UPDATE: 9-12-23

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 Moderna 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.
• Dispose of all bivalent mRNA COVID-19 vaccine vials in accordance with local, state, and federal regulations. 
• Report all disposed inventory as wastage.