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The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) was enacted in the United States to reduce the potential financial liability of vaccine makers due to vaccine injury claims. The legislation was aimed at ensuring a stable market supply, and to provide cost-effective arbitration for vaccine injury claims. Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters.

In the face of mounting potential liabilities that were rapidly increasing along with the number of mandated vaccines, the legislation was passed on behalf of pharmaceutical companies. Vaccine makers indicated they would cease production if their proposal for the NCVIA was not enacted.[1]

Contents 1 Escalating liability controversy 2 The case for limited liability 3 NCVIA provisions 3.1 Vaccine Adverse Event Reporting System 3.2 National Vaccine Program Office 3.3 Vaccine Information Statements 4 References 5 External links

It has been estimated that the current potential vaccine injury liability, in the US alone, may total in the tens of billions of dollars. In light of the growing liability estimates and concern that the NCVIA may not provide an adequate legal shield, the pharmaceutical industry has escalated lobbying efforts, seeking additional protections through a series of new legislative proposals, including the Bioshield Two (Senate bill 1873), a pandemic vaccine act that would put drug companies beyond the reach of civil law. The bill would give the Secretary of the Department of Health and Human Services (DHHS) the absolute authority to decide whether a manufacturer violated laws mandating drug safety and would ban citizens from challenging his decision in the civil court system.

Opponents of the more draconian aspects of the NCVIA, realizing that outright repeal is unlikely in the near term, have sought to scale back certain financial protections for vaccine makers. Congressman Dan Burton, (R-IN), introduced a VICP reform bill which included a one-time look back provision to allow children, injured before 1997, to access the compensation program.

Public health safety, according to backers of the legislation, depends upon the financial viability of pharmaceutical companies, whose ability to produce sufficient supplies in a timely manner could be imperiled by civil litigation on behalf of vaccine injury victims that was mounting rapidly at the time of its passage. Vaccination against infectious illnesses provides protection against contagious diseases and afflictions which may cause permanent disability or even death. Vaccines have reduced morbidity caused by infectious disease; e.g., in the case of smallpox, mass vaccination programs have eradicated a once life-threatening illness.

The NCVIA also mandates that all health care providers must report certain adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS).

The NCVIA also established a committee from the Institute of Medicine (IOM) to review the existing literature on vaccine adverse events occurring after immunization, regardless of whether there was a direct link between events.

As a result of the NCVIA, the National Vaccine Program Office (NVPO) was established within the DHHS. The NVPO is responsible for coordinating immunization-related activities between all DHHS agencies, including the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH) and the Health Resources and Services Administration (HRSA).

The NCVIA requires all health care providers who administer vaccines containing diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, hepatitis B, Haemophilus influenzae type b and varicella must provide a Vaccine Information Statement (VIS) to the vaccine recipient, their parent or legal guardian prior to each dose.

A VIS must be given with every vaccination, including each dose in a multi-dose series. Each VIS contains a brief description of the disease, as well as the risks and benefits of the vaccine. Each VIS is developed by the CDC and distributed to state and local health departments as well as individual providers.

• HRSA.gov - 'National Childhood Vaccine Injury Act: Vaccine Injury Table', United States Department of Health and Human Services (DHHS)
• HRSA.gov - 'Commonly Asked Questions About The National Vaccine Injury Compensation Program', DHHS (last updated December 18, 2002)

• CDC.gov - 'Overview of Vaccine Safety', National Immunization Program
• Dekker.com - 'National Childhood Vaccine Injury Act of 1986'
• LSU.edu - 'Vaccine Law: National Childhood Vaccine Injury Act', Louisiana State University
• NVIC.org - National Vaccine Information Center
• PartnersForImmunization.org - 'National Partnership for Immunization: Promoting Immunization Across the Lifespan'
• VaccineSafety.edu - 'Institute for Vaccine Safety', Johns Hopkins University Bloomberg School of Public Health