The Global Vaccine Initiative

I applaud Bill and Melinda Gates and their astounding donation to the Program for Appropriate Technology in Health (PATH). Having worked with PATH on contraceptive availability in Brazil and hepatitis B vaccine studies in Thailand while I was with the U.S. Agency for International Development (USAID), I am a big fan of both their remarkable vision and their continued commitment to bring innovative technologies to the developing world. While a very large percentage of the Gates endowment will (and should) go to shore up existing immunization programs that are badly in need of funding, I would urge PATH to also take this extraordinary opportunity to address a related problem: the need to develop vaccines for diseases that are epidemic in the Third World but are not prevalent in the United States and therefore not economically viable investments for U.S. pharmaceutical companies. While the World Health Organization (WHO) and USAID have tremendous programs to produce and deliver millions of doses of existing vaccines to the Third World, a coordinated vaccine initiative is urgently needed to control the global epidemic of what are potentially vaccine-preventable diseases throughout the developing world. I propose that a Global Vaccine Initiative (GVI) should be established to coordinate a concerted, global effort for the research and development of vaccines and antibiotics that are necessary to combat diseases endemic to the developing world. One of the cornerstones of this initiative would be that scientists and public health officials from developing countries have a major role in the decision-making process for the research and development of these vaccines and drugs. The general principles of this GVI would be to: Identify and develop new approaches and strategies for the development of novel vaccines and translate rapidly their concepts into improved candidate vaccines. Establish a "bioinformatics" database specific to vaccine research. Identify gaps in the existing research, and design in-house scientific protocols to fill those gaps. This program must not waste valuable resources "reinventing the wheel," but rather should augment existing knowledge. Help coordinate outside research centers to allow for a more concerted effort in novel vaccine and antibiotic research. Initially, the GVI will have two primary functions. First, working closely with pertinent international organizations, the GVI will act as a coordinating center and central repository for data on vaccine and antibiotic research from around the world. Free access to the data bank is essential; intellectual property issues will need to be resolved in advance of the data-bank formation. Second, the GVI will use the collected data to identify gaps in ongoing vaccine research and complement this research at its primary and affiliated centers. With the help of WHO, USAID, the World Bank, and others, multi-institutional consortia of experienced and diverse investigators can be established to explore different experimental approaches to vaccine development. The GVI will create the core of an international vaccine development effort, providing a framework for scientists from different countries and research sectors to collaborate and combine their talents to develop effective vaccine strategies and appropriate models to evaluate vaccines. The GVI would work in conjunction with the WHO and private vaccine manufacturers to develop a "Vaccine Advisory Group" to oversee the basic research of the GVI, suggesting courses of action and prioritizing the research efforts toward the diseases best addressed first. At a later stage a "Vaccine Evaluation Group" would be formed to assess the vaccines in a preclinical setting. This group could be modeled after similar groups at the National Institutes of Health in the United States and the Medical Research Council in the United Kingdom, with a mandate of establishing the best route toward the clinical trials necessary to obtain WHO (and selected national regulatory) approvals for safety and efficacy of the vaccine candidate. Lastly, the WHO's Expanded Programme on Immunization would be utilized for delivery and administration of the vaccine to the people themselves. Such an effort will require teamwork on a global scale. Development of these vaccines will require additional scientific knowledge about the infectious agents and their interactions with human and animal hosts. Strategies must also be designed for translating this knowledge into practical, safe, and effective vaccine products, and studies must be established in international settings where the health and research infrastructure is not well developed. Therefore, it is essential that a collegial relationship be established with all of the relevant agencies throughout the United Nations system, international organizations such as the World Bank and the International Vaccine Institute in Seoul, South Korea, various national government agencies, and finally the private sector to ensure that "political will" for the Global Vaccine Initiative is established. I believe that PATH already has the commitment to lead such an endeavor, and now also has the means to do it. George N. Davatelis, Ph.D. (gdavatelis@aol.com), is manager of program development for Allergan Inc., Costa Mesa, Calif. Formerly, he was a senior program officer for the National Academy of Sciences, senior health adviser to the United Nations Industrial Development Organization, and senior biotechnology officer at the U.S. Department of State.

The Global Vaccine Initiative

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