Vaccine Program Could Spawn Opportunities For Researchers

A report released last month by the Institute of Medicine (IOM) proposes the creation of a National Vaccine Authority (NVA) to oversee the entire process of vaccine research and development in the United States. The authority will also act as a liaison between the federal government and private industry for vaccine production. The report discusses, among other topics, the role of applied research in the development of new or improved vaccines against such diseases as tetanus and cholera both in the United States and internationally. Though the report does not directly address expanded vaccine research opportunities under the proposed authority, Violaine Mitchell, the study director at IOM, says investigators may be attracted to a more directed approach. "In terms of funding streams it might help direct attention to areas of top priority and attract new researchers there," she says. "On the other hand, so much of what science does well is allowing investigator-initiated research to explore new opportunities." The report, entitled The Children's Vaccine Initiative: Achieving The Vision (Washington, D.C., National Academy Press, 1993), was produced by an 18-person committee whose members represent academia, industry, government, and nonprofit groups. The committee met on a regular basis between February 1992 and February 1993 to produce the report. "The National Vaccine Authority is essentially a mechanism for taking the risk out of vaccine development by the public sector accepting that risk," says IOM committee member Jerald Sadoff. Sadoff contends that through investment-tax credits; guaranteed purchase of vaccines produced; financial and technical assistance with clinical trials; and provisions for limiting liability, NVA could ensure the production of targeted vaccines by both large and small manufacturers. "Making a new cholera vaccine for Bangladesh, a better malaria vaccine, or making a long-acting tetanus vaccine that can be given as a single dose are all perceived as high-risk and low- profit ventures," explains Sadoff, the director of the division of communicable disease and immunology at the Walter Reed Army Institute for Research in Washington, D.C. "When you couple high risk with low profit, companies are just not interested." He says NVA would essentially subsidize the development of vaccines with a low profit margin. "This would also increase the number of scientists involved in vaccine research," Sadoff says. "It would open an opportunity for people to work in this field and know the vaccines they work on would not be strictly limited to only those that are immediately commercially viable." Coordinating Development A body like NVA, according to the report, is important for coordinating vaccine development between federal agencies as well as between the public and private sectors. On an international level, it is a way for the U.S. government to respond to the Children's Vaccine Initiative (CVI), an organization created at the World Summit for Children in New York City in September 1990. "In the committee's view," states the report, "the success of U.S. participation in the CVI will depend ultimately on effective cooperation and collaboration among government, universities, and most critically, the private sector, including both biotechnology firms and established vaccine manufacturers." The global CVI--headquartered at the World Health Organization in Geneva--organizes task forces and product development groups to find ways to promote and facilitate the development of new and better vaccines. Two current projects include a single-dose tetanus toxoid vaccine and a heat-stable oral polio vaccine. According to the report, 20 percent of the world's children, mostly in poor and underdeveloped nations, are unvaccinated. Lack of good vaccination programs, states the report, results in more than 2 million deaths and 5 million cases of disability annually as a result of preventable diseases such as measles and Haemophilus influenzae. The report also states that only half of U.S. children under the age of two have received the complete set of recommended immunizations. Domestic Concerns "The problem is there is no organized system within the U.S. government right now charged with developing new and improved vaccines," claims Richard Mahoney, also a member of IOM panel. "What you have is a variety of different agencies--the National Institutes of Health, the Agency for International Development [AID], the Centers for Disease Control [CDC], and the U.S. Army-- all doing their own thing when developing vaccines. "Then there is the National Vaccine Program Office, which was supposed to have coordinated vaccine-related issues, but never succeeded," says Mahoney, director of the Seattle-based Program for Appropriate Technology in Health, an international nonprofit group focused on promoting technology in developing countries. Established by Congress in 1986, the National Vaccine Program Office was intended to coordinate the vaccine R&D programs of AID, NIH, CDC, the Department of Defense, and the Food and Drug Administration by producing a plan of specific goals by January 1987. That plan was never created. Mahoney and others complain that the office never received the money or personnel needed to carry out its given task. "The National Vaccine Program has no operational component," says Jay Sanford, professor of internal medicine at the University of Texas Southwestern Medical School in Dallas and the chairman of the IOM committee. "It's an organization which is supposed to determine policy, but it has never been adequately staffed or funded and is not at a high enough level to ever be heard." The program is to be located within the office of the assistant secretary for health; its proposed appropriation for fiscal year 1994 is more than $8 million. By contrast, the IOM report states, if NVA were to be formed, funding levels would need to be around $75 million. The large amount of money required to run NVA is perhaps the biggest stumbling block in its creation, says Philip Russell, a immunologist at Johns Hopkins Uni- versity and a consultant to the CVI. "The money for NVA would have to come from the budgets of other government agencies," he says. "So it's not going to receive enthusiastic endorsement from them. But there's a kind of powerful logic in the IOM recommendation. "It's tough to get new ideas like this through Congress and the bureaucracy unless there's some powerful champions. So we'll have to see whether the powerful champions arise."

Vaccine Program Could Spawn Opportunities For Researchers

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