A New Model for Vaccine Development
Epidemics of meningococcal A meningitis regularly sweep across 25 countries in sub-Saharan Africa, killing infants and young people within hours and leaving others with permanent disabilities. All the ingredients for a potent, long-lasting vaccine existed, but no manufacturer was willing to make one at a price affordable to African countries. A new model of vaccine development based on public-private partnership led to the creation of MenAfriVac™. The new vaccine could prevent a million cases of the disease over the next decade.
For more than a century, meningococcal A meningitis has swept across sub-Saharan Africa, killing thousands of children and young adults and disabling many more in each epidemic wave. Victims typically die within 48 hours, while up to a quarter of survivors are left with brain damage, hearing loss, or other permanent disabilities. Some 450 million people across 25 countries are at risk. The need for a potent and long-lasting meningitis vaccine that protects infants and children is great.
While advances in biotechnology make it possible to solve many health care problems in the developing world, private industries are often reluctant to invest in products for countries that offer low return and high risk. In the case of epidemic meningitis, African public health officials made it clear that the vaccine needed to cost less than US$0.50 per dose to be sustainable. However, no developed-country firm could produce the vaccine at this price.
In 2001, the Bill & Melinda Gates Foundation provided a grant to establish the Meningitis Vaccine Project, a partnership between PATH and the World Health Organization, to develop, test, license, and introduce a new vaccine. The partnership created a new model of vaccine development by bringing together public and private entities with expertise in pharmaceutical development, vaccine manufacturing, clinical and laboratory work, and other areas.
In December 2010, nearly 20 million children and young adults in Burkina Faso, Mali, and Niger were the first to receive this new vaccine, called MenAfriVac™, in a massive immunization campaign. The safe, affordable, and long-lasting vaccine is currently being rolled out in other countries with 54.5 million people immunized to date. The Meningitis Vaccine Project is an example of how public-private partnerships can stimulate research for neglected diseases. Effectively managing intellectual property (IP) is a fundamental part of this process.
The various components for a group A meningococcal conjugate vaccine already existed. What was needed was a facilitator who could bring the components together in an affordable manner to produce a vaccine. Instead of relying on one manufacturer, the Meningitis Vaccine Project recruited three partners with the necessary skills and knowledge: the raw material came from one source, the technology from another, and the final scale-up for production from another.
SynCo Bio Partners B.V. supplied the critical meningococcal polysaccharide A cell banks. The Serum Institute of India Limited had the second necessary ingredient, the tetanus toxoid, which is used to help boost the immune response to bacteria. Serum Institute was also willing to manufacture the vaccine at the required price point, but it needed affordable conjugation technology to do so.
Conjugation is a key step in the production of the vaccine, chemically linking meningococcal polysaccharide A with the tetanus toxoid. This makes the vaccine highly immunogenic and effective in young children, provides long-lasting protection, and decreases carriage and transmission rates. After an extensive search, the team discovered that the Center for Biologics Evaluation and Research at the US Food and Drug Administration (FDA) had developed a novel conjugation technology that was patent protected.
- World Health Organization
- Center for Biologics Evaluation and Research at the US FDA
- Serum Institute of India Limited
- SynCo Bio Partners B.V.
The IP Strategy
PATH negotiated a nonexclusive license for the FDA conjugation technology from the US National Institutes of Health Office of Technology Transfer. The office granted the license for a fraction of what it would have typically cost. PATH then sublicensed the technology to the Serum Institute at no additional cost. PATH also formed a technical team composed of FDA inventors and other industry and government experts, who helped the project with technology scale-up and standardization.
To protect the project’s mission, the Serum Institute agreed that if it ever stopped developing or producing the vaccine, it would transfer the technology and knowledge gained back to PATH so another manufacturer could produce the vaccine. The Serum Institute had a number of incentives to accept this nonexclusive sublicense for what is a key production process. By combining the lower-cost terms of the sublicense with technology transfer support, pharmaceutical development, and clinical trials funding, PATH enabled the Serum Institute to keep the initial vaccine price at less than US$0.50 per dose.
In the end, the development of the MenAfriVac™ vaccine cost only a fraction of the US$500 million usually required to manufacture and bring a new vaccine to market. It was also the first vaccine designed specifically for Africa and the first introduced in Africa before any other continent. It’s estimated that its use could save as much as US$300 million over a decade and prevent a million cases of the disease.
Said Dr. Marc LaForce, director of the Meningitis Vaccine Project, “The most important lesson we learned is the amazing power of partnerships when all members are committed to the same goal.”
Case study authored by: PATH