Childhood Vaccine Injury Act Health Article

Definition

The Childhood Vaccine Injury Act established a federal program for compensating victims of vaccine-related injuries or death.

Purpose

During the early 1980s childhood immunization programs fell into chaos. Vaccine manufacturers and healthcare providers were overwhelmed with liability lawsuits from parents who believed that their children had been harmed by the DTP vaccine, which protects against diphtheria, tetanus, and pertussis (whooping cough). Companies that developed and produced vaccines halted or threatened to halt production and serious vaccine shortages developed. Childhood immunization rates fell.

To address this problem, physicians, public health agencies, the pharmaceutical industry, government representatives, and the parent-founded and -operated National Vaccine Information Center called for a no-fault alternative to litigation for resolving vaccine injury claims.

In response the U.S. Congress passed the Childhood Vaccine Injury Act of 1986 (PL 99-660). The purpose of the act was to do the following:

• establish the National Vaccine Injury Compensation Program (VICP) as a no-fault alternative to suits against vaccine manufacturers and healthcare providers
• provide victims with an accessible and efficient means of obtaining compensation
• reduce the costs of litigation
• ensure adequate supplies of vaccine
• stabilize the cost of vaccines
• help prevent vaccine injuries through education and a vaccine adverse event reporting system (VAERS)
• create incentives for developing safer vaccines

The Childhood Vaccine Injury Act was part of an initiative to immunize all children against potentially life-threatening diseases. The act was amended several times after its original passage.

Description

In addition to establishing the VICP, the Childhood Vaccine Injury Act requires that vaccination records be included in a patient's permanent medical record and that they include the following:

• date of vaccine administration
• vaccine manufacturer and lot number
• name, address, and title of the healthcare provider

The act also requires that doctors report all adverse events occurring within 30 days of vaccination to the VAERS. About 12,000 vaccine-related adverse reactions are reported annually; however, it is estimated that less than 10 percent of doctors file such reports.

The Vaccine Injury Compensation Program (VICP)

The VICP took effect on October 1, 1988. The program is administered jointly by the Division of Vaccine Injury Compensation within the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS), by the U.S. Court of Federal Claims, and by the U.S. Department of Justice (DOJ). A nine-member Advisory Commission on Childhood Vaccines oversees the VICP. This commission performs the following services:

• recommends improvements to the program
• proposes changes to the Vaccine Injury Table that specifies qualifying vaccines and injuries or deaths
• proposes legislation
• proposes new, safer vaccines for inclusion in the VICP
• collects information about vaccine-related injuries from federal, state, and local immunization programs
• revises vaccine information statements
• revises adverse reaction reporting requirements

Vaccine Injury Table

The VICP applies to all vaccines recommended by the U.S. Centers for Disease Control and Prevention (CDC) for routine administration to children. However, to qualify for compensation, the petitioner must prove one of the following:

• that an injury occurred that is specified in the Vaccine Injury Table
• that a vaccine significantly aggravated a pre-existing condition
• that a vaccine caused a condition

As of August 26, 2002, the Vaccine Injury Table included the following vaccines:

• DTP for diphtheria, tetanus, and pertussis, as well as other tetanus- and pertussis-containing vaccines
• MMR for measles, mumps, and rubella (German measles), as well as other measles- and rubella-containing vaccines
• OPV and IPV for polio, including cases in which polio was contracted from a child vaccinated with OPV
• hepatitis B
• Hib conjugate vaccines for haemophilus influenzae type B that causes meningitis
• varicella (chickenpox)
• pneumococcal conjugate vaccines
• live, oral, rhesus-based rotavirus vaccines for gastroenteritis, administered on or before August 26, 2002 (This vaccine was administered routinely only between October 1, 1998 and October 15, 1999.)
• new vaccines

These vaccines are covered regardless of whether they were administered individually or in combination or whether they were administered by public or private healthcare providers. When a new vaccine is added to the Vaccine Injury Table, coverage is retroactive for eight years. When the CDC recommends a new vaccine for routine administration to children, it may be automatically added to the table. Claims can be filed for other vaccines; however, the claimant must prove that the injury was caused by the vaccine. Since this can be very difficult to prove, most VICP claims fall within the Vaccine Injury Table.

The Vaccine Injury Table contains guidelines for evaluating whether the injury or death was vaccine-related. For example, a claim that a child's seizures were triggered by a vaccine must include proof that the child's first seizure occurred within three days of the vaccine administration.

Furthermore, claims for vaccine-related injuries are only valid if the effects continued for at least six months following the vaccination or resulted in hospitalization or surgical intervention. The claim must be filed within 36 months of the appearance of the first symptoms. Claims for vaccine-related deaths must be filed within 24 months of the death or within 48 months of the onset of the injury that caused the death.