Acambis's joint project with Baxter Healthcare SA to develop a Modified Vaccinia Ankara (MVA) vaccine has been designated as a 'fast track' development programme by the US Food and Drug Administration. Acambis is co-developing its MVA vaccine candidate with Baxter under a contract with the US National Institute of Allergy and Infectious Diseases.
MVA is a weakened form of smallpox vaccine that is being developed for use in people for whom the traditional smallpox vaccine is contraindicated, such as patients with disorders of the immune system or skin conditions such as eczema.
Under the FDA Modernization Act of 1997, designation as a fast track product for a new drug or biological product means that FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. It may also evaluate for filing, and commence review of, portions of an application for approval of a fast track product, under certain conditions.
Acambis is a developer of vaccines to prevent and treat infectious diseases. Recognised internationally as the leading producer of smallpox vaccines, Acambis is developing an investigational second-generation smallpox vaccine and is manufacturing emergency-use stockpiles of this investigational vaccine for the US Government and other governments around the world.