COVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheets/VIS Form

 

Initially available COVID-19 vaccines may be authorized for use under an EUA issued by FDA or approved as licensed vaccines. COVID-19 Vaccine Providers can find information about EUAs, EUA Fact Sheets and VIS forms here.

 

COVID-19 Vaccine EUA General Information

The EUA authority allows FDA to authorize either (a) the use of an unapproved medical product (e.g., drug, vaccine, or diagnostic device) or (b) the unapproved use of an approved medical product during an emergency based on certain criteria. The EUA will outline how the COVID-19 vaccine should be used and any conditions that must be met to use the vaccine. FDA will coordinate with CDC to confirm these "conditions of authorization." Vaccine conditions of authorization are expected to include distribution requirements, reporting requirements, and safety and monitoring requirements. The EUA will be authorized for a specific time period to meet response needs (i.e., for the duration of the COVID-19 pandemic). Additional Information on EUAs can be found here:

 

COVID-19 Vaccine EUA Fact Sheets

Product-specific EUA fact sheet for COVID-19 vaccination providers will be made available that will include information on the specific vaccine product and instructions for its use. An EUA fact sheet for vaccine recipients will also be developed, and both will likely be made available on the FDA website and through the CDC website. Jurisdictions should ensure providers know where to find both the provider and recipient fact sheets, have read and understand them, and are clear on the requirement to provide the recipient fact sheet to each client/patient prior to administering vaccine.

 

COVID-19 Vaccine Information Statements

VISs are required only if a vaccine is added to the Vaccine Injury Table. Optional VISs may be produced, but only after a vaccine has been licensed (e.g., such as with zoster vaccines). Plans for developing a VIS for COVID-19 vaccine are not known at this time but will be communicated as additional information becomes available.

 

COVID-19 Vaccine Standing Orders

Pre-Vaccination Form for Pfizer-BioNTech COVID-19 Vaccine (PDF)