New Novavax COVID-19 vaccine available for order
Texas Health and Human Services Commission sent this bulletin at 10/24/2023 10:00 AM CDT / Este e-mail ha sido enviado por Texas Health and Human Services Commission el 10/24/2023 10:00 AM CDT
Providers,
The newly authorized, updated 2023-2024 Novavax vaccine is available to order with the Texas Vaccines for Children (TVFC) and Adult Safety Net (ASN) programs.
On October 3, 2023, the Food and Drug Administration (FDA) authorized the use of Novavax COVID-19 vaccine, 2023-2024 formula (80631-0105-02) and de-authorized the use of Novavax COVID-19 vaccine, original monovalent (80631-0102-10).
Updated Interim Clinical Considerations are expected from the Centers for Disease Control and Prevention (CDC) in the coming weeks. The Texas Department of State Health Services (DSHS) will share more information with providers as it becomes available.
Providers with the original Novavax monovalent COVID-19 vaccine (NDC 80631-0102-10) on hand should do the following with their inventory:
- Remove all previous Novavax COVID-19 vaccines from storage units immediately, even if unexpired, and dispose of all vaccine vials per DSHS COVID-19 Vaccine Disposal Guidelines.
- Report all disposed of inventory as wastage (See: Reporting Waste in VAOS)
-
Once discarded, zero out self-reported inventories of Novavax
COVID-19 vaccines (See: COVID-19 VAOS Inventory Reporting Requirements.)
The vaccine below is now authorized for use and available for ordering through the TVFC/ASN programs.
| Vaccine | Age Range | How Supplied | NDC (sale) | FDA Status |
| Novavax COVID-19 Vaccine, 2023-2024 formula | 12 years and older | Carton, two vial, five-dose multi-dose vials | 80631-0105-02 | FDA Authorized October 3, 2023 |
To reiterate, due to the 2023-2024 formula update, the previous Novavax COVID-19 vaccine, original monovalent (80631-0102-10) is no longer authorized for use in the United States.
| Vaccine | Age range | How supplied | NDC (sale) | FDA status |
| Novavax COVID-19 Vaccine (Original monovalent) | 12 years and older | Carton, 20 vial, five-dose multi-dose vials | 80631-0102-10 | No longer FDA-authorized |
Additional information on the FDA decision is available online.
For questions about inventory clean-up and waste, please contact DSHS COVID-19 Vaccine Management at COVID19VacMgmt@dshs.texas.gov
Thank you for your continued partnership,
Texas Department of State Health Services
Immunization Program
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