Malaria Vaccine Receives Fast Track Status from FDA
The Food and Drug Administration (FDA) has granted Fast Track designation to Sanaria PfSPZ Vaccine, a preventative vaccine for malaria.
Sanaria PfSPZ Vaccine is currently under investigation in clinical trials in the U.S., Europe and Africa for patients as young as 6 months old to adults. These trials are intended to establish and optimize an immunization regimen against all strains of Plasmodium falciparum malaria, which will be used for the vaccine's upcoming Phase 3 trials.
Phase 1 studies, led by the Vaccine Research Center, National Institute of Allergy and Infectious Disease – NIH, demonstrated that the Sanaria PfSPZ Vaccine protected 100% of subjects at 3 weeks after the last dose and 55% at 14 months.
A Phase 3 trial in Equatorial Guinea is currently underway.
For more information visit Sanaria.com.