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To: Maine Immunization Program Providers
From: Maine Immunization Program
Subject: [IMPORTANT] COVID-19 Vaccine Updates
Date: August 26, 2024
FDA Announces Approval and Authorization of Updated COVID-19 Vaccines
On August 22, 2024, the U.S Food and Drug Administration took action approving and authorizing for emergency use updated mRNA COVID-19 vaccines formulated to target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. These actions relate to updated mRNA vaccines for 2024–2025 manufactured by ModernaTX Inc. and Pfizer Inc., which have been updated to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain. Both, 2024–2025 Formulations of Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine are recommended for use in individuals ages 6 months and older
The 2023–2024 Novavax COVID-19 vaccine remains authorized but is no longer available in the United States, as all doses have expired. Accordingly, at this time, CDC recommendations for use of Novavax COVID-19 vaccine have been removed. CDC recommendations will be updated if FDA approves or authorizes additional 2024–2025 COVID-19 vaccines.
2023–2024 mRNA COVID-19 Vaccines Are No Longer Authorized
As part of FDA’s actions, the 2023–2024 Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. To minimize the risk of vaccine administration errors, providers should:
- Remove all 2023–2024 mRNA COVID-19 vaccines from storage units immediately, even if they are not expired.
- Once all inventory is fully accounted for, delete 2023–2024 mRNA COVID-19 vaccine listings from the available vaccine inventory in your Immunization Information System, as applicable.
- Return all unused 2023–2024 mRNA COVID-19 vaccines to CDC’s centralized distributor using the normal process for returning spoiled/expired vaccines.
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If your provider location has ordered 2023-2024 Moderna vaccines prior to the authorization of the 2024-2025 vaccines and the order is currently in transit, it may still arrive within the next 1-2 days. Providers should accept COVID-19 vaccine orders if they receive them post-FDA action. Providers should then return these vaccines to CDC’s centralized distributor using the normal process for returning spoiled/expired vaccines.
Ordering
The Maine Immunization Program (MIP) has opened ordering for COVID-19 vaccine. All three presentations of COVID-19 vaccines (Pfizer, Moderna, and Novavax) will be available through MIP, though, please note, the timing of availability will differ.
- Ordering for the updated Pfizer COVID-19 vaccines is now open.
- Ordering for the updated Moderna COVID-19 vaccines are anticipated to be open in the next few weeks.
- Ordering for Novavax vaccine will be available at a future date as the updated 24-25 formulation is awaiting approval from FDA at this time.
Please note that currently Maine has received a minimal quantity of vaccine through our vaccine allocation. We anticipate receiving additional vaccine in the coming weeks. Please take this into consideration when placing your orders to ensure our state has an equitable distribution of vaccine and no vaccine is wasted.
For questions, contact the Maine Immunization Program at ImmunizeME.DHHS@maine.gov or call 207-287-2746.
Thank you for your continued commitment to keeping Mainer’s safe from vaccine preventable disease.
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