DHS Supports FDA Authorization for Updated Novavax COVID-19 Vaccine
This email is being sent to local health officers, Tribal health directors, COVID-19 vaccinators, COVID-19 vaccine stakeholders, HERC coordinators, and key DHS staff.
The Wisconsin Department of Health Services (DHS) supports the U.S. Food and Drug Administration’s (FDA) authorization that Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) is authorized for use in individuals 12 years of age and older as follows:
- Individuals previously vaccinated with any COVID-19 vaccine: 1 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.
- Individuals not previously vaccinated with any COVID-19 vaccine: 2 doses of Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) are administered 3 weeks apart.
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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 health care provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances.
On October 3, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted to include the 2023–2024 formula. Consistent with the totality of the evidence and input from the FDA’s expert advisors, the Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023–2024 formula). FDA also issued this press announcement.
As a protein-based vaccine, the updated Novavax COVID-19 vaccine provides an alternative option for individuals 12 years of age and older who do not want to take the updated messenger RNA Pfizer or Moderna COVID-19 vaccines.
Note that the above authorization is based on initial information from the FDA. The Centers for Disease Control and Prevention (CDC) Interim Clinical Considerations have not yet been released. Vaccinators should follow the specific CDC clinical guidance once it is published by the CDC.
Original monovalent Novavax vaccine no longer authorized for use
The Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.
Disposal of and reporting your remaining original monovalent Novavax vaccine inventory as waste
The remaining Novavax original monovalent COVID-19 vaccine is no longer authorized for use. It should be removed from your storage units and disposed of per your facility’s policy. The vaccine must also be reported as wasted in the Wisconsin Immunization Registry (WIR) to remove it from the WIR inventory.
FDA 2023–2024 authorized Novavax COVID-19 vaccine information page
Updated fact sheets and letter of authorization
Vaccine storage and handling information
The Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) is supplied as a carton (NDC 80631-105-02) containing 2 multi-dose vials (NDC 80631-105-01). Each multi-dose vial contains 5 doses of 0.5 mL each.
Storage of Unpunctured Vial: Store the unpunctured multi-dose vaccine vial in a refrigerator between 2 to 8°C (36 to 46°F). Do not freeze. Protect from light.
Storage After First Needle Puncture of the Vial: After the first puncture, hold the vial between 2 to 25°C (36 to 77°F) for up to 12 hours. Discard the vial 12 hours after the first puncture.
Note: Ancillary kits will not be provided by any of the 2023–24 COVID-19 vaccine manufacturers.
Ordering information
Privately purchased: With the transition of the updated 2023–24 COVID-19 vaccines manufactured by Moderna, Pfizer, and Novavax to the private, commercial market, nearly all COVID-19 vaccines will be purchased directly from the manufacturers and/or from your vaccine distributor or wholesaler from whom you order other vaccines. Note that COVID-19 vaccine doses for insured patients must be purchased on the private market.
For Bridge Access Program (BAP) providers: The updated 2023–24 COVID-19 vaccines can be ordered via the DHS BAP COVID-19 Vaccine Ordering Survey. The updated Novavax COVID-19 vaccine will be added to the survey once it is available. BAP providers may, but do not need to, carry multiple brands of COVID-19 vaccine for the same population or age group. If you are interested in becoming a BAP provider, please fill out and submit an updated VFA agreement form.
Please note that if you are a VFA provider, you should continue to order other VFA vaccines via the Wisconsin Immunization Registry (WIR) and that this survey is only to be used to order updated 2023–24 COVID-19 vaccines for your BAP-eligible patients.
For Vaccines for Children (VFC) providers: The updated 2023–24 COVID-19 vaccines can be ordered via the DHS VFC COVID-19 Vaccine Ordering Survey. The updated Novavax COVID-19 vaccine will be added to the survey once it is available. Note that all VFC sites should carry and routinely offer COVID-19 vaccines for all eligible children.
While DHS is using an online survey for VFC providers to order updated 2023–24 COVID-19 vaccines for their VFC sites, other VFC vaccines will continue to be ordered via the WIR.
Note: Redistribution of COVID-19 vaccine doses acquired through the BAP and VFC program, is not permitted. Therefore, the Wisconsin COVID-19 Vaccine Exchange is no longer active.
CDC Clinical Considerations
The updated CDC Interim Clinical Considerations have not been released yet. DHS expects those to be published in the coming days.
Immunization Policy and Procedure Manual
The Immunization Program Policy and Procedure (P&P) Manual is expected to be updated within a week after the release of CDC Interim Clinical Considerations. A reminder that Local Health Departments (LHDs) cannot administer the Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) to the individuals detailed above until the Immunization Program P&P Manual is updated. All other vaccinators can vaccinate in accordance with the updated clinical guidance from the CDC.
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