Frequently Asked Questions

Q1. What are the biggest challenges for MVP?

A. MVP is partnering with several companies that are each responsible for different steps of vaccine development: production of raw materials, conjugation process, and production and distribution.

This new model poses challenges in terms of:

  1. Managerial and technical capabilities: The technical and managerial requirements to bring this vaccine to licensure will be a joint responsibility of MVP and the developing-country manufacturer, as opposed to purchasing these services from an established vaccine manufacturer;
  2. Monitoring: MVP will need to closely monitor process development and subsequent transfer of the technology to the developing country manufacturer;
  3. Clinical trials and licensing: There will be joint responsibility between MVP and manufacturers for the conduct of clinical trials in Africa and for working with regulatory authorities to register the vaccine;
  4. Flexibility: Should the epidemiological situation in the meningitis belt change, MVP will need to be flexible enough to adapt rapidly to the new situation. For instance, until 2002 serogroup A meningococci have accounted for about 80-85 percent of all cases of epidemic meningitis in Africa. Should strains other than serogroup A become epidemic problems, MVP will need to be able to respond adequately to the situation.

After the vaccine is developed, MVP will need to:

  • insure early detection of epidemics in Africa
  • reach high vaccine coverage during mass immunization campaigns
  • integrate meningitis surveillance with surveillance of other epidemic-prone diseases,
  • introduce the vaccine into existing routine childhood immunization programs and in 1-29 years age group.

Q2. What are the biggest opportunities for MVP?

A. If MVP succeeds, 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.

Q3. Does the transfer of vaccine technology to a developing-country manufacturer offer any real advantage?

A. Yes it does.

  1. It considerably reduces the production cost of the vaccine
  2. It reduces distraction or competition with higher value projects because all the efforts are focused on developing a single product
  3. The model allows for the opportunity to design a vaccine based on vaccination needs in Africa. For instance, the vaccine will be formulated in ten-dose vials, which is best suited for mass immunization campaigns.

Q4. Is the $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?

A. No, the $70 million will not be sufficient to fund the whole project. Funding from the 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 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.

Q5. 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?

A. Unlike other global health problems where the solution is somewhat uncertain, the technology exists for developing a safe and effective meningococcal vaccine within a few years.

It is true that meningitis kills fewer people in Africa than other diseases do, but epidemics there are humanly, socially, economically, and politically devastating. Half of the victims are adolescents and young adults, many of whom have children to care for and/or provide income for themselves and their families. Epidemics spread so rapidly that they can lead to widespread panic. These outbreaks can paralyze a region's whole health system within days.

By eliminating meningococcal epidemics in Africa we will not only save lives but we will 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.

Q6. If it takes several years to develop a vaccine that's appropriate for use in Africa, how will people there control meningococcal epidemics until then?

A. 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.

The partnership (ICG - International Coordinating Group) 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 such time as 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 vaccines, the risk of epidemics will remain.

Q7. Once a vaccine is developed, how long will it take to eliminate meningitis in Africa?

A. Unfortunately, it's impossible to give a precise date. Analysis indicates that due to the wide age distribution of meningococcal disease and carriage (from infancy through about age 29), introduction of the new conjugate vaccines into the Expanded Program on Immunization (EPI) alone would take decades to impact on the occurrence of epidemics.

Using mass immunization campaigns, where a large part of a population is vaccinated at one time, in addition to routine infant vaccination can accelerate the process of protecting a population from these deadly epidemics. However, it is impossible to say for sure when meningitis will be eradicated from Africa.

Q8. Why aren't companies in industrialized countries developing a meningococcal vaccine that is appropriate for use in Africa?

A. The pharmaceutical industry bases its decision on several factors:

  • Because serogroup A meningococcus is virtually non-existent in industrialized countries, returns on investment are perceived to be too low for companies to commit substantial resources to the development of vaccines for use mainly in Africa.
  • A few years ago, the UK manifested interest in licensing a meningitis C-only vaccine in response to their meningococcal C epidemics. Vaccine manufacturers interpreted this as a signal that meningococcal A vaccine was not needed in the short term and they started working on other vaccines for a global market.
  • Companies already face internal competition for capital funds needed for the expansion of manufacturing capacity for Hib and pneumococcal conjugate vaccines. They lack space and money to manufacture a new vaccine.

Q9. What was MVP's response to the W135 epidemic in Burkina Faso in 2001 and to the possibility that W135 will become an epidemic strain in the meningitis belt?

A. MVP responded to the W135 epidemic in Burkina Faso by strengthening surveillance in three meningitis belt countries in the fall of 2001. Surveillance activities have since then expanded to nine countries, and they will continue in years to come, thereby providing better data on the contribution of different meningococcal groups to epidemic disease. This information is essential for making decisions about vaccine development. Should W135 emerge as a key cause of epidemics in future years, MVP is in a position to modify its current vaccine development strategy to account for W135.

Q10. How much money is being spent every year responding to meningitis outbreaks and epidemics?

A. This is difficult to say. A very conservative estimate, looking only at treatment and vaccination, is probably a minimum of around $20 million in an average year in Africa's meningitis belt. This does not include the cost of lives lost or those chronically impaired by epidemics. Nor does it include the cost of not being able to provide other essential health services because epidemic response takes over the health care systems during the 6-7 months of an epidemic.

Q11. 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 like with $70 million you could buy a lot of antibiotics. Why not spend the money on that and make a difference right now?

A. 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 U.S. and Europe. The situation is even more difficult in Africa, where current health care systems cannot support an intervention that must be given often in a timely manner. A vaccine that offers long-term protection against the disease is the only long-term solution to the epidemic meningitis situation. The world also has a massive problem with increasing resistance to antibiotics due to overuse. They are simply not a solution to the problem of recurrent epidemics in large populations in Africa.

Q12. How much money will the project need to reach its goal of eliminating epidemic meningitis as a public health problem in sub-Saharan Africa?

A. At a target price of about US$ .50 a dose, it will cost US$100 million to cover a population of 250 million people over ten years. This translates into raising about 10-12 million dollars annually, a figure that will assure the sustainability of the program.

Q13. Were African governments consulted in this process to determine whether this vaccine and program are something they want?

A. Yes. In April 2000, delegates from Burkina Faso, Ethiopia, Mali, Niger, Nigeria, Saudi Arabia, Sudan, the African Regional Office (AFRO), and the Eastern Mediterranean Regional Office (EMRO) 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, their conclusions affirmed the goals of the MVP and emphasized that current strategies focusing on epidemic response or preparedness are not sufficient to prevent epidemics. They endorsed the goal of immediate development of a conjugate vaccine but also made it clear 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.

MVP has been consulting with African Health Officials on an ongoing basis since its creation in 2001, and key advisory groups to the project are composed of African scientists, medical practitioners, and public health officials.

Q14. How will vaccine be delivered to Africa?

A. The meningitis A vaccine will initially be delivered through mass vaccination campaigns targeting individuals from 1 to 29 years of age. Mass immunization 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 from 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 and GAVI is working to strengthen these programs worldwide. Catch-up immunization will be required for older children and adults because, unlike other bacterial infections such as Hib, which affect primarily infants, meningococcal meningitis affects also young adults.

Q15. Will you introduce the vaccine in all of sub-Saharan Africa at once?

A. To coordinate with other ongoing immunization initiatives, introduction of the Meningitis A conjugate vaccine into the meningitis belt countries will be phased according to risk criteria and programmatic strengths. Two countries will be selected, based on these criteria, for demonstration programs during the meningitis vaccine introduction phase. Introduction to other meningitis belt countries will take place over a 5-10 year period.

Q16. Where can I learn more about meningitis?

A. There are many web sites that provide useful information about meningitis but most are related to the state of the disease in developed countries.

General and scientific information

Information for Travelers

Information for Children and Parents

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