Success Story

New Low-Cost Meningitis Vaccine for Sub-Saharan Africa

Meningococcal meningitis, a bacterial infection of the brain that sweeps across sub-Saharan Africa in an area called the “meningitis belt,” is now losing its power to inflict illness and death. Scientists and technology transfer officers from the Food and Drug Administration (FDA), along with technology transfer officers from the National Institutes of Health (NIH), made a critical contribution by developing and transferring the technology needed to manufacture a vaccine against this terrible disease and at an affordable cost for African nations like Burkina Faso, Chad, Ethiopia, and Niger. Meningitis can be prevented with vaccination, but the technology is complex and generally beyond the capacity of scientists in most developing countries.

Under a novel partnership mechanism organized by the international nonprofit PATH (Program for Appropriate Technology in Health), NIH licensed a conjugate vaccine technology developed by FDA Drs. Che-Hung Robert Lee and Carl Frasch to PATH, which worked with the Serum Institute of India, which agreed to produce the vaccine cheaply in exchange for technical know-how. The collaboration agreement was described in SciDev.net as an "intriguing model" of vaccine development in developing countries, in which a vaccine with specific characteristics tailored to a particular population is developed at a modest cost and provisions to ensure sustainable access are built in from the start.

The new vaccine, MenAfriVac, was approved by India in December 2009 for export to Africa. In June 2010, the World Health Organization had prequalified the vaccine for use in global immunization programs. By the end of 2011, an estimated 55 million people had been vaccinated with MenAfriVac at a cost of only 40 cents per dose. In 2012, a low-cost meningitis vaccine designed for use in sub-Saharan Africa without refrigeration or cold-chain custody was launched, with sales of 100 million doses.

The contribution of both the FDA and the NIH to a major health care project in Africa also underscores the recognition by both agencies that infectious diseases know no borders. Protecting human health globally is linked to the FDA’s and NIH’s core mission of protecting human health in the United States.