Center for Global Health R&D Policy Assessment

Last month, we reported on our attendance at the Bill & Melinda Gates Foundation Product-Development Partnership (PDP) Forum “Partnering for Impact.” We discussed the role that our Center plays in this larger picture of neglected disease and global health research and development (R&D) field as well as reflected on the journey PDPs have taken and what might lie ahead for them. In the following PDP blog mini-series, we dig a little deeper and highlight the stories of three PDPs: PATH Meningitis Vaccine Project (MVP), Aeras, and DNDi.

Technically, PDPs are a class of private-public partnerships with mandates to research, develop, and support accessibility of new health technologies (namely vaccines, diagnostics, and treatments, but may include other technologies such as vector control) targeting the diseases of the poor. But what do these partnerships involve, and where have they gone since their inception in the 1990s? What have they accomplished and what lessons have they learned so far? How do their models differ and can they be replicated for other health technologies?

If you have any questions or would like to connect about this PDP mini-series, please contact Edith Han.

As the first in the series, Marc LaForce from PATH MVP discusses the lessons learned and the success of the MVP project:

The meningitis wards in three West African countries were empty this year. This victory came after decades of annual epidemics of group A meningococcal meningitis, and it demonstrates that it is indeed possible to spur research and development to address “diseases of the poor” at the scale necessary and at a sustainable cost. Meningitis A is one of Africa’s most dreaded infectious diseases and is particularly devastating to children and young adults. Even with rapid antibiotic treatment, at least 10 percent of patients die. As many as a quarter of survivors are left with brain damage, deafness, epilepsy, or necrosis leading to limb amputation.

In 2001, the Bill & Melinda Gates Foundation provided a ten-year grant to establish the Meningitis Vaccine Project (MVP)—a partnership between PATH and the World Health Organization (WHO)—to lead the development, testing, licensure, and widespread introduction of a conjugate vaccine against meningitis A. But there were two big questions: How would a partnership between two public health organizations gain access to and license a conjugate vaccine technology? And how would it be able to develop a vaccine that the 25 countries of the African “meningitis belt” could afford? No one in the developed world could produce the vaccine at the desired cost—less than US$0.50 per dose. A new model of vaccine development was needed, so MVP decided to become a virtual vaccine company. We didn’t have a plant, intellectual property, or even the base materials needed for vaccine manufacturing. The challenge was to translate that “nothingness” into a product and prove that it met all international standards. Many people said it couldn’t happen—yet it did. The key to the project’s success was a powerful partnership of public organizations and private companies all committed to the same goal—improving public health. A developing-country vaccine manufacturer, the Serum Institute of India Ltd., agreed to make the vaccine for US$0.40 per dose. We then put together an innovative product development plan where the raw materials came from one source, the technology from another, and the manufacturing capability from a third.

The Serum Institute and SynCo Bio Partners in Amsterdam supplied the raw materials (the tetanus toxoid protein and the group A polysaccharide antigen) to create a conjugate vaccine. However, conjugation technology is highly protected intellectual property. Through a partnership with the Center for Biologics Evaluation and Research at the US Food and Drug Administration, the project team identified a new method for making conjugate vaccine. With help from the National Institutes of Health, the technology was transferred to the Serum Institute at almost no cost.

MVP engaged more partners—from African ministries of health to clinical trial experts—to meet the challenges of simultaneously developing the vaccine, satisfying regulatory and technical rules, setting up clinical trials, and strengthening countries’ ability to host the trials and ultimately administer the vaccine. Because each of the partners believed so deeply in the importance of this effort, it was fast-tracked at many stages along the way.

In less than ten years and at less than one-tenth the cost of the US$500 million typically needed to bring a new vaccine to market, MenAfriVac™ was ready to roll. In December 2010, Burkina Faso, Mali, and Niger became the first African countries to introduce MenAfriVac™, vaccinating nearly 20 million people in a massive immunization campaign. As the meningitis season came to an end in June 2011, only one case of meningitis A had been confirmed in Burkina Faso, the only country to have introduced MenAfriVac™ nationwide, and the individual who developed the disease had not received the vaccine. Mali and Niger reported similar results—an unprecedented drop in the number of meningitis A cases in the districts where the vaccine was introduced.

MenAfriVac™ represents numerous milestones for the region: The first time in history that a vaccine has been specifically designed for Africa. The first vaccine ever introduced in Africa before reaching any other continents. And the first time African health authorities have an affordable, long-term solution that protects even young children against meningitis A.

In the next few years, PATH and WHO plan to bring the vaccine to more than 300 million people in the meningitis belt. This could prevent more than 1 million cases over the next decade and free up as much as US$300 million from national budgets—money that could be used for other health needs. MenAfriVac™ may well serve as a model for developing vaccines in the future to combat other diseases in low-resource settings. PATH plans to build on the accomplishments of MVP with a new vaccine that will cover five meningitis serotype groups—A, C, W, X, and Y.

Dr. Margaret Chan, Director-General of WHO, spoke of the value of MVP’s collaborative effort at the recent World Health Assembly. “This offers evidence of a welcome new trend,” she said. “Africa is the first to receive the best technology that the world, working together, can offer.”