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Vaccines for the 21st Century: A Tool for Decisionmaking
provided in 1985 and in this report do not predict which vaccines will be developed within a specific time frame. They provide comparative cost-effectiveness analyses for candidate vaccines that the committee assumes could be developed and licensed within a specific time frame.
The development of respiratory syncytial virus (RSV) vaccines has been slower than anticipated, in large part because of the extraordinarily cautious approach to the implementation of clinical trials because of the unfortunate experiences with the early inactivated RSV vaccines. The inactivated vaccines augmented clinical disease and resulted in increased rates of hospitalizations and some deaths when administered to the youngest infants, the group at highest risk from RSV disease. Clinical trials with both attenuated live virus and surface glycoprotein RSV vaccines are under way. Influenza virus vaccines consisting of both attenuated live virus variants and a number of subunit preparations are also under continuing research and development.
In contrast, the likelihood of successful licensure of parainfluenza virus vaccines, cytomegalovirus (CMV) vaccine, Neisseria gonorrhoeae vaccine, and Coccidioides immitis vaccines remain more remote. Studies of conjugate group B streptococcal (GBS) vaccines have been promising, particularly in immunization of late third-trimester pregnant women for the prevention of neonatal invasive GBS disease. However, pharmaceutical firms appear to have little enthusiasm for investing in the production of such a vaccine. Concerns regarding litigation that might ensue following unfavorable pregnancy outcomes (discussed in the following section) remain the most visible obstacle. Table 2–1 presents the current stage of development of vaccines against those pathogens assessed in 1985.
LITIGATION AS A BARRIER TO VACCINE DEVELOPMENT
The mid-1980s was a time of great struggle and even crisis for the development and manufacture of vaccines and vaccination program implementation. Public trust in vaccines was shaken and litigation concerns caused several major manufacturers to reduce or eliminate their vaccine development programs. The National Childhood Vaccine Injury Act (NCVIA; P.L. 99–660) was enacted in 1986. The legislation established a compensation fund for people who suffered specific serious adverse health effects that could potentially be attributed to vaccination with mandatory childhood vaccines (diphtheria and tetanus toxoids and pertussis vaccine, measles-mumps-rubella vaccine, oral polio vaccine, inactivated polio vaccine, and individual antigens within those vaccines). IOM embarked on two major projects to evaluate the medical and scientific literature regarding the causal association between vaccines and adverse events (IOM, 1991, 1994a,b). That body of work has been used by the U.S. Department of Health and Human Services to evaluate and refine the conditions and circumstances warranting compensation by the program. The Vaccine Injury Compen-