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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
Concerned About the Safety of Vaccines. More articles and books have been published (e.g., Counter, 1990; Miller, 1992) to alert the public to the potential risks of vaccination.
In 1986, the US. Congress passed the National Childhood Vaccine Injury Act (NCVIA; P.L. 99-660) in response to worries about the safety of currently licensed childhood vaccines and in response to the economic pressures that were threatening the integrity of childhood immunization programs. The litigation costs associated with claims of damage from vaccines had forced several companies to end their vaccine research and development programs as well as to stop producing already licensed vaccines. The NCVIA was an attempt to encourage and ensure vaccine production by creating a no-fault compensation program (the National Vaccine Injury Compensation Program) as a required first resort for those who believed that they or their children had been injured by certain vaccines. The need for a compensation program had long been recognized, and several groups had proposed possible mechanisms for compensating people believed to be injured by vaccination (Institute of Medicine, 1985; Office of Technology Assessment, 1980). This program was envisioned to alleviate, but not completely eliminate, manufacturer liability and encourage research and development of more and safer vaccines. The compensation program is administered by the federal government and is financed by an excise tax on the sale of vaccines covered by the program (Iglehart, 1987; Mariner, 1992).
In addition to establishing the compensation program, the NCVIA set forth other vaccine-related efforts to be carried out by the U.S. Department of Health and Human Services, including mandatory reporting of specific adverse events following childhood immunizations against diphtheria, tetanus, pertussis, measles, mumps, rubella, and polio (see box entitled The Vaccine Injury Table in Chapter 10); voluntary reporting of any reaction to any immunization to the Vaccine Adverse Event Reporting System (see Chapter 10 for a discussion of this passive surveillance system and Figure B-1 for a copy of the reporting form); the creation of a National Vaccine Program Office to coordinate federal vaccine initiatives and to help meet immunization coverage goals; the establishment of advisory groups to the National Vaccine Program and the National Vaccine Injury Compensation Program; and better communication of the potential risks of vaccines through public information pamphlets that are distributed at the time of vaccination (under the direction of the Centers for Disease Control and Prevention) and changes in vaccine package inserts (under the direction of the U.S. Food and Drug Administration).
The NCVIA also mandated that the Secretary of the U.S. Department of Health and Human Services enlist the help of the Institute of Medicine (IOM) of the National Academy of Sciences to study the adverse effects of childhood vaccines. The NCVIA called for two specific studies. The first,