreme fatigue, shortness of breath, coughing, low blood pressure and respiratory failure that can lead to death within 24 hours even with treatment. 

   Symptoms of gastrointestinal Anthrax : After swallowing anthrax spores, fever, nausea, vomiting, abdominal pain, bloody diarrhea develops and can lead to death. If the tonsils are affected, symptoms can include fever, sore throat, swollen lymph nodes, and respiratory distress. 

   Laboratory Diagnosis: A blood test that uses fluorescent antibody staining or culture can confirm anthrax infection, unless the patient has been treated with antibiotics. More sensitive lab tests can be performed for anthrax disease confirmation. 

   Treatment: For skin anthrax, treatments have included a penicillin shot used to destroy viable B. anthracis in skin lesions within 5 hours, followed by a 10 day oral course of penicillin. Other antibiotics, including doxycycline, ciprofloxacin, and chloramphenicol have also been used.  Skin lesions are frequently cleaned and covered and used dressings disinfected before disposal. Antibiotic treatment has also been used with inhalation and gastrointestinal anthrax but with less success. 

   Antibiotic Side Effects:  All drugs, including antibiotics, like all vaccines carry an inherent risk of injury or death for some individuals.  Overuse of antibiotics and use of antibiotics in the absence of bacterial infection has contributed to the development of antibiotic-resistant strains of organisms that can cause life threatening illness.  This has made it necessary to develop more powerful antibiotics, some of which carry serious side effects.  

   In addition to killing unwanted toxic bacteria, such as anthrax, antibiotics also kill the normal flora of the gastrointestinal tract and can cause nausea, diarrhea, vomiting and yeast infections.  Rashes, hives, and other allergic reactions, including anaphylactic shock leading to death, can occur. Some antibiotics can cause central nervous system problems, including severe headaches, drowsiness, dizziness, irritability and restlessness, nerve paralysis and seizures.  Other antibiotic reactions include blood disorders, such as anemia and thrombocytopenia (which can lead to uncontrolled bleeding); kidney and liver dysfunction and serum sickness that causes fatigue, muscle weakness and painful joints. 

   Prognosis: The mortality rate for skin anthrax that is untreated is 10 to 20 percent but very low with antibiotic therapy. The mortality rate for inhalation anthrax is 50 to 90 percent even with antibiotic therapy.  The mortality rate for gastrointestinal anthrax is about 50 percent with antibiotic therapy. If meningitis is a complication of anthrax infection, it is usually fatal. 

NORMAL EXPOSURE TO ANTHRAX: The most common way to get anthrax is to come into contact with an infected animal or animal waste and by-products. Veterinarians, farmers, or researchers working with animals are at higher risk, as are those working in industries that handle animal by-products like meat and animal skins.  As already discussed, the cutaneous (skin) form of anthrax has a very low death rate with appropriate antibiotic therapy after exposure. 

BIOTERRORISM EXPOSURE TO ANTHRAX: If the anthrax bacteria is used as a biological weapon to kill large numbers of people, it will most likely be used in the deadly aerosol form so that large numbers of people will inhale it.  This will mean that the anthrax strain and size of spores will have to be specifically designed for weapons purposes and will require an effective delivery system. So far, there has never been a successful delivery of inhalation anthrax to any large population through a bomb, missile, crop duster or any other means. 

  However, even though inhalation anthrax has never been successfully delivered to large numbers of people, it has become evident that whoever sent the anthrax through the U.S. mail system had access to a strain of weaponized anthrax that had been processed into a high grade powder form. Genetic tests on the anthrax-contaminated letters, which resulted in the deaths of five Americans, have confirmed that it was the variant Ames strain of anthrax developed during experimental research originating at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) at Fort Detrick, Maryland. Reportedly, the Ames strain was provided to other labs doing anthrax research, including Porton Down, a British military lab; Louisiana State University; Northern Arizona University, as well as Dugway Proving Ground military research facility in Utah, where anthrax spores were reportedly processed into the powder form that can be inhaled easily. 

   The fact that the genetically engineered and weaponized anthrax strain used in the contaminated mail can be traced back to a U.S. military research facility suggests that there are internal lab security issues that need to be addressed before it can be assumed that the best solution to preventing bioterrorism is to implement prophylactic mass vaccination or medication programs. 

ANTHRAX VACCINE 

  Harrison’s Principles of Internal Medicine (Thirteenth Edition, 1994) says of the currently licensed anthrax vaccine: 

   “Improved anthrax vaccines for humans are needed because the current vaccines are impure and chemically complex, elicit only slow-onset protective immunity, provide incomplete protection, and cause significant adverse reactions.” 

   In the 1950s, after several government lab researchers died of anthrax , the government began working on an anthrax vaccine. The only anthrax vaccine available in the US today was licensed by the FDA in 1970 for human use by high risk individuals such as researchers, veterinarians, those working in the wool mill and livestock industries and others who handle animals or animal products. In the early 1990’s during the Gulf War, large numbers of US military personnel thought to be at risk for biological warfare exposure were injected with anthrax vaccine, along with 15 other vaccines as well as an experimental drug, to protect against a possible biological warfare attack.  

   Since then, there have been persistent reports of serious anthrax vaccine reactions among military personnel, who received the vaccine and are now suffering with a pattern of autoimmune and brain damage that has come to be known as “Gulf War Syndrome.”   Some sick veterans blame the anthrax vaccine, perhaps in combination with the many other vaccines the soldiers received along with exposures to chemical toxins in the Gulf War, for their disabilities. This has made the U.S. military’s vaccination of all active duty and reserve personnel with anthrax vaccine a very controversial policy.    

   How the Vaccine is Made: The anthrax vaccine is a killed bacterial vaccine produced from a strain of anthrax that does not cause the disease. Additives include aluminum hydroxide, formaldehyde and benzethonium chloride. 

   Strength and Duration of Immunity: The current anthrax vaccine requires six shots given over an 18 month period, followed by annual booster shots to maintain protection. The first three doses are given two weeks apart and then three doses spread over an 18 month period. 

   There is little published data on controlled human trials to test the efficacy of the vaccine.  Developed primarily to protect workers who are exposed to skin anthrax by handling animals and animal by-products, it is reportedly about 90 percent effective against skin anthrax. But there is little data for humans about how effective the current vaccine is in protecting those who get the rarer but more deadly form of inhalation anthrax, although some experimental data in monkeys and other animals suggests the vaccine may be at least partially effective against inhalation anthrax. 

    If humans are exposed to a genetically engineered strain of anthrax that is not covered by the vaccine strain, the vaccine may have limited or no effectiveness. Several years ago there was an article published in the medical literature which revealed that the Russians have developed a genetically engineered strain of anthrax. During the Gulf War, there was fear that Iraq might have this genetically engineered anthrax strain that would make the vaccinated U.S. troops vulnerable but there has been no confirmation that Iraq or any other country outside of Russia has a genetically engineered strain of anthrax.  

   Vaccine Reactions: Most of the safety studies done on anthrax vaccine have been conducted by the Department of Defense, are unpublished, and reportedly do not include long term follow-up, according to military veterans advocacy groups who have reported anthrax vaccine damage. Reported reactions to anthrax vaccine have ranged from mild to severe local reactions, fever, chills and nausea that resolve without permanent damage to serious reactions resulting in permanent autoimmune and brain dysfunction, including chronic disabling fatigue, persistent headaches, severe joint pain and crippling arthritis, numbness and muscle weakness, severe memory loss, paralysis, seizures and death. It is estimated that 20 to 48 percent of all those vaccinated have some kind of reaction to anthrax vaccine, ranging from mild to severe. 

   During the past four years, a series of congressional hearings have been held in the U.S. House of Representatives Government Reform Committee on anthrax vaccine safety, efficacy and lack of informed consent protections in the military’s mandatory vaccination policies. Testimony from vaccine injured military veterans have included several hundred cases where career soliders have faced court martial rather than agree to be vaccinated or revaccinated with anthrax vaccine after serious reactions have occurred. 

   Contraindications:  The vaccine manufacturer warns that: 

•     “Any acute respiratory disease or other active infection is generally considered to be adequate reason for deferring an injection.”
•      “A history of a severe reaction to a previous dose of anthrax vaccine is a contraindication to immunization with this vaccine.”
•     Persons receiving cortico-steroid therapy or other agents which would tend to depress the immune system may not be adequately immunized with the dosage schedule recommended.”

   Other Considerations:  The vaccine manufacturer’s product insert states that “studies have not been performed to ascertain whether Anthrax Vaccine Adsorbed has carcinogenic action or any effect on fertility.” 

   The Vaccine Manufacturer: The anthrax vaccine was developed at Fort Detrick by the Department of Defense, which still holds the patent. For many years, the anthrax vaccine was manufactured by the Michigan Department of Health. In 1998, manufacturing was taken over by Bioport Corporation when they purchased the plant, made modifications, and geared up to meet the Pentagon’s goal of vaccinating all 2.4 million active duty and reserve troops with anthrax vaccine. Bioport has failed FDA quality control inspection several times, which has curtailed vaccine supplies and use of the vaccine in the military.  

   Plans for Vaccination of High Risk Persons: As of November, 2001, about 500,000 of the 2.4 million U.S. troops and reservists had received the anthrax vaccine.  In response to the exposure of U.S. civilians to anthrax through contaminated mail, the Centers for Disease Control began making plans to use some of the military anthrax vaccine stockpiles available to lab technicians, bioterrorism investigators and others currently at high risk for anthrax exposure.  There has also been discussion about making anthrax vaccine available to police, firefighters and postal workers. 

   On December 18, 2001 federal health officials and military anthrax experts urged thousands of U.S. Postal Service employees in Washington D.C, New York and New Jersey, as well as Capitol Hill staffers possibly exposed to mail contaminated with the Ames strain of anthrax to be vaccinated because they are finishing a two month course of antibiotics. Health officials say those who have been exposed to the anthrax could be harboring anthrax spores in their lungs and may become ill once they stop using the antibiotics.  Because the vaccine has not received final FDA approval, the vaccine continues to be classified as experimental. 

BEFORE YOU GET VACCINATED: 

   When making a decision about whether to get vaccinated with a particular vaccine, including anthrax vaccine, you need to become fully informed about the risks and complications of the disease the vaccine is designed to prevent, as well as the risks and complications of the vaccine. In addition to information in this report, you should consult one or more doctors as well as obtain more information from other resources. 

  At a minimum, you should ask yourself the following questions before getting vaccinated: 

1.      Are you sick right now with a viral or bacterial infection?

2.      Have you had a bad reaction to a vaccination before?

3.      Do you have a personal or family history of:

• vaccine reactions
• convulsions or neurological disorders
• severe allergies
• immune system disorders

4.      Do you know if you are at high risk of reacting to vaccines?

5.      Do you have full information on the vaccine’s side effects and contraindications?

6.      Do you know how to identify a vaccine reaction?

7.      Do you know how to report a vaccine reaction?

8.      Do you know the vaccine manufacturer’s name and lot number? 

   Physical Exam: It is a good idea to have your doctor give you a physical exam before each vaccination to make sure the results of the exam are written in your medical record so you have proof that you are in good health at the time of vaccination. Be sure to tell the doctor if you have recently recovered from an illness or if any of the members of your family are ill.

   Detailed Medical History: The examining physician should take a detailed personal medical history, including family history, before you are vaccinated. Be sure to mention if you or anyone in your family has a history of vaccine reactions, convulsions or  neurological disease, severe allergies, immune system disorders (such as thyroid disease, lupus, rheumatoid arthritis, diabetes, asthma, eczema), or other chronic health problems. 

REPORTING A VACCINE REACTION 

   If you suffer a serious health problem within 30 days of vaccination, your doctor should report what happened to the Vaccine Adverse Event Reporting System (VAERS). If your doctor will not report, the National Vaccine Information Center will help you report. You can obtain a government Vaccine Adverse Event Reporting form by calling 1-800-822-7967. 

   Any serious deterioration in mental, physical or emotional health following vaccination should be reported. This includes development of such symptoms as persistent fever; extreme pain and swelling at the site of the injection; severe joint pain; tingling in hands or feet; numbness or muscle weakness; disruption in sensory perception such as vision or hearing; serious memory loss, inability to concentrate or depression; extreme fatigue; persistent headaches; seizures or other chronic health problems that were not present before vaccination or worsened after vaccination. 

   The National Vaccine Information Center also maintains a Vaccine Reaction Registry that serves as an independent oversight mechanism on VAERS.  You can report a vaccine reaction to NVIC on this web site. 

KEEP YOUR OWN RECORDS 

   Ask your doctor to write down any deterioration in health you suffer after vaccination in your permanent medical record, as well as the date, manufacturer’s  name and lot number of all vaccinations given. Ask for a copy for your personal records. 

References: 

Isselbacher KJ, Braunwald E et al, eds. 1994. Harrison’s Principles of Internal Medicine. Thirteenth Edition. New York: McGraw-Hill. 

The Department of Defense. Anthrax Vaccine Immunization Program: About the Vaccine. www.anthrax.osd.mil/ 

Centers for Disease Control.  Anthrax (Bacillus anthracis): Frequently asked questions. www.cdc.gov/ncidod/dbmd/anthrx.htm. 

Bioport Corporation. March 1999. Anthrax Vaccine Adsorbed. Manufacturer Product Insert. (www.bioport.com) 

Physicians’ Desk Reference. 2001. Montvale: Medical Economics Co., Inc. 

Committee on Government Reform, U.S. House of Representatives. Subcommittee on National Security, Veterans Affairs and International Relations. Series of congressional hearings on anthrax vaccine held in 1999. (www.house.gov/reform/ns/past_hearings/anthrax.htm) 

Committee on Government Reform, U.S. House of Representatives. Subcommittee on National Security, Veterans Affairs and International Relations.

Subcommittee Report: The Department of Defense Anthrax Vaccine Immunization Program: Unproven Force Protection. House Report 106-556

(www.house.gov/reform; www.access.gpo.gov/congress/cog005.html) 

U.S. General Accounting Office. September 1999. GAO Report: Combating Terrorism: Need for Comprehensive Threat and Risk Assessments of Chemical and Biological Attacks. GAO/NSIAD-99-163. 

Hafemeister R. February 6, 1998. British avoiding vaccines for troops in Gulf. Belleville News-Democrat. 

Riechmann D. March 4, 1998. Anthrax vaccine works on monkeys. The Associated Press. 

Fukuda K, Nisenbaum R, Stewart G et al. September 16, 1998. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. Journal of the American Medical Association. 

Graham B. October 30, 1998. Dose of explanation comes with anthrax shots. The Washington Post. 

Unwin C, Blatchley N, Coker W et al. January 16, 1999. Health of UK servicemen who served in Persian Gulf War. The Lancet. 

Jackson PJ, Hugh-Jones ME et al. February 3, 1998. PCR analysis of tissuesamples from the 1979 Sverdlovsk anthrax victims: the presence of multiple Bacillus anthracis strains in different victims. Proceedings of the National Academy of Sciences of the United States of America. 

Funk D. June 28, 1999. Marine refuses vaccines, gets jail, discharge. Air Force Times. 

Daniels D. June 29, 1999. Anthrax shots bad medicine?: vaccine’s possible perils listed in military papers.  The San Diego Union-Tribune. (www.uniontrib.com) 

Kreisher O. July 22, 1999. Military personnel assail anthrax shots’ side effects. The San Diego Union-Tribune. 

Manning A. October 19, 1999. Anthrax vaccine injects anger into military: fearing reactions, troops quit the service. USA Today. 

Crawley JW. December 4, 1999. Pentagon postpones its anthrax inoculations. The San Diego Union-Tribune. 

Graham B. December 14, 1999. Pentagon anthrax program suffers setback: new manufacturing plant fails FDA inspection; inoculation expansion delayed. The Washington Post. 

Hudson A. October 10, 2001. Anthrax, smallpox vaccines called for. The Washington Times. 

Hoffman KB. October 10, 2001. Company working on anthrax vaccine. Associated Press. 

Spencer J., Scardaville M. October 11, 2001. Understanding the bioterrorist threat: facts and figures. The Heritage Foundation Backgrounder (www.heritage.org/library/backgrounder). 

Dyer G., Cookson C. October 11, 2001. Spreading calm in small doses. Financial Times. 

Pear R. October 20, 2001. Government talks with drug companies about buying anthrax antibiotics. The New York Times. 

Jackson RL. October 22, 2001. Lansing-based anthrax vaccine maker hit by major lawsuit: suit claims shots caused adverse reactions in soldiers. Los Angeles Times.  

Fleischer-Black M., Van Voris B. October 23, 2001. Anthrax Vaccine’s Liability Issue. The National Law Journal. 

Hanchette J. October 27, 2001. Why can’t we immunize Americans against anthrax? Gannett News Service. 

Johannes L. October 29, 2001. CDC to make anthrax vaccine available to workers put at risk in the line of duty. The Wall Street Journal. 

Walsh E. December 11, 2001. VA links Gulf War, Lou Gehrig’s Disease. The Washington Post. 

Weiss R., Schmidt S. December 16, 2001. Capitol Hill anthrax matches Army’s stocks. The Washington Post. 

Vedantam S., Connolly C.  December 18, 2001. Anthrax vaccine urged for Hill staff. The Washington Post.

Williams TD. June 02, 2001. Anthrax vaccine complaints on rise. The Hartford Courant.

Garrett L. 2000. Betrayal of Trust. New York: Hyperion.

 ABOUT THE EDITOR:  Barbara Loe Fisher is co-founder and president of the National Vaccine Information Center. She is co-author of DPT: A Shot in the Dark; author of The Consumer’s Guide to Childhood Vaccines; and editor of THE VACCINE REACTION and The Vaccine Hotline newsletters.  She served on the National Vaccine Advisory Committee and the Institute of Medicine Vaccine Safety Forum and is the consumer voting member of the FDA Vaccines and Related Biological Products Advisory Committee.

 

 The following statement is authored by Meryl Nass, M.D., A.B.I.M., a biowarfare epidemiologist who is an expert on anthrax vaccine. She has assisted Gulf War veterans suffering from neuroimmune dysfunction and has provided expert testimony to Congress on the safety and efficacy of the anthrax vaccine. Dr. Nass is a member of the Medical Advisory Board of the National Vaccine Information Center. 

ANTHRAX VACCINE CAUSES GULF WAR SYNDROME

by Meryl Nass, M.D. 

 

Until 1998, there existed no published papers that explored whether

receiving anthrax vaccine was related to Gulf War illnesses.  Instead,

several expert committees (lacking experience with anthrax) were asked

to comment on whether anthrax vaccine was likely to be a cause of Gulf

War Illnesses.  The committees were given DOD briefings, did not review

the literature (there were no published studies of safety or efficacy

for the licensed anthrax vaccine), concluded that a relationship was

unlikely, and then recommended against further research (1).

 

Studying American veterans was particularly difficult because many were

not told whether they were given anthrax vaccine, and the vaccinations

were specifically not entered into service members' shot records. Other

centralized vaccine records have been lost.  Despite concerns about the

investigational status of anthrax vaccine when used for biological

warfare, no informed consent was obtained from service members at the

time of the Gulf War, and no waiver of informed consent was sought from

the FDA.

 

The Canadian Department of National Defense (DND) hired a consulting

company (Goss Gilroy Inc.) to study the health of Canadian Gulf Veterans

and look at various exposures.  Their report was published on the DND

website.  They found a significant relationship between receiving

non-routine (biological warfare) immunizations and developing chronic

fatigue, a very common symptom of GWS (2).

 

In 1999 a British study examined a large number of Gulf War exposures in

large cohorts of British Gulf War and non-deployed Gulf-era veterans,

and Bosnia veterans.  They found that for both the Gulf War and the

Bosnia veterans, receiving anthrax vaccine was related to developing an

illness consistent with Gulf War Syndrome (GWS). They wrote,

"Vaccination against biological warfare and multiple routine

vaccinations were associated with the CDC multi-symptom syndrome in the

Gulf War cohort (3)."

 

This group published a follow-up paper in the British Medical Journal

that claimed that only Gulf War veterans who received vaccines after

deployment, not before, showed this relationship.  However, they later

retracted this conclusion, and acknowledged that the timing of

vaccination did not affect the relationship between vaccination and GWS.

 

A study of Kansas Gulf War veterans was published in 2000 (4).  This

study also found that deployment vaccines were related to GWS: 34% of

Gulf War veterans met the definition for GWS, while only 4% of non-deployed, 

non-vaccinated Gulf-era veterans met the definition.  However, 12% of Kansas 

Gulf-era veterans who were vaccinated in preparation for deployment, but then 

were not sent to the Gulf, also met the GWS definition.  The paper concluded, 

"Vaccines used during the war may be a contributing factor."

 

A second study of British Gulf War veterans was published in 4/2001.

This study looked at the relationship between various Gulf War exposures

and subsequent health.  It did not look at specific deployment vaccines,

but instead evaluated the number of vaccinations received in relation to

GWS. It said, "Consistent, specific, and credible relations, warranting

further investigation, were found between health indices and two

exposures, the reported number of inoculations and days handling

pesticides (5)."

 

The Veterans Administration collected data on thousands of Gulf War

veterans who presented for evaluation of Gulf War Syndrome.  Although

unpublished, the data were presented at a conference on GWS in January

2001 (6).   The VA asked veterans if they thought they had received

anthrax vaccine at the time of the Gulf War, among many other potential

exposures, and inquired about symptoms of illness.  Those who believed

they had received anthrax vaccine were twice as likely to report a

multitude of symptoms as those who believed they were not vaccinated.

 

These are all the Gulf War data that are available in the open

literature.  Every study that examined the question of whether vaccines

in general, or specific non-routine vaccines, or anthrax vaccine alone

may have contributed to GWS, has found a positive relationship.

 

The French Ministry of Defense (MOD) recently convened an advisory

committee to study GWS chaired by Professor Roger Salamon.  This

committee reviewed the existing world literature on GWS, and suggested

that "multiple vaccinations given during the war, particularly those for

anthrax, botulinum and plague, seem associated with an excess of (GWS)

signs and symptoms (7)."

 

There are no published long-term adverse event data from the anthrax

vaccine immunization program, which began vaccinating servicemembers in

March, 1998.  However, the unpublished study done by Captain Jean Tanner

at Dover Air Force Base suggests that recent anthrax vaccine recipients

face similar medical problems as the Gulf War veterans (8).  

Meryl Nass, MD

207 865-7000

mnass@anthraxvaccine.org 

________________________

 

1. Expert committees listed in my Testimony to the House National

Security Subcommittee, April 29, 1999.  

http://www.house.gov/reform/na/hearings/testimony/nass2.htm

2. http:// www.dnd.ca/menu/press/Reports/Health/health_study_eng_1.htm

3. Unwin C et al. Health of UK servicemen who served in the Persian Gulf

War. The Lancet 1999; 353:169-178.

4.  Steele L. Prevalence and patterns of Gulf War Illness in Kansas

veterans: Association of symptoms with characteristics of person, place,

and time of military service. Am J Epidemiol 2000; 152:991-1001.

5. Cherry N et al. Health and exposures of United Kingdom Gulf War

veterans. Part II:

The relation of health to exposure. Occup Environ Med 2001; 58: 299-306.

6.  Mahan CM, Kang HK, Ishii EK et al. Anthrax vaccination and

self-reported symptoms, functional status and medical conditions in the

national health survey of Gulf War era veterans and their families.

Environmental Epidemiology Service, Veterans Health Administration,

Washington, DC. Presented January 25, 2001 @ Research Working Group:

Military and Veterans Health Coordinating Board Conference on Illnesses

among Gulf War Veterans: A Decade of Scientific Research

7.  www.gulflink.org/france/RAPPORTa.doc

8.  www.anthraxvaccine.org/Report.pdf

www.anthraxvaccine.org/data.pdfwww.anthraxvaccine.org/remarkst.pdf

What is Anthrax?

Anthrax is a serious bacterial infection caused by Bacillus anthracis. It is not contagious from person to person. The disease most commonly occurs in animals such as cattle, sheep, horses, and goats after they graze in areas contaminated with spores of B. anthracis.  The body wastes and carcasses of infected animals, or flies that eat infected carcasses, and contaminated hides and meat are all sources of anthrax. Individuals who work with animals or animal by-products or are exposed to contaminated soil are at highest risk of contracting anthrax.   

The bacteria, which requires oxygen to survive, produce spores that can survive for years in dry soil but can be destroyed by boiling or treating with hydrogen peroxide or dilute formaldehyde.    Other methods that may be useful include bleach, chlorine dioxide gas, and a combined Ultraviolet-C light/X-ray system.    There are three known strains of anthrax – Ames, Vollum, and Sterne. The Ames strain, considered the most virulent, was initially isolated in Texas in 1981 and found in both the U.S. and the United Kingdom. 

There are four types of anthrax – Cutaneous (Skin), gastrointestinal, inhalation, and injection.

Cutaneous Anthrax

This is the most common and least deadly form of anthrax. This form occurs when spores enter the body through openings in the skin, such as scrapes or cuts. After exposure, infection generally occurs within one to seven days.  Symptoms include bumps or blisters that may be itchy and swelling around the site. An ulcer with a black center may also form after the initial presentation.  Most people who develop cutaneous anthrax become exposed by handling contaminated animal products.  Most cases of cutaneous anthrax resolve without treatment and only between five and 20 percent of untreated cutaneous anthrax cases are fatal. With treatment, nearly all exposed persons survive. 

Inhalation Anthrax

This occurs when anthrax spores are inhaled and enter the respiratory system. The most frequent exposure to anthrax by inhalation occurs during the processing of animal by-products such as hides or wool.  Symptoms of inhalation anthrax are generally non-specific and can include shortness of breath, cough, fever, chills, extreme fatigue, head, and body aches, confusion, dizziness, nausea, vomiting, and stomach pain.  The incubation period of the illness is about one week but can be up to 60 days. Fifty-five percent of persons exposed to anthrax by inhalation during the 2001 bioterrorism attack in the U.S. survived. There is only a 10 to 15 percent survival rate from inhalation anthrax without treatment.   

Gastrointestinal Anthrax

While rare, gastrointestinal anthrax can occur when a person consumes raw or undercooked meat from an infected animal.  It can also occur if a person swallows aerosolized anthrax spores from animal by-products. There are two forms of gastrointestinal anthrax – intestinal and oropharyngeal. Intestinal anthrax occurs when the spores cause ulcers along the intestinal tract. Symptoms of intestinal anthrax include nausea, vomiting, diarrhea, and abdominal pain. Complications include bleeding, perforation, obstruction, and shock. Oropharyngeal anthrax occurs when spores attach to the back of the throat (pharyngeal area). Symptoms of oropharyngeal anthrax can include congestion, neck swelling, and fever.  The incubation period of gastrointestinal anthrax ranges from one to seven days.  Between 25 to 60 percent of cases of gastrointestinal anthrax are fatal. 

Injection Anthrax

A newer form of anthrax, injection anthrax, was first identified in Northern Europe and associated with persons who inject heroin. Symptoms of injection anthrax are like cutaneous anthrax; however, the infection may occur deeper in the skin or into the muscle. No cases of injection anthrax have been identified in the U.S.  Approximately 33 percent of injection anthrax cases are fatal. 

Confirmation of an anthrax diagnosis can include blood antibody testing or specific testing of specimens, including respiratory secretions, spinal fluid, and skin lesions. Testing must be completed before antibiotic treatment begins. More sensitive lab tests can also be performed for anthrax disease confirmation.   

Persons exposed to anthrax but have no symptoms are generally treated prophylactically for 60 days with antibiotics that include doxycycline and ciprofloxacin.  Antibiotics and anthrax antitoxins are available to treat persons with symptoms of anthrax. Outcomes are better if persons receive prompt treatment as soon as symptoms develop. 

One of the biggest concerns with anthrax is its potential to be used again in a bioterrorist attack. In the fall of 2001, 22 individuals developed anthrax (11 inhalation and 11 cutaneous) in the U.S. due to bioterrorism. Twenty of those cases were linked to handling mail items, and five of the 11 people who developed inhalation anthrax died.  Concerns regarding the use of anthrax as a bioweapon include the availability of spores in nature, their ability to last a long time in the environment, and the ease with which it could be added to food and water, powders, and other items without being readily detected. 

Anthrax

Statement by Randi Airola
Executive Director

Military Vaccine Education Center
April 1, 2005

Anthrax Band Reunion Press Conference
New York City

  My name is Randi Airola. I'm the Executive Director of the Military Vaccine Education Center. Our organization helps soldiers and their families who have been hurt by the anthrax and other military vaccines.

The truth is: The Department of Defense knew the anthrax vaccine was experimental before they started forcing the troops to take it in 1998.

In October of 2004, after 6 years of the Department of Defense forcing service members to take the anthrax vaccine, a Federal Judge ruled that the order was indeed illegal.

According to the Government's conservative estimates, more than 4,000 healthy soldiers have been harmed by the anthrax vaccine with different symptoms ranging from convulsions, blood clots, heart problems, extreme fatigue and muscle weakness, severe migraines, paralysis, spontaneous miscarriages, tumors, tremors, loss of hair, loss of eyesight, loss of memory - and even death. Acknowledgement of these serious side affects is included in the vaccine's FDA approved product label.

I have spoken with more than 1,000 soldiers or their family members about their illnesses mentioned above. Some of these victims are in their 20's and need the assistance of a cane to walk. Some of these victims are even forced to pay their own medical bills and medical treatment. Soldiers who have refused vaccination have been fined, court-martialed, and even imprisoned with felony convictions.
Our men and women in uniform who volunteer to lay down their lives for the rest of us should not have to fear losing their health and their careers at the hands of our own Government.

The Department of Defense must cease its illegal misconduct of experimenting on our troops with inadequately tested, experimental vaccines, like the anthrax vaccine.

Who will volunteer to serve this great nation knowing that they must risk their health or lose their careers if they protest illegal orders? Enlistment bonuses treated as a dangling carrot to get potential recruits to enlist will come and go - but your health is yours forever.

The only way to move forward to begin to restore trust and confidence in the military is to give soldiers their legal right to full and informed consent over the experimental vaccines they are ordered to take.
www.MilVacs.org

Is Anthrax Contagious?

Anthrax is not a contagious disease. It is not possible for someone who is directly exposed to anthrax spores and becomes sick to transmit the disease to someone else by coughing or sneezing like many other infectious diseases.  Everyone who gets sick with anthrax must have come into direct contact with the bacteria through a cut in the skin, inhaling the spores into the lungs, or swallowing the spores, such as by eating contaminated meat. Rarely, it is possible to develop anthrax by coming into contact with the skin lesions of someone who is infected with anthrax. 

The most common way to get anthrax is through exposure to an infected animal or animal waste and by-products. Veterinarians, farmers, or researchers working with animals are at higher risk, as are those working in industries that handle animal by-products like meat and animal skins. The cutaneous (skin) form of anthrax, the most common form, has a very low death rate with appropriate antibiotic therapy after exposure.   

 

What is the history of Anthrax in America and other countries?

Anthrax is named from the Greek word “anthrakis,” meaning coal, for the coal-black skin lesions present in cutaneous anthrax cases. It has been acknowledged for thousands of years, and descriptions of the disease can be found in the early writings of the Roman, Greeks, and Hindus. It is believed that an epidemic of the disease among animals in Egypt occurred in biblical times and was recorded in the book of Genesis. The disease decimated Egyptian livestock, including horses, donkeys, camels, sheep, and goats. The Latin Poet Virgil referred to the disease among wild and domestic animals in poems published around 29 BC. 

The first reports of anthrax in the U.S. were documented in 1868 when Dr. Silas Stone described eight patients with symptoms of anthrax. As the cause of symptoms was unknown, Stone referred to the condition as “malignant pustules.” All eight were linked to a factory processing animal hair in Massachusetts.  Six of the eight had severe symptoms, and two died as a result, likely from meningitis. 

Multiple experiments on anthrax took place during the 19^th Century. While anthrax was never confirmed by culture, it was believed to be an organism capable of multiplying in the body, invading the bloodstream, and causing death by sepsis. In 1876, Robert Koch proved that Bacillus anthracis (B. anthracis) was responsible for anthrax and conducted animal experiments. He also discovered what environmental conditions were favorable to the anthrax spore’s survival and determined that certain pastures could be deadly to animals as spores could survive for decades in the soil. 

Pasteur discovered that the remains of animals who had died from anthrax and were buried could still cause anthrax infections, and earthworms could carry anthrax spores to the surface. Pasteur also determined that B anthracis itself could cause anthrax and not a toxic substance produced by the bacterium, as some believed was the case. 

Inhalation anthrax was also recognized in the 19^th Century and was initially labeled as “woolsorters” disease, but also came to be known as Bradford disease after many cases occurred in the Bradford, England area. This disease was first seen in 1847 among British woolsorters working with alpaca hides from Peru and goat hairs from Asia Minor.   

In 1880, Bradford physician John H. Bell published a paper on this disease and described where affected woolsorters would rapidly die from their symptoms. He also discovered B anthracis in the victims’ blood and concluded that this was the cause of the disease.   

Rules regarding the care and treatment of the raw materials were put forth, and in 1897, these rules, known as the Bradford rules, became law. Between 1899 and 1907, there were 447 cases of anthrax and 120 deaths from all forms of anthrax. 

In 1905, the Anthrax Investigation Board was formed and added a bacteriologist, F.W. Eurich. Eurich spent years investigating anthrax and methods to eliminate the bacterium from animal hairs. After many experiments, Eurich discovered that two percent formaldehyde at 100 degrees F for 30 minutes would kill the spores. 

Great Britain enacted the Anthrax Prevention Act in 1919, which required animal hairs considered high-risk for anthrax to be decontaminated before being imported. No additional cases of inhalation anthrax related to the British hair and wool industry were reported after 1929. 

Anthrax was also reported as a health problem in the U.S. during this time and linked to the handling of animal hides. In 1916, an outbreak occurred in Massachusetts, affecting 25 people, of which 23 had direct contact with animal hides. Twenty of those were directly linked to a single source of hides shipped from China. 

In 1919, the U.S. Public Health Service issued a warning about anthrax and shaving brushes. In this report, public health officials warned that the recommended sterilization processes were not being followed, which had resulted in cases of facial anthrax. During World War I, the supply chain disruption was blamed for the rise in cases, as animal hairs used in the production of the brushes were not being properly disinfected. Horsehair and pig bristles imported into the U.S. from Russia, China, and Japan for use in shaving brushes were previously sent to France or Germany and disinfected before shipping to the U.S.; however, due to the war, direct shipments from Asian countries were now commonly occurring. As few brushes were labeled with any mark to trace their origins, public health officials could not pinpoint where the source of the anthrax-containing brushes were from. 

Between 1919 and 1924, 61 anthrax cases and 19 deaths were reported in New York City, and shaving brushes accounted for just over half of the cases. Except for three cases, all sources of anthrax were confirmed as being related to the manufacturing, handling, transporting, or usage of contaminated items made from animal byproducts. 

In the U.S., between 1919 and September 1, 1925, 632 anthrax cases and 177 deaths were documented from 33 reporting states. When the sources of anthrax were known, most were connected to the leather industry. Anthrax related to shaving brushes was reported as declining and was attributed to the increasing awareness of the dangers. 

In the early 20th century, anthrax treatment consisted of anthrax antiserum given locally or intravenously. Surgical excision of the anthrax pustule was also used but often found to be ineffective or harmful.  Physicians treating anthrax found that many cases of cutaneous anthrax would resolve on their own and surgical interventions often caused septicemia, which was frequently fatal. 

Between 1945 and 1951, there were 372 reported anthrax cases, with over 300 cases occurring in the seven northeastern states and linked to industrial exposures. Twenty-nine cases were associated with agriculture exposures and were reported as cutaneous anthrax. Additionally, there were 658 outbreaks of anthrax among animals between 1945 and 1950, and an estimated 8,505 died as a result. 

In 1951 and 1952, numerous anthrax outbreaks among animals were reported and linked to bone meal. Most cases occurred in Indiana, Ohio, and other Midwestern states. There were no human cases associated with this outbreak. The use of penicillin and anthrax antiserum assisted in halting the outbreak. 

Despite an increase in animal anthrax cases, there were fewer human cases and no reports of transmission from animals to humans through meat or milk. Antibiotics were considered effective against anthrax, and public health officials believed that the use of antibiotics could potentially replace antiserum. 

By the 1950s, cases and deaths from anthrax had dropped significantly in the U.S.; however, disease rates remained high in most countries globally. Countries with higher rates were noted to have poor sanitation practices, and health officials suspected that rates were likely even higher than what was being reported.   There were 45 reported anthrax cases in the U.S in 1953. 

The first known outbreak of inhalation anthrax in the U.S. occurred in 1957 at a goat hair factory in New Hampshire. Five individuals developed inhalation anthrax within ten weeks. Four cases were fatal.  In total, for 1957, there were 26 reported anthrax cases. 

In 1960, 23 anthrax cases were reported. All cases were cutaneous and none fatal. Twenty were associated with industrial exposures, with 15 reported from one South Carolina mill that had recently begun processing imported goat hair. This increased from 1959, when 15 cases were reported, and from 1958, which had 17 reported cases. 

Anthrax cases continued to decline, and during the 1960s, there were an average of five cases per year and a total of two deaths.    By 1980, an average of two cases occurred yearly.  Rates continued to decrease, and between 1981 and 2000, there were only six reported anthrax cases. 

In the fall of 2001, 22 cases and five deaths from anthrax occurred due to an anthrax bioterrorism attack. Additionally, one separate anthrax case was reported in 2001 and traced to an anthrax-infected animal.   

Between 2002 to 2019, eight human anthrax cases were reported in the United States.              Several of these cases resulted from exposure to drums made from anthrax contaminated animal skins.       

Anthrax Worldwide

B. anthracis can be found worldwide but is endemic in South America, the Middle East, Africa, and Central Asia. 

One of the largest anthrax outbreaks occurred in Zimbabwe (Rhodesia) in the late 1970s and early 1980s during a period of civil unrest. Researchers estimate that the outbreak infected over 170,000 cattle and over 17,000 humans and caused approximately 200 deaths. 

In 2009 and 2010, an outbreak of anthrax occurred among injection drug users in Europe and the United Kingdom. Anthrax-contaminated heroin was blamed for the outbreak. Fifty-four cases and 17 fatalities were attributed to this outbreak. 

Anthrax and Bioterrorism 

In World War I, the German army attempted to use anthrax to poison animals and animal feed in several countries; however, their efforts were not successful. From 1932 to 1945, Japanese troops occupying China experimented with anthrax and other biological weapons, and it is estimated that 10,000 prisoners may have died as a result. During World War II, the British military tested anthrax delivery systems on an island off the Scottish Coast. The U.S. military also worked on developing anthrax bioweapons and filled more than 5,000 bombs with the substance for use against Germany.     

Development of bioweapons continued in the 1950s and 60s; however, concern over their potential use began growing. In 1969, President Nixon ended the bioweapons program through an executive order. This order also called for the destruction of all bioweapons and a commitment by the U.S. to refrain from using toxic or biological weapons. In 1972, over 100 countries signed a treaty that prohibited the developing, stockpiling, and use of biological weapons. 

Despite signing the treaty in 1972, the Soviet Union continued research on bioweapons. In 1979, a large anthrax outbreak occurred in Sverdlovsk (now Ekaterinburg, Russia). Soviet officials claimed that the outbreak was related to anthrax-contaminated animals sold on the black market; however, in 1992, Russian officials admitted that the outbreak occurred due to an accident at a bioweapons factory. A clogged air filter was removed but not replaced and this incident allowed for the release of anthrax. Soviet Officials reported that 64 of the 96 affected individuals died from gastrointestinal anthrax.   

One article published in the medical literature suggested that the Russians had developed a genetically engineered strain of anthrax. During the Gulf War in the 1990s, there were fears that Iraq might have this genetically engineered anthrax strain that would make the vaccinated U.S. troops vulnerable. However, there has been no public confirmation that Iraq or any other country outside of Russia has developed a genetically engineered, weaponized strain of anthrax that can be successfully deployed in the form of a bioterrorism weapon to harm U.S. citizens.     

In July 1993, an attempted anthrax attack occurred in Japan by members of a religious organization. This attack, however, was not confirmed at the time since there were no reports of anthrax-associated illnesses during the days in question. Confirmation that the liquid suspension aerosolized from the rooftop of a building in Tokyo contained anthrax spores did not occur until November 1999, when the one remaining sample was sent to a lab in Arizona for identification. This lab confirmed the presence of anthrax with a genotype found to be identical to the strain used in the anthrax vaccine targeting animals in Japan. 

In 2001, a bioterrorism attack caused 22 individuals to develop anthrax (11 inhalation and 11 cutaneous) after envelopes containing anthrax spores were mailed to various U.S. government officials and news media outlets. Twenty of the 22 cases were linked to handling mail items, and five people died as a result. 

Genetic testing on the anthrax-contaminated letters confirmed the Ames strain variant of anthrax, developed during experimental research originating at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) at Fort Detrick, Maryland. 

Reportedly, the Ames strain of anthrax was provided to other labs doing anthrax research, including Porton Down, a British military lab; Louisiana State University; Northern Arizona University; as well as Dugway Proving Ground Military Research facility in Utah, where anthrax spores were reportedly processed into the powder form that can be inhaled easily. The fact that the genetically engineered and weaponized anthrax strain used in the anthrax-contaminated mail could be traced back to a U.S. military research facility suggested internal lab security issues that needed to be addressed.   

Federal health officials and military anthrax experts urged Capitol Hill staffers and thousands of U.S. Postal Service employees in Washington D.C, New York, and New Jersey, possibly exposed to mail contaminated with the experimental strain of anthrax, to receive anthrax vaccines.     

The civilians were urged to get the shots and complete a two-month course of antibiotics. Health officials maintained that anyone exposed to the experimental anthrax bacteria could be harboring anthrax spores in their lungs and may become ill once they stop using the antibiotics.  

There hasn’t been a successful delivery of weaponized inhalation anthrax to any large population through a bomb, missile, crop duster, or any other means. If the anthrax bacteria is used as a biological weapon to kill large numbers of people, it will most likely be used in the deadly aerosol form so that large numbers of people will inhale it. This will mean that the anthrax strain and size of spores will have to be designed explicitly for weapons purposes and will require an effective delivery system.  

Timeline of U.S. Anthrax Vaccine

1962
A study of anthrax vaccine involving goat-hair mill workers is published.

1970
The Michigan Department of Public Health receives a license for anthrax vaccine. Most users work at federal biological weapons labs.

1991
About 150,000 U.S. troops deployed for the Persian Gulf War get anthrax shots, the first widespread use of the vaccine.

1997
Defense Secretary William Cohen orders the beginning of mandatory anthrax vaccination. More than 450 troops refuse to take it in following years.

1998
BioPort Corp. is formed. The company buys the anthrax vaccine plant and license rights from Michigan.

2004
A U.S. district judge rules the vaccine was not properly licensed for protection against inhaled anthrax and says troops can't be forced to take it until it's properly licensed.

2005
The Pentagon begins the voluntary anthrax vaccination program. It appeals the ruling that made the vaccinations voluntary.

The Daily Press, Hampton Roads, Virginia

Anthrax

Statement by Barbara Loe Fisher
Co-founder & President
National Vaccine Information Center
April 1, 2005
Anthrax Band Reunion Press Conference
New York City
 

My name is Barbara Loe Fisher. I am co-founder and president of the National Vaccine Information Center. We have been working for the past 23 years to prevent vaccine injuries and deaths through public education and to protect the human right to informed consent.

If you are thinking about going into the military, you need to know that after 9-11, Congress passed a law called Project Bioshield that gives the Secretary of Defense the power to order soldiers to take experimental vaccines without telling them they could die or be permanently injured and without getting their voluntary consent. After 9-11 many states also passed laws that gave power to government health officials to arrest and forcibly vaccinate citizens without their informed consent.

Now Congress wants to pass another law that would give more power to government officials to declare a potential emergency - whether the emergency is real or not - and force you and every other American to take vaccines - whether they are experimental or not - without giving you a choice. And without giving you the information you need about the vaccine's side effects! And if you get hurt, you won't be able to go to court to find out if the drug company or the doctor who gave you the vaccine could have done a better job of protecting you from harm.

The soldiers hurt by the anthrax vaccine, just like the children hurt by mandatory childhood vaccines, had no voice and had no choice. If you want to make sure that you have the freedom to decide which vaccines you are willing to risk your life for, you need to get informed, get involved and stand up for your rights just like the band, Anthrax, is doing today.

You can learn more about diseases and vaccines and protecting your right to informed consent to vaccination by contacting the National Vaccine Information Center at www.nvic.org. Thank you.

Barbara Loe Fisher is co-founder and president of the National Vaccine Information Center. The mother of a son injured by the DPT vaccine in 1980, she is co-author of DPT: A Shot in the Dark (1985), author of The Consumer's Guide to Childhood Vaccines and editor of THE VACCINE REACTION. She worked with Congress on the National Childhood Vaccine Injury Act of 1986 and led demonstrations at the CDC and White House that year before it was made law. She has served on the National Vaccine Advisory Committee; Institute of Medicine Vaccine Safety Forum and the FDA Vaccines and Related Biological Products Advisory Committee.
 

Can Anthrax Cause Injury and Death?

B. anthracis can invade the human bloodstream, multiply and spread to lymph nodes and many organs, and kill quickly. The bacteria, which produces a virulent toxin, can enter the bloodstream through a cut in the skin; by inhaling the anthrax spores through the nose; by swallowing the spores into the gastrointestinal system; or by injecting anthrax contaminated heroin. The cutaneous (skin) route is much less deadly than inhaling, swallowing, or injecting the organism.    

Cutaneous (Skin) Anthrax:  If the anthrax exposure route is through the skin, symptoms include a formation of a small, red skin lesion(s) that become swollen, larger, and blackened over a week’s time. Spontaneous healing occurs in 80 to 90 percent of cases. Ten to 20 percent of untreated cutaneous anthrax cases develop fever, edema, bacteremia (massive bacterial infection of the blood), necrosis, shock, meningitis, and death.             

Inhalation (Lungs) Anthrax:  Symptoms of inhalation anthrax are generally non-specific and can include shortness of breath, cough, fever, chills, extreme fatigue, head, and body aches, confusion, dizziness, nausea, vomiting, and stomach pain.  Complications of inhalation include hypotension, severe breathing problems, toxemia, bacteremia, gastrointestinal disorders, meningitis, shock, and death can occur within 24 hours.  Fifty-five percent of persons exposed to anthrax by inhalation during the 2001 bioterrorism attack in the U.S. survived. Without treatment, there is only a 10 to 15 percent survival rate.   

Gastrointestinal Anthrax: After swallowing anthrax spores, symptoms of gastrointestinal anthrax can include fever, nausea, vomiting, abdominal pain, diarrhea or bloody diarrhea, and sore throat, hoarseness, painful swallowing, and swelling of the neck or abdomen.  Complications include bleeding, perforation, intestinal obstruction, sepsis, respiratory disease, toxemia, meningitis, increased abdominal girth, ascites, bowel perforation, shock, and death.   

Injection Anthrax: Symptoms of injection anthrax are like cutaneous anthrax; however, the infection may occur deeper in the skin or into the muscle.  Complications include skin necrosis, septic shock, multi-organ failure, meningitis, and death.  Approximately 33 percent of injection anthrax cases are fatal. 

Who is at Highest Risk for Getting Anthrax?

NORMAL EXPOSURE TO ANTHRAX

Exposure to anthrax most commonly occurs via contact with an infected animal or animal waste and by-products. Veterinarians, farmers, or researchers working with animals are at higher risk, as well as occupations that require the handling of animal by-products like meat and animal skins.  Most cases of cutaneous anthrax resolve without treatment, and only between five and 20 percent of untreated cutaneous anthrax cases are fatal. With treatment, nearly all exposed persons survive. Ninety-five percent of all anthrax cases are cutaneous anthrax. 

Traveling to areas where anthrax is more common can also place persons at a higher risk for developing anthrax infection. These regions include the Caribbean, Eastern and Southern Europe, Central and southwestern Asia, Sub-Saharan Africa, and South and Central America. Persons who travel to these regions should be cautious about the foods consumed and items they touch. 

BIOTERRORISM EXPOSURE TO ANTHRAX

If anthrax bacteria is used as a biological weapon to kill large numbers of people, it will most likely be used in the deadly aerosol form so that large numbers of people will inhale it. This will mean that the anthrax strain and size of spores will have to be designed explicitly for weapons purposes and will require an effective delivery system. 

In July 1993, an attempted anthrax attack occurred in Japan by members of a religious organization. This attack, however, was not confirmed at the time since there were no reports of anthrax-associated illnesses during the days in question. Confirmation that the liquid suspension aerosolized from the rooftop of a building in Tokyo contained anthrax spores did not occur until November 1999, when the one remaining sample was sent to a lab in Arizona for identification. This lab confirmed the presence of anthrax with a  genotype found to be identical to the strain used in the anthrax vaccine targeting animals in Japan. 

In 2001, a bioterrorism attack caused 22 individuals to develop anthrax (11 inhalation and 11 cutaneous) when envelopes containing anthrax spores were mailed to several U.S. government officials and news media outlets. Twenty of the 22 cases were linked to handling mail items, and five people died. 

So far, there has never been a successful delivery of inhalation anthrax to any large population through a bomb, missile, crop duster, or any other means; however, government agencies have plans in place should an attack occur. 

Anthrax

Court Orders Pentagon to Stop Anthrax Vaccinations

 

BL Fisher Note:
After reviewing all the evidence, the U.S. District Court judge concluded that "Congress prohibited the administration of investigational drugs to service members without their consent. This Court will not permit the government to circumvent this requirement. The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all - public scrutiny.......accordingly the involuntary anthrax vaccination program, as applied to all persons, is rendered illegal absent informed consent or a Presidential waiver..."
 

This judge upheld the spirit and intent of the Nuremberg Code, issued by the Nuremberg Tribunal after The Doctor's Trial in Nuremberg, Germany following World War II. The Nuremberg Code prohibits the forcing of experimental medical interventions on an individual without his or her voluntary, informed consent. It has served as the guiding principle in the ethical practice of all medicine, experimental or not, ever since it was presented to the world in memory of those who were sacrificed in medical experiments conducted by physicians employed by the State during World War II.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

http://www.washingtonpost.com/wp-dyn/articles/A3691-2004Oct27.html
washingtonpost.com
Court Orders Pentagon to Stop Anthrax Vaccinations
By Marc Kaufman
Washington Post Staff Writer
Thursday, October 28, 2004; Page A01

The Defense Department must immediately stop inoculating troops with anthrax vaccine, a federal judge ruled yesterday, saying that the Food and Drug Administration acted improperly when it approved the experimental injections for general use.

Concluding that the FDA violated its own rules by approving the vaccine late last year, U.S. District Court Judge Emmet G. Sullivan said the mandatory vaccination program -- which has inoculated more than 1.2 million troops since 1998 -- is "illegal."

Sullivan said that his ban on involuntary vaccination will remain in place until the FDA reviews the anthrax vaccine properly or until President Bush determines that the normal process must be waived because of emergency circumstances.

The Defense Department has required many troops serving in Iraq and Afghanistan to be vaccinated, and it has punished and sometimes court-martialed those who refused. The Pentagon expanded its anthrax and smallpox vaccination programs in July to include troops stationed in South Korea and other areas in Asia and Africa, despite complaints from some service members that the anthrax vaccine made them sick.
In a statement, the Defense Department said it is reviewing the decision and will "pause giving anthrax vaccinations until the legal situation is clarified. . . . DoD remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe and effective."
In his ruling, Sullivan said that the FDA's approval was invalid because it did not meet the required review standards and the agency failed to seek the necessary public comment.

"Congress has prohibited the administration of investigational drugs to service members without their consent," Sullivan said. "This Court will not permit the government to circumvent this requirement."

"The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all -- public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this court shall compel FDA to follow," Sullivan wrote.

The judge ruled on a suit filed in March 2003 by six service members and civilians who argued that the FDA never properly reviewed the vaccine's ability to protect against inhalation anthrax. The suit contended that the drug was never shown to be effective, and that some vaccinated troops experienced extreme fatigue, joint pain and temporary memory loss after being vaccinated. The vaccine, made by BioPort Corp. of Lansing, Mich., is given in a series of shots.

Mark Zaid, an attorney for the six who has also defended more than a dozen service members court-martialed for refusing the vaccination, said one of his clients is a breast-feeding mother who does not think the vaccine is safe for her child.

"We will now initiate an effort to ensure the government reverses all punishments that were imposed for refusing an order to take the vaccine," Zaid said. He said he will also seek compensation for service members who contend they were harmed. "As we've seen in Iraq, there wasn't any actual threat from anthrax, so there was never any real need for the vaccine," Zaid said.

Sullivan initially ruled in late 2003 that the FDA had never approved the vaccine and ordered that the inoculations be stopped. Eight days later, the FDA approved the vaccine based on an application made 18 years earlier, and the inoculation program was resumed. Yesterday's ruling concluded that the agency did not follow its own rules in declaring the vaccine safe and effective.
In particular, Sullivan criticized the FDA for not allowing the public to comment on its decision -- a prerequisite for any approval. There was some public comment when the approval was first sought in 1986, but the 2003 decision was based on research conducted later and never subjected to public comment.

The FDA argued that comments had been submitted as part of a 2001 citizens' petition questioning proposals to begin the vaccinations, but Sullivan found them insufficient. "It is clear to this Court that if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency," he wrote.

Because the anthrax agent is so deadly, it has been difficult to test a vaccine that might protect against it. The best data have come from a study in the 1950s of workers at a factory that processed animal hides and furs, which can transmit naturally occurring anthrax. That study found that the vaccine now used by the military was effective in reducing the incidence of anthrax spread by contact, but the research involved only a tiny sample of people who might have inhaled the bacteria.

Anthrax vaccine was used in a limited way in the 1991 Persian Gulf War. A more expansive effort began in 1998. Difficulties in manufacturing the vaccine stopped the program in 2000 and 2001, but the vaccination effort was resumed and greatly expanded in 2002.

RULING:
http://www.airforcetimes.com/content/editorial/pdf/102704anthrax_decision.pdf

Anthrax

FOR IMMEDIATE RELEASE:
MARCH 30, 2005

Contacts:

Adrenaline PR:
Maria Ferrero 732-462-4262 

SIRIUS Satellite Radio:
Elise Brown 212-584-5290 

 

ANTHRAX SAYS NO TO DRUGS
ANTHRAX FIGHTS THE VACCINE
ATTACK OF THE KILLER VACCINE

ANTHRAX SAYS "NO MORE!" TO SPREADING THE DISEASE

Slave to the Metal™ Foundation is a portal for Heavy Metal music fans and the music Industry to raise awareness and provide funds to those organizations and individuals that fight against the misuse of heavy metals (i.e. depleted uranium, mercury and lead) and who are rising in outrage over other misanthropic and genocidal initiatives such as the forceful administration to our soldiers of the untested and unapproved Anthrax Vaccine (See: www.anthraxvaccine.org , www.milvacs.org). "Every fan of Heavy Metal music has the chance right now to support our troops as ANTHRAX partners with Slave to the Metal™ Foundation to provide an opportunity for the most affected generation to make a difference and bring public awareness to the dangers of the Anthrax Vaccine." Charlie Benante.

"Heavy Metal music was born out of non-conformity to socially accepted structure. Therefore our roots are seeded in the belief that we must challenge structure as it is based on past viewpoints imposed on the future. With respect to the Anthrax Vaccine it is our responsibility as 'keepers of the faith' of Heavy Metal music to stay true to core belief and challenge Project BioShield - a legislative act that authorizes the mandated use of untested and unapproved vaccines on our soldiers making them in essence first line guinea pigs for the biopharmaceutical industry." Scott Ian. "It has come to us from the most legitimate and politically correct activist circles that our head-banger support is sorely needed to make the public aware of these atrocities." Joey Belladonna.

"Along with the likes of directors, Scott Miller (www.directorder.org), who shed light on the Anthrax Vaccine dangers, and Michael Moore who is working on a Big Pharma expose, we are requesting Heavy Metal fans to channel their fabulous outrage to derail the atrocities that are being committed against innocent human beings." Eileen Dannemann, co-Founder Slave to the Metal™ Foundation. "I oppose all attempts by anyone to take away my right to dissent and say NO to being a guinea pig for the biopharmaceutical industry." Dan Spitz.

Please join us for the biggest event in heavy music - the ANTHRAX Global Press Conference and Luncheon. This history-making music event will take place on April 1, 2005 at 2:00 PM ET/11:00 AM PT at SIRIUS Satellite Radio's national broadcast center in New York City, and will be broadcast live on Hard Attack/27, SIRIUS' extreme heavy metal channel.

Refreshments and light fare will be served. A telephone line (866-510-5377) will be set up for off-site journalists to call in questions to directly ask the band - live on SIRIUS! Photos will be accommodated. To attend in person, press must RSVP by 5 pm ET on March 31, and a photo ID will be required to enter the building.

Slave to the Metal™ Foundation is representative of the highest social aspirations of the heavy metal scene." Frank Bello. In addition to the current efforts surrounding the Anthrax Vaccine, Slave to the Metal™ raises awareness and provides funds to organizations and individuals that fight the misuse of heavy metals (depleted uranium, mercury and lead). For the last 20 years, the heavy metal, "mercury", has been covertly injected directly into the arms of almost every child in this generation under the government's mandated childhood vaccine program. (See www.progressiveconvergence.com, www.NVIC.org and www.mercola.com)  The resulting brain damage has produced a generation of hyperactive, learning disabled, autistic, asthmatic children with behavior disorders that doctors treat with suicidal and homicidal drugs like Paxil, Prozac and Zoloft. (See www.ahrp.org). Notwithstanding the aforementioned, the CDC, FDA and Congress have not seen fit to remove the heavy metal out of vaccines. Moreover, since the first Gulf War, the United States has covertly dropped tons of nuclear wastes in the form of Depleted Uranium munitions (another heavy metal) on Iraq, the Balkans, Yugoslavia, Afghanistan and Iraq which has caused high incidences of birth defects and cancer among civilians in these regions and American soldiers (www.mindfully.org and www.traprockpeace.org).

New York's own ANTHRAX has an unmistakable signature style and distinct sound that breaks musical, cultural and political boundaries - influencing a myriad of bands throughout the spectrum of musical genres for 20 years.

Twice GRAMMY-nominated, MTV/VMA nominees and Multi-Platinum and Gold Awarded music veterans, ANTHRAX has sold over 10,000,000 records worldwide, including nine studio albums, two live albums, three greatest hits, plus two DVDs. Touring pros ANTHRAX performed on over fifty tours spanning the globe - in thirty-two countries on five continents including Europe, North America, South America, Australia and Asia.

Now, for the first time in 13 years, the entire original lineup of Joey Belladonna, Frankie Bello, Charlie Benante, Scott Ian and Danny Spitz will gather together in one room to discuss new music releases, as well as the future plans for this monumental ANTHRAX reunion.

The event will officially kick off the weekend music special "SPREADING THE ANTHRAX" on Hard Attack/27, where millions will hear it first.

Who is at Highest Risk for Suffering Complications from Anthrax? 

All forms of anthrax are treatable if caught early. Persons most at risk for complications from anthrax are those who do not receive antibiotics quickly. 

Complications are more frequently seen among persons who develop gastrointestinal, inhalation, or injection anthrax, as these are more severe, and often fatal if not promptly treated.  Without treatment, 85 to 90 percent of inhalation anthrax victims, 25 to 60 percent of gastrointestinal anthrax victims, and 33 percent of injection anthrax victims will die. 

Persons who develop cutaneous anthrax are less likely to suffer complications; however, between five and 20 percent of untreated cutaneous anthrax cases are fatal. With treatment, nearly all infected persons will survive. 

Anthrax

for immediate release

December 8, 2003

VACCINE SAFETY ADVOCATES SUPPORT
SENATOR'S VACCINE SAFETY RESOLUTION

Washington, D.C. - Americans for Vaccine Safety and Accountability, headed by the National Vaccine Information Center (NVIC), are joining with other parent, veteran and health care organizations in support of a proposed Senate resolution asking Secretary of Defense Donald Rumsfeld to review the safety of the military's mandatory anthrax and smallpox vaccination programs. The resolution is being sponsored by Sen. Jeff Bingaman (D-NM) in response to mounting reports of serious health problems, including un-expected deaths, after soldiers are vaccinated.

"Tragically, national one-size-fits-all vaccine policies are hurting young soldiers in the military just as they are hurting young children in civilian life," said NVIC president Barbara Loe Fisher. "Many are dying or being left chronically ill after receiving multiple vaccines on one day. Nobody is being screened for genetic or biological risk factors be-cause public health agencies and industry have refused to do the scientific studies to identify those vulnerable. Some vaccines, like anthrax and smallpox, are known to be crude and highly reactive. Soldiers are being needlessly sacrificed for a flawed policy and it is inhumane when so much more could be done to prevent this waste of human life."

On Nov. 19, the Pentagon admitted that Rachael Lacy, a 22 year old Army recruit died last April after being injected with five vaccines, including anthrax and smallpox. Military doctors are now saying she may have had a predisposition to a fatal autoimmune condition (lupus) that was triggered by the vaccinations.

Meryl Nass, M.D., a civilian doctor who questions the safety of the anthrax vaccine and has treated many vaccine-damaged soldiers, reviewed Lacy's autopsy report and death certificate and urged the military in September to classify her death as vaccine-related. "The autopsy made it clear and now the military has confirmed that there is no other explanation for her death except the vaccines she received. There was no evidence of lupus on autopsy, although she may have had a genetic predisposition to auto-immunity that would put her at high risk for reacting to vaccines. Ten to 20 percent of the population has genetic predisposition to autoimmunity so everyone should have the right to informed consent to vaccination.," said Nass, who is also a member of NVIC's Medical Advisory Board.

Lacy's death follows persistent reports of other deaths, mysterious pneumonia-like illnesses, heart problems, blood clots, memory loss, disabling fatigue, muscle weakness and pain, weight loss and other serious health problems suffered by young, healthy military recruits after being vaccinated with anthrax, smallpox and many other vaccines.

The Bingaman resolution introduced in the Senate on November 25, cites a General Accounting Office (GAO) report that found that 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." The resolution also points out that the Centers for Disease Control (CDC) stated in June 2003 that 1 in 500 civilians vaccinated for smallpox had a serious vaccine event.

Bingaman maintains that a biological attack against U.S. troops is far less likely now so the risks of the military's compulsory anthrax and smallpox vaccination programs are greater than its benefits. He points out that British and Australian troops have not been required to take anthrax vaccine and that other allied nations have declined to use the vaccine on their troops.

Currently, six military servicemembers are seeking a preliminary injunction in a U.S. District Court in Washington, D.C. that would prevent the forced vaccination of U.S. military personnel with the anthrax vaccine and allow soldiers to give their voluntary, in-formed consent. Attorneys for the plaintiffs argue that the anthrax vaccine was never licensed by the FDA to protect against inhalation anthrax, which is how anthrax would be used as a biological weapon. Federal statute requires that either informed consent be given whenever a drug or vaccine is used for an unlicensed purpose, or that the President assumes responsibility by waiving servicemembers' right of informed consent.

A U.S. soldier's refusal to be vaccinated can result in a court martial, imprisonment, fines and dishonorable discharge from the military. One decorated Air Force physician was court martialed for refusing the anthrax vaccine and fined $21,000. A breast-feeding soldier was court martialed for refusing the anthrax vaccine because she did not want to take the risk of harming her child. A 2002 GAO report found that 69 percent of experienced pilots and aircrew members in the National Guard and the Reserve re-ported that the anthrax shot was the major influence in their decision to change their military status in 2000, including leaving the military entirely.

The Bingaman resolution calls on the Secretary of Defense and Board for Correction of Military Records "to reconsider adverse actions already taken or intended to be taken against servicemembers for refusing to accept the anthrax or smallpox vaccine." The resolution also calls on the Secretary of Veterans Affairs to "assess those adverse events being reported" and research causal relationships as well as estimate the future cost to treat the resulting health problems.

"The use of prophylactic biodefense drugs and vaccines must be solely threat-based and weighed against the health risks to the servicemember. Congress should direct DOD to fully disclose all unpublished medical studies, non-peer reviewed studies and experimental test data on their biodefense drugs and vaccines. These data should be made available to the DVA, the Institute of Medicine and independent researchers for a thorough review of DOD's findings," said Steve Robinson, Executive Director, National Gulf War Resource Center.

Reports of sudden death and chronic illness following receipt of multiple vaccines in the military first began to surface in the early 1990's, when soldiers deploying for the Gulf War were given up to 17 vaccines, including anthrax, as well as investigational drugs. The constellation of symptoms those soldiers experienced, which came to be known as "Gulf War Illness," are very similar to the symptoms being experienced by military recruits today who get vaccinated with multiple vaccines, including anthrax and smallpox.

Americans for Vaccine Safety and Accountability (AVSA), a coalition which includes the National Vaccine Information Center, Parents Requesting Open Vaccine Education, Unlocking Autism, New Hampshire Citizens for Health Freedom, Virginia Families for Vaccine Information and Choice, Vaccine Awareness of North Florida, Massachusetts Citizens for Vaccination Choice, Missouri Citizen's Coalition for Vaccination Choice, Illinois Vaccine Awareness Coalition, World Chiropractic Alliance, International Chiropractic Pediatric Association, Osteomed II, New Hampshire Vaccine Safety Initiative and Mothering Magazine is supporting the Bingaman resolution along with other organizations advocating safer vaccines and informed consent protections in national vaccine policies, including the National Gulf War Resource Center, Military Vaccine Education Center, New Jersey Alliance for Informed Choice in Vaccination, Michigan Opposing Mandatory Shots, Connecticut Vaccine Information Alliance, Kansas Alliance for In-formed Choice in Vaccination, Wyoming Vaccine Information Network, Minnesota Vaccine Awareness, Parents Advocating Vaccine Education and The Autism Autoimmunity Project.

NVIC was founded in 1982 and is the largest and oldest parent-led non-profit organization advocating the institution of vaccine safety and informed consent protections in national vaccination programs. AVSA is an activist coalition of organizations representing more than 200,000 Americans.

For more information and to read the entire resolution being sponsored by Sen. Bingaman, go to www.nvic.org/AVSA/Bingaman.htm

Can Anthrax be prevented and are there treatment options?

Anthrax can be prevented by avoiding items that may be contaminated with anthrax. The most common way to get anthrax is through exposure to an infected animal or animal waste and by-products. Veterinarians, farmers, or researchers working with animals are at higher risk, as are those working in industries that handle animal by-products like meat and animal skins.    Travelers to areas where anthrax is more common should be cautious about foods consumed and items touched. These regions include the Caribbean, Eastern and Southern Europe, Central and southwestern Asia, Sub-Saharan Africa, and South and Central America. 

Persons exposed to anthrax but who have no symptoms are recommended to receive a 60 days course of treatment with antibiotics that include doxycycline and ciprofloxacin.  Outcomes are better if persons receive prompt treatment as soon as symptoms develop. 

All pharmaceutical products, including antibiotics and vaccines, carry an inherent risk of injury or death for some individuals. When taking long-term antibiotic therapy, it is important to be aware of potential side effects. Overuse of antibiotics in the absence of bacterial infection has contributed to the development of antibiotic-resistant strains of organisms that can cause life-threatening illnesses. This has made it necessary to develop more powerful antibiotics, some of which carry serious side effects. 

In addition to killing unwanted toxic bacteria, such as anthrax, antibiotics also kill the normal flora of the gastrointestinal tract and can cause nausea, diarrhea, vomiting, and yeast infections. Rashes, hives, and other allergic reactions can occur, including anaphylactic shock leading to death. 

Some antibiotics can cause central nervous system problems, including severe headaches, drowsiness, dizziness, irritability and restlessness, nerve paralysis, and seizures.      Other antibiotic reactions include blood disorders, such as anemia and thrombocytopenia (which can lead to uncontrolled bleeding), kidney and liver dysfunction, and serum sickness that causes fatigue, muscle weakness, and joint damage.         

There are three licensed anthrax antitoxins available for use from the Strategic National Stockpile - anthrax immune globulin intravenous (AIGIV), obiltoxaximab (Anthim), and raxibacumab (ABthrax). Side effects from these products include:     

• Hypersensitivity reactions
• Anaphylaxis
• Headache
• Pruritis
• Upper respiratory infections
• Cough
• Bruising at the injection site
• Nasal congestion
• Infusion site pain
• Extremity pain
• Itching
• Fever
• Myalgia
• Fatigue
• Chest pain
• Cyanosis
• Dizziness/vertigo
• Vomiting
• Heart palpitations
• Shortness of breath
• Insomnia
• Muscle spasms

Prognosis for Treated Anthrax: The mortality rate for skin-acquired anthrax left untreated is five to 20 percent but very low with antibiotic therapy.  Fifty-five percent of persons exposed to anthrax by inhalation during the 2001 bioterrorism attack in the U.S. survived. There is only a 10 to 15 percent survival rate from inhalation anthrax without treatment.    The mortality rate for gastrointestinal anthrax is between 25 and 60 percent, and 33 percent for injection anthrax. 

What is Anthrax vaccine?

The anthrax vaccine (Biothrax manufactured by Emergent BioSolutions, Inc.) is FDA approved for use in persons between 18 and 65 years of age who are at high risk of exposure to anthrax. It can also be used in this population after a potential or confirmed exposure to anthrax but must be given in conjunction with antibiotic therapy. No anthrax vaccine is approved for persons under 18 or over 65 years of age. 

Read the Product Information Insert

NVIC strongly recommends reading the vaccine manufacturer product information insert before receiving any vaccine, including the anthrax vaccine. Package inserts are published by drug companies making vaccines and list important information about vaccine ingredients, reported health problems (adverse events) associated with the vaccine, and directions for who should and should not get the vaccine.

Links to the anthrax vaccine package insert is available below, or you can ask your doctor to give you a copy of the vaccine package insert to read before vaccination. It is best to ask your doctor for a copy of the package inserts for the vaccines you are scheduled to receive well before your vaccination appointment.

Biothrax, Anthrax Vaccine Adsorbed

•  Ages: Anthrax is approved for use in adults between 18 and 65 years of age
•  Vaccine ingredients: cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, 83kDa protective antigen protein, aluminum hydroxide, sodium chloride, benzethonium chloride, and formaldehyde.
• Commonly reported adverse events: redness, swelling, and pain at the injection site, arm motion limitation, muscle aches, fatigue, and headache.
• Reported serious adverse events: anaphylaxis, angioedema, rash, urticaria, pruritus, erythema multiforme, anaphylactoid reaction, Stevens-Johnson syndrome (a severe skin and mucus membrane reaction), paresthesia syncope, dizziness, tremor, ulnar nerve neuropathy, lymphadenopathy, nausea, malaise, pain, cellulitis, flu-like symptoms, insomnia, pruritis, rash, urticaria, flushing, arthralgia, arthropathy, myalgia, rhabdomyolysis, and alopecia.

Biothrax anthrax vaccine is a Pregnancy Category D vaccine, which means that there is evidence of harm in human studies or fetal risk demonstrated in pre- or post-marketing surveillance data.  Pregnant women should not be vaccinated with Biothrax unless the possible benefits of vaccination outweigh the risks. Vaccination of a breastfeeding mother is cautioned as it is not known whether the vaccine is excreted in human milk.

Biothrax has never been evaluated for safety or efficacy when given with any other licensed vaccine product. 

The CDC’s Advisory Committee on Immunization Practices (ACIP) current recommendations for anthrax vaccination.

Pre-exposure prophylaxis

Anthrax vaccine is approved to be administered intramuscularly (IM) as 3-dose primary series (0, 1, and 6 months) with an initial 2- dose booster (12 months and 18 months). A yearly booster dose is recommended for persons considered at high risk for infection (lab workers handling anthrax, military personnel). For persons who have completed the initial five doses and are not considered high risk but would like to maintain vaccine acquired protection, ACIP recommends a booster dose every three years. 

Post-exposure prophylaxis

Anthrax vaccine can be administered to persons with known or suspected anthrax exposure as a 3-dose series (0, 1, and 4 weeks) in conjunction with antibiotic therapy. ACIP recommends that anthrax vaccine be administered by subcutaneous (SC) injection because higher levels of vaccine acquired antibodies occur within four weeks; however, IM injection is still acceptable. 

AV7909 – Anthrax Vaccine Absorbed with CpG 7909 adjuvant

Emergent BioSolutions is currently in phase 3 testing of an anthrax vaccine specifically for post-exposure prophylaxis. This experimental vaccine uses the CpG 7909 adjuvant to bind to the Toll-like receptor 9 to enhance the body’s immune response to the anthrax antigen. The current clinical trials are evaluating a product containing 0.5 ml of anthrax vaccine and 0.25 ml of CpG 7909 adjuvant administered at 0 and 2 weeks, in conjunction with antibiotics. 

Cytosine phosphoguanine (CpG) is a synthetic form of DNA that mimics viral and bacterial genetic material. Only one FDA-approved vaccine, Heplisav-B Hepatitis B vaccine, uses a CpG adjuvant -  CpG 1018. The FDA twice rejected licensing of Heplisav-B due to outstanding safety concerns. In 2013, the FDA rejected the vaccine due to concerns that this adjuvant could trigger autoimmune disorders. It was rejected again in November 2016 due to concerns over cardiovascular events and deaths. One year later, in November 2017, the FDA approved the vaccine despite unresolved safety concerns. In pre-licensing clinical trials, those who received Heplisav-B had a 7-times higher risk of heart attack than those receiving the control vaccine, Engerix-B hepatitis B vaccine. 

If approved, AV7909 would be added to the Strategic National Stockpile. The CDC has submitted a request for pre–Emergency Use Authorization (EUA) to FDA for permission to use AV7909 in addition to antibiotic therapy in the event of an emergency should the supply of Biothrax be limited. This authorization would allow the use of an unapproved medical product or allow for an unapproved use of an approved medical product. Under the proposed EUA guidelines, AV7909 would be administered by intramuscular injection to persons between 18 and 65 years of age with known or suspected anthrax exposure as a 2-dose series (0 and 2 weeks) in conjunction with antibiotics. 

 

Anthrax

Biowar & Informed Consent

http://www.washtimes.com/upi-breaking/20050330-085257-3105r.htm
The Washington Times
March 30, 2005

Biowar: Informed consent injunction's key?

By Dee Ann Divis
Senior Science & Technology Editor

WASHINGTON, DC, Mar. 30 (UPI) -- The fate of the Defense Department's
anthrax vaccine program appears to hinge on whether Judge Emmet Sullivan
will allow the Pentagon to avoid the notification rules that normally
accompany an informed-consent requirement and the off-label use of a drug.

 On Oct. 27, 2004, Sullivan placed an injunction on the department's
mandatory vaccination program, blocking service personnel from having to
take shots of Anthrax Vaccine Absorbed, a controversial vaccine that critics
said is unsafe.

"Accordingly, the involuntary anthrax vaccination program, as applied to all
persons, is rendered illegal, absent informed consent or a Presidential
waiver," Sullivan said in his injunction.

AVA currently is licensed by the Food and Drug Administration, but only
against anthrax-related skin infections and not the lung infections the
military wants to prevent. The legality of using AVA against inhalation
anthrax was thrown into question after Sullivan ruled FDA had not gone
through all the necessary licensing steps. Under Title 10, which bars such
off-label use without prior consent -- and under a specific injunction
issued by Sullivan -- the military had to stop using the vaccine.

The Defense Department could have continued the program by obtaining the
informed consent of its service members, but officials chose not to.
Instead, they took the controversial step of going to the Department of
Health and Human Services and the Food and Drug Administration for an
Emergency Use Authorization. On the face of it, the EUA allows them to
proceed with the anthrax vaccination program they began in 1997.

Nonetheless, attorneys representing the Pentagon took the odd step of
returning to the U.S. District Court in the District of Columbia to ask
Sullivan to modify the injunction and, specifically, recognize the EUA.

The question is why.

Ostensibly, it is just a housekeeping matter. The EUA did not exist at the
time of the injunction, said Defense Department counsel Brian Boyle. The new
Bioshield Act made an EUA possible and now EUAs should be listed as a third
way to meet the legal requirements set by the injunction.

In a protracted debate, however, Sullivan kept asking if the program would
remain voluntary under the EUA. Boyle said yes, but Sullivan came back to
the question again and again, saying he did not understand why it was
necessary to change the injunction.

Boyle eventually admitted the Pentagon was worried about both requirements
of the injunction -- that the program be voluntary and informed consent be
obtained.

"Informed consent is not required under the EUA," Boyle asserted.

"It sounds to me like they don't want to do informed consent because then
certain things kick in," said Mac Stewart of the law firm Stewart & Stimmel
in Dallas.

Informed consent is a very specific term. It requires providing a great deal
of background and risk information to anyone receiving a medication for a
reason not originally approved. Informed consent, properly executed, also
protects those administering the medication from liability.

"The requirements come out of the Geneva Convention," said Dr. Patricia
Raymond, a physician in Chesapeake, Va., who has performed and overseen drug
trials.

"You need to disclose every side effect that might happen (and) the
possibilities of those side effects," Raymond explained. "You need to fully
disclose what happens to you if you choose not to take it. You've got to
fully disclose ... if the investigators are getting any financial
considerations. You need to do all of that in fifth-grade or sixth-grade
language ... I've got to explain it to you."

There do appear to be negative reactions the Pentagon would have to lay
bare.

John Richardson, an opponent of using AVA, told United Press International
there have been some 4,000 adverse-event reports filed so far.

Bioport of Lansing, Mich., AVA's manufacturer, reported that 18 studies back
up the safety of the vaccine and there are no more problems with AVA than
with any other vaccine. Even if there are no more than a usual number of
adverse reactions, they still would have to be described in some detail
under an informed-consent requirement.

"They are trying to get away from two things in my opinion," said Roman
Kupchynski, a partner in the Dallas law office of Gardere, Wynne, Sewell.
"One, (they) don't want to have to go through the whole process of having to
paper and document what this drug is and what it does and the side effects,
et cetera."

Kupchynski suggested, however, there may be more to the Defense Department's
desire to proceed under the EUA. If the EUA gives the Pentagon cover from
liability while reducing the required paperwork, it would constitute an
attractive alternative to resuming the program using informed consent.

It is not clear what liability protections in the many anti-terrorism laws
might be triggered by the emergency nature of the EUA.

"I can tell you that in any other (non-military) setting there is potential
liability for anybody who's in the chain if there is not informed consent,"
said Kupchynski, who made clear there may be other avenues for government
immunity.

"If I was on the government side," he said, "I would be thinking ... if I
don't really know what this drug is going to do ... I want to be able to
skirt that liability issue."

--

E-mail: ddivis@upi.com

What is the history of Anthrax vaccine use in America?

The first vaccine for anthrax was developed in the late 19^th century by Pasteur for use in animals. This vaccine was believed to be a heat attenuated whole-cell vaccine; however, scientists now believe that the vaccine contained some bacteria that produced small amounts of the toxin. While considered effective at preventing anthrax in animals, it was also known to cause disease and death in some. In the late 1930s, Max Sterne developed a live-spore-containing vaccine for use in animals which largely replaced Pasteur’s vaccine. 

Anthrax vaccines for human use were first tested in the 1950s. Six hundred scientists were administered the vaccine at Fort Detrick, and the vaccine was declared safe for human use. After the initial testing, field studies were conducted on the vaccine’s safety and effectiveness among workers in industrial settings who were known to be at high risk for anthrax. This vaccine was supplied by Wright and associates of the U.S. Army Chemical Corps of Fort Detrick.

Between 1950 and 1959, workers at four mills in the U.S. Northeast were allowed to participate in the study. Those who received the experimental vaccine were administered a product containing a modified version of the Vollum strain of B. anthracis, which included 0.1 percent aluminum potassium sulfate (alum). The control group received a “placebo” containing 0.1 percent alum. Participants were administered a primary vaccine series of 3 doses given at 2-week intervals and three additional booster doses beginning at six months given at 6-month intervals. 

During the study period, 26 cases of anthrax were reported, with four occurring in persons who were partially vaccinated and one in a person who was fully vaccinated. 

Persons participating in the trial were examined 24 and 48 hours after each vaccine dose for local or systemic reaction symptoms. Swelling, redness, and itching at the injection site was the most common symptom reported after vaccination, with most symptoms resolving within two days. However, some vaccine recipients developed persistent nodules at the injection site, and others reported significant swelling. Most reactions occurred after the second and sixth vaccine dose. There were also reports of reactions among persons who received the aluminum-containing “placebo”; however, the symptoms were considered less severe than those who received the vaccine. Thirty-five percent of vaccine recipients reported localized adverse events following vaccination. 

Researchers reported that only two systemic reactions occurred among study participants and these individuals also experienced injection site swelling. Both individuals reported malaise lasting about 24 hours after vaccination. Two study participants who were previously diagnosed with cutaneous anthrax were inadvertently administered the vaccine, and both experienced severe localized reactions, including swelling, redness, and itching. Neither individual received any additional vaccine doses. One person who had previously recovered from inhalation anthrax was administered at least one anthrax vaccine dose but did not report any side effects. 

Researchers reported that while the vaccine appeared to be protective against cutaneous anthrax, the data was inconclusive on whether protection would extend to inhalation anthrax. Additionally, they reported that the vaccine did not offer long-term protection, and three primary vaccine doses and a booster dose were needed to ensure protection against anthrax for at least six months. The vaccine was declared safe and effective based on this study published in 1962, which involved only 1,249 individuals. 

This early vaccine was initially manufactured by Merck Sharp & Dohme; however, the vaccine’s original license was granted to the Michigan Department of Public Health by the Division of Biologics of the National Institutes of Health because FDA had not yet been established. 

For many years, the anthrax vaccine used by veterinarians, researchers, and those handling animal products that could be contaminated with anthrax bacteria, was manufactured by the Michigan Department of Health in a Lansing, Michigan lab. The vaccine manufacturing plant owned by the state had also been used for many years to manufacture and distribute DPT vaccines to Michigan state residents.  In 1995, the plant’s name was changed to Michigan Biologic Products Institute (MBPI). 

In the early 1990s, U.S. military personnel serving during Operation Desert Storm were administered anthrax vaccines due to concerns that Iraq had manufactured weapons capable of dispersing anthrax spores. 

Many military members who served during the Operation Desert Storm era reported significant health issues, including chronic fatigue syndrome, joint and muscle pain, rashes, dizziness, headaches, seizures, and autoimmune issues. These symptoms were eventually labeled Gulf War Syndrome and were found to affect both deployed and non-deployed troops. Additionally, many individuals experiencing these symptoms had anti-squalene antibodies (ASA) that were not present before anthrax vaccination. 

Several lots of anthrax vaccines were tested and found to contain squalene, but the source was unknown. While the FDA considered the levels of squalene in the vaccines to be too low to be capable of harm, researchers disagreed with this conclusion and expressed concerns that there were many unanswered questions. 

FDA inspections of the anthrax vaccine manufacturing plants in the 1990s revealed multiple deficiencies that were not promptly corrected. These deficiencies were believed to impact both the efficacy and safety of the vaccine lots. As a result, vaccine production was halted until problems were adequately addressed. 

Despite issues regarding the manufacturing of the anthrax vaccine, Defense Secretary William Cohen ordered mandatory anthrax vaccination for all military personnel in 1997. 

In 1998, BioPort Corporation, headed by U.S. Admiral William J. Crowe, Jr. (now deceased) and international business entrepreneur Fuad El-Hibri, purchased the Michigan vaccine lab. Anthrax vaccine manufacturing was taken over by BioPort Corporation when they bought the Michigan state plant, made modifications, and geared up to meet the Pentagon’s goal of vaccinating all 2.4 million active-duty and reserve troops with anthrax vaccine.  However, BioPort failed FDA quality control inspection several times, which resulted in the interruption of anthrax vaccine supplies and the use of the vaccine by the military. 

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 in 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 experiencing serious reactions.  

The CDC’s Advisory Committee on Immunization Practices (ACIP) issued guidelines for anthrax vaccine use in 2000 and recommended the vaccine for laboratory workers who had frequent contact with anthrax spores, persons handling animals and animal byproducts in an environment that might place them at risk of exposure, and military personnel. ACIP reported that the vaccine’s manufacturer recommended three primary doses at 0, 2, and 4 weeks subcutaneously, followed by three booster doses at 6, 12, and 18 months, and annual boosters thereafter; however, ACIP also reported that the rationale for this schedule was not known. 

Injection site reactions were associated with vaccination, but studies on chronic illness following vaccination were lacking. There was also insufficient data to support or reject an association between long-term health effects and vaccination. ACIP stated that further studies on the vaccine were underway by the DOD. 

In 2001, a bioterrorism attack caused 22 individuals to develop anthrax (11 inhalation and 11 cutaneous) after envelopes containing anthrax spores were mailed to various U.S. government officials and news media outlets. Twenty of the 22 cases were linked to handling mail items, and five people died as a result. 

Following the 2001 bioterrorism attacks involving postal and Capitol workers, federal health officials with Health and Human Services (HHS) announced that anthrax vaccines would be made available to persons who may have been exposed to anthrax. The use of the anthrax vaccine post-exposure was considered experimental because the vaccine was not approved for post-exposure prophylaxis. HHS stated that they were offering the vaccine but not making a recommendation due to the risk of vaccine reactions and the lack of data to support the vaccine’s use post-exposure. 

The anthrax vaccine given to military personnel and civilians after Sept. 11, 2001, had never received final FDA approval for effectiveness in preventing anthrax inhalation infections, which is theoretically how the organism would be turned into a bioterrorism weapon. Thus, Biothrax vaccine continued to be classified as experimental. 

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. This was significantly higher than the reported 30 percent claimed by the vaccine’s manufacturer. This survey also noted that between September 1998 and September 2000, "about 16 percent of the pilots and aircrew members of the guard and reserve had (1) transferred to another unit (primarily to nonflying positions to avoid or delay receiving the anthrax shots), (2) moved to inactive status, or (3) left the military."    

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."   

On October 27^th, 2004, U.S. District Court Judge Emmet G. Sullivan ordered the Department of Defense (DOD) to immediately halt anthrax vaccinations after ruling that the mandatory vaccination program was illegal. Sullivan initially ruled in 2003 that the FDA had never approved the vaccine and ordered the vaccination programs to be stopped; however, eight days later, the FDA approved the vaccine based on an application made 18 years earlier, and the vaccination program was resumed. The October 27^th, 2004 decision concluded that the FDA did not follow its own rules in declaring the vaccine safe and effective. Specifically, the individuals who filed suit regarding the mandatory anthrax vaccination argued that the FDA did not adequately review the vaccine’s effectiveness against inhalation anthrax. 

In January 2005, the FDA issued an "emergency use authorization" (EUA) that permitted the DOD to resume anthrax vaccination on a voluntary basis. In April 2005, Sullivan granted the DOD permission to continue vaccination programs based on the EUA guidelines. Military personnel would be provided with informed consent and permitted to decline vaccination without repercussions.  However, in October 2006, the DOD once again mandated anthrax vaccination for service members deploying to Korea, Iraq, and Afghanistan.  This mandate followed the December 2005 FDA ruling that reported the vaccine as effective against all forms of anthrax. 

Since 1998, BioPort, now Emergent BioSolutions, has delivered millions of anthrax vaccine doses, primarily to the U.S. Department of Defense as the sole source supplier of anthrax vaccine for the U.S. military. The U.S. government has also given the company millions of dollars in bailouts despite concerns that this money was not used appropriately and could not be accounted for. 

In 2009, the FDA granted Emergent Biosolutions a shelf life extension for its Biothrax anthrax vaccine, from three to four years.  In 2011, the U.S. government awarded Emergent Biosolutions a 5-year sole-source contract for the purchase of nearly 45 million doses of Biothrax. 

ACIP issued updated guidelines for the use of the anthrax vaccine in 2010. In their updated report, ACIP decreased the recommended primary doses from 6 to 5 (0, 4 weeks, 6 months, 12 months, 18 months) for pre-exposure prophylaxis and advised that the vaccine be administered intramuscularly (IM). Annual booster doses were also recommended. For post-exposure, three doses are given subcutaneously at 0, 2, and 4 weeks in conjunction with 60 days of antibiotic treatment were recommended. 

ACIP also stated that while pre-exposure vaccination of pregnant women was not recommended, if a risk of inhalation anthrax existed, pregnant women should be given three vaccine doses (0, 2, and 4 weeks) and 60 days of antibiotics.  This recommendation was made even though the vaccine package insert states that Biothrax anthrax vaccine is a Pregnancy Category D vaccine and demonstrated there was evidence of harm in human studies or fetal risk had been shown in pre- or post-marketing surveillance data. Nursing mothers were also recommended the vaccine both pre- and post-exposure, even though it is unknown whether it can be transmitted to infants through human milk. 

In 2011, the National Biodefense Science Board (NBSB) recommended that the anthrax vaccine be studied in children before an attack, pending a review of the ethical issues. After over a year of meetings and deliberations, the Presidential Commission for the Study of Bioethical Issues recommended that no anthrax vaccine studies be completed on children until studies could confirm that children would not face anything more than minimal risk.   

In January 2020, ACIP updated its guidance on anthrax vaccination and recommended that for pre-exposure prophylaxis, a 3-dose primary series (0, 1, and 6 months) and an initial 2-dose booster series (12 and 18 months) be administered intramuscularly. A yearly booster dose was recommended for persons considered high risk (lab workers handling anthrax, members of the military). For persons who have completed the initial five doses and are not considered high risk but would like to maintain vaccine acquired protection, ACIP recommends a booster dose every three years. 

For post-exposure prophylaxis, ACIP recommended that persons with known or suspected anthrax exposure be administered three vaccine doses subcutaneously (SC) (0, 1, and 4 weeks) in conjunction with antibiotic therapy. 

Currently, Emergent BioSolutions is in phase 3 testing of an anthrax vaccine specifically for post-exposure prophylaxis. This experimental vaccine uses the CpG 7909 adjuvant to bind to the Toll-like receptor 9 to enhance the body’s immune response to the anthrax antigen. The current clinical trials are evaluating a product containing 0.5 ml of anthrax vaccine and 0.25 ml of CpG 7909 adjuvant administered at 0 and 2 weeks, in conjunction with antibiotics. 

Cytosine phosphoguanine (CpG) is a synthetic form of DNA that mimics viral and bacterial genetic material. Only one FDA-approved vaccine, Heplisav-B Hepatitis B vaccine, uses a CpG adjuvant - CpG 1018. The FDA twice rejected licensing of Heplisav-B due to outstanding safety concerns. In 2013, the FDA rejected the vaccine due to concerns that this adjuvant could trigger autoimmune disorders. It was rejected again in November 2016 due to concerns over cardiovascular events and deaths. One year later, in November 2017, the FDA approved the vaccine despite unresolved safety concerns. In pre-licensing clinical trials, those who received Heplisav-B had a 7-times higher risk of heart attack than those receiving the control vaccine, Engerix-B hepatitis B vaccine. 

If approved, AV7909 would be added to the Strategic National Stockpile. The CDC has submitted a request for pre–Emergency Use Authorization (EUA) to FDA for permission to use AV7909 in addition to antibiotic therapy in the event of an emergency should the supply of Biothrax be limited. This authorization would allow the use of an unapproved medical product or allow for an unapproved use of an approved medical product. Under the proposed EUA guidelines, AV7909 would be administered by intramuscular injection to persons between 18 and 65 years of age with known or suspected anthrax exposure as a 2-dose series (0 and 2 weeks) in conjunction with antibiotics. 

How effective is Anthrax vaccine?

The current anthrax vaccine, Biothrax, is given in a five-dose series over 18 months, followed by annual booster shots to maintain protection for those individuals who continue to be at risk for anthrax exposure. For persons who have completed the initial five doses and are not considered high risk but would like to maintain vaccine-acquired protection, ACIP recommends a booster dose every three years. 

There is limited published data on controlled human trials to test the vaccine’s effectiveness. Developed primarily to protect workers exposed to skin anthrax by handling animals and animal by-products, the vaccine was tested in four field trials during the late 1950s. Vaccine researchers stated that while the vaccine appeared to be protective against cutaneous anthrax, the data was inconclusive on whether protection would extend to inhalation anthrax. Additionally, they reported that the vaccine did not offer long-term protection and that three primary vaccine doses and a booster dose were needed to ensure that the vaccine could protect against anthrax for at least six months. Based on one study published in 1962, which involved only 1,249 individuals, the vaccine was reported to be 92.5 percent effective against cutaneous anthrax. 

There is little human data on the current vaccine's effectiveness against persons who get the rarer but more deadly form of inhalation anthrax. Experimental data in macaques and rabbits suggests the vaccine may be partially effective against inhalation anthrax; however, it was not fully effective in guinea pigs and mice. 

The Biothrax vaccine package insert states that the vaccine may not protect all individuals. Individuals who are immunocompromised may have a decreased immune response to the vaccine. 

Can Anthrax vaccine cause injury and death?

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 which revealed that 85 percent of the Air National Guard and Air Force Reserves personnel experienced adverse reactions following anthrax vaccination. This was significantly higher than the reported 30 percent claimed by the vaccine’s manufacturer. This survey also reported that between September 1998 and September 2000 "about 16 percent of the pilots and aircrew members of the guard and reserve had (1) transferred to another unit (primarily to nonflying positions to avoid or delay receiving the anthrax shots), (2) moved to inactive status, or (3) left the military."    

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."    

Serious anthrax vaccine reactions resulting in permanent autoimmune and brain dysfunction have been reported and include: 

• 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 Syndrome (GWS), a debilitating syndrome affecting many military members who served during the Gulf War, has been linked 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 GWS 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.”

As of June 30, 2023, there have been more than 9,306 anthrax vaccine-related health problems reported to the federal Vaccine Adverse Events Reporting System (VAERS), including 418 reports of cases that ended with permanent disability and 31 deaths. 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. 

Who is at highest risk for complications from Anthrax vaccine?

There is a gap in medical knowledge in terms of doctors being able to predict who will have an adverse reaction to anthrax vaccination, and who will not.

Women who receive the anthrax vaccine are at an increased risk of experiencing an adverse reaction. 

Biothrax anthrax vaccine is a Pregnancy Category D vaccine, which means that there is evidence of harm in human studies or fetal risk has been demonstrated in pre- or post-marketing surveillance data. Pregnant women who receive anthrax vaccine may be at high-risk of having an infant with birth defects.   

Persons with a history of latex sensitivity or previous allergic reaction to anthrax vaccine are a high risk of complications if administered anthrax vaccine. 

Who should not get Anthrax vaccine?

The anthrax vaccine (Biothrax - manufactured by Emergent BioSolutions, Inc.) is FDA approved for use in persons between 18 and 65 years of age who are at high risk of exposure to anthrax. Persons younger than 18 or older than 65 should not receive Biothrax anthrax vaccine.

Anyone who has previously experienced an anaphylactic or anaphylactic-like reaction following a previous dose of Biothrax should not receive another dose. The vial stopper of the vaccine contains natural latex and persons with a latex allergy are at an increased risk of an allergic reaction.

Biothrax anthrax vaccine is a Pregnancy Category D vaccine, which means that there is evidence of harm in human studies or fetal risk has been demonstrated in pre- or post-marketing surveillance data. Pregnant women should not be vaccinated with Biothrax unless the possible benefits of vaccination outweigh the risks. Vaccination of a breastfeeding mother is cautioned as it is not known whether the vaccine is excreted in human milk.

Biothrax has never been evaluated for safety or efficacy when given with any other licensed vaccine product.¹

What questions should I ask my doctor about the Anthrax vaccine?

NVIC’s If You Vaccinate, Ask 8! Webpage downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your child. If you review these questions before your appointment, you will be better prepared to ask your doctor questions. Also make sure that the nurse or doctor gives you the relevant Vaccine Information Statement (VIS) for the vaccine or vaccines you are considering well ahead of time to allow you to review it before you or your child gets vaccinated. Copies of VIS for each vaccine are also available on the CDC's website and there is a link to the VIS for vaccines on NVIC's “Quick Facts”  page.

It is also a good idea to read the vaccine manufacturer product insert that can be obtained from your doctor or public health clinic because federal law requires drug companies marketing vaccines to include certain kinds of vaccine benefit, risk and use information in product information inserts that may not be available in other published information. Anthrax vaccine package inserts are located on the Anthrax Quick Facts page.

Other questions that may be useful to discuss with your doctor before getting the anthrax vaccine are: 

• If other vaccines in addition to anthrax vaccine are scheduled for me, am I allowed to modify the schedule so fewer vaccines are given at once?
• What should I do if I become ill after vaccination?
• What other kinds of reaction symptoms should I call to report after anthrax vaccination?
• If the anthrax vaccine doesn’t protect me, do I have any other options for preventing anthrax infection?

In the U.S., vaccine manufacturers are shielded from liability under the 2005 Public Readiness and Emergency Preparedness (PREP) Act if a vaccine or drug developed in response to a health emergency like a bioterrorism attack causes the death or permanent injury of an individual who receives it during pre-licensure clinical trials or after it is released for public use.    The PREP Act was part of a series of “Bioshield” laws created in response to national security fears after 9/11 and subsequent reported weaponized microbe threats, which prompted Congress to encourage pharmaceutical companies to develop anti-bioterrorism vaccines by, in part, eliminating liability for injuries and deaths caused by those vaccines. 

Individuals who die or suffer serious harm due to the administration of covered countermeasures, such as 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. 

HHS has interpreted state and federal law to include tort and contract law, as well as claims for loss relating to compliance with local, state, or federal laws, regulations or other legal requirements. The definition of “loss” under the Act is broad, encompassing both physical and emotional injuries. Although the PREP Act does provide immunity to the pharmaceutical industry from anthrax vaccine injury lawsuits, vaccine manufacturers are not immune from injunctive relief or enforcement actions by the U.S. Food and Drug Administration (FDA) or other federal agencies. 

The CICP is administered by employees in HHS’s Health Resources and Services Administration. HRSA is the same agency responsible for administering the federal vaccine injury compensation program (VICP) created by Congress in 1986 under the National Childhood Vaccine Injury Act, which partially shielded vaccine manufacturers from liability for injuries and deaths caused by FDA licensed vaccines that are recommended by the CDC for children and mandated by states for school entry.  The 1986 Act was later amended to eliminate civil liability from doctors and other vaccine administrators and, in 2011, the U.S. Supreme Court eliminated remaining liability from vaccine manufacturers for defectively designed vaccines. 

HHS regulations govern CICP’s procedures and eligibility determinations. In general, eligible individuals (or their survivors) who suffer death or serious physical injury directly caused by the administration of a covered countermeasure may receive reimbursement for reasonable medical expenses, loss of employment income and survivor benefits in the case of death. Serious physical injuries under CICP are generally limited to those that warrant hospitalization or result in a significant loss of function or disability. Congress funds CICP awards through emergency appropriations to the Covered Countermeasure Process Fund. 

The CICP and the National Vaccine Injury Compensation Program (VICP) are separate programs managed by HRSA. CICP applies to countermeasures (vaccines and drugs) covered by a PREP Act declaration of a public health emergency, such as those issued for the H1N1 “swine flu” influenza pandemic in 2009 and for the Ebola virus outbreak in 2016,  while the VICP applies to vaccines recommended by the CDC for children and, as of 2016 under the 21^st Century Cures Act, vaccines recommended for pregnant women. 

Under the National Childhood Vaccine Injury Act of 1986, doctors and all vaccine providers are legally required to give you vaccine benefit and risk information before vaccination; record serious health problems following vaccination in the permanent medical record; keep a permanent record of all vaccines given, including the manufacturer’s name and lot number; and report serious health problems, injuries and deaths that follow vaccination to VAERS.

Remember, if you choose to vaccinate, always keep a written record of exactly which shots/vaccines you or your child have received, including the manufacturer’s name and vaccine lot number. Write down and describe in detail any serious health problems that develop after vaccination and keep vaccination records in a file you can access easily.

It also is important to be able to recognize a vaccine reaction and seek immediate medical attention if the reaction appears serious, as well as know how to make a vaccine reaction report to federal health officials at the Vaccine Adverse Reporting System (VAERS). NVIC’s Report Vaccine Reactions—It’s the Law webpage can help you file a vaccine reaction report yourself to VAERS if your doctor fails or refuses to make a report. 

NVIC Press Releases, Statements & Commentaries Related to Anthrax

• AHRP Opposition Statement on Pediatric Anthrax Vaccine Trials - February 2013.
• NVIC Opposition Statement on Pediatric Anthrax Vaccine Trials - July 2011.
• NVIC Article -Anthrax Vaccine Victims Still Seek Truth & Justice - April 2008.
• Press Release: NVIC Teams Up With ANTHRAX Band - April 1, 2005.
• Press Statement by Barbara Loe Fisher - April 1, 2005.
• Statement by Anthrax Vaccine victim, Randi Airola - April 1, 2005.
• Heavy Metal Band, ANTHRAX, press release - March 30, 2005.
• NVIC joins with veteran groups to submit comments to FDA - March 29, 2005.
• Court Orders Pentagon to Stop Anthrax Vaccination - October 27, 2004.
• Judge Orders Shots Stopped, December 22, 2003 - Judges Opinion.
• Vaccine Safety Advocates Support Senator Bingaman's Resolution, December 8, 2003 NVIC Press Release.
• NVIC Special Report: Biological Warfare and Anthrax Vaccine, December, 2001.

The Vaccine Reaction

• Parpia R, Fisher BL. The Anthrax Vaccine and Gulf War Illness. The Vaccine Reaction Apr. 30, 2017.

Videos

• “Direct Order” Documentary—Soldiers Ordered to Take Anthrax Vaccine. The Vaccine Reaction  July 15, 2016.

Anthrax & Anthrax vaccine quick facts

Anthrax

• Anthrax is a rare but serious bacterial infection. It can enter the bloodstream from a cut in the skin, inhaling anthrax spores into the lungs, swallowing anthrax spores, or injecting anthrax contaminated heroin. The anthrax bacteria is not contagious and cannot be spread from person to person; 
• The most common way to become infected is through the skin by direct exposure to an infected animal, animal waste and by-products, or contaminated soil. Veterinarians, farmers, or researchers working with animals are at higher risk of being infected by anthrax;   
• If left untreated, lethal toxins from the anthrax bacteria can multiply in the body and kill quickly. The mortality rate for untreated skin acquired (cutaneous) is 10 to 20 percent but rare if antibiotic therapy is promptly started; 
• The mortality rate for anthrax acquired by inhaling into the lungs, through the gastrointestinal tract, or by injection is higher than cutaneous anthrax; 
• One of the biggest concerns regarding anthrax is its potential use in a bioterrorist attack. In 2001, 22 individuals developed anthrax (11 inhalation and 11 cutaneous) in the U.S. because of a bioterrorism attack.  There has never been a successful delivery of weaponized inhalation anthrax to any large population through a bomb, missile, crop duster, or other means.

Anthrax Vaccine

• Anthrax vaccine is licensed for use in adults between the ages of 18 and 65 who are at high risk for exposure to anthrax bacteria. There is no anthrax vaccine licensed for use in children, and the vaccine is not recommended for pregnant women; 
• Biothrax anthrax vaccine manufactured by Emergent BioSolutions is recommended for persons considered high-risk for anthrax exposure. These include U.S. military members deployed to areas of the world considered high-risk, veterinarians or persons handling animals or animal byproducts, and laboratory workers working with the anthrax bacterium (B. anthracis); 
• A series of five shots is given (3 primary and 2 booster doses), and individuals are not considered protected until they have had the full series. Not all individuals who receive the anthrax vaccine may be protected, but there is very limited data on the effectiveness of the vaccine for inhalation anthrax; 
• Reported mild to moderate anthrax vaccine reactions include local swelling, pain, and redness at the injection site, fever, chills, and nausea that resolve without permanent damage. Severe anthrax vaccine reaction reports include autoimmune and brain dysfunction, chronic disabling fatigue, persistent headaches, severe joint pain and crippling arthritis, numbness, and muscle weakness, paralysis, brain inflammation, seizures, and permanent memory loss, and death.   
• Using the MedAlerts search engine, as of June 30, 2023, there were 9,306 adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) for anthrax-containing vaccines. Of those reports, over 83 percent occurred in adults ages 17 to 44. Within the total number of VAERS reports, there were 31 deaths reported, with over half of the deaths reportedly occurring in adults 17 to 44 years of age.

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.

Food & Drug Administration (FDA)

• Anthrax Vaccine Adsorbed (Biothrax) Package Insert and Licensing Information

Centers for Disease Control (CDC)

• CDC Anthrax Information
• Anthrax Vaccine Information Statement (VIS)

Department of Defense (DOD)

MilVax information about anthrax, anthrax vaccine, and mandatory anthrax vaccination policies of the U.S. military. 

Vaccine Reaction Symptoms & Ingredients

Our Ask 8, If You Vaccinate webpage contains vaccine reaction symptoms and more

Search for Vaccine Reactions

NVIC hosts MedAlerts, a powerful VAERS database search engine. MedAlerts examines symptoms, reactions, vaccines, dates, places, and more. 

Reporting a Vaccine Reaction

Since 1982, the NVIC has operated a Vaccine Reaction Registry, which has served as a watchdog on VAERS. Reporting vaccine reactions to VAERS is the law. If your doctor will not report a reaction, you have the right to report a suspected vaccine reaction to VAERS. 

Other Anthrax Statements

Select Military and Biodefense Vaccine Project (MBVP) Articles

• Viral Pandemic H5N1 flu threat: Baxter contaminates European labs by error - March 5, 2009.
• Inside USA's Biological Warfare Center - February 18, 2009.
• UK Researchers Create Anthrax Vaccine Pill - February 17, 2009.
• Court still undecided on report of anthrax testing on soldiers – February 17, 2009.
• U.S. Army Lab Freezes Research on Dangerous Pathogens - February 7, 2009.
• Deadly Bio-Weaponry Build Up Comes to the Heart of the U.S. - January 23, 2009.
• Revisiting the anthrax attack - January 22, 2009.
• Litigants Argue U.S. Regulators Lacked Basis to OK Anthrax Vaccine - January 16, 2009.
• MBVP Article Archive (1999-2009)

News Articles

• Timeline of U.S. Anthrax Vaccine
• Divis DA. Biowar and Informed Consent. Washington Times. Mar. 31, 2003.
• Evans B. How a company cashed in on anthrax. Daily Press. Dec. 7, 2005.
• Mandatory Anthrax Shots Stir Health Fears, Sap Morale USA Today Dec. 11, 2003.

 

Anthrax

Special NVIC Report
Barbara Loe Fisher, Editor
December 2001 

 

BIOLOGICAL WARFARE AND ANTHRAX VACCINE 

   The terrorist attacks on New York City and Washington, D.C. on September 11, 2001 and, soon after, the release of anthrax-contaminated mail in the U.S. postal system, have prompted calls by some for use of anthrax vaccine in the civilian population. Although there is a possibility that terrorists will attempt to launch an attack on civilians in the continental U.S. using anthrax organisms, there are logistical problems associated with a successful biological weapons assault, including difficulty of delivering the organisms to large numbers of people.  Most notably, a successful bioterrorism attack involving large numbers of American civilians will require a failure of both internal and external homeland security measures, which were put in place following September 11. 

   Every vaccine, like every drug, carries an inherent risk of injury or death and some individuals will be genetically or biologically more vulnerable to vaccine reactions than other individuals. All vaccination campaigns result in casualties and, therefore, benefits and risks must be carefully assessed before implementation, especially in the absence of a proven attack.  Every precaution must be taken to minimize vaccine casualties while protecting the informed consent rights of all citizens. 

BIOLOGICAL WARFARE

   Biological warfare is not a new phenomenon. History is full of examples of warring factions trying to weaken each other’s troops or civilian populations by making them sick. From the ancient Greeks and Romans, who polluted the water supplies of their enemies with dead animals, to warriors in medieval times who catapulted corpses of people infected with bubonic plague into the castles of their enemies, to European conquerors who came to the New World and used smallpox contaminated blankets to kill native Indians with no natural immunity to smallpox, there is a long history of man using disease as a weapon. 

  Modern biological weapons using lethal microorganisms were developed in the 1930s by Japanese scientists, including an aerosolized anthrax that was designed to be used in a specially designed fragmentation bomb. Both the U.S. and Britain developed biological weapons during World War II using anthrax, botulinum toxin, encephalitis virus, staph enterotoxin and other deadly organisms.  Even though the U.S. has had biological weapons capability, the U.S. has never used biological weapons on any nation. 

ANTHRAX DISEASE 

    Anthrax is a serious bacterial infection caused by Bacillus anthracis and most commonly occurs in animals such as cattle, sheep, horses and goats after they graze in areas contaminated with spores of B. anthracis. The body wastes and carcasses of infected animals, or flies that eat infected carcasses, and contaminated hides and meat are all sources of anthrax. Individuals who work with animals or animal by-products or are exposed to contaminated soil are at highest risk of contracting anthrax. 

    The bacteria, which must be in the presence of oxygen to survive, produce spores that can survive for years in dry soil but are destroyed by boiling or by treatment with hydrogen peroxide or dilute formaldehyde. Most common strains of B. anthracis are susceptible to penicillin and certain other antibiotics. However, a genetically engineered strain of anthrax that has been chemically treated and designed specifically as a biological weapon may be lethal enough to evade the protection that current antibiotics provide. 

    B. anthracis can invade the human bloodstream, multiply and spread to lymph nodes and many organs and kill quickly. The bacteria, which produce virulent toxin, can enter the bloodstream through a cut in the skin; by inhaling the anthrax spores through the nose; or by swallowing the spores into the gastrointestinal system.  The cutaneous (skin) route is much less deadly than inhaling or swallowing the organism.  

   Anthrax is not a contagious disease. Someone who is directly exposed to anthrax spores and becomes sick cannot pass the disease along to someone else by coughing or sneezing as most infectious diseases can be spread.  Each individual who gets sick with anthrax must have come into direct contact with the bacteria through a cut in the skin, through inhaling the spores into the lungs or through swallowing the spores, such as by eating contaminated meat. 

   Symptoms of Cutaneous (Skin) Anthrax:  If the anthrax exposure route is through the skin, symptoms include a formation of a small, red skin lesion(s) that becomes swollen, larger and blackened over a week’s time. There may or may not be fever and swollen lymph nodes. Spontaneous healing occurs in 80 to 90 percent of cases. In 10 to 20 percent of cases that go on to develop bacteremia (massive bacterial infection of the blood), high fever and rapid death follows. 

   Symptoms of Inhalation (Lungs) Anthrax:  Within one to three days of breathing in the anthrax spores, there is headache, fever, muscle aches, extreme fatigue, shortness of breath, coughing, low blood pressure and respiratory failure that can lead to death within 24 hours even with treatment. 

   Symptoms of gastrointestinal Anthrax : After swallowing anthrax spores, fever, nausea, vomiting, abdominal pain, bloody diarrhea develops and can lead to death. If the tonsils are affected, symptoms can include fever, sore throat, swollen lymph nodes, and respiratory distress. 

   Laboratory Diagnosis: A blood test that uses fluorescent antibody staining or culture can confirm anthrax infection, unless the patient has been treated with antibiotics. More sensitive lab tests can be performed for anthrax disease confirmation. 

   Treatment: For skin anthrax, treatments have included a penicillin shot used to destroy viable B. anthracis in skin lesions within 5 hours, followed by a 10 day oral course of penicillin. Other antibiotics, including doxycycline, ciprofloxacin, and chloramphenicol have also been used.  Skin lesions are frequently cleaned and covered and used dressings disinfected before disposal. Antibiotic treatment has also been used with inhalation and gastrointestinal anthrax but with less success. 

   Antibiotic Side Effects:  All drugs, including antibiotics, like all vaccines carry an inherent risk of injury or death for some individuals.  Overuse of antibiotics and use of antibiotics in the absence of bacterial infection has contributed to the development of antibiotic-resistant strains of organisms that can cause life threatening illness.  This has made it necessary to develop more powerful antibiotics, some of which carry serious side effects.  

   In addition to killing unwanted toxic bacteria, such as anthrax, antibiotics also kill the normal flora of the gastrointestinal tract and can cause nausea, diarrhea, vomiting and yeast infections.  Rashes, hives, and other allergic reactions, including anaphylactic shock leading to death, can occur. Some antibiotics can cause central nervous system problems, including severe headaches, drowsiness, dizziness, irritability and restlessness, nerve paralysis and seizures.  Other antibiotic reactions include blood disorders, such as anemia and thrombocytopenia (which can lead to uncontrolled bleeding); kidney and liver dysfunction and serum sickness that causes fatigue, muscle weakness and painful joints. 

   Prognosis: The mortality rate for skin anthrax that is untreated is 10 to 20 percent but very low with antibiotic therapy. The mortality rate for inhalation anthrax is 50 to 90 percent even with antibiotic therapy.  The mortality rate for gastrointestinal anthrax is about 50 percent with antibiotic therapy. If meningitis is a complication of anthrax infection, it is usually fatal. 

NORMAL EXPOSURE TO ANTHRAX: The most common way to get anthrax is to come into contact with an infected animal or animal waste and by-products. Veterinarians, farmers, or researchers working with animals are at higher risk, as are those working in industries that handle animal by-products like meat and animal skins.  As already discussed, the cutaneous (skin) form of anthrax has a very low death rate with appropriate antibiotic therapy after exposure. 

BIOTERRORISM EXPOSURE TO ANTHRAX: If the anthrax bacteria is used as a biological weapon to kill large numbers of people, it will most likely be used in the deadly aerosol form so that large numbers of people will inhale it.  This will mean that the anthrax strain and size of spores will have to be specifically designed for weapons purposes and will require an effective delivery system. So far, there has never been a successful delivery of inhalation anthrax to any large population through a bomb, missile, crop duster or any other means. 

  However, even though inhalation anthrax has never been successfully delivered to large numbers of people, it has become evident that whoever sent the anthrax through the U.S. mail system had access to a strain of weaponized anthrax that had been processed into a high grade powder form. Genetic tests on the anthrax-contaminated letters, which resulted in the deaths of five Americans, have confirmed that it was the variant Ames strain of anthrax developed during experimental research originating at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) at Fort Detrick, Maryland. Reportedly, the Ames strain was provided to other labs doing anthrax research, including Porton Down, a British military lab; Louisiana State University; Northern Arizona University, as well as Dugway Proving Ground military research facility in Utah, where anthrax spores were reportedly processed into the powder form that can be inhaled easily. 

   The fact that the genetically engineered and weaponized anthrax strain used in the contaminated mail can be traced back to a U.S. military research facility suggests that there are internal lab security issues that need to be addressed before it can be assumed that the best solution to preventing bioterrorism is to implement prophylactic mass vaccination or medication programs. 

ANTHRAX VACCINE 

  Harrison’s Principles of Internal Medicine (Thirteenth Edition, 1994) says of the currently licensed anthrax vaccine: 

   “Improved anthrax vaccines for humans are needed because the current vaccines are impure and chemically complex, elicit only slow-onset protective immunity, provide incomplete protection, and cause significant adverse reactions.” 

   In the 1950s, after several government lab researchers died of anthrax , the government began working on an anthrax vaccine. The only anthrax vaccine available in the US today was licensed by the FDA in 1970 for human use by high risk individuals such as researchers, veterinarians, those working in the wool mill and livestock industries and others who handle animals or animal products. In the early 1990’s during the Gulf War, large numbers of US military personnel thought to be at risk for biological warfare exposure were injected with anthrax vaccine, along with 15 other vaccines as well as an experimental drug, to protect against a possible biological warfare attack.  

   Since then, there have been persistent reports of serious anthrax vaccine reactions among military personnel, who received the vaccine and are now suffering with a pattern of autoimmune and brain damage that has come to be known as “Gulf War Syndrome.”   Some sick veterans blame the anthrax vaccine, perhaps in combination with the many other vaccines the soldiers received along with exposures to chemical toxins in the Gulf War, for their disabilities. This has made the U.S. military’s vaccination of all active duty and reserve personnel with anthrax vaccine a very controversial policy.    

   How the Vaccine is Made: The anthrax vaccine is a killed bacterial vaccine produced from a strain of anthrax that does not cause the disease. Additives include aluminum hydroxide, formaldehyde and benzethonium chloride. 

   Strength and Duration of Immunity: The current anthrax vaccine requires six shots given over an 18 month period, followed by annual booster shots to maintain protection. The first three doses are given two weeks apart and then three doses spread over an 18 month period. 

   There is little published data on controlled human trials to test the efficacy of the vaccine.  Developed primarily to protect workers who are exposed to skin anthrax by handling animals and animal by-products, it is reportedly about 90 percent effective against skin anthrax. But there is little data for humans about how effective the current vaccine is in protecting those who get the rarer but more deadly form of inhalation anthrax, although some experimental data in monkeys and other animals suggests the vaccine may be at least partially effective against inhalation anthrax. 

    If humans are exposed to a genetically engineered strain of anthrax that is not covered by the vaccine strain, the vaccine may have limited or no effectiveness. Several years ago there was an article published in the medical literature which revealed that the Russians have developed a genetically engineered strain of anthrax. During the Gulf War, there was fear that Iraq might have this genetically engineered anthrax strain that would make the vaccinated U.S. troops vulnerable but there has been no confirmation that Iraq or any other country outside of Russia has a genetically engineered strain of anthrax.  

   Vaccine Reactions: Most of the safety studies done on anthrax vaccine have been conducted by the Department of Defense, are unpublished, and reportedly do not include long term follow-up, according to military veterans advocacy groups who have reported anthrax vaccine damage. Reported reactions to anthrax vaccine have ranged from mild to severe local reactions, fever, chills and nausea that resolve without permanent damage to serious reactions resulting in permanent autoimmune and brain dysfunction, including chronic disabling fatigue, persistent headaches, severe joint pain and crippling arthritis, numbness and muscle weakness, severe memory loss, paralysis, seizures and death. It is estimated that 20 to 48 percent of all those vaccinated have some kind of reaction to anthrax vaccine, ranging from mild to severe. 

   During the past four years, a series of congressional hearings have been held in the U.S. House of Representatives Government Reform Committee on anthrax vaccine safety, efficacy and lack of informed consent protections in the military’s mandatory vaccination policies. Testimony from vaccine injured military veterans have included several hundred cases where career soliders have faced court martial rather than agree to be vaccinated or revaccinated with anthrax vaccine after serious reactions have occurred. 

   Contraindications:  The vaccine manufacturer warns that: 

•     “Any acute respiratory disease or other active infection is generally considered to be adequate reason for deferring an injection.”
•      “A history of a severe reaction to a previous dose of anthrax vaccine is a contraindication to immunization with this vaccine.”
•     Persons receiving cortico-steroid therapy or other agents which would tend to depress the immune system may not be adequately immunized with the dosage schedule recommended.”

   Other Considerations:  The vaccine manufacturer’s product insert states that “studies have not been performed to ascertain whether Anthrax Vaccine Adsorbed has carcinogenic action or any effect on fertility.” 

   The Vaccine Manufacturer: The anthrax vaccine was developed at Fort Detrick by the Department of Defense, which still holds the patent. For many years, the anthrax vaccine was manufactured by the Michigan Department of Health. In 1998, manufacturing was taken over by Bioport Corporation when they purchased the plant, made modifications, and geared up to meet the Pentagon’s goal of vaccinating all 2.4 million active duty and reserve troops with anthrax vaccine. Bioport has failed FDA quality control inspection several times, which has curtailed vaccine supplies and use of the vaccine in the military.  

   Plans for Vaccination of High Risk Persons: As of November, 2001, about 500,000 of the 2.4 million U.S. troops and reservists had received the anthrax vaccine.  In response to the exposure of U.S. civilians to anthrax through contaminated mail, the Centers for Disease Control began making plans to use some of the military anthrax vaccine stockpiles available to lab technicians, bioterrorism investigators and others currently at high risk for anthrax exposure.  There has also been discussion about making anthrax vaccine available to police, firefighters and postal workers. 

   On December 18, 2001 federal health officials and military anthrax experts urged thousands of U.S. Postal Service employees in Washington D.C, New York and New Jersey, as well as Capitol Hill staffers possibly exposed to mail contaminated with the Ames strain of anthrax to be vaccinated because they are finishing a two month course of antibiotics. Health officials say those who have been exposed to the anthrax could be harboring anthrax spores in their lungs and may become ill once they stop using the antibiotics.  Because the vaccine has not received final FDA approval, the vaccine continues to be classified as experimental. 

BEFORE YOU GET VACCINATED: 

   When making a decision about whether to get vaccinated with a particular vaccine, including anthrax vaccine, you need to become fully informed about the risks and complications of the disease the vaccine is designed to prevent, as well as the risks and complications of the vaccine. In addition to information in this report, you should consult one or more doctors as well as obtain more information from other resources. 

  At a minimum, you should ask yourself the following questions before getting vaccinated: 

1.      Are you sick right now with a viral or bacterial infection?

2.      Have you had a bad reaction to a vaccination before?

3.      Do you have a personal or family history of:

• vaccine reactions
• convulsions or neurological disorders
• severe allergies
• immune system disorders

4.      Do you know if you are at high risk of reacting to vaccines?

5.      Do you have full information on the vaccine’s side effects and contraindications?

6.      Do you know how to identify a vaccine reaction?

7.      Do you know how to report a vaccine reaction?

8.      Do you know the vaccine manufacturer’s name and lot number? 

   Physical Exam: It is a good idea to have your doctor give you a physical exam before each vaccination to make sure the results of the exam are written in your medical record so you have proof that you are in good health at the time of vaccination. Be sure to tell the doctor if you have recently recovered from an illness or if any of the members of your family are ill.

   Detailed Medical History: The examining physician should take a detailed personal medical history, including family history, before you are vaccinated. Be sure to mention if you or anyone in your family has a history of vaccine reactions, convulsions or  neurological disease, severe allergies, immune system disorders (such as thyroid disease, lupus, rheumatoid arthritis, diabetes, asthma, eczema), or other chronic health problems. 

REPORTING A VACCINE REACTION 

   If you suffer a serious health problem within 30 days of vaccination, your doctor should report what happened to the Vaccine Adverse Event Reporting System (VAERS). If your doctor will not report, the National Vaccine Information Center will help you report. You can obtain a government Vaccine Adverse Event Reporting form by calling 1-800-822-7967. 

   Any serious deterioration in mental, physical or emotional health following vaccination should be reported. This includes development of such symptoms as persistent fever; extreme pain and swelling at the site of the injection; severe joint pain; tingling in hands or feet; numbness or muscle weakness; disruption in sensory perception such as vision or hearing; serious memory loss, inability to concentrate or depression; extreme fatigue; persistent headaches; seizures or other chronic health problems that were not present before vaccination or worsened after vaccination. 

   The National Vaccine Information Center also maintains a Vaccine Reaction Registry that serves as an independent oversight mechanism on VAERS.  You can report a vaccine reaction to NVIC on this web site. 

KEEP YOUR OWN RECORDS 

   Ask your doctor to write down any deterioration in health you suffer after vaccination in your permanent medical record, as well as the date, manufacturer’s  name and lot number of all vaccinations given. Ask for a copy for your personal records. 

References: 

Isselbacher KJ, Braunwald E et al, eds. 1994. Harrison’s Principles of Internal Medicine. Thirteenth Edition. New York: McGraw-Hill. 

The Department of Defense. Anthrax Vaccine Immunization Program: About the Vaccine. www.anthrax.osd.mil/ 

Centers for Disease Control.  Anthrax (Bacillus anthracis): Frequently asked questions. www.cdc.gov/ncidod/dbmd/anthrx.htm. 

Bioport Corporation. March 1999. Anthrax Vaccine Adsorbed. Manufacturer Product Insert. (www.bioport.com) 

Physicians’ Desk Reference. 2001. Montvale: Medical Economics Co., Inc. 

Committee on Government Reform, U.S. House of Representatives. Subcommittee on National Security, Veterans Affairs and International Relations. Series of congressional hearings on anthrax vaccine held in 1999. (www.house.gov/reform/ns/past_hearings/anthrax.htm) 

Committee on Government Reform, U.S. House of Representatives. Subcommittee on National Security, Veterans Affairs and International Relations.

Subcommittee Report: The Department of Defense Anthrax Vaccine Immunization Program: Unproven Force Protection. House Report 106-556

(www.house.gov/reform; www.access.gpo.gov/congress/cog005.html) 

U.S. General Accounting Office. September 1999. GAO Report: Combating Terrorism: Need for Comprehensive Threat and Risk Assessments of Chemical and Biological Attacks. GAO/NSIAD-99-163. 

Hafemeister R. February 6, 1998. British avoiding vaccines for troops in Gulf. Belleville News-Democrat. 

Riechmann D. March 4, 1998. Anthrax vaccine works on monkeys. The Associated Press. 

Fukuda K, Nisenbaum R, Stewart G et al. September 16, 1998. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. Journal of the American Medical Association. 

Graham B. October 30, 1998. Dose of explanation comes with anthrax shots. The Washington Post. 

Unwin C, Blatchley N, Coker W et al. January 16, 1999. Health of UK servicemen who served in Persian Gulf War. The Lancet. 

Jackson PJ, Hugh-Jones ME et al. February 3, 1998. PCR analysis of tissuesamples from the 1979 Sverdlovsk anthrax victims: the presence of multiple Bacillus anthracis strains in different victims. Proceedings of the National Academy of Sciences of the United States of America. 

Funk D. June 28, 1999. Marine refuses vaccines, gets jail, discharge. Air Force Times. 

Daniels D. June 29, 1999. Anthrax shots bad medicine?: vaccine’s possible perils listed in military papers.  The San Diego Union-Tribune. (www.uniontrib.com) 

Kreisher O. July 22, 1999. Military personnel assail anthrax shots’ side effects. The San Diego Union-Tribune. 

Manning A. October 19, 1999. Anthrax vaccine injects anger into military: fearing reactions, troops quit the service. USA Today. 

Crawley JW. December 4, 1999. Pentagon postpones its anthrax inoculations. The San Diego Union-Tribune. 

Graham B. December 14, 1999. Pentagon anthrax program suffers setback: new manufacturing plant fails FDA inspection; inoculation expansion delayed. The Washington Post. 

Hudson A. October 10, 2001. Anthrax, smallpox vaccines called for. The Washington Times. 

Hoffman KB. October 10, 2001. Company working on anthrax vaccine. Associated Press. 

Spencer J., Scardaville M. October 11, 2001. Understanding the bioterrorist threat: facts and figures. The Heritage Foundation Backgrounder (www.heritage.org/library/backgrounder). 

Dyer G., Cookson C. October 11, 2001. Spreading calm in small doses. Financial Times. 

Pear R. October 20, 2001. Government talks with drug companies about buying anthrax antibiotics. The New York Times. 

Jackson RL. October 22, 2001. Lansing-based anthrax vaccine maker hit by major lawsuit: suit claims shots caused adverse reactions in soldiers. Los Angeles Times.  

Fleischer-Black M., Van Voris B. October 23, 2001. Anthrax Vaccine’s Liability Issue. The National Law Journal. 

Hanchette J. October 27, 2001. Why can’t we immunize Americans against anthrax? Gannett News Service. 

Johannes L. October 29, 2001. CDC to make anthrax vaccine available to workers put at risk in the line of duty. The Wall Street Journal. 

Walsh E. December 11, 2001. VA links Gulf War, Lou Gehrig’s Disease. The Washington Post. 

Weiss R., Schmidt S. December 16, 2001. Capitol Hill anthrax matches Army’s stocks. The Washington Post. 

Vedantam S., Connolly C.  December 18, 2001. Anthrax vaccine urged for Hill staff. The Washington Post.

Williams TD. June 02, 2001. Anthrax vaccine complaints on rise. The Hartford Courant.

Garrett L. 2000. Betrayal of Trust. New York: Hyperion.

 ABOUT THE EDITOR:  Barbara Loe Fisher is co-founder and president of the National Vaccine Information Center. She is co-author of DPT: A Shot in the Dark; author of The Consumer’s Guide to Childhood Vaccines; and editor of THE VACCINE REACTION and The Vaccine Hotline newsletters.  She served on the National Vaccine Advisory Committee and the Institute of Medicine Vaccine Safety Forum and is the consumer voting member of the FDA Vaccines and Related Biological Products Advisory Committee.

 

 The following statement is authored by Meryl Nass, M.D., A.B.I.M., a biowarfare epidemiologist who is an expert on anthrax vaccine. She has assisted Gulf War veterans suffering from neuroimmune dysfunction and has provided expert testimony to Congress on the safety and efficacy of the anthrax vaccine. Dr. Nass is a member of the Medical Advisory Board of the National Vaccine Information Center. 

ANTHRAX VACCINE CAUSES GULF WAR SYNDROME

by Meryl Nass, M.D. 

 

Until 1998, there existed no published papers that explored whether

receiving anthrax vaccine was related to Gulf War illnesses.  Instead,

several expert committees (lacking experience with anthrax) were asked

to comment on whether anthrax vaccine was likely to be a cause of Gulf

War Illnesses.  The committees were given DOD briefings, did not review

the literature (there were no published studies of safety or efficacy

for the licensed anthrax vaccine), concluded that a relationship was

unlikely, and then recommended against further research (1).

 

Studying American veterans was particularly difficult because many were

not told whether they were given anthrax vaccine, and the vaccinations

were specifically not entered into service members' shot records. Other

centralized vaccine records have been lost.  Despite concerns about the

investigational status of anthrax vaccine when used for biological

warfare, no informed consent was obtained from service members at the

time of the Gulf War, and no waiver of informed consent was sought from

the FDA.

 

The Canadian Department of National Defense (DND) hired a consulting

company (Goss Gilroy Inc.) to study the health of Canadian Gulf Veterans

and look at various exposures.  Their report was published on the DND

website.  They found a significant relationship between receiving

non-routine (biological warfare) immunizations and developing chronic

fatigue, a very common symptom of GWS (2).

 

In 1999 a British study examined a large number of Gulf War exposures in

large cohorts of British Gulf War and non-deployed Gulf-era veterans,

and Bosnia veterans.  They found that for both the Gulf War and the

Bosnia veterans, receiving anthrax vaccine was related to developing an

illness consistent with Gulf War Syndrome (GWS). They wrote,

"Vaccination against biological warfare and multiple routine

vaccinations were associated with the CDC multi-symptom syndrome in the

Gulf War cohort (3)."

 

This group published a follow-up paper in the British Medical Journal

that claimed that only Gulf War veterans who received vaccines after

deployment, not before, showed this relationship.  However, they later

retracted this conclusion, and acknowledged that the timing of

vaccination did not affect the relationship between vaccination and GWS.

 

A study of Kansas Gulf War veterans was published in 2000 (4).  This

study also found that deployment vaccines were related to GWS: 34% of

Gulf War veterans met the definition for GWS, while only 4% of non-deployed, 

non-vaccinated Gulf-era veterans met the definition.  However, 12% of Kansas 

Gulf-era veterans who were vaccinated in preparation for deployment, but then 

were not sent to the Gulf, also met the GWS definition.  The paper concluded, 

"Vaccines used during the war may be a contributing factor."

 

A second study of British Gulf War veterans was published in 4/2001.

This study looked at the relationship between various Gulf War exposures

and subsequent health.  It did not look at specific deployment vaccines,

but instead evaluated the number of vaccinations received in relation to

GWS. It said, "Consistent, specific, and credible relations, warranting

further investigation, were found between health indices and two

exposures, the reported number of inoculations and days handling

pesticides (5)."

 

The Veterans Administration collected data on thousands of Gulf War

veterans who presented for evaluation of Gulf War Syndrome.  Although

unpublished, the data were presented at a conference on GWS in January

2001 (6).   The VA asked veterans if they thought they had received

anthrax vaccine at the time of the Gulf War, among many other potential

exposures, and inquired about symptoms of illness.  Those who believed

they had received anthrax vaccine were twice as likely to report a

multitude of symptoms as those who believed they were not vaccinated.

 

These are all the Gulf War data that are available in the open

literature.  Every study that examined the question of whether vaccines

in general, or specific non-routine vaccines, or anthrax vaccine alone

may have contributed to GWS, has found a positive relationship.

 

The French Ministry of Defense (MOD) recently convened an advisory

committee to study GWS chaired by Professor Roger Salamon.  This

committee reviewed the existing world literature on GWS, and suggested

that "multiple vaccinations given during the war, particularly those for

anthrax, botulinum and plague, seem associated with an excess of (GWS)

signs and symptoms (7)."

 

There are no published long-term adverse event data from the anthrax

vaccine immunization program, which began vaccinating servicemembers in

March, 1998.  However, the unpublished study done by Captain Jean Tanner

at Dover Air Force Base suggests that recent anthrax vaccine recipients

face similar medical problems as the Gulf War veterans (8).  

Meryl Nass, MD

207 865-7000

mnass@anthraxvaccine.org 

________________________

 

1. Expert committees listed in my Testimony to the House National

Security Subcommittee, April 29, 1999.  

http://www.house.gov/reform/na/hearings/testimony/nass2.htm

2. http:// www.dnd.ca/menu/press/Reports/Health/health_study_eng_1.htm

3. Unwin C et al. Health of UK servicemen who served in the Persian Gulf

War. The Lancet 1999; 353:169-178.

4.  Steele L. Prevalence and patterns of Gulf War Illness in Kansas

veterans: Association of symptoms with characteristics of person, place,

and time of military service. Am J Epidemiol 2000; 152:991-1001.

5. Cherry N et al. Health and exposures of United Kingdom Gulf War

veterans. Part II:

The relation of health to exposure. Occup Environ Med 2001; 58: 299-306.

6.  Mahan CM, Kang HK, Ishii EK et al. Anthrax vaccination and

self-reported symptoms, functional status and medical conditions in the

national health survey of Gulf War era veterans and their families.

Environmental Epidemiology Service, Veterans Health Administration,

Washington, DC. Presented January 25, 2001 @ Research Working Group:

Military and Veterans Health Coordinating Board Conference on Illnesses

among Gulf War Veterans: A Decade of Scientific Research

7.  www.gulflink.org/france/RAPPORTa.doc

8.  www.anthraxvaccine.org/Report.pdf

www.anthraxvaccine.org/data.pdfwww.anthraxvaccine.org/remarkst.pdf

Anthrax

Statement by Randi Airola
Executive Director

Military Vaccine Education Center
April 1, 2005

Anthrax Band Reunion Press Conference
New York City

  My name is Randi Airola. I'm the Executive Director of the Military Vaccine Education Center. Our organization helps soldiers and their families who have been hurt by the anthrax and other military vaccines.

The truth is: The Department of Defense knew the anthrax vaccine was experimental before they started forcing the troops to take it in 1998.

In October of 2004, after 6 years of the Department of Defense forcing service members to take the anthrax vaccine, a Federal Judge ruled that the order was indeed illegal.

According to the Government's conservative estimates, more than 4,000 healthy soldiers have been harmed by the anthrax vaccine with different symptoms ranging from convulsions, blood clots, heart problems, extreme fatigue and muscle weakness, severe migraines, paralysis, spontaneous miscarriages, tumors, tremors, loss of hair, loss of eyesight, loss of memory - and even death. Acknowledgement of these serious side affects is included in the vaccine's FDA approved product label.

I have spoken with more than 1,000 soldiers or their family members about their illnesses mentioned above. Some of these victims are in their 20's and need the assistance of a cane to walk. Some of these victims are even forced to pay their own medical bills and medical treatment. Soldiers who have refused vaccination have been fined, court-martialed, and even imprisoned with felony convictions.
Our men and women in uniform who volunteer to lay down their lives for the rest of us should not have to fear losing their health and their careers at the hands of our own Government.

The Department of Defense must cease its illegal misconduct of experimenting on our troops with inadequately tested, experimental vaccines, like the anthrax vaccine.

Who will volunteer to serve this great nation knowing that they must risk their health or lose their careers if they protest illegal orders? Enlistment bonuses treated as a dangling carrot to get potential recruits to enlist will come and go - but your health is yours forever.

The only way to move forward to begin to restore trust and confidence in the military is to give soldiers their legal right to full and informed consent over the experimental vaccines they are ordered to take.
www.MilVacs.org

Timeline of U.S. Anthrax Vaccine

1962
A study of anthrax vaccine involving goat-hair mill workers is published.

1970
The Michigan Department of Public Health receives a license for anthrax vaccine. Most users work at federal biological weapons labs.

1991
About 150,000 U.S. troops deployed for the Persian Gulf War get anthrax shots, the first widespread use of the vaccine.

1997
Defense Secretary William Cohen orders the beginning of mandatory anthrax vaccination. More than 450 troops refuse to take it in following years.

1998
BioPort Corp. is formed. The company buys the anthrax vaccine plant and license rights from Michigan.

2004
A U.S. district judge rules the vaccine was not properly licensed for protection against inhaled anthrax and says troops can't be forced to take it until it's properly licensed.

2005
The Pentagon begins the voluntary anthrax vaccination program. It appeals the ruling that made the vaccinations voluntary.

The Daily Press, Hampton Roads, Virginia

Anthrax

Statement by Barbara Loe Fisher
Co-founder & President
National Vaccine Information Center
April 1, 2005
Anthrax Band Reunion Press Conference
New York City
 

My name is Barbara Loe Fisher. I am co-founder and president of the National Vaccine Information Center. We have been working for the past 23 years to prevent vaccine injuries and deaths through public education and to protect the human right to informed consent.

If you are thinking about going into the military, you need to know that after 9-11, Congress passed a law called Project Bioshield that gives the Secretary of Defense the power to order soldiers to take experimental vaccines without telling them they could die or be permanently injured and without getting their voluntary consent. After 9-11 many states also passed laws that gave power to government health officials to arrest and forcibly vaccinate citizens without their informed consent.

Now Congress wants to pass another law that would give more power to government officials to declare a potential emergency - whether the emergency is real or not - and force you and every other American to take vaccines - whether they are experimental or not - without giving you a choice. And without giving you the information you need about the vaccine's side effects! And if you get hurt, you won't be able to go to court to find out if the drug company or the doctor who gave you the vaccine could have done a better job of protecting you from harm.

The soldiers hurt by the anthrax vaccine, just like the children hurt by mandatory childhood vaccines, had no voice and had no choice. If you want to make sure that you have the freedom to decide which vaccines you are willing to risk your life for, you need to get informed, get involved and stand up for your rights just like the band, Anthrax, is doing today.

You can learn more about diseases and vaccines and protecting your right to informed consent to vaccination by contacting the National Vaccine Information Center at www.nvic.org. Thank you.

Barbara Loe Fisher is co-founder and president of the National Vaccine Information Center. The mother of a son injured by the DPT vaccine in 1980, she is co-author of DPT: A Shot in the Dark (1985), author of The Consumer's Guide to Childhood Vaccines and editor of THE VACCINE REACTION. She worked with Congress on the National Childhood Vaccine Injury Act of 1986 and led demonstrations at the CDC and White House that year before it was made law. She has served on the National Vaccine Advisory Committee; Institute of Medicine Vaccine Safety Forum and the FDA Vaccines and Related Biological Products Advisory Committee.
 

Anthrax

Court Orders Pentagon to Stop Anthrax Vaccinations

 

BL Fisher Note:
After reviewing all the evidence, the U.S. District Court judge concluded that "Congress prohibited the administration of investigational drugs to service members without their consent. This Court will not permit the government to circumvent this requirement. The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all - public scrutiny.......accordingly the involuntary anthrax vaccination program, as applied to all persons, is rendered illegal absent informed consent or a Presidential waiver..."
 

This judge upheld the spirit and intent of the Nuremberg Code, issued by the Nuremberg Tribunal after The Doctor's Trial in Nuremberg, Germany following World War II. The Nuremberg Code prohibits the forcing of experimental medical interventions on an individual without his or her voluntary, informed consent. It has served as the guiding principle in the ethical practice of all medicine, experimental or not, ever since it was presented to the world in memory of those who were sacrificed in medical experiments conducted by physicians employed by the State during World War II.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

http://www.washingtonpost.com/wp-dyn/articles/A3691-2004Oct27.html
washingtonpost.com
Court Orders Pentagon to Stop Anthrax Vaccinations
By Marc Kaufman
Washington Post Staff Writer
Thursday, October 28, 2004; Page A01

The Defense Department must immediately stop inoculating troops with anthrax vaccine, a federal judge ruled yesterday, saying that the Food and Drug Administration acted improperly when it approved the experimental injections for general use.

Concluding that the FDA violated its own rules by approving the vaccine late last year, U.S. District Court Judge Emmet G. Sullivan said the mandatory vaccination program -- which has inoculated more than 1.2 million troops since 1998 -- is "illegal."

Sullivan said that his ban on involuntary vaccination will remain in place until the FDA reviews the anthrax vaccine properly or until President Bush determines that the normal process must be waived because of emergency circumstances.

The Defense Department has required many troops serving in Iraq and Afghanistan to be vaccinated, and it has punished and sometimes court-martialed those who refused. The Pentagon expanded its anthrax and smallpox vaccination programs in July to include troops stationed in South Korea and other areas in Asia and Africa, despite complaints from some service members that the anthrax vaccine made them sick.
In a statement, the Defense Department said it is reviewing the decision and will "pause giving anthrax vaccinations until the legal situation is clarified. . . . DoD remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe and effective."
In his ruling, Sullivan said that the FDA's approval was invalid because it did not meet the required review standards and the agency failed to seek the necessary public comment.

"Congress has prohibited the administration of investigational drugs to service members without their consent," Sullivan said. "This Court will not permit the government to circumvent this requirement."

"The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all -- public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this court shall compel FDA to follow," Sullivan wrote.

The judge ruled on a suit filed in March 2003 by six service members and civilians who argued that the FDA never properly reviewed the vaccine's ability to protect against inhalation anthrax. The suit contended that the drug was never shown to be effective, and that some vaccinated troops experienced extreme fatigue, joint pain and temporary memory loss after being vaccinated. The vaccine, made by BioPort Corp. of Lansing, Mich., is given in a series of shots.

Mark Zaid, an attorney for the six who has also defended more than a dozen service members court-martialed for refusing the vaccination, said one of his clients is a breast-feeding mother who does not think the vaccine is safe for her child.

"We will now initiate an effort to ensure the government reverses all punishments that were imposed for refusing an order to take the vaccine," Zaid said. He said he will also seek compensation for service members who contend they were harmed. "As we've seen in Iraq, there wasn't any actual threat from anthrax, so there was never any real need for the vaccine," Zaid said.

Sullivan initially ruled in late 2003 that the FDA had never approved the vaccine and ordered that the inoculations be stopped. Eight days later, the FDA approved the vaccine based on an application made 18 years earlier, and the inoculation program was resumed. Yesterday's ruling concluded that the agency did not follow its own rules in declaring the vaccine safe and effective.
In particular, Sullivan criticized the FDA for not allowing the public to comment on its decision -- a prerequisite for any approval. There was some public comment when the approval was first sought in 1986, but the 2003 decision was based on research conducted later and never subjected to public comment.

The FDA argued that comments had been submitted as part of a 2001 citizens' petition questioning proposals to begin the vaccinations, but Sullivan found them insufficient. "It is clear to this Court that if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency," he wrote.

Because the anthrax agent is so deadly, it has been difficult to test a vaccine that might protect against it. The best data have come from a study in the 1950s of workers at a factory that processed animal hides and furs, which can transmit naturally occurring anthrax. That study found that the vaccine now used by the military was effective in reducing the incidence of anthrax spread by contact, but the research involved only a tiny sample of people who might have inhaled the bacteria.

Anthrax vaccine was used in a limited way in the 1991 Persian Gulf War. A more expansive effort began in 1998. Difficulties in manufacturing the vaccine stopped the program in 2000 and 2001, but the vaccination effort was resumed and greatly expanded in 2002.

RULING:
http://www.airforcetimes.com/content/editorial/pdf/102704anthrax_decision.pdf

Anthrax

FOR IMMEDIATE RELEASE:
MARCH 30, 2005

Contacts:

Adrenaline PR:
Maria Ferrero 732-462-4262 

SIRIUS Satellite Radio:
Elise Brown 212-584-5290 

 

ANTHRAX SAYS NO TO DRUGS
ANTHRAX FIGHTS THE VACCINE
ATTACK OF THE KILLER VACCINE

ANTHRAX SAYS "NO MORE!" TO SPREADING THE DISEASE

Slave to the Metal™ Foundation is a portal for Heavy Metal music fans and the music Industry to raise awareness and provide funds to those organizations and individuals that fight against the misuse of heavy metals (i.e. depleted uranium, mercury and lead) and who are rising in outrage over other misanthropic and genocidal initiatives such as the forceful administration to our soldiers of the untested and unapproved Anthrax Vaccine (See: www.anthraxvaccine.org , www.milvacs.org). "Every fan of Heavy Metal music has the chance right now to support our troops as ANTHRAX partners with Slave to the Metal™ Foundation to provide an opportunity for the most affected generation to make a difference and bring public awareness to the dangers of the Anthrax Vaccine." Charlie Benante.

"Heavy Metal music was born out of non-conformity to socially accepted structure. Therefore our roots are seeded in the belief that we must challenge structure as it is based on past viewpoints imposed on the future. With respect to the Anthrax Vaccine it is our responsibility as 'keepers of the faith' of Heavy Metal music to stay true to core belief and challenge Project BioShield - a legislative act that authorizes the mandated use of untested and unapproved vaccines on our soldiers making them in essence first line guinea pigs for the biopharmaceutical industry." Scott Ian. "It has come to us from the most legitimate and politically correct activist circles that our head-banger support is sorely needed to make the public aware of these atrocities." Joey Belladonna.

"Along with the likes of directors, Scott Miller (www.directorder.org), who shed light on the Anthrax Vaccine dangers, and Michael Moore who is working on a Big Pharma expose, we are requesting Heavy Metal fans to channel their fabulous outrage to derail the atrocities that are being committed against innocent human beings." Eileen Dannemann, co-Founder Slave to the Metal™ Foundation. "I oppose all attempts by anyone to take away my right to dissent and say NO to being a guinea pig for the biopharmaceutical industry." Dan Spitz.

Please join us for the biggest event in heavy music - the ANTHRAX Global Press Conference and Luncheon. This history-making music event will take place on April 1, 2005 at 2:00 PM ET/11:00 AM PT at SIRIUS Satellite Radio's national broadcast center in New York City, and will be broadcast live on Hard Attack/27, SIRIUS' extreme heavy metal channel.

Refreshments and light fare will be served. A telephone line (866-510-5377) will be set up for off-site journalists to call in questions to directly ask the band - live on SIRIUS! Photos will be accommodated. To attend in person, press must RSVP by 5 pm ET on March 31, and a photo ID will be required to enter the building.

Slave to the Metal™ Foundation is representative of the highest social aspirations of the heavy metal scene." Frank Bello. In addition to the current efforts surrounding the Anthrax Vaccine, Slave to the Metal™ raises awareness and provides funds to organizations and individuals that fight the misuse of heavy metals (depleted uranium, mercury and lead). For the last 20 years, the heavy metal, "mercury", has been covertly injected directly into the arms of almost every child in this generation under the government's mandated childhood vaccine program. (See www.progressiveconvergence.com, www.NVIC.org and www.mercola.com)  The resulting brain damage has produced a generation of hyperactive, learning disabled, autistic, asthmatic children with behavior disorders that doctors treat with suicidal and homicidal drugs like Paxil, Prozac and Zoloft. (See www.ahrp.org). Notwithstanding the aforementioned, the CDC, FDA and Congress have not seen fit to remove the heavy metal out of vaccines. Moreover, since the first Gulf War, the United States has covertly dropped tons of nuclear wastes in the form of Depleted Uranium munitions (another heavy metal) on Iraq, the Balkans, Yugoslavia, Afghanistan and Iraq which has caused high incidences of birth defects and cancer among civilians in these regions and American soldiers (www.mindfully.org and www.traprockpeace.org).

New York's own ANTHRAX has an unmistakable signature style and distinct sound that breaks musical, cultural and political boundaries - influencing a myriad of bands throughout the spectrum of musical genres for 20 years.

Twice GRAMMY-nominated, MTV/VMA nominees and Multi-Platinum and Gold Awarded music veterans, ANTHRAX has sold over 10,000,000 records worldwide, including nine studio albums, two live albums, three greatest hits, plus two DVDs. Touring pros ANTHRAX performed on over fifty tours spanning the globe - in thirty-two countries on five continents including Europe, North America, South America, Australia and Asia.

Now, for the first time in 13 years, the entire original lineup of Joey Belladonna, Frankie Bello, Charlie Benante, Scott Ian and Danny Spitz will gather together in one room to discuss new music releases, as well as the future plans for this monumental ANTHRAX reunion.

The event will officially kick off the weekend music special "SPREADING THE ANTHRAX" on Hard Attack/27, where millions will hear it first.

Anthrax

for immediate release

December 8, 2003

VACCINE SAFETY ADVOCATES SUPPORT
SENATOR'S VACCINE SAFETY RESOLUTION

Washington, D.C. - Americans for Vaccine Safety and Accountability, headed by the National Vaccine Information Center (NVIC), are joining with other parent, veteran and health care organizations in support of a proposed Senate resolution asking Secretary of Defense Donald Rumsfeld to review the safety of the military's mandatory anthrax and smallpox vaccination programs. The resolution is being sponsored by Sen. Jeff Bingaman (D-NM) in response to mounting reports of serious health problems, including un-expected deaths, after soldiers are vaccinated.

"Tragically, national one-size-fits-all vaccine policies are hurting young soldiers in the military just as they are hurting young children in civilian life," said NVIC president Barbara Loe Fisher. "Many are dying or being left chronically ill after receiving multiple vaccines on one day. Nobody is being screened for genetic or biological risk factors be-cause public health agencies and industry have refused to do the scientific studies to identify those vulnerable. Some vaccines, like anthrax and smallpox, are known to be crude and highly reactive. Soldiers are being needlessly sacrificed for a flawed policy and it is inhumane when so much more could be done to prevent this waste of human life."

On Nov. 19, the Pentagon admitted that Rachael Lacy, a 22 year old Army recruit died last April after being injected with five vaccines, including anthrax and smallpox. Military doctors are now saying she may have had a predisposition to a fatal autoimmune condition (lupus) that was triggered by the vaccinations.

Meryl Nass, M.D., a civilian doctor who questions the safety of the anthrax vaccine and has treated many vaccine-damaged soldiers, reviewed Lacy's autopsy report and death certificate and urged the military in September to classify her death as vaccine-related. "The autopsy made it clear and now the military has confirmed that there is no other explanation for her death except the vaccines she received. There was no evidence of lupus on autopsy, although she may have had a genetic predisposition to auto-immunity that would put her at high risk for reacting to vaccines. Ten to 20 percent of the population has genetic predisposition to autoimmunity so everyone should have the right to informed consent to vaccination.," said Nass, who is also a member of NVIC's Medical Advisory Board.

Lacy's death follows persistent reports of other deaths, mysterious pneumonia-like illnesses, heart problems, blood clots, memory loss, disabling fatigue, muscle weakness and pain, weight loss and other serious health problems suffered by young, healthy military recruits after being vaccinated with anthrax, smallpox and many other vaccines.

The Bingaman resolution introduced in the Senate on November 25, cites a General Accounting Office (GAO) report that found that 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." The resolution also points out that the Centers for Disease Control (CDC) stated in June 2003 that 1 in 500 civilians vaccinated for smallpox had a serious vaccine event.

Bingaman maintains that a biological attack against U.S. troops is far less likely now so the risks of the military's compulsory anthrax and smallpox vaccination programs are greater than its benefits. He points out that British and Australian troops have not been required to take anthrax vaccine and that other allied nations have declined to use the vaccine on their troops.

Currently, six military servicemembers are seeking a preliminary injunction in a U.S. District Court in Washington, D.C. that would prevent the forced vaccination of U.S. military personnel with the anthrax vaccine and allow soldiers to give their voluntary, in-formed consent. Attorneys for the plaintiffs argue that the anthrax vaccine was never licensed by the FDA to protect against inhalation anthrax, which is how anthrax would be used as a biological weapon. Federal statute requires that either informed consent be given whenever a drug or vaccine is used for an unlicensed purpose, or that the President assumes responsibility by waiving servicemembers' right of informed consent.

A U.S. soldier's refusal to be vaccinated can result in a court martial, imprisonment, fines and dishonorable discharge from the military. One decorated Air Force physician was court martialed for refusing the anthrax vaccine and fined $21,000. A breast-feeding soldier was court martialed for refusing the anthrax vaccine because she did not want to take the risk of harming her child. A 2002 GAO report found that 69 percent of experienced pilots and aircrew members in the National Guard and the Reserve re-ported that the anthrax shot was the major influence in their decision to change their military status in 2000, including leaving the military entirely.

The Bingaman resolution calls on the Secretary of Defense and Board for Correction of Military Records "to reconsider adverse actions already taken or intended to be taken against servicemembers for refusing to accept the anthrax or smallpox vaccine." The resolution also calls on the Secretary of Veterans Affairs to "assess those adverse events being reported" and research causal relationships as well as estimate the future cost to treat the resulting health problems.

"The use of prophylactic biodefense drugs and vaccines must be solely threat-based and weighed against the health risks to the servicemember. Congress should direct DOD to fully disclose all unpublished medical studies, non-peer reviewed studies and experimental test data on their biodefense drugs and vaccines. These data should be made available to the DVA, the Institute of Medicine and independent researchers for a thorough review of DOD's findings," said Steve Robinson, Executive Director, National Gulf War Resource Center.

Reports of sudden death and chronic illness following receipt of multiple vaccines in the military first began to surface in the early 1990's, when soldiers deploying for the Gulf War were given up to 17 vaccines, including anthrax, as well as investigational drugs. The constellation of symptoms those soldiers experienced, which came to be known as "Gulf War Illness," are very similar to the symptoms being experienced by military recruits today who get vaccinated with multiple vaccines, including anthrax and smallpox.

Americans for Vaccine Safety and Accountability (AVSA), a coalition which includes the National Vaccine Information Center, Parents Requesting Open Vaccine Education, Unlocking Autism, New Hampshire Citizens for Health Freedom, Virginia Families for Vaccine Information and Choice, Vaccine Awareness of North Florida, Massachusetts Citizens for Vaccination Choice, Missouri Citizen's Coalition for Vaccination Choice, Illinois Vaccine Awareness Coalition, World Chiropractic Alliance, International Chiropractic Pediatric Association, Osteomed II, New Hampshire Vaccine Safety Initiative and Mothering Magazine is supporting the Bingaman resolution along with other organizations advocating safer vaccines and informed consent protections in national vaccine policies, including the National Gulf War Resource Center, Military Vaccine Education Center, New Jersey Alliance for Informed Choice in Vaccination, Michigan Opposing Mandatory Shots, Connecticut Vaccine Information Alliance, Kansas Alliance for In-formed Choice in Vaccination, Wyoming Vaccine Information Network, Minnesota Vaccine Awareness, Parents Advocating Vaccine Education and The Autism Autoimmunity Project.

NVIC was founded in 1982 and is the largest and oldest parent-led non-profit organization advocating the institution of vaccine safety and informed consent protections in national vaccination programs. AVSA is an activist coalition of organizations representing more than 200,000 Americans.

For more information and to read the entire resolution being sponsored by Sen. Bingaman, go to www.nvic.org/AVSA/Bingaman.htm

Anthrax

Biowar & Informed Consent

http://www.washtimes.com/upi-breaking/20050330-085257-3105r.htm
The Washington Times
March 30, 2005

Biowar: Informed consent injunction's key?

By Dee Ann Divis
Senior Science & Technology Editor

WASHINGTON, DC, Mar. 30 (UPI) -- The fate of the Defense Department's
anthrax vaccine program appears to hinge on whether Judge Emmet Sullivan
will allow the Pentagon to avoid the notification rules that normally
accompany an informed-consent requirement and the off-label use of a drug.

 On Oct. 27, 2004, Sullivan placed an injunction on the department's
mandatory vaccination program, blocking service personnel from having to
take shots of Anthrax Vaccine Absorbed, a controversial vaccine that critics
said is unsafe.

"Accordingly, the involuntary anthrax vaccination program, as applied to all
persons, is rendered illegal, absent informed consent or a Presidential
waiver," Sullivan said in his injunction.

AVA currently is licensed by the Food and Drug Administration, but only
against anthrax-related skin infections and not the lung infections the
military wants to prevent. The legality of using AVA against inhalation
anthrax was thrown into question after Sullivan ruled FDA had not gone
through all the necessary licensing steps. Under Title 10, which bars such
off-label use without prior consent -- and under a specific injunction
issued by Sullivan -- the military had to stop using the vaccine.

The Defense Department could have continued the program by obtaining the
informed consent of its service members, but officials chose not to.
Instead, they took the controversial step of going to the Department of
Health and Human Services and the Food and Drug Administration for an
Emergency Use Authorization. On the face of it, the EUA allows them to
proceed with the anthrax vaccination program they began in 1997.

Nonetheless, attorneys representing the Pentagon took the odd step of
returning to the U.S. District Court in the District of Columbia to ask
Sullivan to modify the injunction and, specifically, recognize the EUA.

The question is why.

Ostensibly, it is just a housekeeping matter. The EUA did not exist at the
time of the injunction, said Defense Department counsel Brian Boyle. The new
Bioshield Act made an EUA possible and now EUAs should be listed as a third
way to meet the legal requirements set by the injunction.

In a protracted debate, however, Sullivan kept asking if the program would
remain voluntary under the EUA. Boyle said yes, but Sullivan came back to
the question again and again, saying he did not understand why it was
necessary to change the injunction.

Boyle eventually admitted the Pentagon was worried about both requirements
of the injunction -- that the program be voluntary and informed consent be
obtained.

"Informed consent is not required under the EUA," Boyle asserted.

"It sounds to me like they don't want to do informed consent because then
certain things kick in," said Mac Stewart of the law firm Stewart & Stimmel
in Dallas.

Informed consent is a very specific term. It requires providing a great deal
of background and risk information to anyone receiving a medication for a
reason not originally approved. Informed consent, properly executed, also
protects those administering the medication from liability.

"The requirements come out of the Geneva Convention," said Dr. Patricia
Raymond, a physician in Chesapeake, Va., who has performed and overseen drug
trials.

"You need to disclose every side effect that might happen (and) the
possibilities of those side effects," Raymond explained. "You need to fully
disclose what happens to you if you choose not to take it. You've got to
fully disclose ... if the investigators are getting any financial
considerations. You need to do all of that in fifth-grade or sixth-grade
language ... I've got to explain it to you."

There do appear to be negative reactions the Pentagon would have to lay
bare.

John Richardson, an opponent of using AVA, told United Press International
there have been some 4,000 adverse-event reports filed so far.

Bioport of Lansing, Mich., AVA's manufacturer, reported that 18 studies back
up the safety of the vaccine and there are no more problems with AVA than
with any other vaccine. Even if there are no more than a usual number of
adverse reactions, they still would have to be described in some detail
under an informed-consent requirement.

"They are trying to get away from two things in my opinion," said Roman
Kupchynski, a partner in the Dallas law office of Gardere, Wynne, Sewell.
"One, (they) don't want to have to go through the whole process of having to
paper and document what this drug is and what it does and the side effects,
et cetera."

Kupchynski suggested, however, there may be more to the Defense Department's
desire to proceed under the EUA. If the EUA gives the Pentagon cover from
liability while reducing the required paperwork, it would constitute an
attractive alternative to resuming the program using informed consent.

It is not clear what liability protections in the many anti-terrorism laws
might be triggered by the emergency nature of the EUA.

"I can tell you that in any other (non-military) setting there is potential
liability for anybody who's in the chain if there is not informed consent,"
said Kupchynski, who made clear there may be other avenues for government
immunity.

"If I was on the government side," he said, "I would be thinking ... if I
don't really know what this drug is going to do ... I want to be able to
skirt that liability issue."

--

E-mail: ddivis@upi.com

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