The US Food and Drug Administration (FDA) is designating Sansaria PfSPZ, a malaria vaccine, to the “fast track” a move that will expedite the process for the drug, now in review.
The US Food and Drug Administration (FDA) is designating a malaria vaccine to the “fast track”—a move to expedite the process for drugs in review if they treat serious conditions or fill an unmet need.
Sanaria PfSPZ is the only malaria vaccine, according to the company, to have ever received this distinction. By putting the vaccine on the “fast track,” it now becomes eligible for Accelerated Approval and Priority Review which gets the drug to market more quickly.
Research has shown that the vaccine, “protected 100% of subjects at 3 weeks after the last dose of vaccine and 55% at 14 months. Completed and ongoing follow-on studies at military and civilian sites in the United States 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.”
In a press release, Sanaria Inc. 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. We expect [that 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 and provide protection against malaria to travelers and military personnel visiting malaria endemic regions."
In the United States, where there are 1,500 cases of malaria diagnosed annually, health providers should always obtain travel history from their patients if malaria is suspected. Rapid diagnosis and treatment is critical in preventing the transmission to others. Left untreated, malaria could be fatal. According to the Centers for Disease Control and Prevention, 214 million cases of malaria were estimated in 2015 worldwide and approximately 438,000 people died in the same year, most of them children from the African Region.
The vaccine is currently in phase 3 clinical trials in the United States, Europe, and Africa. The subjects range from 6 month old infants to adults, and the trials will finalize the regimen for immunization.
Phase 3 trials will begin to establish how to safely administer vaccinations to hundreds of thousands of people. In the company’s press release, Dr. Kenneth A. Bertram, MD, PhD, FACP, principal assistant for acquisition for the US Army Medical Research and Materiel Command (USAMRMC) at Ft. Detrick, Maryland said, “We are excited to continue working with Sanaria, the FDA, and academic partners to develop a safe and effective malaria vaccine for United States service members and the world community."
Feature Picture Source: Global Panorama / flickr / Creative Commons.