Common Vaccine Questions

General Product Questions
Indication and Dosage
Safety
Efficacy

General Product Questions

What is the most important information I should know about BioThrax?

  • Only people with a high risk of getting the disease need to get the shots.
  • BioThrax may not completely protect everyone who gets the shots.

What is BioThrax® (Anthrax Vaccine Adsorbed)?

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.

How does BioThrax provide protection?

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.

What are the ingredients in BioThrax?

BioThrax contains aluminum hydroxide, benzothonium chloride and formaldehyde (as preservatives). The vial stopper contains natural rubber latex.

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Indication and Dosage

What is BioThrax indicated to treat?

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 whose occupation or other activities place them at high risk of exposure.

Who should not take BioThrax?

You should not get BioThrax if you had a serious reaction after getting BioThrax before.

Before getting BioThrax, you should tell your healthcare provider

  • If you may be pregnant, plan to get pregnant soon, or are nursing a baby
  • About medicines that you take, including over-the-counter medicines and supplements.
  • About immune problems you have, including steroid treatments and cancer treatments.
  • About blood clotting problems or if you take “blood thinners.”
  • If you are allergic to latex

How is BioThrax given?

BioThrax is given as a shot in your arm. After getting the first shot, you should come back for the next shots on the schedule given to you by your healthcare provider. It is important that you get all your shots to get the best protection.

How many doses of BioThrax are needed?

Pre-Exposure Prophylaxis

The current FDA-licensed schedule for pre-exposure vaccination calls for a three dose primary series to be administered intramuscularly (IM) at 0, 1, and 6 months with boosters at 6 and 12 months and at 1-year intervals thereafter for those who remain at risk. Individuals are not considered protected until they have completed the three-dose primary vaccination series.

Post-Exposure Prophylaxis

The current FDA-licensed schedule for post-exposure vaccination calls for a three dose primary series to be administered subcutaneously (SM) at 0, 2, and 4 weeks post-exposure combined with antimicrobial therapy.

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Safety

What are the possible or reasonably likely side effects of BioThrax?

  • Pain, tenderness, redness, bruising, or problems moving the arm in which you got the shot
  • Muscle aches
  • Headaches
  • Fatigue
  • Fainting

It was observed that groups receiving BioThrax by the IM route had a statistically significantly lower incidence (p ≤ 0.05) of any (one or more) local adverse reactions compared to the BioThrax SC route.

Tell your healthcare provider about any side effects that concern you. Your healthcare provider can give you a complete list of side effects available to healthcare professionals.

How do I report an adverse event following vaccination?

You may report side effects directly to Emergent BioSolutions at 1-877-246-8472 or at productsafety@ebsi.com You may also report side effects to FDA by calling 1-800-822-7967 or to the website www.vaers.hhs.gov.

What warnings and precautions are associated with the use of BioThrax?

Hypersensitivity Reactions
Acute allergic reactions, including anaphylaxis, have occurred with BioThrax. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Latex
The stopper of the vial contains natural rubber latex and may cause allergic reactions to patients with a possible history of latex sensitivity.

Pregnancy
BioThrax can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Weigh the potential benefits of vaccination against the potential risk to the fetus.

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. Results of a large observational study that examined the rate of birth defects 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 (odds ratio = 1.18, 95% confidence interval: 0.997, 1.41) when compared with infants of women vaccinated outside of the first trimester and compared to unvaccinated women.1 While the increased birth defect rates were not statistically significant when compared with infants born to women vaccinated outside of 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.

History of Anthrax Disease
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.

What contraindications exist for the use of BioThrax?

Do not administer BioThrax to individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax or any component of the vaccine, including aluminum, benzethonium chloride, and formaldehyde.

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Efficacy

How effective is BioThrax at preventing anthrax disease?

One of the studies used to support the original pre-exposure indication 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.

The safety and efficacy of BioThrax have not been established in pediatric or geriatric populations.

BioThrax may not protect all individuals vaccinated, particularly patients with impaired immune responses due to congenital or acquired immunodeficiency or immunosuppressive therapy. Individuals are not considered protected until they have completed the three-dose primary vaccination series.

How quickly does BioThrax provide protection?

Since it is not known what levels of anti-PA antibody are needed for protection, the point during the immunization schedule at which protection occurs cannot be predicted. For optimal protection, the licensed immunization schedule should be followed. Individuals are not considered protected until they have completed the three-dose primary vaccination series.

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Next: Side Effects

4 Brachman, et. al. Field Evaluation of a Human Anthrax Vaccine American Journal of Public Health, 1962:Vol 52, No 4 p632-45
 

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.