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The World Health Organization (WHO) and the Program for Appropriate Technology
in Health (PATH) recently announced that they received an award of $70
million from the Bill & Melinda Gates Foundation for a ten-year program
to eliminate deadly meningitis epidemics in Sub-Saharan Africa (see PATH
press release). The grant was a result of efforts begun two years ago
by Dan M. Granoff, MD, an investigator at CHORI, working with Luis Jódar,
MD, at WHO.
Meningococcal meningitis, a bacterial infection of the membranes covering
the brain, is one of the most feared diseases in the African Sub-Saharan
"meningitis belt". Epidemics can infect over 200,000 people
per year. Despite antibiotic therapy, 10 to 15 percent of people with
the disease die, and a similar proportion are left with disabilities such
as epilepsy, deafness, or amputations of limb.
A plain polysaccharide meningococcal vaccine has been available for many
years. However, this vaccine is not very suitable for routine use for
prevention of epidemics. The reason is the vaccine is not effective in
infants and young children, the age groups at highest risk of disease.
Also, protection lasts only a few years, and immunized individuals may
still carry the bacteria in their nose and throat and transmit infection
to others.
For more than a decade the technology has been available to develop an
improved meningococcal vaccine that induces long-term protection, and
which is effective in all age groups ("conjugate vaccine").
A conjugate vaccine for prevention of meningococcal disease caused by
serogroup C strains was introduced in the United Kingdom in 1999. Fifteen
million persons under the age of eighteen were immunized in the first
eighteen months and serogroup C disease has virtually been eliminated
in this age group (Ramsay et al., Lancet 2001). Unfortunately, the vaccine
developed for the UK does not prevent meningococcal disease caused by
the serogroup A strain, which is the main cause of meningococcal disease
in Sub-Saharan Africa.
In the 1990s, several manufacturers, in response to requests by WHO and
the international community, began development of a conjugate vaccine
against the strains causing disease in Africa. By 1999, all of these manufacturers
had suspended or discontinued their projects. The reasons were simple:
vaccine development is expensive, and the profit expected from a vaccine
intended for Africa was too limited to justify the large investment of
capital and human resources required for such a project.
In November 1999, recognizing that the prospects were dim for a low-cost
vaccine for prevention of epidemic meningitis in Africa, Granoff made
a proposal to WHO to explore the feasibility of developing a not-for-profit
company to manufacturer a meningitis vaccine for Africa. As a result,
WHO funded CHORI to conduct a feasibility study.
Working with consultants with expertise in manufacturing and vaccine development,
Granoff determined the time required and cost to develop, license, and
produce a vaccine, including building a manufacturing facility. Granoff
and Jódar also met with each of the major vaccine manufacturers
to determine their interest in reviving development of a meningococcal
vaccine for Africa, should external funding become available. The results
of these analyses were presented to representatives from Africa and scientists
and health care experts from the international community at a meeting
held at WHO in Geneva in April 2000. It was recommended that the project
move forward and apply for funding from international donors.
Subsequently, representatives from the U.S. Centers for Disease Control
and PATH joined the effort, which lead to the $70 million grant from the
Gates Foundation to fund a private-public partnership to develop, manufacture,
and support a pilot introduction of a meningococcal vaccine for Africa.
The project is due to start this summer.
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