Issue #8 - Vaccine Redux - Global Health Magazine

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This is not the time for observing, analyzing or prescribing. It is time for a concerted effort.

and manufacturing has been limited to a few global pharmaceutical companies. This concentration of human talent and industrial capital resulted in inadequate supplies of the most-needed vaccines for global use. A recent example of this was the threat of pandemic flu. The supply of vaccine was immensely inadequate and many developing countries were left struggling to secure a fraction of what they needed from the limited global supply. The restricted global development and manufacturing capacity also results in a diminished interest to scale-up or invest in new vaccine efforts. Indeed, with the complex clinical and regulatory environment, investment in new facilities has been slow and inadequate to meet global needs. The situation is rapidly changing because of an evolving global market for vaccines. Over the past decade, entry of vaccine companies in middle-income countries in the development and manufacturing of sorely-needed supplies of standard vaccines – especially those for childhood immunization programs – is a welcome development. The impact of these manufacturers has been tremendous. For example, more than 50 percent of vaccines procured for GAVI Alliance programs are now supplied by middle-income country vaccine producers. Their entry may have been accelerated by market size growth and future prospects, but it also reflects the expanding base of vaccine manufacturing in these countries. What is also more encouraging is that manufacturers in middle income countries are gradually moving from the production of traditional vaccine products to the development of new vaccines, combination products and others. It is a matter of time until they become fully fledged vaccine development and manufacturing powerhouses capable of playing major roles in the global marketplace. These countries also have the

added advantage of a lower cost structure which allows them a competitive market position. The global interests of big pharmaceutical concerns have changed course as well. Over the past decade, most, if not all, the major global pharmaceutical companies have entered the market either through acquisitions and mergers with existing vaccine companies, or alliances with biotechnology organizations. Today, all largest pharmaceutical companies are heavily invested in vaccine discovery and development. The rationale is complex and probably reflects the recent market appeal as well as the growth curve of global vaccine utilization; the scientific challenge of discovery for some of the major infectious diseases; as well as exploring the potential for vaccines to target cancer and other conditions. Finally, the slowing of drug discovery and development in general has encouraged many big pharmaceutical companies to extend their pipeline into vaccines and biologicals as a companion strategy for growth. It remains unclear whether this expanded repertoire of the pharmaceutical industry in developed countries will take into consideration the total global needs for vaccines or will remain focused on large, economically rewarding markets. The Global Reach of Vaccines The global map of vaccine use and deployment is uneven at best. The global efforts championed by the World Health Organization, UNICEF and organizations such as GAVI Alliance have contributed significantly, but the reach of the vaccine umbrella is still inadequate. A uniform, sustained, high coverage of EPI vaccines has not been achieved. While this situation is multi-faceted, the gaps in immunization rates are staggering. Vaccine use and coverage is inadequate in most developing

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