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# FDA Fast Track Status for Malaria Vaccine
- URL: https://www.fdaweb.com/fda-fast-track-status-for-malaria-vaccine/
- Published: 2016-09-22T12:00:00.000Z
- Updated: 2026-09-14T21:34:12.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136893

FDA has granted Sanaria a fast track designation for its preventative vaccine for malaria, Sanaria PfSPZ Vaccine. The vaccine is in clinical trials in subjects ranging in age from 6-months to adults in the U.S., Europe and Africa. The trials are intended to finalize an immunization regimen to be taken forward into a pivotal Phase 3 trial that should provide the necessary data for licensure, the company says.

In Phase 1 studies led by the National Institute of Allergy and Infectious Disease’s Vaccine Research Center, the vaccine protected 100% of subjects at three weeks after the last dosage and 55% at 14 months, Sanaria says. “Completed and ongoing follow-on studies at military and civilian sites in the U.S. and in Germany and Africa are designed to optimize the immunization regimen, so as to achieve high-level protection against all strains of *Plasmodium falciparum* malaria,” it says.