Common Vaccine Questions
General Product Questions
Indication and Dosage
Safety
Efficacy
General Product Questions
What is BioThrax® (Anthrax Vaccine Adsorbed)?
BioThrax is the only FDA-licensed vaccine available for protection against anthrax disease. It is indicated for the active immunization of individuals between the ages of 18 and 65 who are at high risk of exposure to anthrax. BioThrax is not licensed for use in a post-exposure setting. The safety and efficacy of BioThrax have not been established in pregnant women, nursing mothers, pediatric populations or geriatric populations.
How does BioThrax provide protection?
Like other vaccines, BioThrax stimulates the immune system to produce protective antibodies. These antibodies help the immune system neutralize the toxins produced by anthrax bacteria. These toxins could otherwise be potentially lethal to anyone who became infected with anthrax bacteria.
Does BioThrax contain anthrax?
No. BioThrax is a sterile product, made from cell-free filtrates of cultures of a strain of anthrax bacteria not capable of causing the disease. It contains no whole bacteria, neither live nor dead. The vaccine is prepared from the solution that results after the filtration of the culture of anthrax bacteria.
Indication and Dosage
What is BioThrax indicated to treat?
BioThrax is the only FDA-licensed vaccine available for protection against anthrax disease. It is indicated for the active immunization of individuals between the ages of 18 and 65 who are at high risk of exposure to anthrax. BioThrax is not licensed for use in a post-exposure setting. The safety and efficacy of BioThrax have not been established in pregnant women, nursing mothers, pediatric populations or geriatric populations.
How many doses of BioThrax are needed?
The current FDA-licensed schedule calls for five doses to be administered intramuscularly at 0, 1, 6, 12, and 18 months. Annual booster doses of the vaccine are recommended to sustain ongoing protection.
Safety
What are the most common side effects of BioThrax?
The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache. Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax.
How do I report an adverse event following vaccination?
Suspected adverse events following immunization with BioThrax should be reported to the Medical Affairs Division of Emergent BioSolutions at 877-246-8472. Adverse events may also be reported to VAERS at 1-800-822-7967 or at www.vaers.hss.gov.
Who should not take BioThrax?
Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. 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. This product should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.
Vaccination with BioThrax should be avoided by individuals with a history of an anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.
What warnings and precautions are associated with the use of BioThrax?
Latex
BioThrax should be administered with caution to patients with a possible history of latex sensitivity because the vial stopper contains dry natural rubber and may cause allergic reactions.
Hypersensitivity Reactions
Before administration, the patient's medical immunization history should be reviewed for possible vaccine sensitivities and/or previous vaccination-related adverse reactions, to determine the existence of any contraindications to immunization. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
Pregnancy
Pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If this vaccine is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to a fetus. For additional information, please see the Warnings and Precautions section (5) of the prescribing information.
History of Anthrax Disease
A history of anthrax disease may increase the potential for severe local adverse reactions.
Altered Immunocompetence
If BioThrax is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.
Limitations of Vaccine Effectiveness
Vaccination with BioThrax may not protect all individuals. The extent to which one is protected prior to completion of the full immunization schedule is unknown.
What contraindications exist for the use of BioThrax?
The use of BioThrax is contraindicated in subjects with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.
Efficacy
How effective is BioThrax at preventing anthrax disease?
One of the studies used to support the original marketing approval of BioThrax constituted a controlled field study in which the BioThrax predecessor vaccine was calculated to be 92.5% effective in preventing inhalational and cutaneous anthrax4.
BioThrax may not protect all individuals vaccinated, particularly patients with impaired immune responses due to congenital or acquired immunodeficiency, or immunosuppressive therapy.
How quickly does BioThrax provide protection?
Since it is not known what levels of anti-PA antibody are needed for protection, we cannot predict the point during the immunization schedule at which protection occurs. For optimal protection, the licensed immunization schedule should be followed. Individuals are not considered protected until they have completed the full vaccination series.
