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HHS Issues Rules for Smallpox Vaccine Injury Compensation Program

  [ 89 votes ]   [ Discuss This Article ] • December 12, 2003

HHS Secretary Tommy G. Thompson today announced an interim final rule that implements a law Congress passed earlier this year to identify and compensate people injured as a result of receiving a smallpox vaccine.

The interim rule for the new Smallpox Vaccine Injury Compensation Program describes eligibility criteria, the process for requesting benefits and receiving payments, and other necessary policies and procedures. Funded at $42 million, the program provides financial and medical benefits to eligible members of an HHS-approved smallpox emergency response plan who sustain certain medical injuries caused by a smallpox vaccine.

In addition, unvaccinated individuals injured after coming into contact with vaccinated members of an emergency response plan -- or with a person with whom the vaccinated person had contact -- may be eligible for program benefits. The program also provides benefits to survivors of eligible individuals whose death resulted from a covered injury.

Those who wish to file a claim will find forms and information at HHS is also making special efforts to ensure that all those involved in the smallpox vaccination effort, and especially anyone who may have been injured, will receive notification quickly that the claims system is now operational.

The interim rule will be published in Dec. 16 Federal Register and will be effective immediately. The public may comment on its contents, and HHS may amend it later based on those comments.

HHS began implementation of the compensation program by publishing a Smallpox Vaccine Injury Compensation Table in the Aug. 27, 2003, edition of the Federal Register. The table became effective upon publication.

The table identifies medical injuries and adverse effects presumed to have been caused by a smallpox vaccine or contact. It also lists time intervals in which the first symptom or manifestation must appear in order for the presumption of a vaccine-caused injury to apply. The benefit of such a table is that a causal relationship need not be demonstrated between a smallpox vaccine and an injury listed in it.

Because it is possible to incur a medical injury not listed on the table that may have been caused by a smallpox vaccination or contact, a person who can present sufficient evidence to prove likely causation may still be eligible for program benefits.

In order to be eligible to receive benefits, requesters must satisfy the filing deadlines described in the interim final rule. Because these deadlines may fall as early as Jan. 24, 2004, individuals interested in applying for benefits with the program are encouraged to file a Request Form as soon as possible.

Anyone interested in eligibility or application information can contact the Smallpox Vaccine Injury Compensation Program, located in HHS' Health Resources and Services Administration, at 1-888-496-0338 or by sending an email to

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