Vaccine developers must also take into account the extra costs that may arise from liability claims for injuries or deaths owing to vaccine administration. This concern has forced a number of U.S. vaccine manufacturers out of the market over the past decade. Whereas in 1985, there were 10 licensed manufacturers of human vaccines (seven commercial, two state laboratories, and a single university) (Institute of Medicine, 1985), today there are only five.
Industry currently lacks economic incentives to stimulate efforts at preventing infectious diseases with vaccines for which there is little or no foreseeable market. Nor does the public health sector (with specific exceptions) have a mechanism for setting development programs in motion. There are ways in which industry might be encouraged to assume a greater role in vaccine development. A comprehensive strategy is urgently needed.
One approach would be to establish public/private sector collaborations in vaccine research and development, a strategy exemplified by the National Cooperative Vaccine Development Groups (NCVDG), whose goal is to address the problem of HIV. The NCVDGs represent the core of the investigator-initiated HIV vaccine development effort sponsored by the Vaccine Research and Development Branch (VRDB) of NIAID's Division of AIDS. These collaborative research teams are composed of scientists from industry, academia, and government working to develop and test experimental HIV vaccines. Current vaccine strategies being evaluated in animal models include inactivated virus, recombinant proteins, live recombinant viruses, synthetic peptides, anti-idiotypic antibodies, and passive immunization (Marta Glass, Division of AIDS, NIAID, personal communication, 1992). An alternative approach would be to offer industry economic incentives to develop vaccines. These incentives could range from partial or complete "socialization" of responsibility (government cost sharing and involvement in development decisions) to long-term guaranteed purchases of minimum amounts of a vaccine at a price that would allow the manufacturer to recover the costs of development and production.
Another current study at the Institute of Medicine is exploring issues that are likely to influence the participation and cooperation of American private and public sector organizations in the international initiative to accelerate development of new, improved childhood vaccines. The IOM Committee on the Children's Vaccine Initiative is examining legal, regulatory, economic, and practical impediments to optimal application of available national resources to the International Children's Vaccine Initiative. The results of this study, which is due to be completed in 1993, may have implications for the development of vaccines for microbial diseases in both children and adults.
Emerging microbes offer a different challenge for vaccine development than that presented by a well-established pathogen, and there are potentially catastrophic consequences if the development process is left entirely to free