FDA has granted full approvalexternal icon
for Pfizer-BioNTech (COMIRNATY) COVID-19 Vaccine. CDC’s
Advisory Committee on Immunization Practices is meeting on Monday, August 30, 2021
, to discuss its updated recommendation for this vaccine.
- Moderna materials have been updated to include the updated Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States posted on August 13, 2021.
Updates on 5/15/2021
- Moderna materials have been updated to include the Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States from May 14, 2021.
Janssen COVID-19 Vaccine (Johnson & Johnson):
Effective April 23, 2021, CDC and FDA recommend that use of the Janssen COVID-19 Vaccine resume in the United States. However, women younger than 50 years old especially should be made aware of a rare risk of blood clots with low platelets following vaccination and the availability of other COVID-19 vaccines where this risk has not been observed
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.