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.

What Is a Covered Injury?

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

• An injury (or its health complications) that is the direct result of the administration or use of a covered countermeasure, which includes serious aggravation caused by a covered countermeasure of a pre-existing condition; or
• 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.

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.

What Information Is Needed to Prove 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 the 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 an injury was caused by a covered countermeasure, as described in the section below, Injuries for which Causation Must Be Shown (Non-Table Injuries). In the alternative, a requester can establish that a covered injury was sustained by demonstrating to the program that an injury on a countermeasure injury table occurred as described in the section below, Table Injuries.