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NIH and FDA Win Top National Award

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The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal, for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa.

The 2014 Deals of Distinction Award will be presented to the two federal agencies and their collaborators by the Licensing Executives Society External Web Site Policy at the society’s 50th annual meeting, Oct. 5-8 in San Francisco.

NIH and the FDA teamed with PATH External Web Site Policy, a Seattle-based non-profit leader in global health innovation, and the Serum Institute of India (SII) to develop MenAfriVac. The vaccine has a low production cost and does not require constant refrigeration, making it ideal for use in remote locations. A critical part of the manufacturing process for the vaccine is based upon a patent license granted from the NIH Office of Technology Transfer (NIH OTT) to PATH.

The technology was invented by FDA scientists and subsequently sublicensed by PATH to SII under the Meningitis Vaccine Project, a partnership of PATH and the World Health Organization (WHO). The vaccine targets the most common form of bacterial meningitis, known as serogroup A, found in sub-Saharan Africa. According to WHO, 80 to 85 percent of all meningitis infections in the region are from group A.

Meningococcal meningitis, a deadly bacterial infection of the brain, can be prevented with vaccination, but the production technology is complex and generally beyond the capacity of infrastructures in most developing countries. The patent license agreement involving the FDA-developed technology and the expertise of the NIH technology transfer officers was critical to developing and transferring the technology needed to manufacture MenAfriVac at an affordable cost for the 26 African countries where serogroup A meningitis is most common.

“We are quite pleased about this inspired work in vaccine research as well as being able to transfer the intellectual property in a way to have such a spectacular impact on public health in this region of Africa,” said NIH Director Francis S. Collins, M.D., Ph.D.

Through a partnership organized by PATH, NIH OTT licensed the technology needed to make the new vaccine, which was developed by Dr. Che-Hung Robert Lee and Dr. Carl Frasch of the FDA’s Center for Biologics Evaluation and Research. PATH worked with SII, which agreed to scale up the technology in exchange for technical know-how and produce the vaccine at a cost that African countries could afford, thus providing stable and sustainable access to MenAfriVac.

“This is a compelling example of how the FDA’s unique role in regulatory science makes critical and wide-ranging contributions to public health,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research. “The impact of this truly global partnership has been tremendous.”

MenAfriVac was launched in a vaccination campaign in Burkina Faso in December 2010. To date, more than 150 million people in 12 African countries have been vaccinated with no reported cases of serogroup A meningitis in vaccinated populations.

“The license and collaboration have turned out to be an interesting model for vaccine development to address public health needs in developing countries. The vaccine was tailored to a particular population, developed at a modest cost, and structured from the start with provisions to ensure sustainable access,” said NIH OTT Director, Mark L. Rohrbaugh, Ph.D., J.D.

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

The FDA External Web Site Policy, an agency within the U.S. Department of Health and Human Services (DHHS), protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.