National Childhood Vaccine Injury Act
Encyclopedia
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 master
s.
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.
(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).
, 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 risk
s and benefit
s of the vaccine. Each VIS is developed by the CDC and distributed to state and local health departments as well as individual providers.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
to reduce the potential financial liability of vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
makers due to vaccine injury
Vaccine injury
A vaccine injury is an injury caused by vaccination.Allegations of vaccine injuries in recent decades have appeared in litigation in the United States. Some families have won substantial awards from sympathetic juries, even though most public health officials believed that the claims of injuries...
claims. The legislation was aimed at ensuring a stable market supply, and to provide cost-effective arbitration
Arbitration
Arbitration, a form of alternative dispute resolution , is a legal technique for the resolution of disputes outside the courts, where the parties to a dispute refer it to one or more persons , by whose decision they agree to be bound...
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
United States Court of Federal Claims
The United States Court of Federal Claims is a United States federal court that hears monetary claims against the U.S. government. The court is established pursuant to Congress's authority under Article One of the United States Constitution...
and special master
Special master
In law, a special master is an authority appointed by a judge to make sure that judicial orders are actually followed.In England, at common law, there were "Masters in Chancery," who acted in aid of the Equity Courts. There were also "Masters in Lunacy," who conducted inquiries of the same nature...
s.
Vaccine Adverse Event Reporting System
The NCVIA also mandates that all health care providers must report certain adverse eventsAdverse effect (medicine)
In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...
following vaccination to the Vaccine Adverse Event Reporting System
Vaccine Adverse Event Reporting System
The Vaccine Adverse Event Reporting System is a United States program for vaccine safety, co-managed by the Centers for Disease Control and Prevention and the Food and Drug Administration . VAERS is a post-marketing safety surveillance program, collecting information about adverse events that...
(VAERS).
The NCVIA also established a committee from the Institute of Medicine
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
(IOM) to review the existing literature on vaccine adverse events occurring after immunization
Immunization
Immunization, or immunisation, is the process by which an individual's immune system becomes fortified against an agent ....
, regardless of whether there was a direct link between events.
National Vaccine Program Office
As a result of the NCVIA, the National Vaccine Program OfficeNational Vaccine Program Office
The National Vaccine Program Office 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....
(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
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
(CDC), Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA), National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
(NIH) and the Health Resources and Services Administration
Health Resources and Services Administration
The Health Resources and Services Administration , is an agency of the U.S. Department of Health and Human Services located in Rockville, Maryland...
(HRSA).
Vaccine Information Statements
The NCVIA requires all health care providers who administer vaccines containing diphtheriaDiphtheria
Diphtheria is an upper respiratory tract illness caused by Corynebacterium diphtheriae, a facultative anaerobic, Gram-positive bacterium. It is characterized by sore throat, low fever, and an adherent membrane on the tonsils, pharynx, and/or nasal cavity...
, tetanus
Tetanus
Tetanus is a medical condition characterized by a prolonged contraction of skeletal muscle fibers. The primary symptoms are caused by tetanospasmin, a neurotoxin produced by the Gram-positive, rod-shaped, obligate anaerobic bacterium Clostridium tetani...
, pertussis
Pertussis
Pertussis, also known as whooping cough , is a highly contagious bacterial disease caused by Bordetella pertussis. Symptoms are initially mild, and then develop into severe coughing fits, which produce the namesake high-pitched "whoop" sound in infected babies and children when they inhale air...
, polio, measles
Measles
Measles, also known as rubeola or morbilli, is an infection of the respiratory system caused by a virus, specifically a paramyxovirus of the genus Morbillivirus. Morbilliviruses, like other paramyxoviruses, are enveloped, single-stranded, negative-sense RNA viruses...
, mumps
Mumps
Mumps is a viral disease of the human species, caused by the mumps virus. Before the development of vaccination and the introduction of a vaccine, it was a common childhood disease worldwide...
, rubella
Rubella
Rubella, commonly known as German measles, is a disease caused by the rubella virus. The name "rubella" is derived from the Latin, meaning little red. Rubella is also known as German measles because the disease was first described by German physicians in the mid-eighteenth century. This disease is...
, hepatitis B, Haemophilus influenzae
Haemophilus influenzae
Haemophilus influenzae, formerly called Pfeiffer's bacillus or Bacillus influenzae, Gram-negative, rod-shaped bacterium first described in 1892 by Richard Pfeiffer during an influenza pandemic. A member of the Pasteurellaceae family, it is generally aerobic, but can grow as a facultative anaerobe. H...
type b and varicella must provide a Vaccine Information Statement
Vaccine Information Statement
Vaccine Information Statement is a formal description of a vaccine, required as a provision of the United States National Childhood Vaccine Injury Act...
(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
Risk
Risk is the potential that a chosen action or activity will lead to a loss . The notion implies that a choice having an influence on the outcome exists . Potential losses themselves may also be called "risks"...
s and benefit
Benefit
Benefit or Benefits may refer to:* Benefit concert, any activity performed for a charitable purpose* Benefit , an album by Jethro Tull* "Benefits" , a 2009 episode of the show How I Met Your Mother...
s of the vaccine. Each VIS is developed by the CDC and distributed to state and local health departments as well as individual providers.
External links
- CDC.gov - 'Overview of Vaccine Safety', National Immunization Program
- LSU.edu - 'Vaccine Law: National Childhood Vaccine Injury Act', Louisiana State UniversityLouisiana State UniversityLouisiana State University and Agricultural and Mechanical College, most often referred to as Louisiana State University, or LSU, is a public coeducational university located in Baton Rouge, Louisiana. The University was founded in 1853 in what is now known as Pineville, Louisiana, under the name...
- VaccineSafety.edu - 'Institute for Vaccine Safety', Johns Hopkins UniversityJohns Hopkins UniversityThe Johns Hopkins University, commonly referred to as Johns Hopkins, JHU, or simply Hopkins, is a private research university based in Baltimore, Maryland, United States...
Bloomberg School of Public Health