Resources

There are several websites that provide extensive scientific libraries and references to medical journal articles relevant to anthrax disease and the anthrax vaccine.

Anthrax Vaccine Immunization Program (AVIP)

http://www.vaccines.mil/Anthrax

AVIP is the official program under which the U.S. Department of Defense currently requires vaccination for designated military personnel, emergency-essential DoD civilians and contractors, based on defined geographic areas or roles. The AVIP website provides information about anthrax, the disease, the threat, and the vaccine.

Centers for Disease Control and Prevention (CDC)

http://www.cdc.gov/anthrax/index.html

CDC is a federal government agency and a component of the U.S. Department of Health and Human Services. CDC's mission is to promote health and quality of life by preventing and controlling disease, injury, and disability. Its website has information on several bioterrorism agents and threats, including anthrax, as well as the latest recommendations for prevention.

U.S. Food and Drug Administration (FDA)

http://www.fda.gov/biologicsbloodvaccines/vaccines/ucm061751.htm

FDA is an agency within the U.S. Department of Health and Human Services. The Center for Biologics Evaluation and Research (CBER) is one center within the FDA, and its website provides information about anthrax disease, the vaccine, and a series of resources and references, including reviews of and recommendations for BioThrax® (Anthrax Vaccine Adsorbed).

Infectious Diseases Society of America (IDSA)

http://www.idsociety.org/Content.aspx?id=4294

IDSA is a non-profit organization aiming to improve the health of individuals and communities by promoting excellence in patient care, education, research, public health, and prevention of infectious diseases. Its website provides information about bioterrorism and includes a comprehensive list of resources about anthrax and the anthrax vaccine.

 

IMPORTANT SAFETY INFORMATION

Indication

BioThrax is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons 18 through 65 years of age. BioThrax is approved for:

  1. Pre-exposure prophylaxis of disease in persons at high risk of exposure.
  2. 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.

Contraindication

Severe allergic reaction (e.g. anaphylaxis) after a previous dose of BioThrax or a component of the vaccine.

Adverse Reactions

The most common (≥10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema, edema, and arm motion limitation. The most common (≥5%) systemic adverse reactions were muscle aches, headache, and fatigue. Acute allergic reactions, including anaphylaxis, have occurred with BioThrax.

Warnings and Precautions

Vaccination with BioThrax should be avoided by individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax or any component of the vaccine. If BioThrax is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to the fetus. Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. It is not known whether BioThrax is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BioThrax is administered to a nursing woman.

BioThrax should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.