Sanaria has received fast-track designation from the US Food and Drug Administration (FDA) for candidate malaria vaccine PfSPZ.

PfSPZ is currently in clinical trials that are intended to finalise an immunisation regimen to be taken forward into pivotal Phase III clinical trials.

If successful, the clinical trials provide the necessary data for licensing the vaccine, according to the company.

The fast track designation programme has been designed to speed up the development and review of new therapies to treat serious conditions.

Sanaria CEO Stephen Hoffman said: "US FDA Fast Track designation for our malaria vaccine is a strong indicator that we've gotten beyond the proof of science and are moving toward licensure.

"US FDA Fast Track designation for our malaria vaccine is a strong indicator that we've gotten beyond the proof of science and are moving toward licensure."

“We expect the PfSPZ vaccine will be the world's first FDA licensed malaria vaccine, and we will be able to use it to halt transmission and eliminate Plasmodium falciparum malaria from geographically defined regions, as well as provide protection against malaria to travellers and military personnel visiting malaria endemic regions."

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So far, Sanaria's PfSPZ-based products were administered to 1,165 volunteers in more than two dozen clinical trials in the US, Europe and Africa.

Clinical trials are currently underway in Tanzania, Kenya, Mali, Burkina Faso, Germany and two sites within the US, with plans to begin in Equatorial Guinea.

The malaria vaccine is made using non-replicating, irradiated whole sporozoites.


Image: A Plasmodium from the saliva of a female mosquito moving across a mosquito cell. Photo: courtesy of Ute Frevert.