Denmark’s Bavarian Nordic has completed a placebo-controlled Phase II trial in 745 healthy subjects who received one or two doses of Imvamune, a third-generation smallpox vaccine.
The study, together with other Phase II studies of the drug in immune-compromised people, will help the company obtain an emergency use authorization (EUA).
The company said it expects to receive approval of the EUA in the second half of 2008.