In order to prevent and ultimately eliminate epidemic meningococcal disease in the African meningitis belt, The World Health Organization (WHO) and the Bill and Melinda Gates Children's Vaccine Programme (CVP) at PATH under the umbrella of the Global Alliance for Vaccines and Immunization (GAVI), have created a partnership to accelerate the development, evaluation and introduction of serogroup A plus C meningococcal conjugate vaccine in a short time and at an affordable price. The technology to produce a safe and effective meningococcal conjugate vaccines for Africa has been available for more than 10 years. Highly successful prototypes have been evaluated and have been shown to be highly immunogenic and to induce immunologic memory in African infants. Yet, these programmes have been halted because serogroup A meningococcal disease is limited to the poorest countries and the returns on investment are perceived to be too low for any serious investment consideration.

In order to overcome these barriers, WHO explored different alternatives to establish a public/private sector partnership aiming at lowering costs and risks of product development and seeking incentives by creating a market, providing other economic rewards or removing economic deterrents. An independent and comprehensive analysis of costs and timelines, manufacturing capacity, process development, clinical and regulatory activities and an estimate of the cost per dose provided a realistic, estimates which formed the basis for formal negotiations with manufacturers and importantly, it also provided the blueprint for alternative public-private partnerships for other developing country market vaccines. On April 5-7th, 2000, delegates from Burkina Faso, Ethiopia, Mali, Niger, Nigeria, Saudi Arabia, Sudan, African Regional Office (AFRO), and Eastern Mediterranean Regional Office (EMRO) gathered at WHO to evaluate the strategy and analysis of the different options for public/private sector partnership for the development of a meningococcal conjugate vaccine. Together with multilateral organizations, vaccine manufacturers and the scientific community, their conclusions affirmed the goals of the proposed project and agreed that the preferred strategy was to negotiate with pharmaceutical manufacturers to develop, license and produce a vaccine in sufficient quantities and at an acceptable price. As a result of a formal request for proposals by the WHO/PATH team, negotiations are ongoing with two companies proposing two separate but compatible vaccines.

In June 2001, The Bill and Melinda Gates Foundation awarded the partnership US $70 million over the next decade to:

• Develop a Meningococcal A/C conjugate vaccine and evaluate it in Africa
• Create a pathway for the licensure of vaccine which will be used largely in Africa
• Assure production in sufficient volume to meet projected needs
• Monitor throughout to assure the effectiveness and safety of the intervention
• Pilot introduce the vaccine in at least two countries

The MVP will establish a partnership with a developing-country manufacturer for the development of a group A meningococcal conjugate vaccine at a ceiling price of 40 cents/dose. Key elements include availability of raw materials (group A PS and TT), a laboratory for in-process development of conjugation and a developing country manufacturer for up-scale production and fill/finish at a rate of 25 million doses per year for 10 years. Suppliers of raw materials as well as laboratories for in-process development and technology transfer to a developing country manufacturer have been identified. Several interested developing country manufacturers with the capacity for large-scale production of monovalent conjugate A and for lyophilization and fill/finish facilities have been visited and assessed.

(Posted June 2002)