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Weakened Form of Smallpox Vaccine Undergoing Fast Track Review
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 co-developing its MVA vaccine candidate with Baxter under a contract with the US National Institute of Allergy and Infectious Diseases.