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This email is being sent to approved Childhood and Adult (Bridge) Vaccine Program Providers, COVID-19 Vaccine Program Providers, Local Health Jurisdictions, and Emergency Preparedness Contacts.
Dear COVID-19 Vaccine Partners,
On Tuesday, October 3, 2023, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted, for use in individuals 12 years of age and older to include the 2023-2024 formula. The 2023-2024 formula Novavax COVID-19 Vaccine, Adjuvanted, “supports the change to the 2023-2024 formula and non-clinical immune response data on the updated formulations including the XBB.1.5 component.” The amended EUA allows the updated 2023-2024 Novavax COVID-19 Vaccine, Adjuvanted, product to be administered to individuals 12 years of age and older.
Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) is authorized for use in individuals 12 years of age and older as follows:
- Individuals aged 12 years and older who are moderately or severely immunocompromised, not vaccinated, and are unable or choose not to get an updated Pfizer-BioNTech or Moderna COVID-19 vaccine, can consider Novavax COVID-19 vaccine.
- Individuals previously vaccinated with any COVID-19 vaccine: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) may be administered at least two months after the last dose of COVID-19 vaccine.
- Individuals not previously vaccinated with any COVID-19 vaccine: two doses of Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) may be administered three weeks apart.
- Immunocompromised individuals: an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023–2024 Formula). Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 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: The original monovalent Novavax COVID-19 vaccine is no longer authorized for use in the United States.
- Please report unused original Novavax vaccines as wastage and update your inventory in the Washington State Immunization Information System (WAIIS).
- Unused original Novavax COVID-19 vaccine should be discarded according to local medical waste guidelines.
- Ordering for the original Novavax product in the WAIIS is no longer available.
Note: This vaccine is automatically included within the recent updated Advisory Committee on Immunization Practices (ACIP) COVID-19 recommendations and the ACIP will not need to vote on this vaccine.
Initial supply and availability of 2023-2024 COVID-19 vaccines may be limited and may vary by location compared to earlier vaccine releases. Please help your patient populations understand these considerations and thank them for their patience.
Thank you for your continued partnership in providing COVID-19 vaccines to eligible children, adolescents, and adults in Washington State. Please reach out to us at COVID.Vaccine@doh.wa.gov with any questions you have.
In partnership,
COVID-19 Vaccine Program
Prevention and Community Health Division
Washington State Department of Health
COVID.vaccine@doh.wa.gov
360-236-3873 | www.doh.wa.gov
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