Health Affairs, 24, no. 3 (2005): 596-597 doi: 10.1377/hlthaff.24.3.596 © 2005 by Project HOPE	New Online   Pay Cuts For Medicare Docs   Access To Care Woes   Public Coverage More Efficient   Empowering Consumers

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Foreword

The Vaccine Enterprise: Time To Act

Looking to the future, the biotechnology revolution has enabled us to develop new vaccines for diseases once thought to be out of reach for prevention efforts. With the advent of antigen conjugation, viruslike particles, recombinant technologies, and other scientific developments, nearly a dozen new vaccines are likely to become available soon for diseases such as human papillomavirus, meningitis, and rotavirus gastroenteritis. We are poised to reach another high point in prevention during the next two decades.

The development and delivery of new and existing vaccines—both in the United States and globally—remain a formidable challenge. In the United States, the vaccine industry faces a number of major hurdles, including an increasingly expensive and risky research and development (R&D) process, lengthy and capital-intensive manufacturing prerequisites, societal forces that do not adequately recognize the value of vaccines, and a complex regulatory environment. These factors are compounded by an anti-immunization movement and a surge in liability litigation. A thoughtful summary of these challenges was spelled out in a 2003 report of the Institute of Medicine (IOM), which noted the erosion of the number of vaccine manufacturers in the U.S. market since the 1970s from twenty-five to five today. The report concluded that there are "declining financial incentives to develop and produce vaccines."

In developing countries, where the burden of disease is greatest, still larger challenges exist, including the lack of political will, an inadequate appreciation of the burden of illness, a limited capacity for vaccine delivery, and the absence of sustainable funding. As a result, there is a growing divide in vaccine reach between industrialized and developing countries. Tragically, an estimated two to three million children die each year from vaccine-preventable diseases in the developing world. The Global Alliance for Vaccines and Immunization (GAVI), the Bill and Melinda Gates Foundation, and others are taking important steps to address these challenges, but much greater support is needed from the public and private sectors to ensure sufficient funding for new vaccines, predictable demand, and adequate means of delivery.

Solving these challenges will not be trivial. We believe that the ideas generated by this special issue of Health Affairs will prompt a continued international dialogue on how to galvanize the world’s immunization systems and bring us a good deal closer to achieving the meaningful policy reforms needed to strengthen vaccine development and delivery. We are proud to support this special issue, and we respect the independence of this peer-reviewed journal.

We are heartened by the enormous interest shown by policymakers, the public health community, academe, industry, and others in contributing papers. We believe that this issue presents an excellent examination of the vaccine enterprise, including the critical areas of vaccine financing and the economics of the industry. Equally valuable is the series of papers highlighting the limitations of immunization delivery systems, both in the United States and abroad. Of particular importance is the challenge of delivering emerging vaccines to adolescents and adults, given the lack of immunization infrastructure for these age groups and the challenges of obtaining adequate reimbursement for providers. Finally, we welcome the discussion of creative new mechanisms to address market failures for vaccines for diseases that primarily affect the poorest countries or result only from bioterrorist threats.

The challenges facing the vaccine enterprise are becoming ever more critical. In the past five years, the United States has faced shortages of several childhood vaccines and, more recently, a crisis in the influenza vaccine supply. At the same time, new demands are being placed on the industry to undertake work on vaccines for biodefense in the wake of September 11, 2001, and the anthrax attacks of that year. This issue of Health Affairs will help focus the discussion and provide solutions to a fundamental weakness: that one of our most effective preventive health care measures is also the most threatened. The need to act could not be more urgent.

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