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PEI approves Emergent to market BioThrax in Germany

The Paul-Ehrlich-Institut (PEI) has given its approval to Emergent Biosolutions' marketing authorization application for BioThrax (Anthrax Vaccine Adsorbed) in Germany.

The only vaccine licensed by the FDA to prevent anthrax disease, BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. It is also the only anthrax vaccine approved by PEI.

Indicated for the active immunization of adults who are at high risk of exposure to anthrax, BioThrax ia approved to be administered in a three-dose schedule with boosters at three-year intervals recommended thereafter.

Emergent BioSolutions biodefense division executive vice president and president Adam Havey said, "Based on this regulatory approval we look forward to further expanding international registration of BioThrax within the EU to support member states’ efforts to protect their citizens against the threat of anthrax as a biological weapon."

The vaccine is not licensed for use in a post-exposure setting.