Emergent BioSolutions has received FDA approval for its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax to a three-dose primary series of intramuscular injections at zero, one, and six months.
BioThrax (Anthrax Vaccine Adsorbed) is the vaccine for pre-exposure protection of adults against anthrax disease.
The booster series consists of intramuscular injections at 12 and 18 months after initiation of the primary series, and at one-year intervals thereafter for those who remain at risk.
Until the individuals have completed the three-dose primary immunization series, they are not considered protected.
Emergent president and chief executive officer Daniel Abdun-Nabi said, "Emergent applauds the Centers for Disease Control and Prevention (CDC) for their dedicated research to optimize the dosing schedule of BioThrax and the FDA for a timely review and approval process."
