Moderna’s Investigational Zika Vaccine Is Granted FDA Fast Track Designation

From Moderna 

From the press release we learned that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Moderna’s (MRNA) investigational Zika vaccine (mRNA-1893) currently being evaluated in a Phase 1 study for the prevention of Zika virus infection in healthy adults.

This is good news for Moderna as the Fast Track designation will facilitate the development of mRNA-1893 for Zika and expedite the review of therapies and vaccines for serious conditions filling unmet medical needs.

Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. 

mRNA-1893 contains an mRNA sequence encoding for the structural proteins of Zika virus and is designed to cause cells to secrete virus-like particles, mimicking the response of the cell after natural infection.

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