Dear Providers,
On Wednesday, Aug. 27, 2025, FDA approved the updated 2025-2026 COVID-19 vaccines and rescinded Emergency Use Authorizations (EUA) for previously authorized COVID-19 vaccines.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 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
Further guidance may be forthcoming following the Advisory Committee on Immunization Practices (ACIP) meeting scheduled on September 18–19, 2025.
Thank you for your attention to this important update.
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