Giving Developing Countries the Best Shot: An overview of vaccine access and R | Vaccines

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Vaccines have contributed to some of the greatest public health successes of the past century, averting 2.5 million child deaths every year and millions more bouts of illness and disability. Yet even as the demand for existing, new and planned vaccines grows in developing countries, financing for immunization in poor countries has reached a crisis point, and major problems in the vaccines market mean that access to existing vaccines and development of new vaccines will be impeded and delayed. This joint report of Oxfam International and Medecins Sans Frontieres provides critical insights on the existing challenges to ensure children across the developing world get timely, affordable and appropriate access to vaccines, while ensuring that the unmet needs of poor children are met by the public and private sector in the coming years.
  Giving developing countries the best shot: An overview of vaccine access and R&D  Author: Paul WilsonThis paper draws on studies conducted by Andrew Jones for MSF and Paul Wilson for OxfamCover photos: Nico Heijenberg/MSF, Oliver Asselin Back cover photos: Guillaume Ratel, Oliver AsselinCover design and layout: Daniel JaquetApril 2010  An overview of vaccine access and R&D ã  1 Executive summary   2 Background  5 Overview of vaccines and immunisationVaccine marketsVaccine suppliers and business models  Access to vaccines  7 The current situationInternational nancing for vaccine purchase GAVI The situation of middle-income countries The pneumococcal Advance Market CommitmentVaccine prices Tiered pricing of vaccines and the PAHO controversy Manufacturing costsBarriers to new entrantsSummary of access challenges  Vaccine research and development   15 Overview of vaccine development Regulatory approval of vaccines R&D costsAlternative models for R&D Push funding The Malaria Vaccine Initiative (MVI) The Meningitis Vaccine Project (MVP) Pull funding Advance Market Commitments FDA Priority Review Vouchers Prize fundsAccess to technologySummary of R&D challenges Conclusion and policy objectives  22  Abbreviations and Acronyms  24 Glossary   25 References  27 Table of Contents  Vaccines have made possible some of the greatest public health successes of the past century. Immunisation helps avert an estimated 2.5 million child deaths each year, as well as millions more bouts of illness and disability. 1  Poor countries as well as rich have benefited, although developing countries almost always benefit only after long delays. Basic childhood immunisation is one of the few health interventions to which most of the world’s poor have access, free of charge and through the public sector. In fact, immunisation is one of the most equitable health interventions, protecting girls and boys alike, and reaching the poor within countries at higher rates relative to the wealthy than other services. 2 Despite their impact, vaccines have generally received less attention than drugs. But the vaccine landscape is shifting, and new opportunities, challenges, and debates have pushed vaccines to the centre of global health discussions. The issues are complex and the experience gained in the struggle for access to HIV medications is an imperfect guide. The basic principles—equitable access and research and development (R&D) based on needs—are the same, but vaccines differ from drugs in important ways. There are multiple factors that make delivering vaccines to children in developing countries difcult. These include – among others – high prices of newer vaccines, the lack of R&D for better-adapted and needed vaccines, as well as weak health systems with corresponding health worker shortages. This paper will focus on the rst two points, outlining some of the major issues and exploring possible solutions. Two fundamental challenges surround vaccine access and R&D: First, the newest vaccines are often prohibitively expensive, in part because of a lack of adequate competition in the market, hindering their use in developing countries. Second, because there is little incentive for pharmaceutical companies to conduct R&D for diseases that affect populations with limited purchasing power, some diseases continue to be unaddressed by vaccines altogether, while many vaccines are not well-adapted for people in developing countries. Challenges in expanding access to newer vaccines Basic immunisation coverage has improved substantially in recent decades. According to WHO/UNICEF estimates, coverage of the third dose of the DTP (diphtheria-tetanus-pertussis) combination vaccine, a standard measure of immunisation coverage, reached about 80% in 2007 – a remarkable increase from only 20% in 1980. 3  Nonetheless, 26 million children – roughly one in ve born each year – remained unimmunised globally. 4  Wider use of available vaccines could help avert a further two million deaths annually in children under ve years. 5 The Global Alliance for Vaccines and Immunization (GAVI) was founded in 2000 to expand the scope and accelerate the delivery of newer vaccines to children in the poorest countries. Initially, GAVI focused on adding two newer vaccines to the basic package: Hib (Haemophilus influenzae type b) and hepatitis B – vaccines that were already in routine use in wealthy countries by the early to mid 1990s. 6  By the end of 2008, global coverage of the Hib vaccine was 28%, while Hep B was 69%. 7  While this demonstrates important progress, it also illustrates the lag in vaccine delivery between developed and developing countries. GAVI is currently focusing on adding two newer vaccines that have been introduced in wealthy countries over the last several years: vaccines to prevent the severe diarrhea caused by rotavirus and vaccines to prevent pneumococcal disease, which together account for 1.3 million child deaths per year. 8  It is also looking to provide a new meningitis vaccine, the human papillomavirus (HPV) vaccine that helps prevent cervical cancer, and several others. The goal is to shorten dramatically the delivery time lag between rich and poor countries.Yet since these newer vaccines remain relatively expensive, and since GAVI is facing serious funding shortfalls, ambitious introduction plans may be jeopardized. GAVI’s ability to provide broad access to newer vaccines will depend on bringing prices down dramatically, as well as on filling the multi-billion dollar funding gap. Of the U.S.$7 billion it will need for the ve-year period until 2015, GAVI has secured only 40%, leaving a $4.3 billion funding shortfall. 9 Although an increasing number of developing country ‘emerging’ producers (from whom 53% of vaccines funded by GAVI are purchased) 10  have entered the global vaccine market, the new and most expensive vaccines continue to be produced by a handful of multinational pharmaceutical companies whose oligopoly status allows them to charge high prices. Executive summary  2  ã An overview of vaccine access and R&D
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