FDA extends review date for the liquid-frozen formulation of the MVA-BN smallpox vaccine

Bavarian Nordic A/S announced that it has received information from the FDA that the review of the Company's Biologics License Application (BLA) for the liquid-frozen formulation of the MVA-BN smallpox vaccine will be extended by three months. The BLA was granted a priority review in December 2018, originally targeting a six months review process.

However, the FDA has assessed that due the amount of data submitted during the review phase, the agency now requires more time and has extended the target PDUFA action date to September 2019. The BLA maintains priority review status with the FDA, and thus Bavarian Nordic would still be eligible to receive a Priority Review Voucher when MVA-BN is approved. "The BLA for MVA-BN is unusual as we have already manufactured 28 million doses prior to a full regulatory approval and the development involved generating safety and immunogenicity data from 22 clinical studies. So while the review process has not raised any significant concerns to date, we understand that the MVA-BN BLA is unusually large and that the FDA requires more time to complete the review," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.