Most vaccine-related adverse events are rare. But reactions can occur, and some patients may experience serious events. To help patients obtain compensation for vaccine-related injuries, the federal government has established two “no-fault” programs that serve as alternatives to the traditional legal system for resolving vaccine injury petitions. These programs are known as the National Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP).
Both cover select vaccines, and the CICP covers additional medications and diagnostic devices. As one of the primary providers administering vaccinations, pharmacists should be familiar with these programs so they may appropriately educate patients on their availability, scope, and filing requirements.
In the early 1980s, a series of lawsuits were filed by parents against vaccine manufacturers and providers as a result of serious adverse events related to administration of the diphtheria–tetanus–pertussis vaccine. These lawsuits prompted some manufacturers to stop producing vaccines, resulting in vaccine shortages and some parents opting not to vaccinate their children. To prevent further problems, the VICP was created—as part of the National Childhood Vaccine Injury Act of 1986—to compensate those found to be injured by childhood vaccines. This “no-fault” federal program pays petitioners (i.e., those who file a claim) for medical costs, rehabilitation, special education, pain and suffering, and other injuries determined to be caused by select vaccines, without the need for a costly lawsuit.
The U.S. Department of Health & Human Services, the U.S. Department of Justice, and the U.S. Court of Federal Claims all have a role in the VICP, with the U.S. Court of Federal Claims determining who will be paid. Only vaccines that are recommended for routine administration to children by CDC are covered under the program. Claims may be filed on behalf of infants, children, and adolescents, or by adults receiving VICP-covered vaccines. In addition, limitations exist on the number of years that have passed since the vaccine injury occurred to file a claim, and specific injury criteria must be met to be eligible to file a claim.
According to the program’s website (www.hrsa.gov/vaccinecompensation), the effects of a person’s injury must have: 1) lasted for more than 6 months after the vaccine was given; or 2) resulted in a hospital stay and surgery; or 3) resulted in death. The VICP has a list of injuries and conditions that are associated with the covered vaccines, and the time period in which symptoms are most likely to occur. For example, anaphylaxis is listed for several of the vaccines, as is encephalopathy. For parents and patients interested in this program, provide them with basic information in terms of covered vaccines, filing limitations, and eligibility criteria, and refer them to the website or the informational number (1-855-338-2382).
As noted above, the CICP is another federal program that provides benefits to individuals who are seriously injured as a result of an adverse reaction to a vaccine and other products, but its scope is different in that it only covers “countermeasures,” which are used to prevent, treat, or diagnose certain illnesses that the Secretary of the U.S. Department of Health & Human Services declares to be a present or future public health emergency. For example, currently covered countermeasures include vaccines, drugs, and devices used to prevent, treat, or diagnose the 2009 pandemic H1N1 influenza, smallpox, anthrax, botulism, acute radiation syndrome, and Ebola. This program is only to be used for these select conditions. Patients wanting more information about CICP should be referred to the website (www.hrsa.gov/countermeasurescomp) or informational number (1-855-266-CICP ).
For frequently asked questions and other information, please visit http://www.hrsa.gov/vaccinecompensation/index.html.