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Why is there a National Vaccine Injury Compensation Program?

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Common Questions- doctor giving adolescent a vaccine

Vaccines save lives by preventing disease. But in rare cases, a vaccine may cause an injury. In these instances, the National Vaccine Injury Compensation Program (VICP) may provide compensation to people found to be injured by certain vaccines.source: 1

The VICP was created in the 1980s after lawsuits against vaccine companies and health care providers over side effects of the DTP vaccine (diphtheria, tetanus, whole-cell pertussis).source: 1,source: 2 At the time, the DTP vaccine used whole-cell pertussis, and one of the side effects was febrile seizures. A febrile seizure is a convulsion that’s caused by a fever. These febrile seizures led many people to incorrectly think the DTP vaccine caused a number of neurological issues. After investigation, scientists found the febrile seizures were unrelated to the DTP vaccine.source: 2,source: 3

The lawsuits against the DTP vaccine were costly and led many manufacturers to stop making the DTP vaccine. By 1984, there was only one company left making the DTP vaccine.source: 4 This threatened the nation’s vaccine supply and children’s health, so Congress stepped in and created the VICP. By limiting manufacturers’ liability burden of immunization related injuries, VICP helped stabilize the vaccine supply and protect the public from dangerous outbreaks related to a decline in vaccination.source: 5

The DTaP vaccine was licensed in 1991 and was developed to address concerns with the DTP vaccine. While there were no neurological issues with DTP vaccination, scientists worked to create a vaccine with a lower risk of febrile seizure.source: 2

Key Evidence

It's important to understand what the VICP does and does not do. The VICP:

  • DOES protect vaccines as a public good. The nature of vaccines means that they typically do not make a lot of money for manufacturers.source: 6 Some medicines, like for blood pressure or high cholesterol drugs, are profitable because they are taken daily for months or years. But many vaccines only require one or two doses. 
    • Consider this: If every child younger than 5 years old in the United States got three doses of DTaP in a year, that would be a total of around 74.7 million doses given.source: 7 In the same year, the 34 million adults recommended to take high blood pressure medicine would take more than 1.2 billion doses of medicine.source: 8 When a child is done with a vaccine series, they do not get more of that vaccine. But a person on high blood pressure meds will take them for months or likely years.
    • That is why most medicines are far more profitable than vaccines.source: 6 And why vaccine manufacturers need the protection that the VICP provides. Without the VICP, vaccines may become too expensive to make. If that happened, we would see outbreaks, serious illness, and deaths from vaccine-preventable diseases.
  • DOES NOT give manufacturers a “free pass.” Vaccines are some of the most heavily monitored products in the world. Before a manufacturer is allowed to make the vaccine for public use, the vaccine is studied in clinical trials and extensively reviewed by health experts. Once the vaccine is approved, manufacturers are held to very high standards. The U.S. Food and Drug Administration (FDA) works with manufacturers on a process that tests every lot (batch) of vaccines. The FDA also regularly inspects vaccine manufacturing facilities. And finally, no vaccine lot can be released by the manufacturer until the FDA reviews quality testing and releases the lot.source: 9
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A Deeper Dive: Myths vs. Facts

  • FACT: The VICP reinforces vaccine safety. Some people will point to the existence of the VICP as “proof” that vaccines are harmful. The reality is that it reinforces the exact opposite. Although few things in the world are without risk, the risks of vaccines are extremely small. Between 2006 and 2021, more than 4 billion doses of vaccines were distributed, but only 11,247 claims were filed—that is 0.0000028% of vaccine doses.source: 10 And the no-fault character of the VICP means that not all claims were actually related to vaccines.source: 3,source: 4
  • FACT: The federal government is very transparent about the VICP. There is a public VICP website that contains all the data associated with VICP claims.
  • FACT: The VICP protects children. Because vaccines are so safe and effective, we often forget how dangerous the diseases are that they prevent. By supporting the vaccine supply chain, the VICP protects our children from diseases like rubella and measles. In the United States, rubella caused the death of 2,100 newborns and 20,000 cases of congenital rubella syndrome (CRS) in the year before the vaccine was introduced.source: 11 Worldwide, measles caused about 2.6 million deaths every year before the vaccine was available.source: 12,source: 13

Back to the common questions

More information

Still have questions? Talk to your child’s doctor, nurse, or pharmacist.

Sources

  1. HRSA: National Vaccine Injury Compensation Program
  2. Nature: Pertussis: a tale of two vaccines
  3. CDC: About CDC’s Vaccine Safety Monitoring Program
  4. immunize.org: Vaccine Injury Compensation Programs An Effective Balance of Public Health and Personal Remedy
  5. HRSA: About the National Vaccine Injury Compensation Program
  6. National Library of Medicine: Financing Vaccines in the 21st Century: Assuring Access and Availability
  7. Childstats.gov: POP1 Child population: Number of children (in millions) ages 0–17 in the United States by age, 1950–2022 and projected 2023–2050
  8. CDC: High Blood Pressure Facts
  9. FDA: The Path for Vaccines
  10. HRSA: Data and Statistics
  11. CDC: Impact of U.S. MMR Vaccination Program
  12. CDC: Fast Facts: Global Measles
  13. WHO: Measles
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