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VACCINE PURCHASE GUARANTEES FOR MANUFACTURERS

Executive Summary

VACCINE PURCHASE GUARANTEES FOR MANUFACTURERS would create incentives to enable development of new vaccines in response to imminent pandemics, the Institute of Medicine said in an Oct. 15 report. Purchase guarantees would be "analogous to farm commodity loans," IoM said. Guaranteed purchases are part of a larger recommendation that "the U.S. develop a means for generating stockpiles of selected vaccines and a 'surge' capacity for vaccine development and production that could be mobilized to respond quickly to future infectious disease emergencies," the institute report states. Vaccine stockpiling is an issue that has been raised repeatedly over the past several years as the number of vaccine manufacturers worldwide has dwindled. The vaccine industry has attributed its attrition to a combination of liability concerns, uncertain returns and development costs. The IoM report notes that there are "only five vaccine manufacturers" in the U.S., which consequently "is in a precarious position should an infectious disease emergency occur." Prepared by the Committee on Emerging Microbial Threats to Health, the report, entitled "Emerging Infections: Microbial Threats to Health in the United States," cites AIDS, Lyme Disease, multi-drug resistant tuberculosis and a new form of streptococcal bacteria as examples of "emerging new diseases" that have "appeared seemingly out of nowhere....New diseases will emerge, although it is impossible to predict their individual emergence in time and place." One alternative to purchase guarantees would be the creation of "government-supported" R&D and production facilities modeled after the National Cancer Institute's program for cancer therapeutics and the federal space, energy and defense laboratories. "The assigned mission for these new facilities would be vaccine development for future infectious disease contingencies," the report states. The committee notes that "there is no infrastructure in place today that allows for anticipatory vaccine development in response to future pandemics." The report urges that a comprehensive strategy be developed that takes advantage of existing research capacities at Public Health Service agencies and "relies as much as possible on the capability of private industry to manage the vaccine development process." To further strengthen intervention capabilities, the committee recommends "the expansion and coordination of NIH-supported research on the agent, host, vector and environmental factors that lead to emergence of infectious disease." Such research "should include studies on the agents and their biology, pathogenesis and evolution; vectors and their control; vaccines; and antimicrobial drugs." The IoM report offers several recommendations for improving the federal government's surveillance efforts. While the individual efforts of the various agencies should continue, the report recommends that either the Centers for Disease Control or a subcommittee of the Federal Coordinating Council for Science, Engineering and Technology be assigned to coordinate surveillance efforts. "As is the case for domestic efforts...international infectious disease surveillance activities undertaken by the U.S. government remain largely uncoordinated and in need of a strategy to focus them in appropriate areas," the report states. Additionally, PHS should develop "a comprehensive, computerized infectious disease database," which could consolidate existing information from specialized sources, the report recommends. Information on vaccine and drug availability could be included and made accessible to physicians, health care workers and clinical laboratories. The 19-member panel was co-chaired by Joshua Lederberg, Rockefeller University, and Robert Shope, Yale University. Project sponsors included CDC, Fogarty International Center, Lederle- Praxis Laboratories, the National Institute of Allergy and Infectious Diseases, and the U.S. Army Medical Research and Development Command.

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