FDA grants fast track designation for malaria vaccine

Sanaria announced today that it has received fast track designation from the FDA for its investigational malaria vaccine, the only one of its kind to receive such a designation.

The PfSPZ Vaccine is a live-attenuated Plasmodium falciparum sporozoite vaccine. The fast track designation, which is meant to speed up the development and review of drugs intended to treat serious conditions and fill unmet medical needs, will make the preventive malaria vaccine eligible for accelerated approval and priority review, potentially bringing it to market more quickly.

“The 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,” Stephen L. Hoffman, MD, CEO of Sanaria, said in a press release. “We are hopeful 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.”

Stephen L. Hoffman

Previous studies have shown that PfSPZ offered protection against malaria 3 weeks after immunization. Findings published in May suggest that four IV immunizations of PfSPZ conferred “durable protection” to malaria-naive adults up to 59 weeks after vaccination. The vaccine was well-tolerated and was not associated with any adverse events, according to the NIH.

The vaccine is being tested in adults and children aged as young as 6 months in the U.S., Europe and Africa, according to the manufacturer. The trials are intended to finalize the regimen used in phase 3 trials necessary for its approval, and to iron out logistics for delivering and administering PfSPZ to thousands of people during mass vaccination campaigns. So far, 1,165 volunteers have been vaccinated with PfSPZ.

According to Kenneth A. Bertram, MD, PhD, principal assistant for acquisition for the U.S. Army Medical Research and Materiel Command in Fort Detrick, Maryland, U.S. servicemen deployed worldwide remain at risk for malaria, underscoring the need for an FDA-approved vaccine.

“We eagerly await a vaccine against this deadly and incapacitating disease,” he said in the release. “We are excited to continue working with Sanaria, the FDA, and academic partners to develop a safe and effective malaria vaccine for U.S. service members and the world community.”

Reference:

Ishizuka AS, et al. Nat Med. 2016;doi:10.1038/nm.4110.

Disclosure: Hoffman is CEO of Sanaria.