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 U.S. Food and Drug Administration (FDA), along with technology transfer officers from the National Institutes of Health (NIH) Office of Technology Transfer (OTT), made a critical contribution in 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. This new vaccine, designed specifically for the serotype that affects Africa, is based on a conjugate structure formed by a chain of sugars connected to a protein that the immune system responds to very well. 

Under a novel partnership mechanism organized by the Program for Appropriate Technology in Health (PATH), NIH OTT licensed to PATH a conjugate vaccine technology developed by Dr. Che-Hung Robert Lee and Dr. Carl Frasch of the FDA. The Serum Institute of India, which worked with PATH, agreed to produce the vaccine cheaply in exchange for technical know-how. The collaboration agreement has been described by 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 that sustainable access is built in from the start. 

After preclinical animal studies and a series of clinical trials in people in India and Africa’s meningitis belt to assess its safety and effectiveness, the new vaccine, MenAfriVac, was approved by India in December 2009 for export to Africa. In June 2010, the World Health Organization (WHO) 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-Sahara Africa without refrigeration or cold-chain custody was launched, with sales of 100 million doses. 

Awardees

FDA - Food and Drug Administration

• Dr. Carl Frasch
• Dr. Che-Hung Robert Lee
• Beatrice Droke
• Dano Murphy
• Dr. Willie Vann

NIH - Office of Technology Transfer

• Steven Ferguson
• Dr. Uri Reichman
• Peter Soukas