Emergent BioSolutions receives approval to market anthrax vaccine in Germany

Emergent BioSolutions, Inc., a Rockville, Maryland-based specialty pharmaceutical company, announced on Monday that it received approval to market BioThrax, the company's anthrax vaccine, in Germany.

Emergent's marketing authorization application was approved by the Paul-Ehrlich-Institut. BioThrax is now the only anthrax vaccine approved by PEI for the prevention of anthrax vaccine. The vaccine is already the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax disease.

"Emergent is pleased with this first marketing authorization of BioThrax within the European Union," Adam Havey, the executive vice president and president of the biodefense division of Emergent BioSolutions. "Based on this regulatory approval we look forward to further expanding international registration of BioThrax within the (European Union) to support member states' efforts to protect their citizens against the threat of anthrax as a biological weapon."

PEI's marketing authorization allows for the administration of BioThrax in a three-dose schedule with boosters at three-year intervals recommended after all three doses are completed.

BioThrax is indicated for actively immunizing adults at high risk of exposure to anthrax and is not licensed for use in a post-exposure setting. Individuals are not considered protected unless they have finished the three-dose primary immunization series.

To date, Emergent distributed more than 66 million doses of BioThrax to the U.S. government and continues to deliver doses through active procurement contracts.