Anthrax antigen Other names: Bacillus anthracis antigen Anthrax vaccine

Pregnancy Category D.

Healthcare practitioners are encouraged to register women who receive anthrax antigen during pregnancy in Emergent’s vaccination pregnancy registry by calling 1-619-553-9255.

Male Fertility: A retrospective study was performed at an in-vitro fertilization clinic to evaluate whether anthrax antigen may impact reproductive function in men. This study compared semen parameters, embryo quality, and pregnancy outcomes in 254 male clients who stated that they had received anthrax antigen, with those of 791 male clients who did not². Prior receipt of anthrax antigen did not influence semen parameters (including concentration, motility, and morphology), fertilization rate, embryo quality or clinical pregnancy rates.

It is not known whether anthrax antigen is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when anthrax antigen is administered to a nursing woman.

The effect of anthrax antigen on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rabbits. One group of rabbits was administered anthrax antigen twice prior to gestation and during the period of organogenesis (gestation day 7). A second group of rabbits was administered anthrax antigen twice prior to gestation and on gestation day 17. Anthrax antigen was administered at 0.5 ml/rabbit/occasion, by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study.

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.