Meningococcal conjugate vaccine for Africa: a model for development ...

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Meningococcal conjugate vaccine for Africa: a model for development of new vaccines for the poorest countries Luis Jódar, F Marc LaForce, Costante Ceccarini, Teresa Aguado, Dan M Granoff There are major disparities in drug and vaccine development for diseases that mainly affect the developing world, as opposed to those that affect industrialised nations. From the time of introduction of a new vaccine in Europe or the USA, the adoption of these vaccines in developing countries takes a decade or more.1 For example, hepatitis B vaccine and Haemophilus influenzae type b conjugate vaccines have been used routinely for over 10 years in North America and in most European countries, with very successful control of disease, but although these vaccines have also proven highly effective in developing countries, vaccine uptake has mostly been slow. Several factors have contributed to this situation, such as insufficient information on local disease burden, and questions of programme feasibility. However, the main reason is that the poorest countries cannot afford to purchase the vaccines.2 In 2001, three vaccine manufacturers developed group C meningococcal conjugate vaccines in response to public health concerns in the UK, where there had been about 10 000 cases of group C meningococcal disease and 1000 deaths during the previous decade.3 By contrast, no manufacturer was interested in developing a group A meningococcal conjugate vaccine for prevention of meningococcal disease in sub-Saharan Africa where, during the same period, there were more than 700 000 cases and 100 000 deaths.4,5 For virtually all diseases that largely affect poor countries, choice of drug and vaccine development is market driven, and is not based on disease burden or mortality. In response to this inequality, the public sector (International organisations [European Commission, WHO], Governments [Ministries of Health, Education, Science and Technology] and academic institutions) has encouraged pharmaceutical companies to develop new drugs or vaccines for use in poor countries by appealing to corporate altruism, and through provision of incentives (push strategies) such as funding for basic research, supporting the cost of clinical trials, or strengthening of field sites in developing countries. Because development of new vaccines is costly, these incentives have proved insufficient. Other than typhoid or cholera vaccines,6,7 no new vaccines have been developed for diseases that mainly affect the developing world. Increased funding from international donors and the inception of the Global Alliance for Vaccines and Published online April 1, 2003 http://image.thelancet.com/extras/02art7254web.pdf WHO, Geneva, Switzerland (L Jódar PhD, T Aguado PhD); Programme for Appropriate Technology for Health, Ferney-Voltaire, France (F M LaForce MD, C Ceccarini PhD); and Children’s Hospital Oakland Research Institute, Oakland, California, USA (D M Granoff MD) Correspondence to: Dr Luis Jódar, International Vaccine Institute, Building no 81, SNU Campus, Shillim Dong, Kwanak Ku, Seoul, Korea 151 600 (e-mail: [email protected])

Immunization8 have opened new opportunities to explore alternative models for development of such vaccines. In 2000, WHO commissioned an independent assessment of existing intellectual property on conjugation technology and costs of development and production of a group A or group A/C meningococcal conjugate vaccine for use in Africa (panel). They showed that the cost of goods for production in Europe of 25 million doses per year of a lyophilised monovalent conjugate vaccine in ten-dose vials would be less than US$0·40 per dose, or even lower if a liquid product were feasible. The results of this feasibility study, together with a preliminary plan for introduction of the vaccine in Africa, were presented and endorsed in April, 2000, by a group of internationally recognised experts convened by WHO, as well as by ministries of health in African and eastern Mediterranean countries.1 A year later, the Bill and Melinda Gates Foundation awarded a $70 million, 10-year grant to WHO and the Programme for Appropriate Technology for Health (PATH) to support the Meningitis Vaccine Project (MVP), with the goal of eliminating meningococcal epidemics in sub-Saharan Africa. Members of MVP considered two approaches for vaccine development: alliance with an established vaccine manufacturer in an industrialised country; or transfer of technology to a manufacturer in a developing country (figure). To determine the feasibility of the first approach, we had meetings with the major vaccine manufacturers in Europe and the USA to explore commercial development of a low-priced group A meningococcal conjugate vaccine. Incentives discussed included: a low interest loan for increasing manufacturing plant capacity; underwriting of costs of process development, production of investigational vaccine lots, and organisation of clinical

Preferred profile of a vaccine for prevention of epidemic meningococcal disease in sub-Saharan Africa ● ●



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Confers durable protective immunity after one dose Interrupts transmission of the organism in the population, thereby indirectly protecting unimmunised people from disease (herd immunity) Safe and manufactured in compliance with European Pharmacopoeia and WHO standards—ultimate acceptance of the vaccination program in Africa depends on high standards for quality control, production, and rigorous licensure process Available in the shortest timeframe possible without compromising effectiveness or safety Production of 25 million doses per year for 10 years* Price low enough to facilitate widespread use in Africa (estimated