FDA Announces Approval and Authorization of Updated COVID-19 Vaccines
On September 11, 2023, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated 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 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc., which have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.
- Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula): individuals ages 6 months and older
- Moderna COVID-19 Vaccine (2023-2024 Formula): individuals ages 6 months and older
Note that FDA has not yet authorized or approved an updated Novavax vaccine for 2023-2024. As a result, the existing Novavax vaccine may still be administered at this time if it is determined that the individual should not wait for a 2023-2024 Novavax COVID-19 vaccine.
Bivalent mRNA COVID-19 Vaccines Are No Longer Authorized
As part of FDA’s actions, the bivalent 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 bivalent mRNA COVID-19 vaccines from storage units immediately, even if they are not expired.
- Once all inventory is fully accounted for, delete bivalent mRNA COVID-19 vaccine listings from the available vaccine inventory in your Immunization Information System. (Jurisdictions only)
- Dispose of all bivalent mRNA COVID-19 vaccine vials in accordance with local, state, and federal regulations.
- Report all disposed inventory as wastage.
- Use the VTrckS ExIS (External Information System) Interface for Wastage and select “other” as the option for wastage code. Jurisdictions should follow their routine processes for submitting wastage information to VTrckS by either by uploading a wastage file using the ExIS interface in VTrckS or by direct entry into VTrckS.
- Federal agencies and pharmacies can use Vaccine Provider Ordering Portal (VPoP) to generate wastage files to upload into VTrckS.
Remove Bivalent mRNA COVID-19 Vaccines from Your Inventory
The table below provides a listing of COVID-19 bivalent vaccines that should be removed from your inventory. For additional information, see IIS COVID-19 Vaccine Related Code | CDC.
|Unit of Sale NDC
|Ped 6m-5y; MDV2; 10pk
|Ped 5y-11y; MDV10; 10pk
|Ped 6m-4y; MDV10; 10pk
Accept and Dispose of Shipped Bivalent mRNA COVID-19 Vaccine
Providers should accept and dispose of bivalent mRNA COVID-19 vaccine orders if they receive them post-FDA action.
- Bivalent vaccine replacements were not shipped post-FDA action; however, some shipments were in route at the time of the authorization. Bivalent mRNA vaccine shipments received post-FDA action should not be refused.
- Providers should discard diluent sent with bivalent vaccine orders. Providers should not save diluent for use with any other product.