1. What vaccines are covered by the National Vaccine Injury Compensation Program (VICP)?
The following vaccines are covered by the VICP:
If a vaccine or combination of vaccines is not listed above, call 1-800-338-2382 to determine if it is covered under the Program.
2. What is the Vaccine Injury Table?
The Vaccine Injury Table (Table) is a listing of covered vaccines and associated injuries that makes it easier for some people to get compensation. The Table lists and explains injuries/conditions that are presumed to be caused by vaccines. The Table’s Qualification and Aids to Interpretation (Aids) define some of the injuries/conditions listed on the Table. The Table also lists time periods in which the first symptom of these injuries/conditions must occur after receiving the vaccine to receive the Table presumption. If the first symptom of an injury/condition listed on the Table occurs within the listed time period, and any associated definition(s) included in the Aids are satisfied, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found. For example, if you received the tetanus vaccine and had a severe allergic reaction (anaphylaxis) as defined within the Aids within 4 hours after receiving the vaccine, then it is presumed that the tetanus vaccine caused the injury if no other cause is found. In these circumstances, the petitioner need not show that the vaccine actually caused the anaphylaxis (because meeting the Table requirements provides a presumption of causation).
If your injury/condition is not on the Table or if your injury/condition did not satisfy the Table requirements (e.g., did not occur within the time period on the Table or did not meet the Aids), you must prove that the vaccine caused the injury/condition. The Table and Aids change sometimes. The Secretary of Health and Human Services modifies the Table by regulation after consulting with the Advisory Commission on Childhood Vaccines, posting a notice and soliciting public comment. The Secretary may place injuries or conditions on the Table based upon scientific and/or policy reasons. To obtain a copy of the latest Table and Aids, visit the VICP Website or call 1-800-338-2382.
3. What are the filing deadlines for claims filed with the National Vaccine Injury Compensation Program (VICP)?
To be eligible for compensation, claims must be filed within the following periods:
For injury claims: within 3 years after the first symptom or manifestation of onset or of the significant aggravation of the injury; or
For death claims: within 2 years of the death and within 4 years of the first symptom or manifestation of onset or of the significant aggravation of the injury from which the death resulted; or
For certain Vaccine Injury Table (Table) changes (new vaccines or injuries added to the Table or other changes to the Table if the revision makes a petitioner eligible to seek compensation or significantly increases the likelihood of a petitioner obtaining compensation): 2 years from the date of the Table change for injuries or deaths that occurred up to 8 years before the Table change. For example, hepatitis A vaccines were covered by the VICP as of December 1, 2004, and claims (that did not meet other deadlines) had to be filed by December 1, 2006 for injuries or deaths that occurred on or after December 1, 1996.
General Information: For individuals filing a claim, the appropriate filing deadline is the one above that provides them with the most time to file their claims. In very limited circumstances, the Courts may extend such deadlines using equitable tolling.
4. If a new vaccine product is licensed, what needs to occur before the vaccine will be covered by the National Vaccine Injury Compensation Program (VICP)?
It depends on whether the vaccine falls within a category of vaccines already covered by the VICP. If the vaccine is of a type that is already covered by the VICP, then the vaccine is already covered even before the date of licensure. For example, hepatitis B vaccines are covered under the Program under Category VIII of the Vaccine Injury Table. If a new hepatitis B vaccine is licensed in the U.S., it is already automatically covered under the VICP.
If the vaccine is of a type that is not already covered by the VICP (e.g., yellow fever vaccines), then the vaccine will not be covered under the VICP until the general category of vaccines is covered. In order for a category of vaccines to be covered, the category of vaccine must be recommended for routine administration to children by the Centers for Disease Control and Prevention (for example, vaccines that protect against seasonal influenza), subject to an excise tax by Federal law, and added to the VICP by the Secretary of Health and Human Services.
5. Are vaccine-related injuries or deaths relating to vaccines that are not yet licensed in the U.S. compensable under the National Vaccine Injury Compensation Program (VICP)?
Yes, as long as other eligibility requirements are satisfied. An otherwise eligible person who receives a vaccine that is under a category of vaccines covered by the VICP within the applicable time limits would be entitled to apply for compensation under the VICP even if the vaccine is not licensed in the U.S
6. Do settlements in the VICP indicate any safety concerns by the Department of Health and Human Services (DHHS) regarding the vaccine alleged to cause the injury?
No. Conclusions regarding the safety of the vaccines should not be drawn based upon the fact that cases were settled. Settlements are one way of quickly resolving a petition or claim. Settlements are an agreement between the respondent (the DHHS, represented by the U.S. Department of Justice (DOJ)), and the petitioner (the person who filed the vaccine injury claim). Settlements are not an admission by the United States or the Secretary of Health and Human Services (Secretary) that the vaccine caused the petitioner’s alleged injuries. In settled cases, the United States Court of Federal Claims does not determine that the vaccine caused the injury. Claims may be resolved by settlement for many reasons, including consideration of prior court decisions; a recognition by both parties that there is a risk of loss in proceeding to a decision by the Court making the certainty of settlement more desirable; a desire by both parties to minimize the time and expense associated with litigating a case to conclusion; and a desire by both parties to resolve a case quickly and efficiently.
Persons Eligible To File A Claim
1. Are there age restrictions on who may file a claim with the VICP?
No. Claims may be filed on behalf of infants, children and adolescents, or by adults receiving VICP-covered vaccines. Other legal requirements, such as the statute of limitations for filing an injury or death claim, must be satisfied in order to pursue compensation.
2. Are adults who think that they have been injured after receiving seasonal influenza vaccine (e.g. trivalent influenza vaccines) eligible to file claims with the National Vaccine Injury Compensation Program (VICP)?
Yes. An otherwise eligible person (who may be a child or an adult) who receives a seasonal influenza vaccine within the applicable limits would be eligible to apply for compensation under the VICP even if the vaccine administered is licensed by the Food and Drug Administration (FDA) exclusively for adults.
3. Are individuals who receive a covered vaccine outside of the U.S. eligible to file a claim with the National Vaccine Injury Compensation Program (VICP)?
It depends. If a person received a vaccine covered by the VICP outside of the U.S. (or its trust territories), he or she may be eligible for compensation if: (1) the person was, at the time of vaccination, a U.S. citizen serving abroad as a member of the Armed Forces or as an employee of the U.S., or a dependent of such a citizen; or (2) the vaccine's manufacturer was located in the U.S. and the person returned to the U.S. within 6 months after the date of vaccination.
4. If I received both the seasonal flu vaccine and the 2009 H1N1 vaccine and suffered a serious injury, can I file a claim with both the CICP and the VICP?
Yes. The CICP covers several vaccines, including the 2009 H1N1 pandemic flu vaccine. The National Vaccine Injury Compensation Program (VICP) also covers many vaccines, including the seasonal flu vaccine. Since the vaccines are covered under two different programs, you may wish to file in one or both programs. But, depending on your circumstances, you may not be eligible to receive compensation under both programs, or under either program.
1. Does the National Vaccine Injury Compensation Program (VICP) cover influenza vaccines?
Some. The VICP covers all seasonal influenza vaccines (including trivalent and quadrivalent influenza vaccines). Trivalent influenza vaccines were covered under the VICP as of July 1, 2005. Other seasonal influenza vaccines were covered under the VICP as of November 12, 2013.
The VICP does not cover other non-seasonal influenza vaccines, such as the 2009 monovalent H1N1 influenza vaccine used in connection with a pandemic. That vaccine is covered by the Countermeasures Injury Compensation Program.
2. Are all pneumococcal vaccines covered by the VICP?
No, all pneumococcal vaccines are not covered by the National Vaccine Injury Compensation Program (VICP). There are two types of pneumococcal vaccines given in the U.S. The pneumococcal conjugate vaccine (PCV7), which is administered routinely to infants and children up to age 5, and the pneumococcal polysaccharide vaccine (PPV23), which is given to adults age 65 and older and individuals of varying age with certain medical conditions making them at higher risk for pneumococcal infection. The VICP covers only the pneumococcal conjugate vaccine (PCV7). Pneumococcal conjugate vaccines have been covered under the VICP since December 18, 1999.
3. Are human papillomavirus vaccines (HPV) covered under the VICP?
Yes. HPV vaccines are covered under the National Vaccine Injury Compensation Program (VICP) as of February 1, 2007.
4. Are all formulations of meningococcal vaccine, including those that are not licensed in the United States and are under Investigational New Drug application (IND), covered under the VICP?
Yes. Individuals thought to be injured by any meningococcal vaccine may be eligible for compensation from the National Vaccine Injury Compensation Program (VICP) as of February 1, 2007. To be eligible for compensation, claims must be filed within the applicable filing deadlines, discussed above. An otherwise eligible person who receives any meningococcal vaccine in the U.S. would be entitled to apply for compensation under the VICP. This is true even if the vaccine administered is not licensed in the U.S. and was distributed under an IND (including an expanded access IND). While VICP materials sometimes describe coverage for conjugate and polysaccharide meningococcal vaccines, all other categories of meningococcal vaccines, such as vaccines produced by recombinant DNA technology, are also covered under the VICP in otherwise eligible individuals. Meningococcal vaccines administered under an IND on or after November 2013 at colleges and/or universities in the United States in connection with an outbreak are covered under the VICP. See also General Information Qs & As #4 (concerning coverage for vaccines when new vaccine products are licensed) and #5 (concerning coverage for vaccine-related injuries and deaths relating to vaccines that are not yet licensed in the U.S.).
1. What vaccine liability protection is afforded to vaccine administrators?
The National Vaccine Injury Compensation Program (VICP) is an alternative to the tort system for resolving vaccine injury claims. Whether a vaccine administrator is afforded the liability protections of the National Childhood Vaccine Injury Act of 1986, as amended, (the Act) depends upon whether the vaccine is covered under the VICP.
Under the Act, persons with claims of vaccine-related injuries or deaths resulting from covered vaccines must first exhaust their remedies under the VICP before they can pursue legal actions against vaccine administrators. In order to exhaust the remedies available under the VICP and pursue a legal action against a vaccine administrator outside of the VICP, a VICP petitioner must either withdraw his or her petition (if the special master of the Court has failed to issue a decision or the Court has failed to enter judgment within the time provided by the Act) or reject the judgment under the VICP.
Although the Act provides liability protections to vaccine administrators who administer covered vaccines in many circumstances, these protections are not absolute. There are instances when a vaccine administrator who gives a covered vaccine is not protected from liability by the Act, such as when an individual files a claim and is requesting damages of $1,000 or less. In this case, the individual is not able to file a claim under the VICP and may be permitted to file a civil suit against the vaccine administrator in a state or federal court. In addition, if the VICP has paid a petitioner for a vaccine-related injury, the VICP may be able to pursue its own action against a vaccine administrator using its subrogation rights.
2. Is eligibility to receive compensation under the National Vaccine Injury Compensation Program (VICP) affected by whether a covered vaccine, such as Tdap, is administered "off-label" or against ACIP administration recommendations?
No, eligibility for the VICP is not affected by the standard of care in administration of a vaccine. In other words, an individual may file a petition and be eligible for compensation regardless of negligence of the administrator.
The VICP is a "no-fault" compensation program. Generally, petitioners need only show that the injured person received a vaccine set forth in the Vaccine Injury Table (a "covered" vaccine); and sustained an injury that is set forth on the Table, or that the injury was caused by the vaccine (if the injury is not listed on the Table).
For a fuller description of eligibility requirements, see the VICP website.
To be a covered vaccine, a vaccine must be recommended by the Centers for Disease Control and Prevention (CDC) for routine administration to children, subject to an excise tax by Federal law, and added to the VICP by the Secretary of Health and Human Services. There are no requirements that the petitioner show that the vaccine was used pursuant to Food and Drug Administration (FDA) labeling or specific Advisory Committee on Immunization Practices (ACIP) or CDC administration recommendations, or otherwise was administered pursuant to any standard of care.
3. Are there legal requirements for vaccine companies to distribute and administer vaccines not licensed in the U.S.?
Yes. Vaccines not licensed in the U.S. must be distributed and administered in accordance with all applicable Food and Drug Administration (FDA) requirements. In order for a vaccine company to receive all of the liability protections offered by the National Childhood Vaccine Injury Act of 1986, as amended, the company must comply in all material respects with all applicable requirements under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act (including regulations issued under such provisions).
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These questions and answers are taken from the United States Department of Health and Human Services website. These answers do not create or confer any rights for or on any person and does not operate to bind the Department or the public. The ultimate decision about the scope of the statutes authorizing the VICP is within the authority of the United States Court of Federal Claims, which is responsible for resolving claims for compensation under the VICP.