Monovalent Moderna and Pfizer-BioNTech COVID-19 Vaccines No Longer Authorized for Use in U.S. (SNF/AL)

Today, April 19, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines to be used for all doses administered to individuals aged 6 months and older. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

The CDC Advisory Committee on Immunization Practices (ACIP) meets today to discuss updates to the clinical considerations for COVID-19 vaccine. After the meeting, the Michigan Department of Health and Human Services (MDHHS) will send out further information regarding these upcoming changes. Until MDHHS receives guidance from CDC, please review FDA guidance and the respective EUAs for Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines.

Monovalent Vaccine Ordering:

• The monovalent Moderna and Pfizer COVID-19 vaccines are NO LONGER AUTHORIZED for use. Due to these changes, all monovalent COVID-19 products have been disabled for ordering and will no longer be available. EUAs for Novavax and J&J are unaffected by this change.
• Affected NDCs: Pfizer: 59267-0078-04, 59267-1000-02, 59267-1000-03, 59267-1025-03, 59267-1025-04, and 59267-1055-04. Moderna: 80777-273-98/15, 80777-273-99/10, 80777-275-99/05, and 80777-279-99/05
• Bivalent COVID-19 vaccines and Novavax will continue to be available.

MDHHS asks that you keep your monovalent mRNA vaccine supply in its current storage conditions until the CDC issues further instructions. Questions? Contact [email protected].