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  Answer ID  
243
  Products  
  Answers.hrsa.gov
  Category  
  Vaccine Injury Compensation
    Covered Vaccines & Vaccine Injury Table
  Date Created  
12/03/2004 09:11 AM
  Last Updated  
09/01/2006 04:08 PM

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  Unlicensed Trivalent Influenza Vaccines Under IND
  Question
  Will coverage for trivalent influenza vaccines that are not licensed in the United States and under Investigational New Drug Exemption Submissions (IND) be included?
  Answer
 

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.

 

This answer reflects the current thinking of the United States Department of Health and Human Services on the topics addressed. This answer does 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.


 
 
 
  
 
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