The purpose of the Production and Testing of a Modified Vaccinia Ankara (MVA) Vaccine contract is to support the advanced development and manufacture of a Modified Vaccinia Ankara (MVA) vaccine for smallpox. The Scope of Work includes milestones for the development and validation of a large-scale manufacturing process, the demonstration of safety and immunogenicity in extensive preclinical studies, and the demonstration of the safety and immunogenicity of MVA in a variety of different human populations (normal healthy individuals, as well as those with atopic dermatitis and HIV). The contract also provides for the maintenance and storage of the vaccine inventory, as well as stability testing. Although licensure of an MVA vaccine is not planned within the timeframe of this contract, all activities and studies conducted in this contract shall be those required for a licensure path.
