Meningitis Vaccine Project

Meningitis in Africa : Why It Matters

Globally, epidemic meningitis does not kill as many people as HIV, malaria, and tuberculosis. But in sub-Saharan Africa , meningitis puts over 250 million people at risk of illness and wreaks havoc on already under-resourced health systems. Despite antibiotic therapy, at least 1 out of every 10 children with invasive disease will die, and up to 25 percent of survivors are left with chronic neurologic sequelae (hearing loss and mental retardation) and loss of limbs.

Meningococcal meningitis is the most feared disease in the "meningitis belt" of Africa, an area that extends from Ethiopia in the east to Senegal and The Gambia in the west. Meningitis epidemics caused by serogroup A meningococcus occur almost every year in one or more countries in that region and may infect over 200,000 people at one time. Symptoms of the disease include high fever, vomiting, and confusion, which can progress over several hours to death. Given the acute onset of severe illness, the rapid spread of disease through communities, and the serious morbidity and mortality, meningitis is one of the more visible causes of human suffering in sub-Saharan Africa .

The Current Strategy

In response to outbreaks of meningitis, countries must tap into already stretched public health systems and implement massive, disruptive, programmatically expensive vaccination campaigns that are only partially effective. In the meantime, essential functions of the health system are halted or cut back until the epidemic is under control, leaving many more people at risk of illness and disease.

The shortcomings of the vaccination campaigns stem from several factors. Most significantly, the available polysaccharide vaccine for meningitis was created for a different market. While the vaccine meets the needs of industrialized countries where meningitis outbreaks are small, it does not provide long-lasting protection, and it does not protect the very young. As a result, individuals do not develop immunity and need to be re-vaccinated year after year. This type of repeated vaccination of a broad target age group—representing more than half the population—is programmatically complicated in Africa .

The current approach for prevention and control of meningococcal epidemics has become dependent upon the early detection of these epidemics. But even under optimal conditions, the existing vaccine is a blunt instrument, preventing less than half of the cases in an epidemic.

Barriers to an Appropriate Vaccine

The technology to produce a safe and effective meningococcal conjugate vaccine for Africa has been available for more than 10 years. Intellectual property rights for an appropriate vaccine are in the public domain, but the know-how rests in the private sector. A decade ago, several manufacturers were developing conjugate vaccines against serogroups A and C meningococci. Unfortunately, the type of meningitis found in sub-Saharan Africa is different from the disease found in industrialized countries. Uncertainties about the commercial market in developing countries together with high costs of development and production have discouraged manufacturers from investing in a vaccine directed specifically against the type of meningococcal meningitis for Africa . Consequently, development of an affordable vaccine that would work for Africa is highly unlikely without public sector support.

The Meningitis Vaccine Project

In 2001, the Bill & Melinda Gates Foundation awarded the World health Organization (WHO) and PATH a US$70 million seed grant to launch the Meningitis Vaccine Project (MVP). The mission of MVP is to eliminate epidemic meningitis as a public health problem in sub-Saharan Africa . Leveraging the strengths of each organization and using the experience and know-how of industry, this partnership creates a credible platform for the development, evaluation, and licensure of meningococcal conjugate vaccines for use in sub-Saharan Africa . Working with the U.S. Centers for Disease Control and Prevention and other organizations, companies, and alliances, this project can set the stage for introduction through mass and routine infant immunization in countries of the African meningitis belt.

Over the next decade, MVP will involve a number of other partners in its effort to:

·        Develop meningococcal conjugate vaccines and evaluate them in Africa

·        Create a pathway for the licensure of vaccine which will be used largely in Africa

·        Ensure production in sufficient volume to meet projected needs

·        Monitor programs to assure the effectiveness and safety of the intervention

·        Finance the procurement of vaccine through existing or new global programs

·        Introduce the vaccine through mass and routine immunization programs in synergy with other public health programs such as measles control/elimination initiatives.

Already, the international health community has renewed efforts to help countries in the meningitis belt improve surveillance, strengthen laboratory capacity, plan and implement rapid response, and maintain political and health service commitment to these activities. Since 2001 MVP has provided important technical and financial support to WHO Enhancing Meningococcal Disease Surveillance efforts, resulting in improved surveillance teams at national and regional levels, better surveillance, more timely detection of epidemics, use of appropriate vaccine (e.g., trivalent groups A, C, and W135 meningococcal vaccine [ACW] when indicated versus groups A and C meningococcal vaccine [AC]), and better targeting of supplies and strategies for treatment. Governments in the region perceive meningococcal disease as a major public health problem and have made a clear commitment to using a safe and effective vaccine. Other vaccine initiatives, most notably the Global Alliance for Vaccines and Immunization (GAVI), are working in these countries to improve routine immunization services and enhance the ability of health systems to deliver and monitor new vaccines safely and efficiently. The efforts of the Meningitis Vaccine Project will dovetail with the efforts of GAVI and other disease control initiatives, helping to pave the way for new vaccines that will prevent HIV, tuberculosis, and malaria.

By applying proven, scientifically feasible technology to the meningitis pathogen prevalent in sub-Saharan Africa, the project aims to develop a viable product in four to five years, thus bringing a halt to recurring epidemics of a disease that has plagued countries in Africa ’s meningitis belt for more than a century. This would represent the first time that the public sector has successfully commissioned the development of a vaccine that is critically needed in Africa but would not otherwise have been made commercially.

(Posted November 2004)