FAQs

What lessons has MVP learned since 2001, and what will be the biggest challenges in the years to come?

What are the biggest opportunities for MVP?

The group A meningococcal conjugate vaccine is produced by Serum Institute of India. Does the transfer of vaccine technology to a developing-country manufacturer offer any real advantage?

Why are you developing a vaccine against meningitis when there are other diseases, like malaria, HIV/AIDS, or tuberculosis, that kill more people in Africa?

Large epidemics occur every 8 to 12 years in sub-Saharan Africa. The last large epidemic occurred in 1996–1997. What will happen if a large epidemic occurs between now and when the vaccine becomes available? How will meningococcal epidemics be controlled until then?

How long will it take to eliminate epidemic group A meningococcal meningitis in Africa?

Why aren't companies in industrialized countries developing a meningococcal vaccine that is appropriate for use in Africa?

Why are you developing a monovalent meningococcal A vaccine and not a bivalent A/C or a trivalent A/C/W135 vaccine?

How much money is being spent every year responding to meningitis outbreaks and epidemics?

If antibiotics can be given during outbreaks to limit the spread and severity of the disease, why not use antibiotics instead of creating new vaccines, since the drugs already exist and are probably cheaper? It seems that US$70 million could buy you a lot of antibiotics. Why not spend the money on that and make a difference right now?

Does the US$70 million from the Bill & Melinda Gates Foundation cover vaccine introduction? If not, what does it cover, and how much money will the project need to reach its goal of eliminating epidemic meningitis as a public health problem in sub-Saharan Africa?

What's the role of the Global Alliance for Vaccines and Immunization (GAVI) in this project?

Were African governments consulted in this process to determine whether this vaccine and program are something they want?

How will the vaccine be introduced in Africa?

What lessons has MVP learned since 2001, and what will be the biggest challenges in the years to come?

Developing and introducing a new meningitis vaccine for sub-Saharan Africa is no simple matter. There are complex regulatory and technical rules that govern vaccine production, testing, and licensing. In addition, to successfully introduce a new vaccine in sub-Saharan Africa requires having a clear understanding of how epidemic meningitis and new vaccines are perceived. As far as the future is concerned, the transition to vaccine introduction, from product development, clinical study, and the regulatory process, signals a change within the MVP partnership. Vaccine introduction falls squarely on the World Health Organization and the public health systems of the countries concerned. MVP is well aware of the need to manage this transition well, and part of this process has been to ensure that African ministries of health are fully supportive of the vaccination strategy. MVP is also working hard to ensure that funding is available for vaccine introduction throughout the whole meningitis belt.

What are the biggest opportunities for MVP?

If MVP succeeds in eliminating epidemic meningitis from sub-Saharan Africa, it will be the first instance where a consortium—including public, private, and non-governmental/non-profit organizations—and a philanthropic foundation (the Bill & Melinda Gates Foundation) have come together to develop a vaccine that is critically needed in Africa but that would not otherwise have been made by the private sector. This model could pave the way for the development of other drugs or vaccines for use in the developing world.

The group A meningococcal conjugate vaccine is produced by Serum Institute of India. Does the transfer of vaccine technology to a developing-country manufacturer offer any real advantage?

It does, mainly for two reasons: It considerably reduces the production cost of the vaccine, and the strategy can be tailored to vaccination needs in Africa. For instance, the vaccine will be formulated in ten-dose vials, which is best suited for mass immunization campaigns.

Is the US$70 million given by the Gates Foundation enough to cover MVP's costs for a whole decade? If not, how will additional project needs be funded?

No, the US$70 million will not be sufficient to fund the whole project. Funding from the Bill & Melinda Gates Foundation is being used to:

  • Launch the project.
  • Enable negotiations with industry to develop and license a product.
  • Provide the necessary impact data to show that use of the group A meningococcal conjugate vaccine prevents epidemics.

Funds covering purchase of vaccine, additional epidemiologic and microbiologic studies, and program implementation costs will need to be found elsewhere. MVP is working globally and at country-level to raise the needed additional resources.

Why are you developing a vaccine against meningitis when there are other diseases, like malaria, HIV/AIDS, or tuberculosis, that kill more people in Africa?

It is true that meningitis kills fewer people in Africa than other diseases, but it is one of the most feared diseases, and meningitis epidemics are humanly, socially, economically, and politically devastating. The technology for developing a safe and effective meningococcal vaccine exists, and within a few years we can make a real impact. By contrast, other diseases such as HIV/AIDS or malaria are more intractable.

The socioeconomic factors should also not be underestimated. Half of the victims in Africa are adolescents and young adults, many of whom have dependent children. A recent socioeconomic study has shown that a single case of meningitis in a family results in a sudden expenditure of what amounts to three or four months of the family’s disposable income. Families with few resources cycle inexorably downward to the next level of poverty. In addition, about 25 percent of survivors have long-term sequelae such as deafness leaving them less likely to be economically productive citizens, and they often become wards of an already financially stretched extended family.

Finally, a single meningitis outbreak can paralyze a region's whole health system within days. Eliminating meningococcal epidemics in Africa will save lives and also remove a major public health problem in Africa. This will enable African health officials and stakeholders to focus more attention on other health problems.

Large epidemics occur every 8 to 12 years in sub-Saharan Africa. The last large epidemic occurred in 1996–1997. What will happen if a large epidemic occurs between now and when the vaccine becomes available? How will meningococcal epidemics be controlled until then?

The only way to control meningococcal epidemics in sub-Saharan Africa today is through early detection of the disease and mass vaccination campaigns with meningococcal polysaccharide vaccine. Countries will use the polysaccharide vaccines that are currently available, either the bivalent A/C or the trivalent A/C/W polysaccharide vaccine. The partnership (International Coordinating Group [ICG] on Vaccine Provision for Epidemic Meningitis Control) that currently manages the emergency stockpile of vaccine will work with vaccine manufacturers to ensure that sufficient quantities of polysaccharide vaccine will continue to be produced until the epidemic threat has been eliminated. Although new conjugate vaccines will eventually eliminate meningitis epidemics in Africa, there will be a need for polysaccharide vaccines for epidemic control for some years to come. Until all the countries of the meningitis belt have achieved sufficient levels of coverage with new conjugate vaccines, the risk of epidemics will remain.

How long will it take to eliminate epidemic group A meningococcal meningitis in Africa?

It is not possible to give a precise date. However, what we can say at this point is that using mass vaccination (catch-up) campaigns, where a large part of the population is vaccinated at one time, in addition to Expanded Programme on Immunization or follow-up vaccination campaigns, will accelerate the process. We estimate that it will take less than 10 years to eliminate meningitis epidemics in sub-Saharan Africa—that is, the estimated time to do the catch-up campaigns in hyperendemic countries (Burkina Faso, Chad, Ethiopia, Mali, Niger, the nine northern states of Nigeria, and Sudan). Community immunity is expected to be so high at that point that we won't see any meningococcal A epidemics in sub-Saharan Africa.

Why aren't companies in industrialized countries developing a meningococcal vaccine that is appropriate for use in Africa?

Group A meningococcus is virtually nonexistent in industrialized countries, and returns on investment are perceived to be too low to commit substantial company resources to the development of vaccines for use mainly in Africa.

Why are you developing a monovalent meningococcal A vaccine and not a bivalent A/C or a trivalent A/C/W135 vaccine?

  • Group A meningococci are dominant in Africa, where they have a long history of causing massive epidemics. Enhanced bacteriologic surveillance conducted in 2003–2009 showed that over 80 percent of meningococcal isolates were group A. By comparison, group W135 is relatively new, and W135 epidemics have been geographically restricted to one country (Burkina Faso, in 2002), with isolated cases occurring in other meningitis belt countries.
  • MVP and its advisory groups in Africa have prioritized maximum public health benefit within the shortest timeline and at the lowest cost. With that in mind, they have decided to develop a vaccine that will fight the one group that is responsible for most meningococcal cases in Africa—group A. African public health officials also feel that at a cost of US$0.40 per dose, the new vaccine can be easily integrated into existing vaccine budgets. Developing a monovalent vaccine also makes it possible to plan for vaccine introduction as early as 2010.
  • Developing bivalent, trivalent, or even tetravalent conjugate meningococcal vaccines is technologically feasible but this would push the development timeline back by several years. However, it is possible that the development of an affordable polyvalent conjugate vaccine will be a next step in the fight against meningitis in Africa.

How much money is being spent every year responding to meningitis outbreaks and epidemics?

This is difficult to say. A very conservative estimate, looking only at the cost of medical treatment and reactive vaccination, is probably a minimum of around US$30 million in an average year in Africa's meningitis belt. This does not include the cost of lives lost or loss of earnings for those chronically impaired by epidemics. Nor does it include the cost of not providing other essential health services because epidemic response takes over the health care systems during the 6–7 months of an epidemic.

If antibiotics can be given during outbreaks to limit the spread and severity of the disease, why not use antibiotics instead of creating new vaccines, since the drugs already exist and are probably cheaper? It seems that US$70 million could buy you a lot of antibiotics. Why not spend the money on that and make a difference right now?

Even with aggressive therapy, the mortality and morbidity rate from bacterial meningitis is high. That is why vaccines have been so valuable in the prevention of Hib meningitis in the United States and Europe. The situation is even more difficult in Africa, where current health care systems are ill equipped to provide urgent care to those that need it. A vaccine that offers long-term protection against the disease is the only long-term solution to the epidemic meningitis situation. The use of antibiotics moreover is less than ideal because of increasing resistance to antibiotics due to incorrect use and over-prescription. Antibiotics are simply not the solution to the problem of recurrent epidemics in large populations in Africa.

Does the US$70 million from the Bill & Melinda Gates Foundation cover vaccine introduction? If not, what does it cover, and how much money will the project need to reach its goal of eliminating epidemic meningitis as a public health problem in sub-Saharan Africa?

The US$70 million grant covers basic vaccine research and development: namely, project launch, preclinical work, and production of the necessary clinical data to show that MenAfriVac™,  the new group A meningococcal conjugate vaccine, can be used on a large scale to prevent epidemics. Funds for additional studies (for example, epidemiologic, microbiologic, and carriage studies) and for vaccine introduction need to be found elsewhere. It will cost about US$475 million to cover the targeted population over a ten-year period. That's about US$1.20 per vaccinee (US$0.80 for administration cost + US$0.40 for vaccine cost). MVP actively is seeking funding that will guarantee vaccine introduction throughout the whole meningitis belt.

What's the role of the Global Alliance for Vaccines and Immunization (GAVI) in this project?

GAVI has always shown interest in the evolution of the project because it represents a major change in how new vaccines can be developed and introduced. In 2008, the GAVI Alliance Board approved US$29 million for the introduction of the MenA conjugate vaccine in three hyperendemic meningitis belt countries (Burkina Faso, Mali, and Niger). In 2011, the Alliance released US$ 100 million to support the introduction of MenAfriVac™ in Cameroon, Chad, and Nigeria. We expect that GAVI will continue to be an important partner as MenAfriVac™ is introduced throughout the entire meningitis belt.

Were African governments consulted in this process to determine whether this vaccine and program are something they want?

Yes. It has always been well understood that without the involvement and cooperation of African governments the project could not succeed.

In April 2000, delegates from African and Eastern Mediterranean countries gathered at the World Health Organization to evaluate proposals for the development of a conjugate vaccine. Together with multilateral organizations, vaccine manufacturers, and the scientific community, they recognized that the current strategies focusing on epidemic response or preparedness are not sufficient to prevent epidemics. They endorsed the goals of MVP and the immediate development of a conjugate vaccine and stressed that the vaccine needed to be priced at significantly less than US$1.00 per dose to guarantee sufficient use for a positive public health impact in Africa. Recognizing the importance of costs for the success of the project, MVP secured a cost of US$0.40 per vaccine dose for Africa.

MVP has consulted African health officials on an ongoing basis since its creation in 2001; the project is also advised by a key advisory group composed of African scientists, medical practitioners, and public health officials.

Health ministers from countries of the African meningitis belt have restated their commitment to introduce the new group A meningococcal conjugate vaccine which is designed to prevent periodic epidemics of the deadly disease in these countries. Read the statement of commitment by health ministers in Africa (pdf 27.1 kb).

How will the vaccine be introduced in Africa?

MenAfriVac™ will initially be delivered through mass vaccination campaigns targeting individuals 1 to 29 years of age. Mass campaigns using measles and meningococcal polysaccharide vaccines have already demonstrated success in reaching large segments of the African population effectively, and MVP will be using the same strategy. There is a high demand for a meningococcal conjugate vaccine in sub-Saharan Africa, and MVP is building partnerships with national health systems in each of the affected countries. A second step will be to reach infants through routine EPI programs.