other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.

Reports of fatalities included sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma (1).

Post Licensure Survey Studies

In addition to the VAERS data, adverse events following anthrax vaccination have been assessed in survey studies conducted by the Department of Defense in the context of their anthrax vaccination program. These survey studies are subject to several methodological limitations, e.g., sample size, the limited ability to detect adverse events, observational bias, loss to follow-up, exemption of vaccine recipients with previous adverse events and the absence of unvaccinated control groups. Overall, the most reported events were localized, minor and self-limited and included muscle or joint aches, headache and fatigue. Across these studies, systemic reactions were reported in 5-35% of vaccine recipients and included reports of malaise, chills, rashes, headaches and low-grade fever. Women reported these symptoms more often than men.

Reporting Adverse Events

Adverse events following immunization with BioThrax should be reported to the Medical Affairs Division of BioPort Corporation (517) 327-1675 during regular working hours and (517) 327-7200 during off hours. Adverse events may also be reported to the U. S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System. Report forms and reporting requirement information can be obtained from VAERS through a toll free number 1-800-822-7967.

DOSAGE AND ADMINISTRATION
Dosage

Immunization consists of three subcutaneous injections, 0.5 mL each, given 2 weeks apart followed by three additional subcutaneous injections, 0.5 mL each, given at 6, 12, and 18 months. Subsequent booster injections of 0.5 mL of BioThrax at one-year intervals are recommended.

Administration

Use a separate 5/8-inch, 25- to 27-gauge sterile needle and syringe for each patient to avoid transmission of viral hepatitis and other infectious agents. Use a different site for each sequential injection of this vaccine and do not mix with any other product in the syringe.

  1. Shake the bottle thoroughly to ensure that the suspension is homogeneous during withdrawal and visually inspect the product for particulate matter and discoloration. If the product appears discolored or has visible particulate matter, DISCARD THE VIAL.

  2. Wipe the rubber stopper with an alcohol swab and allow to dry before inserting the needle.

  3. Clean the area to be injected with an alcohol swab or other suitable antiseptic.

  4. Holding the needle at a 45° angle to the skin, inject the vaccine subcutaneously.

  5. DO NOT inject the product intravenously. Follow the usual precautions to ensure that you have not entered a vein before injecting the vaccine.

  6. After injecting, withdraw the needle and briefly and gently massage the injection site to promote dispersal of the vaccine.



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