Dear Local Health Departments,
On Wednesday, Aug. 27, 2025, FDA approved the updated 2025-2026 COVID-19 vaccines and rescinded Emergency Use Authorizations (EUA) for previously authorized COVID-19 vaccines.
As a result of the 2024–2025 COVID-19 EUA rescissions, providers are required to stop using those vaccine products or presentations immediately. Any COVID-19 vaccine products that were authorized under an EUA should be removed from storage, removed in NCIR as wasted, and returned per routine NCIP vaccine wastage guidelines.
The following 2024-2025 COVID vaccine products are no longer authorized under EUA:
- Pfizer-BioNTech COVID-19 Vaccine
- 6 months through 4 years: multiple-dose vials with yellow caps and labels with yellow borders
- 5 through 11 years: single-dose vials with blue caps and labels with blue borders
- Moderna COVID-19 Vaccine
- 6 months through 11 years: manufacturer-filled syringe (MFS), 0.25mL
- Novavax COVID-19 Vaccine
- 12 years and older: manufacturer-filled syringe, 0.5mL
The remaining 2024-2025 COVID-19 vaccines continue to have FDA approval and can be administered until expiration if the benefits outweigh the risk of waiting for ACIP guidance to begin administering the 2025-2026 products.
The following 2025-2026 vaccines received FDA approval:
- Pfizer’s COMIRNATY COVID-19 vaccine was approved for those 65 and older and for those 5-64 years with at least one high-risk condition
- Moderna’s SPIKEVAX for those 65 and older and for those 6 months to 64 years with at least one high-risk condition
- Novavax’s NUVAXOVID for those 65 and older and for those 12-64 years with at least one high-risk condition
The Common Health Coalition has published an explainer (PDF) that describes implications of the FDA COVID-19 label change in more detail.
How to contact us:
For assistance, please contact the NCIP Help Desk by phone at 1.877.USE.NCIR (1-877-873-6247) or by email.
Thank you for your ongoing partnership and dedication to improving immunization outcomes in North Carolina.
In Health,
NC Department of Health and Human Services