Anthrax is a serious infectious disease caused by the bacteria Bacillus anthracis. People or animals can contract anthrax from contact with infected animals or contaminated animal products. Bacillus anthracis forms spores than can survive in the environment, especially soil or animal products (e.g., rawhide) for decades. The most common route of exposure is via skin scrapes when working with infected animals resulting in cutaneous anthrax. Gastrointestinal infection occurs following eating raw or undercooked infected or contaminated meat. The most dangerous form of anthrax follows after inhalation of aerosolized anthrax spores, typically during industrial processing of infected animal products (e.g., rawhide, wool). In the United States, anthrax is very rare. Vaccination of livestock is recommended in areas with historical occurrences of anthrax. Moreover, all food animals are examined before slaughter (Mayo Clinic, Guide to Understanding Anthrax, ACIP). Anthrax spores had been mass-produced as a bioweapon by the Soviet Union (STAT News). In 2001, anthrax was also used as a bioweapon when letters laced with anthrax were mailed to several news media offices and Democratic Senators Tom Daschle and Patrick Leahy, killing five and sickening 17 (Amerithrax investigation). Anthrax vaccine BioThrax is given to adults at increased risk of exposure in five doses, with a booster dose each year. It is also used as post-exposure prophylaxis in combination with antibiotics. VAERS Explorer https://www.aretezoe.com/vaers-explorer You can follow VAERS Explorer on social media: Facebook: https://www.facebook.com/VAERSExplorer/ LinkedIn: https://www.linkedin.com/showcase/vaers-explorer/ Twitter: https://twitter.com/AreteZoe MeWe: https://mewe.com/i/veronikavaldova1 Gab: https://gab.com/VAERSExplorer TruthSocial: https://truthsocial.com/@vaersexplorer Parler: https://parler.com/VAERSExplorer YouTube: https://www.youtube.com/playlist?list=PLB6cShh65rNpo1dHiAQJ3-QEHyyM9zSJ1 Rumble: https://rumble.com/user/VAERSExplorer

1. VAERS EXPLORER
RESOURCEGATEWAY
ANTHRAX VACCINE
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BIOTHRAX- bacillus anthracis injection, suspension
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2.  Gram-positive, rod-shaped bacteria,
forms endospores
 Plasmides pXO1 and pXO2
responsible for pathogenicity
 Synthesizes protein capsule that
disguises the vegetative bacterium
from the host immune system
ANTHRAX
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3. ANTHRAX
CUTANEOUS ANTHRAX:
 Painless sore with a black center, swelling of regional lymph nodes, flu-like symptoms
GASTROINTESTINAL ANTHRAX:
 Nausea, vomiting, abdominal pain, loss of appetite, fever, headache
 Severe, bloody diarrhea, sore throat, swollen neck
INHALATION ANTHRAX:
 Flu-like symptoms, chest discomfort,
 Shortness of breath, coughing up blood, high fever, shock, meningitis
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4. AFFECTED POPULATION
ZOONOTIC TRANSMISSION
 People handling livestock, animal carcasses or rawhide
 Contact with contaminated soil or animal products
LABORATORY
 Accidental exposure in specialized laboratories
WEAPONIZED ANTHRAX
 Terrorist attacks, 2001 (Amerithrax investigation)
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5. BIOTHRAX- bacillus anthracis injection, suspension
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BIOTHRAX-
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6. VACCINETECHNOLOGY
 Cell-free filtrate of microaerophilic cultures of an avirulent, non-encapsulated strain of Bacillus anthracis.
 Grown in a chemically defined protein-free medium consisting of a mixture of amino acids, vitamins,
inorganic salts, and sugars.
 The final product contains proteins, including the 83kDa protective antigen (PA) protein, released during
the growth period and contains no dead or live bacteria.
 Contains 1.2 mg/mL aluminum (aluminum hydroxide in 0.85% sodium chloride), 25 mcg/mL
benzethonium chloride and 100 mcg/mL formaldehyde as preservatives.
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7. INDICATIONS & USAGE
INDICATIONS
 Active immunization for the prevention of disease caused by Bacillus anthracis
 Pre-exposure prophylaxis of disease in persons whose occupation or other activities place them at high risk
of exposure.
 Post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when
administered in conjunction with recommended antibacterial drugs.
 The efficacy of BioThrax for post-exposure prophylaxis is based solely on studies in animal models of
inhalational anthrax.
POPULATION
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 Persons 18 through 65 years of age.
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8. CONTRAINDICATIONS
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Severe Allergic Reaction.
 Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
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9. WARNINGS & PRECAUTIONS
Hypersensitivity
 Appropriate medical treatment must be available
Altered Immunocompetence
 Diminished immune response in immunocompromised persons
History of anthrax disease
 Increased the potential for severe local adverse reactions
Limitation of vaccine effectiveness
 BioThrax may not protect all recipients
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10. WARNINGS & PRECAUTIONS
Pregnancy (Category D)
 BioThrax can cause fetal harm when administered to a pregnant woman.
 Pregnant women should not be vaccinated against anthrax unless the potential
benefits of vaccination outweigh the potential risk to the fetus.
 Observational study among 37,140 infants born to U.S. military service women who
received anthrax vaccine in pregnancy between 1998 and 2004 showed that birth
defects were slightly more common in first trimester-exposed infants.
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Ryan MA, Smith TC, Sevick CJ, Honner WK, Loach RA, Moore CA, Erickson JD. 2008. Birth defects among infants born to
women who received anthrax vaccine in pregnancy. Am J Epidemiol, 168:434-442.

11. LOCAL:
Warmth
Tenderness
Itching
Erythema
Induration
Edema
Nodule
Bruise
Arm motion limitation
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ADVERSE
REACTIONS
Experience from
clinical trials
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SYSTEMIC:
Fatigue
Muscle ache
Headache
Fever
Tender axillary lymph
nodes
PRE-EXPOSURE PROPHYLAXIS

12. LOCAL:
Lump
Tenderness
Erythema
Skin hyperpigmentation
Decreased joint range of
motion
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ADVERSE
REACTIONS
Experience from
clinical trials
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SYSTEMIC:
Fatigue
Muscle ache
Headache
POSTEXPOSURE PROPHYLAXIS

13. Allergic reactions:
 Anaphylaxis
 Angioedema
 Rash
 Urticaria
 Pruritus
 Erythema multiforme
 Anaphylactoid reaction
 Stevens Johnson syndrome
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ADVERSE
REACTIONS
Post-marketing
experience
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to vaccine exposure.
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POSTMARKETING EXPERIENCE

14.  Lymphadenopathy
 Nausea
 Paresthesia
 Syncope, dizziness, tremor
 Ulnar nerve neuropathy
 Arthralgia, arthropathy, myalgia, rhabdomyolysis
 Alopecia
 Malaise, pain, flu-like symptoms
 Cellulitis
 Insomnia
 Flushing
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ADVERSE
REACTIONS
Post-marketing
experience
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to vaccine exposure.
https://www.aretezoe.com/vaers-explorer
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POSTMARKETING EXPERIENCE

15. Infrequent reports of Multisystem disorders
defined as chronic symptoms involving:
 fatigue,
 mood-cognition,
 and musculoskeletal system.
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ADVERSE
REACTIONS
Post-marketing
experience
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their
frequency or establish a causal relationship to vaccine exposure.
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POSTMARKETING EXPERIENCE

16. CDC List of Reportable AEs:
 None listed
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ADVERSE
EVENTS
OFSPECIAL
INTEREST
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17. PREGNANCY & BREASTFEEDING
PREGNANCY
Pregnancy category D
 Emergent’s vaccination pregnancy
registry
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BREASTFEEDING
 No information on excretion in
breast milk, caution advised

18. MALE FERTILITY
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 A retrospective study was performed at an in-vitro
fertilization clinic
 BioThrax did not influence semen parameters (including
concentration, motility, and morphology), fertilization
rate, embryo quality or clinical pregnancy rates.
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19. OTHER POPULATIONS
 The vaccine was not tested in children
 The vaccine was not tested in the elderly (>65 years of age)
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20. VACCINE/DRUG INTERACTIONS
Co-administration with ciprofloxacin:
 Does not alter pharmacokinetics of ciprofloxacin or the immunogenicity of BioThrax
Concomitant administration with other vaccines:
 Concomitant administration with other vaccines not evaluated
 Do not mix with other vaccines in one syringe/vial. Administer at different injection sites
ImmunosuppressiveTherapies:
 No data regarding use with immunosuppressive therapies.
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21. COMPLETEDCLINICALTRIALS – PHASE I
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NCT # Title Interventions Population Enrollment Completion
NCT01263691
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax
Vaccine in Healthy Adults BioThrax|AV7909 |Control 18 to 50 (M, F) 105 Jun-12
NCT04148118
A Safety and Immunogenicity of Intranasal Nanoemulsion
Adjuvanted Recombinant Anthrax Vaccine in Healthy Adults
BW-1010 |Saline (Placebo)
|BioThrax (positive control) 18 to 49 (M, F) 84 Sep-21
NCT00114621 Anthrax Vaccine Clinical Trials Anthrax Vaccine 18 to 45 (M, F) 93 May-11
NCT00057525
A New Anthrax Vaccine Administered by the Intramuscular (IM)
Route in Healthy Adults Anthrax|Alhdryogel or PBS 18 to 40 (M, F) 70 Aug-04
NCT01979406
A Phase 1 Ascending Dose Study to Assess the Safety and
Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines AVA|Ad4-PA-1|Ad4-PA-GPI-1 18 to 40 (M, F) 120 Sep-15
NCT02239172
PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA)
Anthrax Vaccine PA83-FhCMB 18 to 49 (M, F) 30 May-15
NCT01867957 Efficacy and Safety of Anthrax Vaccine, GC1109
Low-dose GC1109|High-dose
GC1109|Placebo 18 to 45 (M) 20 Dec-09
NCT00063843 Anthrax-rPA: Safety, Tolerability, Immunogenicity
Recombinant Protective Antigen,
Anthrax Vaccine Adsorbed
Child, Adult,
Older Adult 80 Aug-05
NCT02655549
A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult
Subjects Px563L, RPA563, or placebo 18 to 55 (M, F) 54 Jun-17
NCT00103467
Trial to Evaluate the Safety and Immunogenicity of an Anthrax
Recombinant Protective Antigen Vaccine rPA102 Vaccine 18 to 40 (M, F) 100
NCT04415749 NasoShield in Healthy Adults to Study Safety and Immunogenicity NasoShield|Other: Placebo 18 to 49 (M, F) 42 Mar-21

22. COMPLETEDCLINICALTRIALS – PHASE II
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NCT # Title Interventions Population Enrollment Completion
NCT03518125 BARDA Securing Anthrax Immunity For the Elderly BioThrax|AV7909|Placebo
18+ (Adult,
Older Adult) 305 Dec-19
NCT01770743
A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine
Using 3 Schedules and Two Dose Levels AV7909|BioThrax 18 to 50 (M, F) 168 Dec-14
NCT01753115 Ciprofloxacin BioThrax Co-Administration Study BioThrax|Ciprofloxacin 18 to 45 (M, F) 154 Aug-13
NCT04067011 Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
Ciprofloxacin |Doxycycline |
AV7909 18 to 45 (M, F) 210 Mar-20
NCT00170469
Safety, Tolerability and Immunogenicity of Recombinant Anthrax
Vaccine Compared With Anthrax Vaccine Adsorbed
AVA|rPA vaccine containing
alhydrogel 18 to 50 (M, F) 226 Feb-07
NCT00170456 Phase II Study of Range and Schedule of rPA Doses
rPA vaccine containing
alhydrogel 18 to 50 (M, F) 415 Feb-07

23. COMPLETED
CLINICAL
TRAILS
VELOCITY: An Anthrax Vaccine Clinical Study
 AV7909 | BioThrax
 Study design: Randomized, parallel assignment
 Masking: Participant, Care Provider, Investigator,
Outcomes Assessor)
 Participants: 3862 (18 – 65 years)
 Date: 3/2019 – 8/2020
 Completed, Results posted
 Study Protocol
 Statistical Analysis Plan
 Informed Consent Form
 NCT03877926
Phase III
NCT03877926
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24. COMPLETED
CLINICAL
TRAILS
Immunogenicity and Safety Study of a Three-
Dose BioThrax Regimen for Post-Exposure
Prophylaxis in Healthy Adults
 BioThrax
 Study design: Single group assignment,Open label
 Participants: 200 (18 – 65 years)
 Date: 11/2011 – 5/2012
 Available documentation:
 Study Results
 NCT01491607
Phase III
NCT01491607
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25. COMPLETED
CLINICAL
TRAILS
Immunogenicity and Safety Study of a Three-
Dose BioThrax Regimen for Post-Exposure
Prophylaxis in Healthy Adults
 BioThrax
 Study design: Randomized, parallel assignment
 Participants: 200 (18 – 65 years)
 Date: 11/2011 – 5/2012
 Available documentation:
 Study Results
 NCT01491607
Phase IV
NCT00119067
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26. COMPLETED
CLINICAL
TRAILS
CDC Anthrax Vaccine Clinical Trial
 BioThrax or AnthraxVaccineAdsorbed
 Study design: Randomized, parallel assignment
 Masking: Participant,Care Provider, Investigator,
Outcomes Assessor
 Participants: 1560 (18 – 61 years)
 Date: 5/2002 – 2/2010
 Available documentation:
 No results posted
 NCT00119067
Phase IV
NCT00119067
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27. COMPLETED
CLINICAL
TRAILS
Assessment of the Immunogenicity and Safety
of a Dose-Sparing BioThrax AVA Schedule
 BioThrax
 Study design: Randomized, parallel assignment
 Masking:Open label
 Participants: 328 (18 – 65 years)
 Date: 7/2012 – 6/2013
 Available documentation:
 Study Results
 NCT01641991
Phase IV
NCT01641991
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28. COMPLETED
CLINICAL
TRAILS
Effect of Raxibacumab on Immunogenicity of
Anthrax Vaccine Adsorbed
 AVA | Raxibacumab | Diphenhydramine
 Study design: Randomized, parallel assignment
 Masking: Open label
 Phase I
 Participants: 573 (18 – 65 years)
 Date: 2/2015 – 6/2017
 Available documentation:
 Study Results
 Study Protocol
 Statistical Analysis Plan
 NCT02339155
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Phase IV
NCT02339155

29. OTHERCLINICALTRIALS
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NCT # Title Interventions Population Enrollment Completion
NCT00133484
Phase II
UMD rPA Regimen Trial in
Adults
Anthrax vaccine absorbed made from
Bacillus anthracis (AVA)
Recombinant protein antigen (rPA)
made from Bacillus anthracis
Recombinant protein antigen (rPA)
made from Escherichia coli 18 to 50 (M, F)
270
Terminated
No results
NCT03352466
Phase I
NasoShield Study of Safety
and Immunogenicity
NasoShield
BioThrax
Placebo
18 to 49 (M, F)
145
Unknown status
No results

30. ONGOINGCLINICALTRIALS
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NCT # Title Interventions Population Enrollment Completion
NCT04660201
Phase I Anthrax AV7909 Liquid vs
Lyophilized AV7909 18 to 45 (M, F) 40
Recruiting
No results available
NCT01624532
Phase II
A Study to Assess Dose-Response,
Efficacy (Immunogenicity) and the
Safety of GC1109 GC1109 or Placebo 19 to 65 (M, F) 345
Not yet recruiting
No results available
NCT00050310
n/a
Natural History of Anthrax: a Study
of Primary Infected, Recovered, and
Exposed Individuals (SPoRE); and
Evaluation of AVA-Vaccinated
Recipients
evaluate the natural history of
anthrax and immune response
to anthrax antigens over time
3 + (Child, Adult,
Older Adult), (M, F) 200
Recruiting
No results available
NCT02177721
Phase IV
Clinical Benefit, Safety and PK of
Raxibacumab in Subjects Exposed to
Bacillus Anthracis Collection of samples
Child, Adult, Older
Adult 100
Not yet recruiting
No results available

31. RECOMMENDED USE
The vaccine is not available to the general public
Recommended by CDC for adults with high-risk occupational exposure:
• Laboratory workers who work with anthrax
• People who handle infected animals or animal products (veterinarians)
• Certain U.S. military personnel
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32. RESOURCES
 DailyMed – BioThrax label
 ClinicalTrials.gov
 CDC - Anthrax
 CDC – Anthrax vaccination
 FBI – Amerithrax investigation
 STAT News – Soviet bioweapon production program
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