Bavarian Nordic A/S – Manufactures and releases MVA-BN doses two months ahead of schedule to US government
Two-months ahead of schedule, Bavarian Nordic A/S has manufactured and released 5000 doses of MVA-BN to the National Institute of Allergy and Infectious Diseases (NIAID) as a part of the US government’s program to develop a safe smallpox vaccine. The vaccine will be used for clinical studies in the USA.
By delivering two months ahead of schedule, Bavarian Nordic has demonstrated its expertise in manufacturing MVA-BN as well as confirmed the advanced stage of its smallpox vaccine development program. Peter Wulff, President and CEO of Bavarian Nordic commented, “We are pleased to have reached this key milestone two months ahead of schedule. Reaching a milestone before requested, and doing so in such a competitive development program further enhances our reputation as the leading company developing a safe smallpox vaccine.”
The contract to develop a safer smallpox vaccine was announced by Department of Health and Human Services Secretary Tommy G. Thompson in February of this year. Current smallpox vaccines cannot be given to individuals with weakened immune systems, children and pregnant women. The accelerated milestone-based contract administered by NIAID, (a component within the National Institutes of Health) puts emphasis on the timely completion of pre-determined objectives. The first two milestones dealt with the manufacture of 5000 doses of the test vaccine and had to be completed in August.
This achievement is the latest in Bavarian Nordic’s ongoing worldwide program to develop MVA-BN as the safe smallpox vaccine. Bavarian Nordic continues to be the only company that has completed small animal studies, a clinical Phase I trial, and initiated a Phase II clinical study investigating safety and immunogenicity of MVA-BN in healthy volunteers. Furthermore, Bavarian Nordic is the only company to have produced and supplied commercial quantities of MVA.
