Anthrax vaccine BioThrax gained market authorization in five countries in the European Union (EU) on Thursday after manufacturer Emergent BioSolutions successfully completed the mutual recognition procedure application process.
Emergent will market the BioThrax in Italy, the Netherlands, Poland, the United Kingdom, and France. Existing marketing authorization for BioThrax in Germany served as the foundation for the MRP application.
“Expanding licensure of BioThrax globally has been part of Emergent’s strategy and we are pleased with the completion of this process and positive outcome of our application for market authorization in these member states,” Adam Havey, the executive vice president of business operations at Emergent BioSolutions, said. “With the heightened awareness of the need to protect militaries and civilians against public health threats, we are proud to be able to support allied governments with preparedness solutions that align with their national security plans. Based on this regulatory approval, we look forward to further expanding our footprint within the EU.”
BioThrax is administered in three doses over a six-month period. The vaccine then requires boosters at three-year intervals to maintain effectiveness. It’s currently approved by the U.S. Food and Drug Administration (FDA) for treatment of pre-exposure and post-exposure to Bacillus anthracis in individuals older than 18.