The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) was signed into law by United States President

Ronald Reagan Ronald Wilson Reagan ( ; February 6, 1911June 5, 2004) was an American politician, actor, and union leader who served as the 40th president of the United States from 1981 to 1989. He also served as the 33rd governor of California from 1967 ...

as part of a larger health bill on November 14, 1986. NCVIA's purpose was to eliminate the potential financial liability of

vaccine A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified.

manufacturers due to vaccine injury claims to ensure a stable market supply of vaccines, and to provide cost-effective

arbitration Arbitration is a form of alternative dispute resolution (ADR) that resolves disputes outside the judiciary courts. The dispute will be decided by one or more persons (the 'arbitrators', 'arbiters' or 'arbitral tribunal'), which renders the ...

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 The United States Court of Federal Claims (in case citations, Fed. Cl. or C.F.C.) is a United States federal court that hears monetary claims against the U.S. government. It was established by statute in 1982 as the United States Claims Court, ...

and

special master In the law of the United States, a special master is generally a subordinate official appointed by a judge to ensure judicial orders are followed, or in the alternative, to hear evidence on behalf of the judge and make recommendations to the jud ...

Background

In the 1970s and 1980s, a controversy erupted related to the question of whether the whole-cell pertussis component of the

DPT vaccine The DPT vaccine or DTP vaccine is a class of combination vaccines against three infectious diseases in humans: diphtheria, pertussis (whooping cough), and tetanus. The vaccine components include diphtheria and tetanus toxoids and either kil ...

caused permanent brain injury known as pertussis vaccine

encephalopathy Encephalopathy (; from grc, ἐνκέφαλος "brain" + πάθος "suffering") means any disorder or disease of the brain, especially chronic degenerative conditions. In modern usage, encephalopathy does not refer to a single disease, but r ...

, in rare cases. No studies showed a causal connection, and later studies showed no connection of any type between the DPT vaccine and permanent brain injury. The alleged vaccine-induced brain damage proved to be an unrelated condition, infantile

epilepsy Epilepsy is a group of non-communicable neurological disorders characterized by recurrent epileptic seizures. Epileptic seizures can vary from brief and nearly undetectable periods to long periods of vigorous shaking due to abnormal electrica ...

. In 1990, an editorial in the ''

Journal of the American Medical Association ''The Journal of the American Medical Association'' (''JAMA'') is a peer-reviewed medical journal published 48 times a year by the American Medical Association. It publishes original research, reviews, and editorials covering all aspects of b ...

'' by a contractor of the vaccine makers called the connection a "myth" and "nonsense". https://jamanetwork.com/journals/jama/article-abstract/381528 However, before that point, criticism of the studies showing no connection and a few well-publicized anecdotal reports of permanent disability that were blamed on the DPT vaccine gave rise to 1970s anti-DPT movements. In the United States, low profit margins and an increase in vaccine-related lawsuits led many manufacturers to stop producing the DPT vaccine by the early 1980s. By 1985, vaccine manufacturers had difficulty obtaining

liability insurance Liability insurance (also called third-party insurance) is a part of the general insurance system of risk financing to protect the purchaser (the "insured") from the risks of liabilities imposed by lawsuits and similar claims and protects the in ...

. The price of DPT vaccine skyrocketed, leading providers to curtail purchases, limiting availability. Only one company was still manufacturing pertussis vaccine in the US by the end of 1985. Because of this, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986, establishing a federal no-fault system to compensate victims of injury caused by mandated vaccines.

NCVIA provisions

Vaccine Adverse Event Reporting System

The NCVIA also mandates that all health care providers must report certain adverse events following vaccination to the

Vaccine Adverse Event Reporting System The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveil ...

(VAERS). The NCVIA also established a committee from the

Institute of Medicine The National Academy of Medicine (NAM), formerly called the Institute of Medicine (IoM) until 2015, is an American nonprofit, non-governmental organization. The National Academy of Medicine is a part of the National Academies of Sciences, Eng ...

(IOM) to review the existing literature on vaccine adverse events occurring after

immunization Immunization, or immunisation, is the process by which an individual's immune system becomes fortified against an infectious agent (known as the immunogen). When this system is exposed to molecules that are foreign to the body, called ''non-s ...

National Vaccine Program Office

As a result of the NCVIA, the

National Vaccine Program Office The National Vaccine Program Office (NVPO) is an office of the United States Department of Health and Human Services that plays a role in the coordination of vaccine policy. It was established by the National Childhood Vaccine Injury Act. On October ...

(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 The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georg ...

(CDC),

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA),

National Institutes of Health The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the lat ...

(NIH) and the

Health Resources and Services Administration The Health Resources and Services Administration (HRSA) is an agency of the U.S. Department of Health and Human Services located in North Bethesda, Maryland. It is the primary federal agency for improving access to health care services for peopl ...

(HRSA).

Vaccine Information Statements

The NCVIA requires that all health care providers who administer vaccines against

diphtheria Diphtheria is an infection caused by the bacterium '' Corynebacterium diphtheriae''. Most infections are asymptomatic or have a mild clinical course, but in some outbreaks more than 10% of those diagnosed with the disease may die. Signs and s ...

tetanus Tetanus, also known as lockjaw, is a bacterial infection caused by ''Clostridium tetani'', and is characterized by muscle spasms. In the most common type, the spasms begin in the jaw and then progress to the rest of the body. Each spasm usually ...

, pertussis,

polio Poliomyelitis, commonly shortened to polio, is an infectious disease caused by the poliovirus. Approximately 70% of cases are asymptomatic; mild symptoms which can occur include sore throat and fever; in a proportion of cases more severe sy ...

measles Measles is a highly contagious infectious disease caused by measles virus. Symptoms usually develop 10–12 days after exposure to an infected person and last 7–10 days. Initial symptoms typically include fever, often greater than , cough, ...

mumps MUMPS ("Massachusetts General Hospital Utility Multi-Programming System"), or M, is an imperative, high-level programming language with an integrated transaction processing key–value database. It was originally developed at Massachusetts Gene ...

rubella Rubella, also known as German measles or three-day measles, is an infection caused by the rubella virus. This disease is often mild, with half of people not realizing that they are infected. A rash may start around two weeks after exposure and ...

hepatitis B Hepatitis B is an infectious disease caused by the '' Hepatitis B virus'' (HBV) that affects the liver; it is a type of viral hepatitis. It can cause both acute and chronic infection. Many people have no symptoms during an initial infection. ...

Haemophilus influenzae ''Haemophilus influenzae'' (formerly called Pfeiffer's bacillus or ''Bacillus influenzae'') is a Gram-negative, non-motile, coccobacillary, facultatively anaerobic, capnophilic pathogenic bacterium of the family Pasteurellaceae. The bact ...

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

risk In simple terms, risk is the possibility of something bad happening. Risk involves uncertainty about the effects/implications of an activity with respect to something that humans value (such as health, well-being, wealth, property or the environm ...

s 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.

References

HRSA.gov
– 'Vaccine Injury Table',

United States Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is ...

(DHHS)
HRSA.gov
– 'Commonly Asked Questions About The National Vaccine Injury Compensation Program', DHHS (last updated December 18, 2002)

External links

– 'Overview of Vaccine Safety',

National Immunization Program The National Center for Immunization and Respiratory Diseases (NCIRD), formerly known as the National Immunization Program until April 2006, is charged with responsibility for the planning, coordination, and conduct of immunization activities in ...

LSU.edu
– 'Vaccine Law: National Childhood Vaccine Injury Act',

Louisiana State University Louisiana State University (officially Louisiana State University and Agricultural and Mechanical College, commonly referred to as LSU) is a public land-grant research university in Baton Rouge, Louisiana. The university was founded in 1860 n ...

VaccineSafety.edu
– 'Institute for Vaccine Safety',

Johns Hopkins University Johns Hopkins University (Johns Hopkins, Hopkins, or JHU) is a private research university in Baltimore, Maryland. Founded in 1876, Johns Hopkins is the oldest research university in the United States and in the western hemisphere. It consi ...

Bloomberg School of Public Health {{Vaccine safety 1986 in law United States federal health legislation Vaccination law Vaccine Injury Federal sovereign immunity in the United States Vaccine controversies Vaccination in the United States