The current anthrax vaccine is given in a five-dose series over an 18 month period, followed by annual booster shots to maintain protection for those individuals at risk. Individuals are not considered protected until they have completed the full five-dose vaccination series.
The anthrax vaccine product information insert states that ”Vaccination with BioThrax may not protect all individuals. The extent to which one is protected prior to completion of the full immunization schedule is unknown.”
There is limited published data on controlled human trials to test the effectiveness 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 acquired anthrax.
However, 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. 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, weaponized strain of anthrax that is not covered by the vaccine strain, the vaccine may have limited or no effectiveness.
The anthrax vaccine product information insert states: “ The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, headache, and fatigue. Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax.”
Most of the safety studies done on anthrax vaccine have been conducted by the Department of Defense. Many of these studies are unpublished and reportedly do not include long term follow-up, according to military veterans advocacy groups who have reported anthrax vaccine damage. Some have estimated that 20 to 48 percent of all those vaccinated have some kind of reaction to anthrax vaccine, ranging from mild to severe. Reported mild to moderate anthrax vaccine reactions have included not only severe local pain, swelling and redness at the injection site, but also fever, chills, and nausea that resolve without permanent damage.
Serious anthrax vaccine reactions resulting in permanent autoimmune and brain dysfunction have been reported and include:
- chronic disabling fatigue;
- persistent headaches;
- severe joint pain and crippling arthritis;
- numbness and muscle weakness;
- severe memory loss;
- brain inflammation
The BioThrax product information insert lists, among other serious health problems reported after use of anthrax vaccine, the following:
- erythema multiforme;
- Stevens Johnson syndrome;
- paresthesia syncope;
- alopecia (hair loss);
- chronic fatigue;
- mood-cognition problems.
As of August 2011, there have been more than 7,000 anthrax vaccine-related health problems reported to the federal Vaccine Adverse Events Reporting System (VAERS), including 300 reports of cases that ended with permanent disability and 26 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.
In the late 1990’s and early 2000’s, 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 have faced court martial rather than agree to be vaccinated or revaccinated with anthrax vaccine after serious reactions have occurred.
Anthrax vaccine is licensed for individuals between the ages of 18 and 65, who are at high risk for being exposed to anthrax. There is no anthrax vaccine that has been tested or licensed for children under age 18.
What the Manufacturer Says: The anthrax vaccine manufacturer, Emergent BioSolutions, warns that "the use of BioThrax is contraindicated in persons with a history of anaphylactic or anaphylactic like reaction following a previous dose of BioThrax."
Pregnant Women: Anthrax vaccine has been assigned a Pregnancy Category “D” rating by the FDA, which means that there is positive evidence of risk revealed in human studies or fetal risk has been demonstrated in investigational or post-marketing surveillance data. The Emergent BioSolution product information insert also states: “BioThrax can cause fetal harm when administered to a pregnant woman” and also states that “Pregnant women should not be vaccinated against anthrax unless the potential benefit of vaccination have been determined to outweigh the potential risk to the fetus.”
Simultaneous Administration With Other Vaccines: The Emergent BioSolutions product information insert states” No prospective controlled clinical studies to assess the concomitant administration of BioThrax with other vaccines have been performed.”
The anthrax vaccine was developed in the 1960’s at Fort Detrick by the Department of Defense, which still holds the patent. It was approved for licensure by the FDA in 1970.
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 also had been used for many years to manufacture and distribute DPT vaccine for Michigan state residents.
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 state lab. Anthrax vaccine manufacturing was taken over by Bioport Corporation when they purchased 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.
Bioport failed FDA quality control inspection several times, which resulted in interruption of anthrax vaccine supplies and use of the vaccine by the military. In 2004, BioPort underwent corporate restructuring and was renamed Emergent BioSolutions.
Since 1998, BioPort/Emergent BioSolutions has delivered more than 30 million doses of anthrax vaccine, primarily to the U.S. Department of Defense as the sole source supplier of anthrax vaccine for the U.S. military. In 2009, the FDA granted Emergent Biosolutions a shelf life extension for BioThrax from three to four years.
In May 2011, the U.S. government awarded Emergent Biosolutions a 5-year sole source contract for the purchase of nearly 45 million doses of BioThrax.
After September 11, 2001, about 500,000 of the 2.4 million U.S. troops and reservists were given anthrax shots by November 2001. In response to the exposure of U.S. civilians to anthrax in 2001 through contaminated mail, the Centers for Disease Control made plans to make some of the military anthrax vaccine stockpiles available to lab technicians, bioterrorism investigators, “first responders” (police, firefighters, medical personnel) and others at high risk for weaponized anthrax exposure.
The anthrax vaccine given to military personnel and civilians after Sept. 11, 2001 had never received final FDA approval for being an effective way to prevent infection with inhalation anthrax, which is theoretically how the organism would be turned into a bioterrorism weapon. Therefore, BioThrax vaccine continued to be classified as experimental.
In December 2003 in response to a lawsuit brought on behalf of soldiers injured by anthrax vaccine, a federal court judge issued an injunction preventing the U.S. military from requiring soldiers to get anthrax shots without their voluntary, informed consent until the vaccine was no longer classified as “experimental” and was licensed by the FDA as safe and effective against inhalation anthrax. Between December 2003 and the end of 2005, the Department of Defense was compelled to inform military personnel about the benefits and risks of anthrax vaccine and obtain their informed, voluntary consent before vaccination.
In December 2005, the FDA licensed BioThrax as safe and effective against any form of anthrax exposure, including inhalation anthrax. Anthrax vaccine safety advocacy groups protested that the government had not done adequate additional testing of the vaccine’s safety and effectiveness against inhalation anthrax to justify removal of the “experimental vaccine” designation.
In 2006, the DOD reinstituted a mandatory anthrax vaccination policy for all soldiers and adult U.S. military personnel, which did not require obtaining informed consent.
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. For more information on general questions to consider when deciding about whether or not to use a particular vaccine, please visit our Ask 8