Posted by Michael Wonder on 23 Dec 2018
Bavarian Nordic announces FDA acceptance and priority review of biologics license application for MVA-BN smallpox vaccine
21 December 2018 - Bavarian Nordic today announced that the U.S. FDA has accepted its Biologics License Application (BLA) for the liquid-frozen version of the MVA-BN for active immunisation against smallpox in adults age 18 years and older.
The FDA has granted priority review to the BLA, which means that the agency is targeting completion of the review in six months rather than the standard time of ten months. Priority review is granted by the FDA to applications for medicines that, if approved, would offer a significant improvement in the safety or effectiveness of 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 regulatory submission for the MVA-BN smallpox vaccine is based on a comprehensive development program, comprising 22 clinical studies, including two Phase 3 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, and the frequency of Grade 3 or higher related adverse events was less in MVA-BN (1.2%) in comparison to the replicating smallpox vaccine (10.3%).
