Innovation in Product Development
First vaccine to be licensed using the FDA Animal Rule
When developing medical countermeasures for potential bioterror threats, human challenge studies would not be ethical or feasible. In these cases, FDA may grant approval based on animal efficacy studies once the product is shown to be safe in humans. (Read more about the FDA animal rule)
BioThrax® (Anthrax Vaccine Adsorbed) is the only FDA-licensed vaccine for the prevention of anthrax disease. In 2015, we expanded the indication for BioThrax to include post-exposure prophylaxis against anthrax. This made BioThrax the first vaccine to be licensed using the FDA Animal Rule and marked the culmination of a 10-year collaborative effort between Emergent, BARDA and NIAID.
https://emergentbiosolutions.com/our-innovation