Barvarian Nordic's smallpox vaccine meets in Phase III
Bavarian Nordic A/S (CSE:BAVA) reported data from an open-label Phase III trial showing that its Imvamune smallpox vaccine met the co-primary endpoints of non-inferiority to ACAM2000, an FDA-approved, second-generation smallpox vaccine from Emergent BioSolutions Inc. (NYSE:EBS). Bavarian Nordic plans to submit a BLA to FDA next half for the vaccine. If approved, the company said it would also be eligible to receive a Priority Review voucher.
The trial enrolled 440 vaccinia-naïve healthy volunteers at a U.S. military garrison in South Korea to receive a single vaccination of ACAM2000 or two doses of Imvamune given four weeks apart followed four weeks later by a single vaccination of ACAM2000. The trial was conducted in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)...
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