Frequently Asked Questions

On this page: General Information | Persons Eligible To File A Claim | Covered Vaccines | Administrative Requirements

General Information

What vaccines are covered by the National Vaccine Injury Compensation Program (VICP)?
Diphtheria, tetanus, pertussis (DTP, DTaP, Tdap, DT, TT, or Td), measles, mumps, rubella (MMR or any components), polio (OPV or IPV), hepatitis A (HAV), hepatitis B (HBV), Haemophilus influenza type b (Hib), varicella (VZV), rotavirus (RV), pneumococcal conjugate (PCV), and trivalent influenza (TIV, LAIV), human papillomavirus (HPV), and meningococcal (MCV4, MPSV4) vaccines are covered by the Vaccine Injury Compensation Program.
To be eligible for compensation, claims must be filed:
within 3 years after the first symptom of the vaccine injury; or
within 2 years of the vaccine-related death and not more than 4 years after the start of the first symptom of the vaccine-related injury from which the death occurred; or
2 years from the date the vaccine is covered for injuries or deaths that occurred up to 8 years before the date the vaccine is covered. For example, hepatitis A was covered by the VICP as of December 1, 2004, and claims have to be filed by December 1, 2006 for injuries or deaths that occurred on or after December 1, 1996.
For individuals filing a claim, the appropriate filing deadline is the one above that provides them with the most time to file their injury or death claims.
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 vaccines must be recommended for routine administration to children by the Centers for Disease Control and Prevention, subject to an excise tax by Federal law, and added to the VICP by the Secretary of Health and Human Services.
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.
Does section 9510 of the IRS Code (26 USC 9510) need to be amended in order to pay claims relating to vaccines recently covered by the VICP?
Generally, no. The fact that a new vaccine is covered by the VICP does not necessitate an amendment to section 9510 of the IRS Code (26 USC 9510) in order to pay claims. The limitation included in section 9510 (c)(1)(A) concerning the Public Health Service Act (the PHS Act), as in effect on October 18, 2000, does not apply to the coverage of additional vaccines under the VICP because the list of taxable vaccines is described in the IRS Code (26 USC 4132), not the PHS Act. However, if the PHS Act is amended, an amendment to the IRS Code (to update the October 18, 2000 date) is required in order to pay compensation from the Vaccine Injury Compensation Trust Fund for claims affected by the amendment to the PHS Act.
Will coverage for trivalent influenza vaccines that are not licensed in the United States and under Investigational New Drug Exemption Submissions (IND) be included?
Yes. An otherwise eligible person who receives a trivalent influenza vaccine in the U.S. within the applicable time limits would be entitled to apply for compensation under the National Vaccine Injury Compensation Program (VICP). This is true even if the vaccine administered is not licensed in the U.S. and/or was distributed under an IND application.

Persons Eligible To File A Claim

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.
Are adults who think that they have been injured after receiving 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 trivalent influenza vaccine in the U.S. within the applicable time 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.
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.
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 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.

Covered Vaccines

Does the National Vaccine Injury Compensation Program (VICP) cover influenza vaccines?
Yes. To be eligible for compensation, claims must be filed: within 3 years after the first symptom of the vaccine injury; or within 2 years of the vaccine-related death and not more than 4 years after the start of the first symptom of the vaccine-related injury from which the death occurred.
Are all pneumococcal vaccines covered by the VICP?
No, all pneumococcal vaccines are not covered by the 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).
Since 1999, the pneumococcal conjugate vaccine has been covered under Category XIII of the Vaccine Injury Table. This category does not include any Table injuries. To be eligible for compensation, claims must be filed:
within 3 years after the first symptom of the vaccine injury; or
within 2 years of the vaccine-related death and not more than 4 years after the start of the first symptom of the vaccine-related injury from which the death occurred.
Is the human papillomavirus vaccine (HPV) covered under the VICP?
Yes. Individuals thought to be injured by the human papillomavirus (HPV) vaccine may be eligible for compensation from the National Vaccine Injury Compensation Program (VICP) as of February 1, 2007. This coverage permits individuals to file a claim for compensation beginning on February 1, 2007. To be eligible for compensation, claims must be filed within one of the following periods: within 3 years after the first symptom of the vaccine injury; or within 2 years of the vaccine-related death and 4 years after the start of the first symptom of the vaccine-related injury from which the death occurred; or 2 years from the date the vaccine is covered for injuries or deaths that occurred up to 8 years before the date the vaccine is covered. The HPV vaccine is covered by the VICP as of February 1, 2007 and claims have to be filed by February 2, 2009 for injuries or deaths that occurred on or after February 1, 1999 that do not qualify under the other filing periods. Although two years from the date of February 1, 2007 would be February 1, 2009, under the current Rules of the United States Court of Federal Claims, the deadline under section 2116(b) of the PHS Act would be February 2, 2009 because February 1, 2009, falls on a Sunday.
Does the National Vaccine Injury Compensation Program (VICP) cover meningococcal (conjugate and polysaccharide) vaccines?
Yes. Individuals thought to be injured by the meningococcal (conjugate and polysaccharide) vaccines may be eligible for compensation from the National Vaccine Injury Compensation Program (VICP) as of February 1, 2007. This coverage permits individuals to file a claim for compensation beginning on February 1, 2007. To be eligible for compensation, claims must be filed within one of the following periods: within 3 years after the first symptom of the vaccine injury; or within 2 years of the vaccine-related death and 4 years after the start of the first symptom of the vaccine-related injury from which the death occurred; or 2 years from the date the vaccine is covered for injuries or deaths that occurred up to 8 years before the date the vaccine is covered. The meningococcal (conjugate and polysaccharide) vaccine is covered by the VICP as of February 1, 2007 and claims have to be filed by February 2, 2009 for injuries or deaths that occurred on or after February 1, 1999 that do not qualify under the other filing periods. Although two years from the date of February 1, 2007 would be February 1, 2009, under the current Rules of the United States Court of Federal Claims, the deadline under section 2116(b) of the PHS Act would be February 2, 2009 because February 1, 2009, falls on a Sunday.

Administrative Requirements

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.
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, and subject to an excise tax imposed by Congress. 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) administration recommendations, or otherwise was administered pursuant to any standard of care.
Individuals may pursue a civil action against negligent administrators, albeit in a limited context. Individuals must first
(1) go through the VICP;
(2) obtain a judgment by the Court of Federal Claims; and
(3) file an election to reject the judgment and to pursue a civil action for damages.
Are there legal requirements for distributing and administering vaccines not licensed in the U.S.?
Yes. Vaccines not licensed in the U.S. must be distributed and administered in accordance with the 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, 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).

These answers reflect the current thinking of the United States Department of Health and Human Services on the topics addressed. 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.