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On August 30, 2024, the Food and Drug Administration amended the emergency use authorization (EUA) of Novavax COVID-19 Vaccine, Adjuvanted to include the updated 2024-2025 formula. The Novavax COVID-19 Vaccine, Adjuvanted, (2024-2025 Formula) includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.
With this regulatory action, the formerly available Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is no longer authorized for use in the United States.
Novavax COVID-19 Vaccine, Adjuvanted (updated 2024–2025 Formula) is authorized for use in individuals 12 years of age and older as follows:
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Individuals who have never been vaccinated with any COVID-19 vaccine: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is administered at least 2 months after receipt of the last previous dose of an original monovalent (Original) or bivalent (Original and Omicron BA.4/BA.5) COVID-19 vaccine.
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Individuals who have been vaccinated only with one dose of any Novavax COVID-19 Vaccine, Adjuvanted: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is administered at least 3 weeks after receipt of the previous dose.
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Individuals who have been vaccinated with a prior formula of a COVID-19 vaccine from another manufacturer or with two or more doses of a prior formula of Novavax COVID-19 Vaccine, Adjuvanted: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) at least 2 months after the last dose of the COVID-19 vaccine.
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Immunocompromised individuals: an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2024-2025 Formula). Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances.
Fact sheets can be found here:
Immediate action for remaining inventories: 2023-2024 Novavax COVID-19 vaccine is no longer authorized for use in the United States and should not be administered. To minimize risk of vaccine administration error, providers should:
- Remove any/all 2023–2024 Novavax COVID-19 vaccines remaining from storage units immediately.
- Once all inventory is fully accounted for, delete 2023–2024 Novavax COVID-19 vaccine listings from the available vaccine inventory in your Immunization Information System, as applicable.
- Return all unused 2023–2024 Novavax COVID-19 vaccines to CDC’s centralized distributor using the normal process for returning spoiled/expired vaccines.
- Providers must use the category "Spoiled" and the reason "Expired BUD" to reconcile and submit the return of these vaccines in the IIS. Please do not use the "Recall" category.
Preparation/next steps for ordering 2024-2025 COVID-19 vaccine:
It may take a few weeks before Novavax ordering becomes available. Until that time, ordering is now available for the updated 2024-2025 mRNA COVID-19 vaccine through the Childhood Vaccine Program and will be available through the Adult Vaccine Program soon. Please remember:
- It can take up to two weeks from the approval date to receive your shipment.
- All respiratory products can be ordered at any time. You do not need to wait for your assigned ordering window to place an order for these products.
- Place smaller orders more frequently, rather than large orders.
- Orders may be reduced to meet allocation and product availability. The goal is to ensure all providers receive some product.
- Providers are required to carry and offer all Advisory Committee on Immunization Practices (ACIP) recommended vaccines for the population they serve.
Thank you for your continued partnership in providing COVID-19 vaccines to children, adolescents, and adults in Washington State. Please reach out to us at WAChildhoodVaccines@doh.wa.gov with any questions you have.
Intranasal flu vaccine (FluMist) for the 2024-2025 season is now available for providers to order in the IIS. Childhood flu orders will be processed weekly initially and more frequently once we receive additional allocation. It can take up to two weeks from the approval date to receive your shipment. Please remember to plan mass vaccination clinics later in September and early October when more flu vaccine is available.
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