Globally, more than 300 million cases of malaria occur annually and one million people, mostly children, die of the disease. Resistance to existing drugs and lack of both affordable and adequate treatments continue to make 40 percent of the world's population susceptible to malaria, especially in Africa, where a child dies every 30 seconds from the disease.
OneWorld Health has chosen to use part of its Gates Foundation grant to enter into a funded research arrangement with Sanaria Inc., a company that is developing a novel malaria vaccine. In addition to funding research and development activities, over the next 12 months, OneWorld Health will provide to Sanaria regulatory consulting and expertise on the project. This may include guidance in developing the quality assurance and quality control program for monitoring the manufacturing process, as well as planning for an Investigational New Drug (IND) application. Sanaria, based in Rockville, Md., will conduct various studies to confirm that key vaccine components can be produced with the ultimate goal of meeting U.S. Food and Drug Administration requirements.
Various independent studies conducted from the early 1970s through the late 1990s showed that exposure of human volunteers to the bites of mosquitoes infected with weakened (attenuated) malaria parasites, called sporozoites, protected more than 90 percent of those volunteers against developing malaria for at least 10 months. However, until Sanaria was launched, little effort was made to develop a malaria vaccine based on this approach. Sanaria is applying its unique manuf
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Contact: Joanne Hasegawa
jhasegawa@oneworldhealth.org
415-421-4700
Institute for OneWorld Health
13-Jul-2004