Emergent BioSolutions Inc. (EBS) announced that the U.S. Food and Drug Administration or FDA has approved its supplemental Biologics License Application or sBLA to change the administration schedule of BioThrax (Anthrax Vaccine Adsorbed) to a three-dose primary series of intramuscular injections at 0, 1, and 6 months.
The booster series consists of intramuscular injections at 12 and 18 months after initiation of the primary series, and at 1-year intervals thereafter for those who remain at risk. Individuals are not considered protected until they have completed the three-dose primary immunization series. BioThrax is the only FDA-licensed vaccine for pre-exposure protection of adults against anthrax disease.
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