Bavarian Nordic receives authorization for smallpox vaccine

Bavarian Nordic announced on Wednesday that it was granted marketing authorization for its IMVANEX smallpox vaccine by the European Commission.

The authorization applies to all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. In accordance with the official national recommendations of the members countries included in the authorization, IMVANEX will be available for governments to purchase and use.

"The marketing authorization of IMVANEX marks a significant milestone for our company and our MVA-BN vaccine technology platform, which we have taken from early research through regulatory approval and now serves as the foundation for multiple candidates in our development pipeline," Anders Hedegaard, president and CEO of Bavarian Nordic, said. "We are delighted to receive our first regulatory product approval, and we look forward to working with the European governments to address the requirements for their national preparedness plans, focusing on the advantages that IMVANEX brings in terms of safety and administration for people at risk."

IMVANEX is used for active immunization against smallpox in the general population, including adults with weakened immune systems. The vaccine is capable of addressing biological threats and has been implemented in the U.S. Strategic National Stockpile for emergency use. IMVANEX is the only smallpox vaccine approved for marketing by the European Commission.