Anthrax
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Bacillus anthracis
stain of anthrax

Bacillus anthracis is an aerobic, spore-forming bacterium that causes anthrax disease. Anthrax occurs globally, especially in agricultural areas that do not have a livestock vaccination program. Naturally occurring anthrax is rare in the United States, which has successful vaccination programs among livestock and strict importation regulations. In 2001, anthrax bacteria were used in bioterrorism attacks involving the postal system and government buildings. Regardless of the cause, all suspected cases of anthrax must be reported to the local health department for investigation.

Anthrax bacteria infect people and animals when spores are inhaled, ingested, or enter the body through a break in the skin. Once inside the body, the spores replicate and produce three proteins: edema factor (EF), lethal factor (LF), and protective antigen (PA). It is the combination of these proteins that is believed to cause tissue damage, shock, and death. Sometimes there is a delayed onset of anthrax disease. This is because anthrax spores can remain in the lungs for weeks without replicating. Antibiotics do not kill the spores. When the spores finally do replicate, anthrax disease develops.

There are three forms of anthrax disease:

  • Cutaneous (Skin)
    Incubation period: 1-12 days
    Signs and symptoms: painless lesion(s) with black center
  • Gastrointestinal (Ingestion)
    Incubation period: 1-7 days
    Signs and symptoms: throat ulcers, abdominal pain, fever, bloody diarrhea, vomiting
  • Inhalation
    Incubation period: 1-7 days (can be longer)
    Signs and symptoms: initially presents as flu-like symptoms, such as non-productive cough, myalgia, fatigue, and fever. In later stages there may be brief improvement, followed by high fever, dyspnea, cyanosis, and shock.
    This is the most dangerous form of anthrax, with case-fatality rates of up to 75% even with antibiotic therapy. Death can occur within hours of the onset of symptoms.

Antibiotics, such as ciprofloxacin, doxycycline, and amoxicillin, are the most important therapeutic interventions for any form of anthrax. A combination of antibiotics needs to be started as soon as the disease is suspected. In addition, aggressive supportive care will be needed.

About the Vaccine

In 1991, DoD Service members deploying for the Persian Gulf War received one or two doses of anthrax vaccine, labeled Vaccine A or Vacc A. Other abbreviations for anthrax vaccine include AVA and ANT. Before November 2008, the vaccine was given as a 6-dose series. Research on the vaccine showed, however, that five doses are as effective as six doses in preventing anthrax. So, in November 2008, the primary series of anthrax vaccine was changed to five doses. See "Dose/Schedule" for more information.

Anthrax Vaccine Licensed for Use in the U.S.

Product: Biothrax® (Anthrax Vaccine Adsorbed)
Manufacturer: Emergent BioDefense Operations Lansing Inc
Year licensed: 1970
Product Insert

Indications Contraindications and precautions
People aged 18-65 years who are:
  • military personnel with operational or other job-related indications, such as deployment to a high threat area for 15 days or more.
  • military personnel who have received at least one dose of vaccine and wish to complete the series.
  • laboratory workers who handle cultures or animals that are infected with anthrax.
  • People who are younger than 18 years old or older than 65 years, because the vaccine is not licensed for use in these age groups.
  • People who have had a severe allergic reaction to a previous dose of anthrax vaccine or vaccine component.
  • People who are moderately or severely ill, who should wait until recovery before receiving any vaccine. Minor illnesses, such as a cold, are not a contraindication.
  • People with a possible history of latex sensitivity because the vial stopper contains dry natural rubber and may cause allergic reactions. Administer with caution to these people.
  • Women who are currently pregnant. Pregnant women should be vaccinated only if the potential benefits outweigh the potential risks to the fetus.
  • People who have a history of anthrax disease, specifically cutaneous anthrax, because this can increase the risk for severe local reactions.
  • People who are immunocompromised, including those receiving immunosuppressive therapy, because they may have a diminished immune response.
  • People with coagulation disorders or receiving medications that affect coagulation. When medically indicated, anthrax vaccine may be administered by the SQ route. Note the aluminum component of the vaccine can cause irritation of the SQ tissue.
Inadvertent vaccination during pregnancy:

Pregnant women who have received the anthrax vaccine during pregnancy should receive regular prenatal care and should discuss their anthrax vaccination with their healthcare provider and/or obstetrician. MILVAX-VHCN has the latest information regarding pregnancy and vaccination, as well as adverse event research. MILVAX-VHCN also offers pregnancy monitoring for women inadvertently vaccinated during pregnancy. For more information, please visit the Pregnancy page or contact MILVAX-VHCN.

Vaccine Dose/Route Routine Administration Schedule
BioThrax Dose: 0.5 ml

Route: Intramuscular (IM) into deltoid muscle of arm. It is recommended that injections be alternated between the right and left arm.
Administer one dose at 0 weeks, 4 weeks, 6 months, 12 months, and 18 months. A booster dose should be administered every 12 months thereafter to those who remain at risk. For Service members, a booster dose is required for those deploying to a high-threat area for 15 days or more.
Note: Do NOT restart the series if a dose is late, just continue the schedule from the last dose given.
Anthrax Side Effects
  • Soreness, redness, or itching at the injection site (about 1 out of 10 men and 1 out of 6 women)
  • Lump at the injection site (about 1 out of 2 people, especially if given SQ)
  • Muscle aches or joint aches (about 1 out of 5 people)
  • Headaches (about 1 out of 5 people)
  • Fatigue (about 1 out of 15 men and 1 out of 6 women)
  • Chills or fever (about 1 out of 20 people)
  • Nausea (about 1 out of 20 people)
  • Large area of redness at the injection site (1 out of 20 people)
  • Serious allergic reactions (very rare)
Product Name Supplied Storage and Handling
BioThrax®
Emergent Biosolutions
5 mL multidose vial containing ten 0.5 mL doses Store refrigerated between 2° to 8°C (36° to 46°F). Do not freeze. Shake well before withdrawing dose from the vial. Observe for discoloration and particles. Discard if vaccine appears discolored or has visible particulate matter after shaking.

Biothrax® should appear as a milky-white suspension.
CNN 23 Jul 14
CDC lab director resigns after anthrax incident
Includes AVIP key messages, current policy, the threat, the disease and the vaccine, dosage schedule and route of administration, exemptions and adverse reactions.
Includes AVIP key messages, current policy, the threat, the disease and the vaccine, dosage schedule and route of administration, exemptions, adverse reactions, storage and handling of the vaccine, and documentation.
GENADMIN PDF 21 Jun 13
III MEF FORCE HEALTH PROTECTION (FHP) REQUIREMENTS 2014
COMSEVENTHFLT PDF 20 Sep 12
IMMUNIZATION REQUIREMENTS FOR DEPLOYMENT TO SEVENTH FLEET
ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP) UPDATE
BUMED PDF 07 Jul 10
SUSPENSION OF REGISTRATION AND MONTHLY REPORTING REQUIREMENT FOR THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)
ALARACT PDF 04 May 10
SUSPENSION OF THE ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP) REGISTRY AND MONTHLY REPORTING REQUIREMENTS
BUMED PDF 05 Nov 09
CLINICAL POLICY FOR THE ADMINISTRATION OF THE ANTHRAX VACCINE ADSORBED (AVA) UPDATE
ALMAJCOM/SG PDF 14 Jan 09
CHANGE IN ADMINISTRATION ROUTE AND DOSING SCHEDULE FOR THE ANTHRAX VACCINE ADSORBED (AVA)
02 Jan 14

Sample Q&A: The Anthrax Vaccine

Is the Food & Drug Administration concerned about the quantity of squalene found in these vaccines?
No. In Congressional testimony on 3 October 2000, FDA's Mark Elengold said that the trace quantities of squalene detected were "within the realm of both naturally occurring and safe."
Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009
VAERS 19 Mar 14
Vaccine Adverse Event Reporting System
Did You Receive the Anthrax Vaccine While Pregnant?
Safety Review PDF 01 Jan 12
Detailed Safety Review of Anthrax Vaccine Adsorbed
Vaccine Healthcare Centers Network
What You Need to Know About Anthrax Vaccine
Did You Receive the Anthrax Vaccine While Pregnant?
Centers for Disease Control and Prevention
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
Recommendations of the Armed Forces Epidemiological Board (AFEB)
VAERS 19 Mar 14
Vaccine Adverse Event Reporting System
Supplemental Form for Anthrax Vaccine in Pregnancy Registry
FAV111 PDF 17 Mar 05
FAV114 PDF 17 Mar 05
FAV113 PDF 22 Feb 05
FAV112 PDF 15 Feb 05
FAV109 PDF 30 Dec 04
FAV110 PDF 30 Dec 04
FAV107 PDF 27 Dec 04
Package Insert - Vaccine
VAERS 19 Mar 14
Vaccine Adverse Event Reporting System
Centers for Disease Control and Prevention
Department of Health and Human Services
Anthrax Vaccine Information
BioThrax
Anthrax eTool - Protecting the Worksite against Anthrax
MMQC-14-1298 09 Apr 14
Availability of the New Anthrax Trifold Brochure
MMQC-12-1518 27 Aug 12
RECEIPT OF THE NEW ANTHRAX TRIFOLDS
MMQC-12-1379 18 Jun 12
ANTHRAX VACCINE EXPIRATION NOTIFICATION FOR FAV304
MMQC-12-1376 15 Jun 12
ANTHRAX VACCINE EXPIRATION NOTIFICATION FOR FAV297
MMQC-12-1345 04 Jun 12
ANTHRAX VACCINE TWO WEEK NOTIFICATION FOR LOT FAV304
MMQC-12-1341 01 Jun 12
ANTHRAX VACCINE TWO WEEK NOTIFICATION FOR LOT FAV297
MMQC-12-1311 18 May 12
ANTHRAX VACCINE EXPIRATION 30-DAY NOTICE LOT FAV304
What You Need to Know About Anthrax Vaccine
Did You Receive the Anthrax Vaccine While Pregnant?
Safety Review PDF 01 Jan 12
Detailed Safety Review of Anthrax Vaccine Adsorbed
Vaccine Healthcare Centers Network
Vaccine Information Statement
Includes AVIP key messages, current policy, the threat, the disease and the vaccine, dosage schedule and route of administration, exemptions, adverse reactions, storage and handling of the vaccine, and documentation.
Includes AVIP key messages, current policy, the threat, the disease and the vaccine, dosage schedule and route of administration, exemptions and adverse reactions.
Safety Review PDF 01 Jan 12
Detailed Safety Review of Anthrax Vaccine Adsorbed
Vaccine Information Statement
Anthrax Vaccine Package Insert Change
FAV183 PDF 04 Apr 07
FAV188 PDF 13 Mar 07
FAV186 PDF 01 Mar 07
FAV181 PDF 22 Feb 07
FAV182 PDF 22 Feb 07
FAV184 PDF 07 Feb 07
Vaccine Information Statement
CNN 23 Jul 14
CDC lab director resigns after anthrax incident
CNN 15 Jul 14
Anthrax investigation: USDA finds more CDC lab problems
NBC News 11 Jul 14
CDC Cracks Down on Labs After Anthrax, Bird Flu Scares
Author(s): Bradley JS, Peacock G, Krug SE, Bower WA, Cohn AC, Meaney-Delman D, Pavia AT and AAP Committee on Infectious Diseases and Disaster Preparedness Adviso
Publication: American Academy of Pediatrics
Subject: Vaccine-General
Disease: 
Anthrax
Category: 
Clinical
Author(s): ACIP
Publication: MMWR, vol. 59, no. RR-6
Subject: Vaccine-General
Disease: 
Anthrax
Author(s): Grunow R, Klee SR, Beyer W, George M, Grunow D, Barduhn A, Klar S, Jacob D, Elschner M, Sandven P, Kjerulf A, Jensen JS, Cai W, Zimmermann R, Schaad
Publication: Eurosurveillance
Subject: Disease
Disease: 
Anthrax
Author(s): Food & Drug Administration
Publication: Federal Register 2005;70,242:75180
Subject: Vaccine-General
Disease: 
Anthrax