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sation Program (NVICP) is funded by excise taxes on the sale of vaccines covered by the program.

Although NCVIA does not protect vaccine manufacturers from all litigation, the number of suits filed against manufacturers greatly decreased, public trust in vaccines increased, and vaccine research and development returned to its previous levels. Serious litigation issues that have not been ameliorated by the 1986 legislation remain, however. Vaccines that are not mandated for use in children are not covered by NVICP. Federal vaccine advisory bodies have discussed the possibility of including influenza and pneumococcal vaccines in the program, which are aimed primarily at adults. Advocacy organizations key to the passage of the 1986 law are not supportive of that move, and no system of protection against litigation exists for these vaccines. It must be noted, however, that with the exception of year-specific concerns about a relation between influenza vaccine and Guillain-Barré syndrome, these vaccines have not caused safety concerns similar to those engendered by the childhood vaccines. This difference is probably due to differences in host reactions as well as the fact that childhood vaccines are, for the most part, mandated by the Federal government while adult vaccines are not (IOM, 1997b).

Immunization of Pregnant Women

Many researchers believe that litigation concern with regard to the immunization of pregnant women is a key factor in the slow progress in the development of a vaccine against GBS in particular. A discussion of the principles and problems surrounding immunization of pregnant women is necessary to understanding this barrier to vaccine development, which has not been resolved since the 1985 report.

Preventing infections in neonates and young infants by vaccinating pregnant women is a concept that is more than a century old. The rationale for immunization of pregnant women is based on two premises: (1) the occurrence of a substantial burden of disease from certain infectious agents during the first 3 to 6 months of life, an interval before which protection by active immunization of the infant could be achieved, and (2) the likelihood that immunization prior to or during pregnancy would induce high concentrations of specific antibodies in maternal serum that would be transferred across the placenta, thereby passively protecting the infant. This strategy has been studied extensively for the prevention of diphtheria, tetanus, and pertussis infections in infants. Worldwide, immunization of pregnant women for the prevention of infection in the infant is used routinely for neonatal tetanus, a major cause of infant mortality (Schofield, 1986). The World Health Organization (WHO) has recommended that this approach be extended for the prevention of diseases caused by other infectious agents.

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