Search

The National Childhood Vaccine Injury Act of 1986 established the National Vaccine Injury Compensation Program to compensate people thought to be injured by certain vaccines. The act's goals are to ensure an adequate supply of vaccines, to stabilize vaccine costs, and to establish and maintain an accessible and efficient setting for providing compensation to people found to have been injured by certain childhood vaccines. In addition, the legislation called for the reporting of adverse events after vaccination, the creation of vaccine-information materials that detail vaccine benefits and risks, and Institute of Medicine studies of possible vaccine-related injuries and encouraged research and development of new and safer vaccines. Over its 22-year history, the National Vaccine Injury Compensation Program has been a key component in stabilizing the US vaccine market through liability protection to both vaccine companies and health care providers and by providing a forum for people, no matter what age, to seek compensation.

On July 3, 1991, the National Academy of Sciences' Institute of Medicine (IOM) released a reported entitled, Adverse Effects of Pertussis and Rubella Vaccines,1 in response to a congressional request to review evidence about a set of serious adverse events and immunization with pertussis and rubella vaccines. The request originated in the 1986 National Childhood Vaccine Injury Act (Public Law 99-660), whose primary purpose was to establish a federal compensation scheme for persons potentially injured by a vaccine; Section 312 of Public Law 99-660 called for the IOM review. Over the course of its 20-month study, the 11-member interdisciplinary committee constituted by IOM to conduct the review examined altogether 18 adverse events for pertussis vaccine—infantile spasms; hypsarhythmia; aseptic meningitis; acute encephalopathy; chronic neurologic (permanent brain) damage; deaths classified as sudden infant death syndrome (SIDS); anaphylaxis, autism; erythema multiforme or other rashes; Guillain-Barré syndrome (polyneuropathy); peripheral mononeuropathy; hemolytic anemia; juvenile diabetes; learning disabilities and hyperactivity; protracted inconsolable crying or screaming; Reye's syndrome; shock and "unusual shock-like state" with hypotonicity, hyporesponsiveness, and short-lived convulsions (usually febrile); and thrombocytopenia—and 4 adverse events for rubella vaccine—acute arthritis; chronic arthritis; radiculoneuritis and other neuropathies; and thrombocytopenic purpura. In conducting its review, the committee recognized that its charge was to focus on questions of causation and not broader topics, such as cost-benefit or risk-benefit analyses of vaccination. This summary begins with a brief history of events leading to the IOM study, then reviews the methods used by the committee to evaluate the evidence, summarizes the committee's conclusions for these adverse events, and offers directions for future investigation of adverse events in connection with widely used health interventions, such as vaccination.

The National Childhood Vaccine Injury Act of 1986 (the Act) established the National Vaccine Injury Compensation Program (VICP) as a federal "no-fault" compensation system for individuals who may have been injured by specific covered vaccines. Entering its ninth year of operation, the VICP has ensured childhood vaccine supplies by dramatically reducing vaccine companies' and providers' liability that threatened the production of vaccines during the 1980s. The VICP has received 5057 petitions filed for possible injury from vaccines covered under the VICP, including 4240 filed for vaccines administered before October 1988, and 817 for vaccines administered between October 1988 and August 1996. Over 3700 claims have been adjudicated, 985 of which have been found to be compensable, and the remainder have been dismissed. The Vaccine Injury Table (the Table) lists specific injuries or conditions and timeframes after vaccination that may be compensated under the VICP. The Table establishes legal presumptions about causation, which are used by the US Court of Federal Claims (the Court) to adjudicate petitions. The VICP covers seven "childhood" vaccines: diphtheria, pertussis, tetanus, measles, mumps, rubella, and polio. Effective March 10, 1995, the Table was revised to better reflect current scientific knowledge about vaccine injuries (Table 1). As part of the Act, Congress mandated a review of the scientific literature and other information on specific adverse consequences of pertussis and rubella vaccines. The Institute of Medicine (IOM) performed and published a report of this review in 1991, and a review of a follow-up study of the National Childhood Encephalopathy Study in 1994.

On February 22, 2011, in the case of Bruesewitz v Wyeth ,1 the US Supreme Court preserved the crucial role of the National Childhood Vaccine Injury Act (NCVIA) in ensuring the continuing availability of children's vaccines in the United States. Although at first glance the Bruesewitz case may seem to be simply a technical decision that addressed the legal intricacies of products liability law, the case has important implications for pediatricians, their patients, and the continuity of our vaccine supply. By the 1980s, vaccines had become so successful at preventing many infectious diseases that the public was becoming much less alarmed by those diseases2 and much more concerned with the risk of injury from the vaccines themselves.3 As a result, the number of lawsuits alleging vaccine-related injuries exploded, driving manufacturers from the market and producing vaccine shortages. In 1986, the US Congress enacted … Address correspondence to Gary N. McAbee, DO, JD, Department of Neuroscience, New Jersey Neuroscience Institute, 65 James St, Edison, NJ 08818. E-mail: gmcabee{at}solarishs.org

* Abbreviations: AAP = : American Academy of Pediatrics • ACIP = : Advisory Committee on Immunization Practices • IPV = : inactivated polio vaccine • FDA = : Food and Drug Administration • DTwP = : diphtheria and tetanus toxoids and whole-cell pertussis vaccine • DTaP = : diphtheria and tetanus toxoids and acellular pertussis vaccine • DTP = : diphtheria, tetanus, and pertussis vaccine • CDC = : Centers for Disease Control and Prevention • NCVIA = : National Childhood Vaccine Injury Act • VICP = : Vaccine Injury Compensation Program • IOM = : Institute of Medicine • OPV = : oral polio vaccine • VIS = : Vaccine Information Statements Concern over vaccine safety has been a major determinant of immunization policy—from passage of the Biologics Control Act in 1902 to the recent American Academy of Pediatrics (AAP) and Advisory Committee on Immunization Practices (ACIP) recommendations for expanded use of inactivated polio (IPV) and acellular pertussis vaccines.1-4 With the availability of new vaccines and vaccination options comes the challenge of how best to communicate these options to patients and their parents. Lessons from the field of risk communication on predictors of risk acceptability and vaccination decision heuristics provide insight into why some parents resist vaccination. This article provides a historical perspective on vaccine adverse events and applies lessons from risk communication research to help physicians improve their ability to discuss vaccine risks. Immunizations have been described as the single most effective health intervention after clean water and sewage disposal,5 and have an extraordinary safety record. However, public policy has long reflected concern for the safety of vaccines and related biologics. In 1902, Congress passed the Biologics Control Act in response to the death of 13 children who had received injections of diphtheria antitoxin contaminated with tetanus toxin.6 This act required biologics to be manufactured in a manner that assured their safety, purity, and potency. Responsibility for these regulations was assigned originally to the Hygienic Laboratory of the Public Health Service, which evolved into the National Institutes of Health. The regulation of biologics including vaccines was transferred to the Food and Drug Administration (FDA) in 1972. The first published accounts of serious adverse events after whole cell pertussis vaccine occurred in 1933 with Madsen's7 report of two deaths within 48 hours of immunization, and in 1948 with the report in Pediatrics by Byers and Moll8 of encephalopathy after diphtheria and tetanus toxoids combined with whole-cell pertussis …