FDA approves BioThrax (vaccine subcutaneous) to prevent Anthrax following suspected or confirmed exposure to Bacillus anthracis- Emergent BioDefense Operations

The FDA has approved a new indication for BioThrax (vaccine subcutaneous), from Emergent BioDefense Operations, to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine�s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.

BioThrax is the first vaccine to receive approval based on the Animal Rule. The Animal Rule allows animal efficacy data to be used as a basis for approval when human efficacy studies are not ethical or feasible. The safety and antibody responses to BioThrax in humans were evaluated in a multi-center study conducted in the United States. Subcutaneous injections were given to 200 healthy adults in three doses at zero, two, and four weeks. The majority of study participants generated antibody responses that correlated to a 70 percent probability of survival that was observed in animal models. The observed adverse reactions were comparable with those observed when BioThrax is used for pre-exposure disease prevention. The safety profile for BioThrax is well-established, with the majority of localized adverse events reported as tenderness, pain, swelling, and redness at the injection site, as well as limited movement of the injected arm. The most common systemic adverse reactions were muscle aches, headache, and fatigue.