Maine Department of Health & Human Services sent this bulletin at 09/03/2025 10:55 AM EDT
Correction Notice: Date Error in Previous Communication
Please note that the communication distributed on September 3, 2025, contained an incorrect date.
The previous communication listed "August 3, 2025" as the sent date. The correct date should be September 3, 2025.
We apologize for any confusion this may have caused and appreciate your understanding.
To: Maine Immunization Program Providers
From: Maine Immunization Program
Subject: 2025 – 2026 COVID-19 Vaccine Updates
Date: September 3, 2025
FDA Announces Approval and Authorization of Updated COVID-19 Vaccines
On August 27, 2025, the U.S. Food and Drug Administration approved COVID-19 vaccines for the 2025–2026 season manufactured by Moderna, Pfizer, and Sanofi/Novavax. Details about these approvals can be found online at Coronavirus Disease 2019 (COVID-19) | FDA.
In addition, on August 27, 2025, the U.S. Food and Drug Administration revoked the Emergency Use Authorization (EUA) for the following vaccines: Novavax COVID-19 Vaccine, Adjuvanted; Moderna COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine. Details about these revocations can be found online at Emergency Use Authorization--Archived Information | FDA.
Use of 2024–2025 COVID-19 Vaccines
EUA vaccines for children 6m–11y
Vaccines whose EUAs have been revoked should no longer be administered to patients.
Licensed vaccines for persons aged 12y+
It is preferred that patients being vaccinated for the 2025–2026 season receive vaccine licensed for use in the 2025–2026 season, rather than vaccines licensed for use in the 2024–2025 season.
Remove all 2024–2025 COVID-19 vaccines from storage units immediately, even if they are not expired.
Once all inventory is fully accounted for, delete 2024–2025 COVID-19 vaccine listings from the available vaccine inventory in your Immunization Information System, as applicable.
Return unused 2024–2025 COVID-19 vaccines ordered through CDC that are still on hand to CDC’s centralized distributor using the normal process through ImmPact for returning spoiled/expired vaccines.
Important: The new FDA approved 2025 – 2026 COVID-19 vaccine formulations are not yet available for ordering through the Maine Immunization Program and Vaccines for Children (VFC) program. The Advisory Committee on Immunization Practices (ACIP) is scheduled to meet September 18 – 19, 2025. Further guidance may be forthcoming. The Maine Immunization Program will provide additional details about placing orders for 2025 – 2026 COVID-19 vaccines as soon as they become available.
For questions, contact the Maine Immunization Program at ImmunizeME.DHHS@maine.gov or call 207-287-3746.
