Drug news
CHMP recommends approval of Imvanex (Bavarian Nordic) for Smallpox
The EU's CHMP has adopted a positive opinion recommending the granting of a marketing authorization for Imvanex vaccine, from Bavarian Nordic, for active immunization against Smallpox for the general adult population, including people with immunodeficiencies (people diagnosed with HIV or atopic dermatitis). The application was supported by clinical data in more than 3,400 people. The European Commission generally delivers its final decision within three months.
It is the first new vaccine developed under the US government's "Project BioShield" program to protect at risk populations from bioterrorism. Bavarian Nordic has manufactured and supplied 16 million doses of the vaccine for emergency use in the US.