Smallpox vaccine adds to potential biodefense stockpile

Bavarian Nordic A/S, focusing on biodefense, has announced that it expects to file a new drug submission for Imvamune, its third-generation smallpox vaccine.

The new drug submission will be filed with Health Canada in the second half of 2010 and, if successful, would be the first marketing approval of Imvamune as soon as 2011.

Bavarian Nordic has completed Phase II development for Imvamune and met with Health Canada officials in October, which reviewed the manufacturing, clinical and animal data on Imvamune.

Health Canada has recommended that Bavarian Nordic submit an NDS application for consideration to license Imvamune as a smallpox vaccine to the general population.

To date, Imvamune has been shown to be safe and well tolerated in more than 2,700 people through 12 ongoing or completed clinical trials, including approximately 1,000 people contraindicated for licensed smallpox vaccines - specifically HIV-infected people or people diagnosed with atopic dermatitis.

The announcement of a new smallpox vaccine on the horizon comes at a time when United States officials have begun questioning both the available stockpile of vaccines in the event of a bioterrorist attack as. This new vaccine, if eventually approved for use in the United States, could potentially aid in alleviating worries that the United States' stockpile of biodefenses is currently not sufficient to fight a bioattack.