Background

From Senegal to Ethiopia, a wave of devastating illness sweeps across the 26 countries of Africa’s “Meningitis Belt” every 5 to 14 years. Meningitis is one of the most feared diseases in Africa. The infection, which makes the protective membranes around the brain and neck painfully swell, is difficult to diagnose and swift to kill. Common symptoms such as fever, headache, and neck stiffness may be missed or altogether absent. One could go to sleep healthy and never wake up. When untreated, meningitis fatality rates can soar to more than 80 percent and, and even with treatment, 5 to 10 percent of infected individuals die, often within hours of symptom onset.

A New Vaccine for Africa

Periodic meningitis epidemics present yet one more challenge in a region already suffering from extreme poverty, food insecurity, climate risks and a host of other health issues, including malaria, polio, measles, and Ebola. During epidemics, meningitis fills hospitals and strains health sector resources. This is particularly true in the seven “hyperendemic" countriesBurkina Faso, Chad, Ethiopia, Mali, Niger, Nigeria and Sudanwhere incidence is highest.

On an individual level, caring for family members with meningitis is a huge financial burden. For instance, households in Ghana lose an average of 29 days of work per case and households in Burkina Faso source spend up to US$90 per case (34 percent of annual GDP per capita).source For households struggling to make ends meet under normal circumstances, the costs are unmanageable.

Over one million meningitis cases have been reported in Africa since 1988, 80-85 percent of them caused by meningitis A.source In 1996-1997, the largest epidemic on record resulted in over 250,000 cases and 25,000 deaths. Without an effective preventive vaccine against meningitis A, the region remained vulnerable to it happening again. Enter MenAfriVac: the first effective, affordable, meningococcal vaccine created specifically for an extremely poor African population.

On the long-term effects of meningitis A, one victim said, "People think you are crazy. It is like you don’t exist anymore."

—Monique Berlier, Director of Communications, PATH

Program Rollout

Following the devastating 1996-7 epidemic, it was clear that the current approach to managing meningitis was neither effective nor efficient. This spurred African health leaders to ask the World Health Organization (WHO) for help.source In response, the WHO convened a series consultations and commissioned a study on the feasibility and cost of developing a serotype A conjugate vaccine—which past experience had suggested could radically reduce infection and transmission of meningitis A in Africa. The study findings were supportive and gained widespread endorsement for the development of a preventive conjugate vaccine to safeguard against future epidemics. The new vaccine would be called MenAfriVac.

The WHO also concluded that a development and delivery partnership was needed.source In collaboration with the Program for Appropriate Technology in Health (PATH), the WHO submitted a proposal to the Bill & Melinda Gates Foundation and was successfully awarded $70 million to make the partnership a reality. In 2001, the Meningitis Vaccine Project (MVP) was born. Its mandate: develop, test, license, and introduce a low-cost meningococcal conjugate vaccine.

MVP director Dr. Marc LaForce and WHO colleagues then spent eight months meeting with African health officials across the Meningitis Belt to determine an affordable vaccine price and estimate demand.source Projections placed need at 25 million doses per year for the next decade.source But to ensure demand could be met, the vaccine had to be affordable for the Belt countries. Government leaders had long stressed they could not afford MenAfriVac at more than $1 per dose, and MVP determined it had to cost less than $0.50 per dose to ensure sustainable uptake. The vaccine manufacturer, the Serum Institute, ultimately did even better: the company agreed to sell MenAfriVac at $0.40 per dose.source

LaForce and colleagues also set out to define a vaccine development plan and identify partners. A network of organizations, including the US Food and Drug Administration’s Center for Biologics Evaluation and Research, the Serum Institute of India Ltd., SynCo Bio Partners, and the UK National Institute for Biological Standards and Control, soon joined MVP.source At the country level, Ministers of Health in all Belt countries signed the Yaoundé Declaration, solidifying their commitment to eliminating meningitis A disease in the region.source

Meanwhile, approval of MenAfriVac was underway. From 2005-2009, safety and efficacy trials took place. The results deemed the vaccine safe and much more effective than the earlier polysaccharide (PS) vaccine.source In 2009, MenAfriVac secured Indian drug authority licensure and, in 2010, the vaccine received WHO fast-track approval.source UN agencies now had the green light to buy MenAfriVac and distribution could begin.

MenAfriVac rollout began in December 2010. To determine which country would be first, a joint WHO-AFRO and Gavi, the Vaccine Alliance, sub-committee assessed disease burden, epidemic risk, and country preparedness. Countries also had to commit to cover half the operational costs of vaccination to be approved.source

Impact of MenAfriVac in Chad and Burkina Faso

Burkina Faso, the country most affected by meningitis since 2000, was first to introduce MenAfriVac. A massive campaign was launched under the auspices of Burkinabè President Blaise Compaoré and WHO Director-General Margaret Chan at an event celebrating “what could be the beginning of the end of one hundred years of meningitis epidemics in the country.”source Media outlets broadcast a steady stream of messages urging citizens to get vaccinated as local “town criers” and volunteers helped raise awareness. The Ministry of Health deployed more than 10,000 health workers and 650 supervisors across the country to roll-out the campaign. Starting with school children, 11 million Burkinabè (70 percent of the population) aged 1-29 were vaccinated in just 10 days.

Phased introduction across the Belt continued in Mali and Niger, followed by Chad, Cameroon, and Nigeria. Special campaigns targeted specific populations, such as nomadic and refugee groups. In some cases, MenAfriVac introduction was integrated with other vaccination campaigns. By the end of 2013, more than 153 million people were vaccinated in 12 countries. Vaccination across the entire Meningitis Belt will be complete by 2016.

From inception, MVP worked closely with countries to strengthen surveillance and laboratory capacity to track progress. Starting in 2003, the Multi-Disease Surveillance Center, based in Burkina Faso, produced weekly meningitis surveillance updates for the entire region.source

By the end of 2013, more than 153 million people were vaccinated with MenAfriVac in 12 countries

Impact

Meningitis incidence has dropped dramatically and, so far, not a single case of the disease has been reported among the 153 million people who received the vaccine under the MVP program. Though infection rates in some countries were already falling when the vaccination rollout began, evidence shows the vaccine dramatically accelerated these positive trends.source

In Burkina Faso, in the year following mass vaccination, no cases if meningitis A disease were detected source and the number of cases fell to the lowest rate since 1995.source Data from Mali and Niger has further confirmed the vaccine’s impact. Even more definitive proof of the vaccine’s effectiveness comes from in Chad, where a 2013 study found that MenAfriVac not only stopped meningitis A in its tracks but also led to a decrease in the bacterium that causes it. Meningitis cases dropped significantly in the three districts where mass vaccination took place while the epidemic raged on unabated elsewhere, leading to an incredible 94 percent difference in incidence.source

Meningitis Across Africa’s Meningitis Belt

Number of suspected meningitis cases reported
 

 WHO (World Health Organization). 2016. “Global Health Observatory (GHO) data.” Accessed March 14. http://www.who.int/gho/database/en/.

200920102011201220132014

MenAfriVac is predicted to have saved 142,000 lives, averted 284,000 permanent disabilities, and prevented more than 1 million meningitis cases over a decade in the seven hyperendemic countries of Africa’s Meningitis Belt. Hopes are high that Africa is experiencing the elimination of meningitis A disease across the Belt.

MenAfriVac is predicted to have saved 142,000 lives, averted 284,000 permanent disabilities, and prevented more than 1 million meningitis cases over a decade in the 7 hyperendemic countries of the African Meningitis Belt

Cost

Bringing a human vaccine to market typically costs between $200-$900 million.source MenAfriVac was developed less than one-fifth the average cost.source The Gates Foundation awarded $70 million to the MVP for operational and vaccine development costs, and later provided an additional $17 million for clinical studies including for the infant vaccine. USAID and the Dell Foundation also provided support. 

The mass vaccination campaign cost $1.40 per person, reflecting vaccine and injection materials, operational, and infrastructure costs.source The first three countries to introduce MenAfriVacBurkina Faso, Mali, and Niger — contributed to the operational costs of vaccine rollout, subsequent country introduction costs were covered by Gavi.source Since 2009, Gavi has committed $262 million for Meningitis A campaigns in Africa. Additional funding for the remaining country campaigns will be made available based on country application requests.source

In a calculation undertaken for Millions Saved, researchers estimated that the vaccine likely prevented 12,469 deaths in Chad, which translated to averting 875,844 DALYs over the entire three-year study period, 2010 to 2013.source The calculation determined that MenAfriVac offered a cost per DALY averted of US$96.36, confirming that its low cost and large health impact reflect good value. Another analysis estimated that the introduction of MenAfriVac could save US$350 million or more over a decade in the seven countries where meningitis is hyperendemic, mostly by eliminating the need to continuously buy and deliver the polysaccharide vaccine.source

 

The widespread introduction of MenAfriVac in the Meningitis Belt’s hyperendemic countries is estimated to save countries $350 million over a decade

Reasons for Success

Factors underlying the MenaAfriVac’s incredible impact have been creative partnerships, technological innovation, widespread coverage, and strengthened surveillance. African government leadership—including the Yaoundé Declaration, sustained funding, and regular announcements in the media—has also been critical.

The innovative vision of the MVP was fundamental, as was its funding from the Gates Foundation and Gavi. The MVP’s elastic organizational structure and informal, open operation enhanced collaboration and forged trust among partners. Partnership director LaForce stated that MVP’s initial country visits were “seminal in terms of starting things (and) made the equation more likely to succeed.”source

MVP also stayed firm on its price ceiling for the vaccine. When partnership staff first approached multinational firms about a meningitis A conjugate vaccine, they were astounded by Big Pharma’s lack of interest in manufacturing the vaccine for less than $2 per dose.source MVP therefore brought lower profile, less traditional partners on board—such as SII, whose willingness to charge $0.40 per dose further enabled the vaccine effort. PATH’s ability to secure a non-exclusive license for the FDA’s new conjugation method at a very low price was also vital.

Factors underlying the MenaAfriVac’s impact have been creative partnerships, technological innovation, widespread coverage, and strengthened surveillance

Implications

All signs point to the end of meningitis A in the worst-affected region of the world. Successful future meningitis A control is dependent on securing country and donor funding to vaccinate new generations with the infant formulation of MenAfriVac. A promising development came early in 2015 when the WHO opened the door to make MenAfriVac part of countries’ routine immunization programs.source

The duration of the vaccine’s protection, which will affect its cost-effectiveness, remains to be seen. However, recent evidence suggests that MenAfriVac is the first meningitis vaccine to maintain its effectiveness in warm ambient temperatures, retaining full potency for up to four days without refrigeration. This enables vaccine administration outside the traditional "cold chain" delivery system, which could cut administration costs in half.source

If the MenAfriVac rollout can maintain its current intensity and momentum, universal access and protection could soon be a reality. But LaForce wants to see efforts go even further: an affordable, heat-stable, pentavalent conjugate meningococcal vaccine targeting all meningitis strains in Africa. Development of this improved vaccine is now under development. And the goal of a meningitis-free Africa is within reach.

The end of meningitis A in the worst affected region of the world will depend on several factors, not least country and donor funding to vaccinate new generations with an infant formulation. But the goal of a meningitis-free Africa is within reach.

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