The Food and Drug Administration fast tracked Rockville, Md.-based Sanaria's investigational malaria vaccine.
The agency's Fast Track program is intended to expedite the development and review of new drugs that can treat serious or life-threatening illness and address unmet medical needs, according to the FDA's website.
In recent phase 1 clinical trials, the PfSPZ vaccine protected 100 percent of participants three weeks after the last vaccine dose and 55 percent after 14 months.
"We expect PfSPZ Vaccine will be the world's first FDA licensed malaria vaccine," said Stephen Hoffman, MD, CEO of Sanaria. "[W]e will be able to use it to halt transmission and eliminate Plasmodium falciparum malaria from geographically defined regions and provide protection against malaria to travelers and military personnel visiting malaria-endemic regions."
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