PATH
Menu

Smiling kids on a bicycle on a dirt road.

To ensure success, MVP reached out to communities who will receive the vaccine. Photo: WHO/Mali.

Developing and introducing a new vaccine for sub-Saharan Africa was no simple matter

To successfully introduce a new vaccine to sub-Saharan Africa, the Meningitis Vaccine Project (MVP) had to work two sides of an intricate equation, considering the vaccine’s scientific merits as well as how it would be introduced into Africa once it was approved. The work involved simultaneously developing the conjugate vaccine, meeting the rigorous regulatory and technical rules that govern the production and testing of new vaccines, setting up clinical trials to test the safety and efficacy of the vaccine, and strengthening countries’ ability to host clinical trials and to administer the vaccine, once available.

To meet these challenges, the MVP team formed three partnerships very early in the project:

  • A panel composed of pharmaceutical and clinical trial experts that oversaw the development of the vaccine and provided guidance on choosing a manufacturing partner.
  • A group of consultants with expertise in carbohydrate chemistry, vaccine regulatory issues, and pharmaceutical development that helped to address specific questions or problems that arose as the vaccine was developed.
  • A WHO project advisory group, made up of senior African public health officials, that advised MVP on the choice of African clinical trial sites and the design of the clinical trials.

Besides providing key technical know-how and guidance, this strong network of support also helped MVP overcome initial skepticism from others in the scientific world that a meningococcal A conjugate vaccine could indeed be produced at a cost African countries could afford.

Clinical trials

By 2005, after two years of careful, detailed work to perfect the conjugate vaccine, the MVP team launched the first clinical trial to evaluate the vaccine in humans. Seventy-four healthy adults in India took part in the phase 1 trial, which showed the vaccine’s safety and immunogenicity.

In 2006, as a new epidemic wave swept over the meningitis belt, the MVP team launched a more intensive phase 2 trial in Africa to evaluate the vaccine among a younger age group. A year later, more good news: the pivotal study confirmed that the conjugate vaccine was safe and demonstrated that it produced antibody levels almost 20 times higher than those obtained with the marketed polysaccharide vaccine used in reactive immunization campaigns. These encouraging results cleared the way for more studies among age groups and populations that would eventually be targeted by the mass campaigns.

By 2009, the MVP team had enough clinical data to submit the vaccine dossier to the Drugs Controller General of India for Indian licensure and to WHO for prequalification for use in Africa. The vaccine was nearly ready for introduction.

Preparing the way for a vaccine

To prepare for introduction once the vaccine became available, the MVP team began to build countries’ capacities to integrate the vaccine into their health programs. In the countries hardest hit by meningitis, WHO led the strengthening of disease surveillance and enhancing of laboratory capacity to provide up-to-date information about meningitis outbreaks and improve the data base necessary for vaccine introduction.

In addition, the MVP team collaborated with in-country partners to train staff and develop know-how for conducting clinical trials, ensuring they would have the skills and capacity for managing not only studies of the conjugate vaccine but future studies of other new vaccines or drugs in development.

To build understanding of the vaccine among the populations of the meningitis belt countries, the MVP team reached out to journalists, national officials, health workers, and communities with information and training about the disease and the vaccine. The team also developed an online e-learning tool specifically for immunization managers in developing countries to receive comprehensive, interactive information on meningococcal meningitis and the new conjugate vaccine.

Bolstering all these efforts was the historic Yaounde Declaration, issued by the ministers of health of meningitis belt countries on September 4, 2008, during a meeting in Cameroon. The declaration pledged the ministers’ commitment to fast-track introduction of the new vaccine once it was approved for widespread use and to strengthen disease surveillance, control plans, and information-sharing across borders to collectively enhance the region’s response to meningitis.

MenAfriVac is a registered trademark of Serum Institute of India Ltd.

Next Ready for launch