Safety

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema, edema, and arm motion limitation.

Injection site adverse reactions, including warmth, tenderness, itching, erythema, induration, edema, and nodule occurred at lower frequencies in participants given BioThrax by the intramuscular route after each dose, in almost all comparisons. The incidence of arm motion limitation was usually higher in each intramuscular group compared to the subcutaneous group

Local Adverse Reactions

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Study Design: A randomized, double-blind, placebo-controlled, and active-controlled multi-center clinical study in which 1,564 healthy adult volunteers were enrolled to evaluate the effect of (1) changing the route of vaccine administration from subcutaneous (SC) to intramuscular (IM), and (2) of reducing the number of doses on the safety and immunogenicity of BioThrax.

* Per-dose, statistical assessment performed on Intent-to-Treat population data. Evaluations performed at 15-60 minutes and 1-3 days following each injection and prior to the next scheduled injection.
** N is the highest number per treatment arm (received at least one dose); denominator (N) varied with dose number due to attrition over time.
† Subjects received saline (instead of BioThrax) for the Week 2 dose. Placebo dose data for 7IM group is in italics.
‡ The two saline groups (SC and IM) were combined.
§ Moderate = causes discomfort and interferes with normal daily activities; Severe = incapacitating and completely prevents performing normal daily activities. This is based on the local AE categories of warmth, tenderness, itching, pain, and arm motion limitation.
¦ Large = an occurrence of induration, erythema, edema, nodule, and bruise with a largest diameter greater than 120 mm.

The most common (>5%) systemic adverse reactions were muscle aches, headaches, and fatigue.

The change in the route of administration from subcutaneous to intramuscular did not affect the occurrence of systemic adverse reactions, with the exception of muscle ache, which had increased incidence in the BioThrax intramuscular groups after most doses.
There was no clear pattern for differences in the incidence of any moderate or severe systemic adverse reactions for BioThrax intramuscular groups compared to the subcutaneous group after each dose.

Study Design: A randomized, double-blind, and active-controlled multi-center clinical study in which 1,564 healthy adult volunteers were enrolled to evaluate the effect of (1) changing the route of vaccine administration from subcutaneous (SC) to intramuscular (IM), and (2) of reducing the number of doses on the safety and immunogenicity of BioThrax.

* Per-dose, statistical assessment performed on Intent-to-Treat population data. Evaluations performed at 15-60 minutes and 1-3 days following each injection and prior to the next scheduled injection.

** N is the highest number per treatment arm; denominator (N) varied with dose number due to attrition over time.
† Subjects received saline (instead of BioThrax) for the Week 2 dose.
‡ The two saline groups (SQ and IM) were combined.
†† Moderate = causes discomfort and interferes with normal daily activities; Severe = incapacitating and completely prevents performing normal daily activities. This is based on the systemic AE categories of fatigue, muscle ache, headache, and fever.

Acute allergic reactions, including anaphylaxis, have occurred with BioThrax.

Next: Efficacy

 

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.