A pivotal phase 3 trial of the freeze-dried formulation of MVA-BN® smallpox vaccine is underway among 1,110 healthy, vaccine-naïve subjects.
The randomized, double-blind, multicenter trial will evaluate the immunogenicity and safety of three consecutive vaccine lots of the freeze-dried formulation of MVA-BN smallpox vaccine, similar to the prior completed phase 3 study for the liquid-frozen MVA-BN formulation.
The biologics license application (BLA) for the liquid-frozen formulation is currently being reviewed by the FDA, with anticipated completion and licensure during the second half of 2019. On completion of the current study, expected to take place in 2021, Bavarian Nordic plans to submit a BLA supplement to extend the approval for both vaccine formulations. A prior phase 2 study has confirmed bioequivalence between the freeze-dried and liquid-frozen formulations of MVA-BN.
Based on the successful completion of the study and subsequent regulatory process, approval of the freeze-dried vaccine is expected in 2022.
The phase 3 study and regulatory activities toward licensure is part of an ongoing contract with the Biomedical Advanced Research and Development Authority (BARDA) to develop and supply freeze-dried MVA-BN to the U.S. Strategic National Stockpile.
Since 2003, Bavarian Nordic has worked with the U.S. government on the development and production of MVA-BN smallpox vaccine and has supplied 28 million doses of the liquid-frozen version to the U.S. Strategic National Stockpile (SNS) for emergency use. At the same time, BARDA has supported the development of the freeze-dried version, which has a longer shelf life, to replace the current stockpile that has expired.
Source: BioSpace, June 19, 2019