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Novavax gets FDA fast track designation for flu vaccine

A Gaithersburg biotechnology company has received a designation from the Food and Drug Administration aimed at quickening the development of one of its drugs.

Novavax Inc. received fast track designation for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate.

Stanley C. Erck, President and Chief Executive Officer of Novavax, said in a news release that the designation reflects the urgent unmet medical need for a more effective vaccine against influenza, particularly for older adults.

The company is researching the immunogenicity and safety of NanoFlu. Data from the research is expected by the end of the first quarter of 2020 and could support a biologics license application and licensure for NanoFlu.

 


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