National Vaccine Injury Compensation Program

Little boy holding his earsThe National Childhood Vaccine Injury Act of 1986 established the National Vaccine Injury Compensation Program (NVICP) effective October 1, 1988. The law was passed in a climate of increasing lawsuits against vaccine manufacturers, threats by manufacturers to discontinue vaccine production, and dwindling vaccine supply. NVICP awards compensation for injuries from any one of the following vaccines: diphtheria, tetanus, pertussis (DTP, DTAP, DT, TT, OT, TD), measles, mumps, rubella (MMR or any components), polio (OPV or IPV), hepatitis B, Hemophilus influenzae type b (HiB) and varicella (chicken pox) vaccines.

Since its inception, the program has received over 5,000 claims seeking compensation; 85 percent of these claims were for vaccines administered prior to 1988. Of those 5,000 claims, over 1,100 awards totaling $800 million in compensation have been made to individuals or families. Compensation is awarded when there is evidence that a condition listed on the Vaccine Injury Table was caused by a vaccine covered by NVICP and when no other factor explains the condition.

Between 1989 and 1994, the Institute of Medicine (IOM) carried out mandated reviews of all scientific evidence concerning the possible adverse effects of the vaccines covered under NVICP. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of medical, scientific, and other professions to examine public health policy matters. The study committees of IOM operate under procedures intended to ensure the highest levels of scientific competence, protect against potential biases, and preserve the independence of the committee process.

Based on the IOM reviews, initial recommendations regarding revisions of the Vaccine Injury Table were made by the Department of Health and Human Services (DHHS) and reviewed by the National Vaccine Advisory Committee and the Advisory Commission on Childhood Vaccines. Following review by the advisory groups, the secretary of health and human services proposed changes to the table. These proposed changes were published in the Federal Register, and were subject to public hearings and written comment periods.

NVICP has achieved its policy goals of awarding compensation to those claiming vaccine injuries, providing liability protection for vaccine manufacturers and healthcare providers, and ensuring vaccine market stabilization. The program continues to work with other public and private entities to address national questions about vaccine risks and benefits, and to strengthen the national capacity for research and development of safer vaccines.

Adverse events following vaccinations are currently monitored through the Vaccine Adverse Events Reporting System (VAERS), the Centers for Disease Control and Preventions Vaccine Safety Datalink (VSD), and through surveillance measures by vaccine manufacturers. VAERS is solely a reporting system and monitors all cases of suspected sickness, injury, or death following administration of any vaccine and serves to identify unique or unanticipated reactions to vaccines. Reports can be made by patients, family members, or healthcare providers.

Vaccine Safety Datalink (VSD) is a linkage of databases from four health maintenance organizations containing information regarding 500,000 children. The CDC established VSD to better assess potential vaccine-related events. The large size of VSD allows for possible detection of rare adverse events and the establishment of background rates. VSD also allows for comparison studies of vaccinated children with unvaccinated children and the identification of possible groups at risk for adverse events. For example, a current VSD study is looking at the risk to premature infants of convulsions following pertussis vaccine (DTP, DTAP). Other research studies possible immune reaction disorders triggered by vaccines. While some questions remain unanswered regarding vaccine risks and ways to lower risks, efforts toward increasing our knowledge about the safety of vaccines continue.

For more information: National Vaccine Injury Compensation Program Health Resources and Services Administration, Parklawn Building, Room 8A-35 5600 Fishers Lane Rockville, MD 20857 (800) 338-2382 www.hrsa.dhhs.gov/bhpr/vicp

Vaccine Adverse Events Reporting System (VAERS), Department of Health and Human Services PO Box 1100 Rockville, MD 20849-1100 (800) 822-7267 www.fda.gov/cber/vaers/vaers.htm

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