COVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheets for Recipients and Caregivers
For each COVID-19 vaccine authorized under an Emergency Use Authorization (EUA), the Food and Drug Administration (FDA) requires that vaccine recipients or their caregivers are provided with certain vaccine-specific EUA information to help make an informed decision about vaccination. This is accomplished by providing an EUA Fact Sheet for Recipients and Caregivers. The Fact Sheet is similar in purpose and content to vaccine information statements (VISs) for licensed vaccines but differs in that the EUA Fact Sheet is specific to each authorized COVID-19 vaccine, is developed by the manufacturer of the vaccine, and is authorized by the FDA.
There is no VIS for COVID-19 vaccines authorized under an EUA. Instead, the FDA-issued EUA Fact Sheet for Recipients and Caregivers for each COVID-19 vaccine must be used.
To help facilitate documentation of having provided the EUA Fact Sheet in electronic medical records/immunization information systems, CDC is leveraging the existing VIS Code Set infrastructure, barcoding, and URLs to provide the information needed for various systems, analogous to electronic system and workflow documentation of VISs.
It is important to note again that although CDC’s VIS Code Set files are used to convey the codes for EUA Fact Sheets for Recipients and Caregivers, these Fact Sheets are distinct from VISs. VISs will become available when there are licensed COVID-19 vaccines.
Thus far, the codes and URL links to access the EUA Fact Sheet documents have been developed for the following current and potential COVID-19 EUA vaccines:
- COVID-19 Pfizer BioNTech Vaccine EUA Fact Sheet for Recipients
- COVID-19 Pfizer BioNTech Vaccine EUA Fact Sheet for individuals 5 though 11 years of age
- COVID-19 Moderna Vaccine EUA Fact Sheet for Recipients
- COVID-19 Janssen Vaccine EUA Fact Sheet for Recipients
Note: URL links cited in the codes for the EUA Fact Sheets are not active until after the FDA provides Emergency Use Authorization for the vaccine.