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Criteria to Demonstrate that a Covered Injury Occurred

To be eligible for benefits under the Program, a requester must submit documentation showing that a covered injury was sustained as the direct result of the administration or use of a covered countermeasure pursuant to the terms of a declaration

Covered Injury

A covered injury means serious injury, or a death, determined by the Secretary to be:

  • An injury meeting the requirements of a covered countermeasures injury table, which is presumed to be the direct result of the administration or use of a covered countermeasure unless the Secretary determines there is another more likely cause; or
  • An injury (or its health complications) that is the direct result of the administration or use of a covered countermeasure. This includes serious aggravation caused by a covered countermeasure of a pre-existing condition.

To establish a covered injury, the CICP must determine that the injury sustained was the direct result of the administration or use of a covered countermeasure. Under the Public Readiness and Emergency Preparedness Act (PREP Act), the CICP may only make such determinations based on compelling, reliable, valid, medical and scientific evidence. 

Proving a Covered Injury Occurred

Requesters may need to submit sufficient relevant medical documentation or scientific evidence (such as studies published in peer reviewed medical literature). In evaluating such claims, the Secretary will take into consideration relevant medical and scientific evidence, including relevant medical records. Under the PREP Act, this determination is not reviewable by any court.  Temporal association between administration or use of the covered countermeasure and onset of the injury (i.e., the injury occurs a certain time after the administration or use) is not sufficient, by itself, to prove that an injury is the direct result of a covered countermeasure.

A requester can establish that a covered injury was sustained by demonstrating to the program that an injury on a countermeasure injury table occurred described in (a) below. In the alternative, a requester can establish that an injury was actually caused by a covered countermeasure, as described in (b) below.

Table Injuries

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.

Injuries for which Causation Must be Shown (Non-Table Injuries)

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.

Temporal association between receipt of the countermeasure and onset of the injury is not sufficient by itself to prove that the countermeasure caused the injury.

Date Last Reviewed:  November 2020