Low-Cost Meningitis Vaccine for Sub-Saharan Africa

This 2014 Deals of Distinction™ Award from the LES Industry-University-Government Interface Sector (IUGI) went to the U.S. Food and Drug Administration (FDA), along with the National Institutes of Health (NIH), PATH, and the Serum Institute of India (SII) for MenAfriVac, a low-cost meningitis vaccine designed for use in sub-Saharan Africa. The pioneering vaccine, and the first one for developing countries that does not require constant refrigeration, is based upon a patent license from the NIH and FDA to PATH, and was subsequently sublicensed by PATH to SII under the Meningitis Vaccine Project, a partnership of PATH and the World Health Organization. 

Meningococcal meningitis, a deadly bacterial infection of the brain, can be prevented with vaccination, but the technology is complex and generally beyond the capacity of infrastructures in most developing countries. This patent license agreement involving scientists and and technology transfer officers of FDA and NIH has made a critical contribution to developing and transferring the technology needed to manufacture a vaccine against the disease, and at an affordable cost for 26 African countries where group A meningitis is most common. 

Under a novel partnership mechanism organized by PATH, NIH licensed a conjugate vaccine technology developed by Dr. Che-Hung Robert Lee and Dr. Carl Frasch of FDA’s Center for Biologics Evaluation and Research to PATH. PATH worked with the Serum Institute of India, which agreed to scale up the technology and produce the vaccine at a cost that Africian countries could afford in exchange for technical know-how. The collaboration has been described in SciDev.Net as an “intriguing model” of vaccine development for 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.

This license agreement includes financial incentives to the licensee for achievement of certain distribution milestones. The true “return on investment” goal for the NIH and FDA is not financial, but rather maximuming the public health impact of the license agreement. Introduced at large scale in the Burkina Faso in December 2010, the vaccine has now reached more than 150 million people in 12 African countries, with no case of group A meningitis reported so far in vaccinated populations. 

“This deal stood out because it shows the true collaboration and teamwork of all parties involved,” said IUGI Deals of Distinction Chair Thierry Musy-Verdel. “It also demonstrates that it is possible for research organizations such as federal laboratories and universities to license their technologies to organizations other than traditional pharmaceutical and biotech companies and to successfully achieve product commercialization and thus public utilization of their research.”