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BioThrax Gets FDA Approval on New Dosing Schedule

The only FDA-licensed vaccine for pre-exposure protection of adults against anthrax disease, BioThrax, last week received FDA approval for a newly optimized dosing schedule.

According to a press release from the drug’s maker, Emergent BioSolutions Inc., the FDA has approved its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax(R) (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. To date, Emergent has delivered over 55 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 11 million doses have been administered to more than 2.7 million military personnel.

“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. Achieving this milestone is a testament to our continued efforts to advance BioThrax,” said Daniel J. Abdun-Nabi, President and Chief Executive Officer of Emergent BioSolutions. “We are pleased that the U.S. government shares our commitment to enhance the utility of BioThrax and its attractiveness as protection for military personnel deployed in high risk areas.”

The new dosing schedule was based on a Final Study Report from a large multi-center study initiated by the CDC in 2002. This study was designed to evaluate whether as few as three doses of BioThrax administered over six months, with booster doses to follow, would confer an adequate immune response. CDC completed the study in 2009, and Emergent submitted the supplemental license application to the FDA in 2010.

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