Bavarian Nordic’s BLA for the liquid-frozen version of the MVA-BN for active immunization against smallpox has been accepted by the FDA and granted priority review. The agency is targeting completion of the review in six months rather than the standard 10 months. Priority review is granted to applications for medicines that would offer a significant improvement in the treatment, diagnosis, or prevention of serious conditions. If approved, MVA-BN would be the first and only approved non-replicating smallpox vaccine in the U.S. 

“The acceptance of our BLA is a significant milestone for Bavarian Nordic, and for our long-standing collaboration with the U.S. Government on the development of MVA-BN to address public health threats, such as smallpox,” said Paul Chaplin, president and chief executive officer of Bavarian Nordic. “While MVA-BN has already been approved in the EU and in Canada, an FDA approval would represent an important acknowledgment of our core platform technology, which we are actively investigating across multiple infectious disease and cancer indications.” 

The regulatory submission is based on a development program comprising 22 clinical studies, including two Phase III studies, the latter of which showed non-inferiority of MVA-BN compared to ACAM2000, the current U.S. licensed, replicating smallpox vaccine. In addition, no serious adverse events related to MVA-BN were reported. 

If approved, Bavarian Nordic would also be eligible to receive a Priority Review Voucher, which provides incentives to developers of medical countermeasures among others. The voucher can be used to accelerate the review of a future BLA and is also transferrable. The Company intends to sell the voucher to a third party.