Will there be a vaccine information statement to give out to patients?
Vaccine Information Statements (VISs) are required by law for licensed vaccines that are added to the Vaccine Injury Table, as determined by the CDC. Optional VISs may be produced for other licensed vaccines that have not been added to the Vaccine Injury Table. Plans for developing a VIS for the COVID-19 vaccine are not known at this time but will be communicated as additional information becomes available.
Additional information on VISs is located on the CDC’s website.
Once a vaccine is approved through the FDA’s Emergency Use Authorization (EUA) authority, product-specific EUA fact sheets for COVID-19 vaccination providers will be made available and will include information on the specific vaccine product and instructions for use. EUA fact sheets for vaccine recipients will also be developed. Both types of EUA fact sheets will be made available on the FDA and the CDC websites.
Vaccination providers will be required to provide these fact sheets to recipients of the vaccine and should document this was provided.
To get the latest information on the vaccines, follow this link: https://www.cvdvaccine-us.com/
Pfizer vaccine fact sheets are linked below:
- Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)
- Fact Sheet for Recipients & Caregivers
Moderna vaccine fact sheets are linked below:
- Fact sheet for Recipients and Caregivers
- Fact Sheet for Health Care Providers Administering Vaccine (Vaccination Providers)
J&J/Janssen vaccine fact sheets are linked below: