Bavarian Nordic smallpox vaccine meets in two trials

Bavarian Nordic A/S (CSE:BAVA) gained DKK13.50 to DKK327 on Wednesday after two formulations of its Imvamune smallpox vaccine met the primary endpoints in clinical trials. In a Phase III study, three separate lots of a liquid-frozen formulation of Imvamune produced equivalent antibody responses in 3,000 vaccine-naive patients. In Phase II study, a freeze-dried formulation of the third-generation modified vaccinia Ankara (MVA) virus vaccine produced the same antibody response as the liquid-frozen version.

Bavarian Nordic plans to submit a BLA to FDA for the liquid-frozen form of the vaccine after a second Phase III study is completed. Spokesperson Seth Lewis would not give a timeline for BLA submission; the vaccine is already approved in Europe and Canada. Lewis added that the U.S. Strategic National Stockpile has stored 28 million doses of the liquid-frozen formulation. ...