Anthrax is an infectious disease caused by Bacillus anthracis, a bacterium that forms spores. A bacterium is a very small organism made up of one cell. Many bacteria can cause disease. A spore is a cell that is dormant (asleep) but may come to life with the right conditions. There are three types of anthrax:

• skin (cutaneous)
• lungs (inhalation)
• digestive (gastrointestinal)

Anthrax is not known to spread from one person to another. Humans can become infected with anthrax by handling products from infected animals or by breathing in anthrax spores from infected animal products (like wool, for example). People also can become infected with gastrointestinal anthrax by eating undercooked meat from infected animals. In most cases, early treatment with antibiotics can cure cutaneous anthrax and even if untreated, 80 percent with cutaneous anthrax recover. Gastrointestinal anthrax is more serious but inhalation anthrax is the more severe. In 2001, about half of the cases of inhalation anthrax ended in death.

The anthrax vaccine is primarily given to members of the military. Recently, there have been discussions regarding testing anthrax vaccines for children.

Biothrax Anthrax Vaccine Adsorbed Manufacturer: Emergent BioDefense Operations Lansing Inc., License #1755 – Indication:  For the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.

Biothrax – Package Insert (PDF – 165KB)

Supporting Documents

• May 17, 2012 Summary Basis for Regulatory Action – BioThrax (PDF – 152KB)
• May 17, 2012 Approval Letter – BioThrax
  To change the dosing schedule from a five-dose primary schedule at 0, 1, 6, 12, 18 months with annual booster to a three-dose primary schedule at 0, 1, 6 months.
• September 16, 2010 Approval Letter – BioThrax
  Patient Package Insert (PPI).
• December 11, 2008 Approval Letter
  Updated to to include a change in schedule from 0, 2, 4 weeks and 6, 12 and 18 months to 0, 4 weeks, and 6, 12, and 18 months, and a change in route of administration from subcutaneous to intramuscular.
• April 27, 2005 Approval Letter
  Updated to include an extension of dating to 36 months has been approved.
• January 31, 2002 Approval Letter

FDA Online Label Repository – Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.

If You Are Refusing A Direct Order To Take A Vaccine – Military  Biodefense Vaccines

September 14, 2019 – Comparative immunogenicity and efficacy of thermostable (lyophilized) and liquid formulation of anthrax vaccine candidate AV7909. “The anthrax vaccine candidate AV7909 is being developed as a next-generation vaccine for a post-exposure prophylaxis (PEP) indication against anthrax. AV7909 consists of the anthrax vaccine adsorbed (AVA) (Emergent BioSolutions Inc., Lansing, MI) bulk drug substance adjuvanted with the immunostimulatory oligodeoxynucleotide (ODN) compound, CPG 7909. The addition of CPG 7909 to AVA enhances both the magnitude and the kinetics of antibody responses in animals and human subjects, making AV7909 a suitable next-generation vaccine for use in a PEP setting.”

April 2019 – Development of a novel multiepitope chimeric vaccine against anthrax “Amongst these, PA-based vaccines are most effective for providing immunity against BA, but their low shelf life limits their usage.

February 27, 2019 – Anthrax Vaccine Working Group update “Informational session on use of new anthrax vaccine, AV7909,
for post -exposure prophylaxis (PEP)

June 21, 2017 – Updating recommendations for use of anthrax vaccine in the United States “Animal (Stern) vaccination started in 1957 after OK epizootic. Recommended for annual use in animals in endemic regions”

August 25, 2016 – First vaccine approval under the FDA Animal Rule “The US Food and Drug Administration’s Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical. In November, 2015 BioThrax became the first vaccine to receive approval for a new indication via this pathway. … The FDA also considers the Animal Rule a pathway of last resort, when approval under any other mechanism is not possible. The regulations allow for approval of a product based on ‘adequate and well controlled’ animal studies that suggest it is ‘reasonably likely to produce clinical benefit in humans’ and require that is has been shown to have an acceptable safety profile from clinical studies in humans.”

May 1, 2016 – Non-specific activation of autoreactive B cells after anthrax vaccination delays protection “Anthrax Vaccine Adsorbed (AVA) vaccination protects against anthrax infection by eliciting a neutralizing antibody response. However, protective antibody titers are not observed in human sera until at least three vaccinations have been administered over six months.”

November 25, 2015 – FDA Expands Use of Anthrax Vaccine to Include Postexposure Prevention “The expanded approval was based on animal trials, says the FDA, because it wasn’t possible to conduct efficacy studies in humans. The drug’s safety was studied in some 200 adults, the majority of whom generated protective antibody levels similar to those seen in animal models (70% probability of survival).”

July 26, 2014 – Anthrax and smallpox errors highlight gaps in US biosafety “Unfortunately, this was not an isolated incident. The CDC report listed four similar incidents in the past decade in which dangerous pathogens were mistakenly sent to other laboratories. In 2006, BRRAT accidentally sent viable B anthracis DNA to two external laboratories, and another CDC laboratory accidentally sent out live botulism bacteria. In 2009, it was discovered that a strain of brucella that the CDC had been sending out since at least 2001 was not the attenuated vaccine strain as had been thought. And just before the report was published the CDC learned that in March this year a strain of low-pathogenic avian flu was accidentally cross-contaminated with highly pathogenic H5N1 before being sent to a US laboratory.” Comment do you trust the CDC with vaccines for your loved one?

May 15, 2015 – Evaluation of anthrax vaccine safety in 18 to 20 year olds: A first step towards age de-escalation studies in adolescents “Rates of any elicited local AEs were not significantly different between younger and older age groups for local events (79.2% vs. 83.8%, P = 0.120) or systemic events (45.4% vs. 50.5%, P = 0.188). Robust and similar proportions of seroresponses to vaccination were observed in both age groups. Conclusions AVA was safe and immunogenic in 18 to 20 year-olds compared to 21 to 29 year-olds. These results provide initial information to anthrax and pediatric specialists if AVA studies in adolescents are required.”

April 28, 2014 – Pediatric Anthrax Clinical Management: Executive Summary (pdf) “Within 10 days of exposure, public health authorities plan to further define those who have had a clear and significant exposure and will require an additional 50 days of antimicrobial PEP, as well as beginning the 3-dose anthrax vaccine, anthrax vaccine adsorbed (AVA [BioThrax, Emergent BioSolutions, Rockville, MD]) series for children. Because there are insufficient data for the anthrax vaccine in children, it will be made available under an Investigational New Drug protocol. For children younger than 6 weeks of age (who are not candidates for AVA), antimicrobial prophylaxis should begin immediately, but the vaccine series should be delayed until the child reaches 6 weeks of age.”

April 24, 2014 – Evaluation of sex, race, body mass index and pre-vaccination serum progesterone levels and post-vaccination serum anti-anthrax protective immunoglobulin G on injection site adverse events following anthrax vaccine adsorbed (AVA) in the CDC AVA human clinical trial “Female and non-black participants had a higher proportion of AVA associated AEs and higher anti-PA IgG concentrations. Antibody responses to other vaccines may also vary by gender and race. Further studies may provide better understanding for higher proportions of AEs in women and non-black participants.”

November 2013 – Increasing the Potency of an Alhydrogel-Formulated Anthrax Vaccine by Minimizing Antigen-Adjuvant Interactions “Aluminum salts are the most widely used vaccine adjuvants, and phosphate is known to modulate antigen-adjuvant interactions. Here we report an unexpected role for phosphate buffer in an anthrax vaccine (SparVax) containing recombinant protective antigen (rPA) and aluminum oxyhydroxide (AlOH) adjuvant (Alhydrogel).

June 26, 2013 – Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers “The most common adverse events (AEs) in the BioThrax and AV7909 groups assessed as related to vaccination were injection site reactions. Transient lymphopenia was observed after the first dose in each AV7909 group. Frequencies of injection site and systemic reactions recorded by subjects in diaries for 7 days after each injection were highest with AV7909 Formulation 1. No AEs of special interest (autoimmune events) were observed in the study.”

May 6, 2013 – Human Leukocyte Antigens and Cellular Immune Responses to Anthrax Vaccine Adsorbed “Inter-individual variations in vaccine-induced immune responses are in part due to host genetic polymorphisms in the human leukocyte antigen (HLA) and other gene families.”

April 2013 – Pathology and Pathophysiology of Inhalational Anthrax in a Guinea Pig Model (full text) “It is neither feasible nor ethical to perform human trials to support the development of medical countermeasures against anthrax.Therefore, the use of adequate animal models of inhalational anthrax that closely mimic human disease and accurately reflect mechanisms of host-pathogen interaction is critical for the development and licensure of prophylactic or therapeutic countermeasures against the disease.”

March 28, 2013 – Safeguarding Children — Pediatric Research on Medical Countermeasures “In 2011, a bioterrorism-preparedness exercise conducted by the U.S. government examined the likely result of a large-scale release of weaponized anthrax spores in a city such as San Francisco. Code-named Dark Zephyr, the simulation was sobering: nearly 8 million people would be affected, nearly a quarter of them children.1 If such an event occurred, current response plans call for distribution of appropriate antibiotics and vaccination of affected civilian populations using anthrax vaccine adsorbed (AVA). Although the vaccine has been produced for more than four decades and has been safely administered to more than a million adults in the military,there is no history of use in children and no definitive understanding of how the vaccine would affect them.”

February 18, 2013 – ALLIANCE FOR HUMAN RESEARCH PROTECTION Advancing Honest and Ethical Medical Research by Meryl Nass, MD, Vera Sharav AHRP (pdf) “In the absence of an imminent anthrax threat to public health, how can you and the Commission even consider endorsing a proposal to subject American children to significant risks from a toxic, controversial vaccine, in an experiment that offers no benefit for the children? The performance of such an illegitimate experiment would suspend foundational ethical, legal and scientific norms protecting children–who are not volunteers, who are legally precluded from giving informed consent to research. How can you justify such an abrogation of the human rights of children?

January 2013 – An Adenovirus-Vectored Nasal Vaccine Confers Rapid and Sustained Protection against Anthrax in a Single-Dose Regimen “To mitigate an onslaught from airborne anthrax spores that are maliciously disseminated, it is of paramount importance to develop a rapid-response anthrax vaccine that can be mass administered by nonmedical personnel during a crisis. We report here that intranasal instillation of a nonreplicating adenovirus vector encoding B. anthracis protective antigen could confer rapid and sustained protection against inhalation anthrax in mice in a single-dose regimen in the presence of preexisting adenovirus immunity.”

September 21, 2012 – Disability among US Army Veterans vaccinated against anthrax “Vaccination against anthrax was four times more likely among disabled Veterans Vaccinated Soldiers with HFP had lower odds of disability separation from the Army 0.89 (0.80, 0.98); there was no association between vaccine and receiving Army disability benefits among those without HFP (OR = 1.05, CI: 0.96, 1.14). with hostile fire pay records (HFP, a surrogate for deployment). Vaccination was negatively associated with receiving VA disability benefits for those with HFP (OR = 0.66, CI: 0.65, 0.67), but there was little or no association between vaccine and receipt of VA disability benefits for those without HFP (OR = 0.95, CI: 0.93, 0.97).”

September 17, 2012 – BioShield report shows growth in biodefense stockpile ” In addition, in 2011 BARDA completed the acquisition of 10,000 doses of Anthrax Immune Globulin (AIG) from Cangene, also used to treat anthrax. The supply at the end of 2010 was listed as 7,327 doses. Total spending on Raxibacumab and AIG comes to $478 million, the report shows. BARDA previously bought a total of 28.75 million doses of the anthrax vaccine BioThrax from Emergent BioSolutions, at a cost of $691 million.

September 12, 2012 – Anthrax Vaccine–Induced Antibodies Provide Cross-Species Prediction of Survival to Aerosol Challenge “Because clinical trials to assess the efficacy of vaccines against anthrax are not ethical or feasible, licensure for new anthrax vaccines will likely involve the Food and Drug Administration’s “Animal Rule,” a set of regulations that allow approval of products based on efficacy data only in animals combined with immunogenicity and safety data in animals and humans.”

September 10, 2012 – DHS Should Reevaluate Mission Need and Alternatives before Proceeding with BioWatch Generation-3 Acquisition “The 2001 anthrax attacks brought attention to the potentially devastating consequences of a biological attack. DHS operates a program, known as BioWatch, intended to help detect such an attack by airborne pathogens. The currently deployed technology can take 12 to 36 hours to confirm the presence of pathogens. DHS has been pursuing a third generation of the technology that will perform automated testing, potentially generating a result in under 6 hours and reducing labor costs.”

July 6, 2012 – A genome-wide association study of host genetic determinants of the antibody response to Anthrax Vaccine Adsorbed “We estimated the proportion of additive genetic variance explained by common SNP variation for the AbPA response after the 6 month vaccination. This analysis indicated a significant, albeit imprecisely estimated, contribution of variation tagged by common polymorphisms (p=0.032). Future studies will be required to replicate these findings in European Americans and to further elucidate the host genetic factors underlying variable immune response to AVA.”

August 11, 2011 – Risk of disability for US army personnel vaccinated against anthrax, 1998-2005. “There was a dose-related trend in risk of disability for soldiers with 2 years’ service, limited to those entering service in 2000 or later. Divergent patterns in risk suggest confounding by temporal or occupational risks of disability.”

January 9, 2012 – Meryl Nass on Vaccines video – Meryl Nass, M.D., Internal Medicine, Anthrax Vaccine, and Gulf War Syndrome Expert speaks out on vaccines.

July 23, 2010 – Use of Anthrax Vaccine in the United States – “During January 1, 1998–December 31, 2008, VAERS received 6,015 nonduplicate reports from U.S. sources of adverse events after receipt of AVA, either alone or concurrently with other vaccines (CDC, unpublished data, 2010).Of these, 600 (9.9%) were categorized as serious events (i.e., events resulting in death, hospitalization, or permanent disability) (165). Approximately 74% of all reported adverse events that occurred after administration of AVA were in persons aged <40 years.”…”As of December 31, 2008, VAERS had received 25 reports of death among AVA recipients. Causes of death included a spectrum of cardiovascular disorders, unintentional or intentional injuries, malignancies, and chronic illnesses (CDC, unpublished data, 2010). Death reports have been summarized elsewhere.”

October 2009 – Unanswered questions and ethical issues concerning US biodefence research “For decades, scholars have reported that the human anthrax vaccine field trials conducted in the 1950s by Brachman and his colleagues were single-blind rather than double-blind. Nevertheless, in March 2005, Dr Philip S Brachman reported in a letter to the US Food and Drug Administration that his study had been double-blind. It is here argued that, rather, the field trial of a human anthrax vaccine should continue to be deemed as single-blind unless more detailed information is provided to explain exactly how the investigators were kept unaware of which subjects were in the treatment and control groups.”

May 2009 – The Anthrax Vaccine: A Dilemma for Homeland Security “Additional oversight reports cited Pentagon studies acknowledging that up to 35 percent of soldiers had adverse reactions to the anthrax vaccine, and that 6 percent of recipients reported serious complications after vaccination.  The military studies caused authorities to alter previously low adverse reaction rates, changing warnings listed on the approved labeling. Despite the changes, the military continued to insist on the safety of the vaccine, while the Government Accountability Office disclosed that “a significantly large number of vaccine recipients reported experiencing adverse events.” Government oversight reports confirmed the long-term safety of the vaccine had not been assessed, while raising questions about ingredient alterations and problems with human efficacy testing of the vaccine.

May-August 2008 – Vaccines, biotechnology and their connection with induced abortion. “Diploid cells (WI-38, MRC-5) vaccines have their origin in induced abortions. Among these vaccines we fi nd the following: rubella, measles, mumps, rabies, polio, smallpox, hepatitis A, chickenpox, and herpes zoster. Nowadays, other abortion tainted vaccines cultivated on transformed cells (293, PER.C6) are in the pipeline: flu, Respiratory Syncytial and parainfluenza viruses, HIV, West Nile virus, Ebola, Marburg and Lassa, hepatitis B and C, foot and mouth disease, Japanese encephalitis, dengue, tuberculosis, anthrax, plague, tetanus and malaria.”

March 2007 – Adverse Reactions to Anthrax Vaccine (eg, Optic Neuritis) May Be More Complex or Delayed Than Reported Initially by Payne et al (2006) “However, many immune disorders take time to develop. If such disorders were related to vaccinations, symptoms might not develop for many months after the vaccinations; yet the authors limited their time frame to less than 18 weeks. Some research that has suggested a relationship between anthrax vaccination and declines in subjective health reports has involved follow-up periods of several years.2 Furthermore, there appears to be a genetic component to many immune disorders. Some research has found that Gulf War illness symptoms were primarily related to vaccinations for those veterans who later reported that adverse reactions to their vaccines had occurred immediately after their vaccinations.

December 6, 2006 – Department of Defense Implementation of the Anthrax Vaccine Immunization Program (AVIP) (pdf) “Individuals not subject to mandatory vaccination who wish to continue vaccine dosing series. The following individuals who received at least onc dose of anthrax vaccine and who are not subject to mandatory vaccination shall (subject to medical exemptions) be offered additional vaccine doses, consistent with the FDA-approved dosing schedule, on a voluntary basis. Vaccines will be available at designated DoD registcred clinics.”

February 8, 2005 – Testimony of Meryl Nass, MD – Senate HELP Committee, Subcommittee on Bioterrorism “A historical lesson that industry may not want to acknowledge is that when the removal of manufacturers’ liability is sought and obtained, the resulting products have usually been associated with serious safety issues. And when the government assumes the liability, it has a strong disincentive to perform appropriate scientific studies that will identify and quantify the health risks of such products. Thus we still lack reliable statistical data on the types and rates of adverse reactions for anthrax vaccine. And despite CDC surveillance of 40,000 smallpox vaccine recipients, we remain in the dark about the rates of other vaccine complications, apart from myocarditis and certain skin conditions.”

September 29, 2004 – Bioterrorism and compulsory vaccination Rapid Responses (full text) “The total number of workers who ever experienced edema-producing reactions was only 21. However, the two mills involved, the attrition rates for each mill as of each inoculation, and the denominator of workers after each inoculation were never provided, rendering data interpretation difficult, if not meaningless. Thus, the Brachman et al study, the first holy grail of efficacy and safety for the defenders of the current anthrax vaccine, suffers from multiple design flaws, incomplete reporting, and relatively weak statistics.”

April 2002 – Self-reported changes in subjective health and anthrax vaccination as reported by over 900 Persian Gulf War era veterans. “Gulf War veterans were more likely to report poorer health than non-Gulf veterans. Female veterans were more likely to report mild or severe reactions to vaccines than male veterans. Those veterans who received anthrax vaccine reported more reactions to vaccines than those who did not receive anthrax vaccine. Declines in long-term subjective health were associated with receipt of anthrax vaccine by Gulf War veterans but not for those who did not deploy to the Gulf, although few of the latter received anthrax vaccine.”

March-April 2002 – Anthrax vaccination and joint related adverse reactions in light of biological warfare scenarios. “A certified copy of the VAERS database was obtainedfrom the CDC. In this study, we conducted a retrospective analysis using Microsoft Access for all joint attributed adverse reactions reported following anthrax vaccination. The employment of chi-square analysis determined if the elevated incidence rates of associated adverse reactions in anthrax vaccine recipients were statistically significant. Our analysis shows a very large and statistically significant increase in joint symptoms following vaccination with AVA when compared to our control population consisting of adverse joint reactions reported following vaccination with hepatitis A vaccine and Td vaccine.”

February 15, 2002 – Notice to Readers: Use of Anthrax Vaccine in Response to Terrorism: Supplemental Recommendations of the Advisory Committee on Immunization Practices “Because of the importance of protecting women of childbearing age from adverse health events, both military and civilian health-care providers should continue to ask women if they are pregnant or intend to become pregnant and should not vaccinate women who state that they are pregnant.

November 14, 2001– Preparing a Medical Response to Bioterrorism – Invited submission to the Committee on Government Reform for its November 14, 2001 Hearing: Comprehensive Medical Care for Bioterrorism Exposure —  A broad view of the problem — Seeking affordable protection — Identifying research needs — How much protection is obtainable? by Meryl Nass, MD