FDA Fast Track Status for Malaria Vaccine

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.