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MenAfriVac: A New Paradigm in Vaccine Development

by Andrea Fletcher

Pharmceutical and biotech companies are often criticized for their lack of transparency: billions of dollars spent on drugs that never reach the market, and little investment into the development of drugs for orphan and neglected diseases.  These companies are largely market-driven and invest in projects that are profitable.  International drug development raises a lot of interesting ethical questions: Do these companies have a responsibility not only to their shareholders but also to the global community?  What constitutes a “fair price” in the world of medicine?  Which diseases should take precedence in drug development?

Hundred of millions of people suffer from malaria, African sleeping sickness, trachoma, and many other horrific and neglected diseases.  These are diseases of the poor, and therefore have little or no market value and are left behind in the world of big pharmaceuticals and biotech.  However, there are new paradigms in drug development beyond the typical outcry for generic drugs—enter the public-private partnership, a novel approach to the progression of technology for those diseases that affect the poorest people.

In the United States the debate over vaccines primarily involves our right to refuse vaccination, concerns about safety, and issues surrounding over-vaccination of children.  However, the harsh reality is that in many parts of the world vaccines are difficult to access and there are no vaccines able to prevent the most severe diseases.  Access, equity, prioritization, and costs are all major issues in the distribution of vaccines.  Public-private partnerships are developing to address these issues, particularly the Global Alliance for Vaccines and Immunization (GAVI) and The Meningitis Vaccine Project (MVP), a global partnership whose goal is to decrease the burden of Meningitis in the African “Meningitis Belt.”[1]

The “Meningitis Belt” spreads across a strip of sub-Saharan Africa from Senegal on the west coast to Ethiopia on the east coast, covering a total of 25 countries.  Bacterial meningococcal meningitis is caused primarily by Neisseira meningitides in the “Meningitis Belt”.  N. meningitides is mostly carried in the respiratory tract, but can sometimes overwhelm the body and spread through the bloodstream, infecting the membranes of the brain and spinal cord.  This can cause severe brain damage and is fatal in 50% of cases if left untreated.  Those who are lucky enough to survive are left disabled and with large medical bills.

Serotype group A accounts for about 80-85% of the cases in the “Meningitis Belt”, with a severe epidemic occurring roughly every 7–14 years.[2]  During these epidemic outbreaks, thousands of people die.  In 1996 the most severe epidemic occurred in Nigeria causing over 100,000 cases, close to 12,000 deaths, and a case fatality rate of 7–10%.  Two of the main factors that contributed to the outbreak were low vaccination coverage and poor socio-economic conditions.[3]

Sub-Saharan Africa carries much of the global burden of disease, but this area specifically is characterized by severe epidemics of meningococcal meningitis serotype A, a serotype which is not common in other parts of the world.  For example, until the 1990s Haemophilus influenzae type b (Hib) was the predominate cause of meningitis in the United States until a vaccine was later introduced.[4]  The two vaccines in the US which are most widely used for N. meningitis, MCV4 (Sanofi Aventis) and Menactra (Novartis), are not widely available in the “Meningitis Belt” due to issues with cost and prioritization of resources.

Recently, The Meningitis Vaccine Project spearheaded the development and distribution of MenAfriVac, a vaccine that addresses the epidemic serotype A specifically and costs less than fifty cents per dose.  It is currently being introduced only in Africa, bypassing the typical 7–10 year lag time it normally takes for vaccines to reach the continent.  Many institutions and key players were involved in the development of the Meningitis Vaccine Project and the introduction of MenAfriVac.  The project was funded through a $70 million seed grant from the Bill and Melinda Gates Foundation in collaboration with The World Health Organization (WHO) and The Programme for Appropriate Technology for Health (PATH), and is manufactured by the Serum Institute of India.[5]

MenAfricVac is the first vaccine to be developed and targeted for Africa specifically.  Geography plays an important role in the epidemiology of the disease and also in the justification for the vaccine.  Not only is the location of the implementation of the vaccine unique, but the private-public partnership in the development of the vaccine is also a new venture.  MenAfriVac was developed within less than a decade and at a fraction of the cost it normally takes to bring a new vaccine to the global market.

It is a new approach to vaccine implementation that strays away from the traditional model of a vaccines being introduced into developed countries first and then several years, sometimes decades later, trickling its way into poorer areas of the world. This model can be transferred to other orphan and neglected diseases whose primary markets are low-income countries in the developing world.[6]

Public-private partnerships like the Meningitis Vaccine Project and the Global Alliance for Vaccines and Immunizations are transforming the landscape of global vaccine implementation, but we still must ask the question as to whether public-private partnerships are beneficial to humanitarian efforts, or if they should stay segregated.  MenAfriVac is revolutionary, and saves lives. While it is unlikely to have a large effect on the vaccine debate within the United States, it is challenging the international community and pharmaceutical industry on the future of vaccines and the ethics of drug development.

Andrea Fletcher is in Kenya as a Global Health Institute Field Scholar researching the intersections between health, faith, and development.  She is a Master of Public Health candidate at the Rollins School of Public Health at Emory University in Atlanta, GA.  As part of the Hubert Department of Global Health she focuses primarily on evidence based strategic planning, health policy, and human rights. Her interests in ethics began as an undergraduate at Washington & Jefferson College in Washington, PA, where she wrote her own major in bioethics combining courses in biology and philosophy and completing an internship at Bioethics International in New York, NY.

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[1]  A. Molesworth MCT, S.J. Connor, M.P. Cresswell,  A.P. Morse, P. Shears, C. A. Hart, L.E. Cuevas. Where is the meningitis belt? Defining an area at risk of epidemic meningitis in Africa. Trans. R. Soc. Trop. Med. Hyg. 2002;96:242-49.

[2] World Health Organization Meningococcal meningitis Fact Sheet, 2010.

[3] I. Mohammed AN, A.S. Alkali, M.A. Garbati, E.K. Ajayi-Obe, K. Audu, A.Usman, S. Abdullahi. A severe epidemic of meningococcal meningitis in Nigeria, 1996. Trans. R. Soc. Trop. Med. Hyg. 200;94:265-70.

[4] Centers for Disease Control and Prevention

[5]Luis Joday FML, Constante Ceccarini, Teresa Aguado, Dan Granoff. Meningococcal conjugate vaccine for Africa: A model for development of new vaccines for the poorest countries. Lancet Published online 2003.

[6] Mayor S. New meningococcal A vaccine is being introduced in Africa. BMJ 2010;341(c6736).

 

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