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Frequently Asked Questions

1. What protections are there for individuals who receive the 2009 pandemic H1N1 influenza vaccine?
   
   Individuals who receive the 2009 pandemic H1N1influenza vaccine (H1N1 vaccine) may be eligible for compensation through the Countermeasures Injury Compensation Program (CICP) for serious physical injuries or deaths directly resulting from the H1N1 vaccine. The CICP, authorized by the Public Readiness and Emergency Preparedness (PREP) Act, compensates eligible individuals for serious physical injuries or deaths from covered countermeasures identified in declarations issued by the Secretary of the U.S. Department of Health and Human Services (HHS). The Secretary of HHS has issued a PREP Act declaration for the H1N1 vaccine.
   
   
2. What types of compensation are provided for people who suffer serious physical injuries or death as a result of vaccines or other countermeasures identified in declarations issued by the Secretary of the U.S. Department of Health and Human Services under the Public Readiness and Emergency Preparedness Act because of a present or future threat of a public health emergency?
   
   Individuals who suffer serious physical injuries or death following the administration or use of covered countermeasures may be compensated as follows:
   Out-of-Pocket Medical Expenses
   Reasonable and necessary medical items and services may be paid or reimbursed to treat a covered countermeasure-related injury of an eligible individual
   Lost Employment Income
   The individual may receive compensation for loss of employment income incurred as a result of the covered countermeasure injury. The amount of compensation is based on income at the time of injury. Certain limitations are placed on such benefits.
   Survivor Death Benefits
   Death benefits may be paid to certain survivors of covered countermeasures recipients who have died as a direct result of a covered injury.
   Individuals have one (1) year from the date the vaccine or other covered countermeasure was administered or used to request benefits.
   The U.S. Department of Health and Human Services is the payer of last resort, therefore payments are reduced by those paid or payable by other third party payers.
   
   
3. What should a person who believes that he or she suffered a serious vaccine-related injury (or families of those believed to have suffered a vaccine-related death) do if the person received both the seasonal influenza vaccine and the 2009 pandemic H1N1 influenza vaccine?
   
   Individuals who believe that the pandemic 2009 H1N1 influenza vaccine caused their injury may file with the Countermeasures Injury Compensation Program (CICP) and individuals who believe that the seasonal influenza vaccine caused their injury may file with the National Vaccine Injury Compensation Program (VICP). Until it is scientifically determined which, if any, vaccine caused an injury, an individual who believes he or she has suffered an injury may choose to file under both programs.
   
   
4. Which antiviral medications used to treat the 2009 pandemic H1N1 influenza may be covered by the Countermeasures Injury Compensation Program (CICP)?
   
   The CICP currently covers Tamiflu® (oseltamivir), Relenza® (zanamivir) and peramivir when used or administered in accordance with a Public Readiness and Emergency Preparedness (PREP) Act Declaration. Tamiflu® and Relenza® are covered under a PREP Act Declaration effective October 10, 2008, 73 Fed. Reg. 61861 (October 17, 2008) amended by 74 Fed. Reg. 29213 (June 19, 2009). Peramivir is covered under a PREP Act Declaration effective September 28, 2009 74 Fed. Reg. (October 2, 2009). These declarations are available on the CICP Website.
   Tamiflu® and Relenza® are prescription drugs designed to fight against the influenza (flu) and can be used for the treatment and prevention of the 2009 Pandemic H1N1 influenza. They are a second line of defense against the flu with vaccination being a first line.In addition to their usual indications and uses, Tamiflu® and Relenza® are also being used under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) to allow them to be used in more ways during the emergency involving the 2009 H1N1 influenza pandemic.
   Peramivir intravenous is an antiviral drug given to certain people in the hospital with suspected or confirmed 2009 H1N1 flu under an FDA issued EUA. Peramivir is still being studied; there is limited information about the safety and effectiveness of using peramivir.
   
   
5. What if there are serious physical injuries or death from taking antiviral medications?
   
   If you or your child has had a reaction to Tamiflu®, Relenza® or peramivir, your ability to sue may be limited by law.
   Countermeasures Injury Compensation Program, however, has been created to help pay for unreimbursed medical care, lost employment income, and death benefits of certain persons who have a serious reaction from the use of these medications. Not everyone using these medications is covered; the medications must have been used or administered in accordance with a Public Readiness and Emergency Preparedness Act Declaration. These declarations are available on the Countermeasures Injury Compensation Program (CICP) website.
   
   
6. Is there a filing deadline for the Countermeasure Injury Compensation Program (CICP)?
   
   Yes, there is a filing deadline of one year from the date of the administration or use of a covered countermeasure. The Program is currently obtaining approval for the forms and the processes and procedures to be used in administering the program. Until these forms are approved, a Letter of Intent to File may be submitted and this submission of the Letter of Intent to File would satisfy the one year filing deadline if it is submitted within the deadline.
   
   
7. What types of compensation are provided for people who suffer serious physical injuries or death as a result of taking Tamiflu®, Relenza® or peramivir?
   
   The Countermeasure Injury Compensation Program only provides benefits that are not payable by a third party payer. These benefits may include:
   Out-of-Pocket Medical Expenses
   Reasonable and necessary medical items and services may be paid or reimbursed to treat a Tamiflu®, Relenza® or peramivir related injury of an eligible individual.
   Lost Employment Income
   The individual may receive compensation for loss of employment income incurred as a result of a serious injury caused by Tamiflu®, Relenza® or peramivir. The amount of compensation is based on income at the time of injury. Certain limitations may be placed on such benefits
   Survivor Death Benefits
   Death benefits may be paid to certain survivors of Tamiflu®, Relenza® or peramivir recipients who have died as a direct result of the use of these medications.
   
   
8. What are other useful links with clinical information regarding antiviral medication use in the pandemic public health emergency?
   
   Further information on these medications can be found at the following U.S. Department of Health and Human Services websites:
   Centers for Disease Control and Prevention H1N1 Treatment (Antivirals)
   Food and Drug Administration H1N1 (Swine) Flu Page
   
   
9. If a healthcare provider, employee or volunteer sustains an injury at or near the vaccine administration site (e.g., injury resulting from a slip or fall), is he/she eligible for benefits for that injury from the Countermeasures Injury Compensation Program (CICP)?
   
   No. Anyone who sustains an injury that is not an adverse reaction to the administration or use of a vaccine or other countermeasure is not eligible for benefits under the CICP.
   Only individuals who receive (i.e., are administered or use) a vaccine or other countermeasure and are seriously injured as a direct result are eligible for benefits under the CICP. For example, a nurse trips and falls while walking toward the patient to administer the 2009 H1N1 vaccine. She gets up and administers the vaccine to the patient. The nurse later determines that her ankle is sprained. She is not eligible for benefits under the CICP because she was not injured as a direct result of the administration or use of the vaccine.
   
   
10. If an individual to whom the 2009 H1N1 vaccine or other countermeasure is being administered sustains an injury at or near the vaccine administration site (e.g., injury resulting from a slip or fall), is he/she eligible for benefits for that injury from the Countermeasures Injury Compensation Program (CICP)?
    
    No. Anyone who sustains an injury that is not an adverse reaction to the administration or use of a vaccine or other countermeasure is not eligible for benefits under the CICP.
    Only individuals who receive (i.e., are administered or use) a vaccine or other countermeasure and are seriously injured as a direct result are eligible for benefits under the CICP. For example, a person trips and falls after receiving the 2009 H1N1 vaccine at a clinic. The person determines that he/she has a sprained ankle. He/she is not eligible for benefits under the CICP because he/she was not injured as a direct result of the administration or use of the vaccine.