If an injury is not included on a countermeasures injury table or if the injury does not meet the requirements for an injury listed on a Table (e.g., the first sign or symptom of the injury did not occur within the time interval specified on the Table), the requester must demonstrate that the injury occurred as the direct result of the administration or use of a covered countermeasure. Such proof must be based on compelling, reliable, valid, medical, and scientific evidence.
The temporal association between receipt of the countermeasure and the onset of the injury is not sufficient by itself to prove that the countermeasure caused the injury.
A Table lists and explains injuries that, based on compelling, reliable, valid, medical, and scientific evidence, are presumed to be caused by a covered countermeasure, and the time periods in which the onset (i.e., first sign or symptom) of these injuries must occur after administration or use of the covered countermeasures. If an injury occurred within the listed time periods, and at the level of severity required, there is a rebuttable presumption that the covered countermeasure was the cause of the injury. A Table is accompanied by Qualifications and Aids to Interpretation which provide an explanation of the injuries listed on a Table.
A requester may establish that a covered injury occurred by demonstrating that the countermeasure recipient sustained an injury listed on a Table, within the time interval defined by the Table’s Definitions and Requirements. In such circumstances, the requester need not demonstrate the cause of the injury because the Secretary will presume, only for purposes of making determinations under the CICP, that the injury was the direct result of the administration or use of a covered countermeasure.
Even if the Table requirements are satisfied, however, an injury will not be considered a covered injury if the program determines, based on a review of the evidence, that a source other than the countermeasure more likely caused the injury. In such circumstances, the Table presumption of causation will be rebutted.