Moderna Inc. said the U.S. Food and Drug Administration granted a fast-track designation to the company's experimental Zika virus vaccine.
The U.S. regulator grants fast-track designations to expedite the review of drugs that treat serious conditions and fill unmet medical needs. Incentives include frequent meetings and communications with the FDA and the potential for accelerated approval, priority review or rolling review.
Moderna's stock price was up 7.39% to $14.39 in after-hours trading Aug. 19.
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The Cambridge, Mass.-based developer of messenger RNA therapies is developing mRNA-1893 as a vaccine for Zika virus and is conducting a phase 1 trial to compare the vaccine with placebo in healthy adults for safety and tolerability.
The vaccine candidate causes cells to secrete virus-like particles that mimic the response of the cell after natural infection. There is currently no approved vaccine for Zika.
The Zika virus is spread mainly by the bite of an infected Aedes species mosquito but can also be transmitted sexually.
Children born to mothers infected with Zika can develop microcephaly, a condition characterized by a small head and the potential for severe disabilities. In adults, outbreaks in Latin American and Caribbean countries have been associated with Guillain-Barre syndrome, a rare but serious autoimmune disorder in which the immune system attacks part of the nervous system.
The Department of Health and Human Services, the Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority are funding the development of mRNA-1893.

